{"docstore/data": {"4888e378-a9c5-430c-8bcc-5369b51d6efb": {"__data__": {"id_": "4888e378-a9c5-430c-8bcc-5369b51d6efb", "embedding": null, "metadata": {"page_label": "1", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Blank Canvas: A Collection of Diverse Entities\"", "questions_this_excerpt_can_answer": "Based on the provided context, here are three questions that the context can provide specific answers to, which are unlikely to be found elsewhere:\n\n1. **What is the file size of the \"ISPE Manufacturing Execution Systems\" PDF document stored in the PharmaWise Engineer directory on Google Drive?**\n   - This question is specific to the document's digital footprint and storage details, which are unique to this file and its storage location. The context directly provides the file size as 7322258 bytes, which is a detail not commonly available without access to the file's properties.\n\n2. **What are the creation and last modification dates of the document titled \"Blank Canvas: A Collection of Diverse Entities\" within the PharmaWise CSV & Data Integrity project?**\n   - The context uniquely identifies the document's creation and last modification dates, which are specific to the document's lifecycle and version control within a project. Knowing these dates (creation date: 2024-04-07 and last modified date: 2024-04-04) can be crucial for understanding the document's currency and relevance.\n\n3. **Under what file path and name can the \"ISPE Manufacturing Execution Systems\" document be found within the PharmaWise Engineer project's directory structure?**\n   - This question targets the document's storage location and naming convention, which are specific to the organization and categorization of files within the PharmaWise Engineer project. The context provides a precise file path (/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf) and file name, which would be difficult to ascertain without direct access to the project's file management system.\n\nThese questions are tailored to extract information that is uniquely available from the provided context, emphasizing the document's storage details, version history, and organizational specifics within a project's infrastructure.", "excerpt_keywords": "Keywords: ISPE, Manufacturing Execution Systems, PharmaWise Engineer, PDF document, file size"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "bb2a5c0c-d87d-4dd9-af7f-23c497567d2d", "node_type": "4", "metadata": {"page_label": "1", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "34ba55b462989db14bab134ef00077c309cb36c2d90d2fa5ff4eac561e5074b8", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "19425551-b537-499c-b556-a7926c9ddcb4", "node_type": "1", "metadata": {}, "hash": "310e496ba98c323eacbecc90119b6701e54f75d496a3d92ef5c636c893f4ee41", "class_name": "RelatedNodeInfo"}}, "text": "no_content_here", "start_char_idx": 0, "end_char_idx": 15, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "19425551-b537-499c-b556-a7926c9ddcb4": {"__data__": {"id_": "19425551-b537-499c-b556-a7926c9ddcb4", "embedding": null, "metadata": {"page_label": "2", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Healthcare Industry Partner for Paperless Manufacturing Solutions: A Comprehensive Overview", "questions_this_excerpt_can_answer": "1. What specific services does Halfmann Goetsch Peither AG (HGP) offer to healthcare industry partners looking to implement paperless manufacturing solutions within a GMP-regulated environment?\n\n2. How does Halfmann Goetsch Peither AG (HGP) support healthcare organizations in ensuring their Manufacturing Execution Systems (MES) comply with global regulatory standards such as GMP, GLP, and GCP?\n\n3. Who can healthcare industry professionals contact at Halfmann Goetsch Peither AG (HGP) for expert consultation on implementing Manufacturing Execution Systems (MES) and what is the best way to reach this contact?", "prev_section_summary": "The section provides specific details about a PDF document titled \"ISPE Manufacturing Execution Systems\" stored in the PharmaWise Engineer directory on Google Drive. It includes information such as the file size (7322258 bytes), creation date (2024-04-07), last modified date (2024-04-04), file path, and file name. Additionally, it mentions a document titled \"Blank Canvas: A Collection of Diverse Entities\" within the PharmaWise CSV & Data Integrity project, highlighting its creation and last modification dates. The section emphasizes the importance of understanding the document's digital footprint, version control, and organizational structure within a project.", "excerpt_keywords": "Healthcare industry, GMP-regulated environment, Paperless manufacturing, Manufacturing Execution Systems (MES), Global regulatory standards"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "204ed345-a4bf-43fb-9f14-f57cac048f3f", "node_type": "4", "metadata": {"page_label": "2", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "b1e8badf013359d70853307726d89fc9cbf19870afb50cf453b5375540ece8a0", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "4888e378-a9c5-430c-8bcc-5369b51d6efb", "node_type": "1", "metadata": {"page_label": "1", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "34ba55b462989db14bab134ef00077c309cb36c2d90d2fa5ff4eac561e5074b8", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "22d70eef-e00d-4970-b19a-c9f972ecb99e", "node_type": "1", "metadata": {}, "hash": "c8942a9bbe6d8af43e930f8d682be273ef1b86919a55900be346197c893a55ab", "class_name": "RelatedNodeInfo"}}, "text": "healthcare industry partners\n\nas industry insiders, we understand your needs and challenges in a gmp-regulated environment. our expertise is here to help you implement paperless manufacturing.\n\nyou need a reliable partner who knows the latest regulatory and technical requirements. our extensive experience consulting to the healthcare industry ensures smooth, cost-efficient selection and implementation of manufacturing execution systems (mes) into your operations.\n\n- mes and paperless manufacturing feasibility studies\n- manufacturing processes analysis (isa-95) and improvement (lean)\n- global deployment strategies\n- implementation project and program management\n- vendor assessments and evaluation support\n- computer system validation (gamp)\n- gmp, glp and gcp consulting\n\nhgp analyzes your processes comprehensively, and offers you solutions for the future.\n\nhalfmann goetsch peither ag (hgp)\n\nbasel, switzerland\n\nwww.hgp.ag, info@hgp.ag\n\nyour mes contact:\n\nthomas halfmann\n\ne-mail: thomas.halfmann@hgp.ag\n\ntel: +41 78 749 99 20", "start_char_idx": 0, "end_char_idx": 1036, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "22d70eef-e00d-4970-b19a-c9f972ecb99e": {"__data__": {"id_": "22d70eef-e00d-4970-b19a-c9f972ecb99e", "embedding": null, "metadata": {"page_label": "3", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Comprehensive Guide to Manufacturing Execution Systems Control and Compliance in the Pharmaceutical Industry", "questions_this_excerpt_can_answer": "1. What is the primary purpose of the \"Comprehensive Guide to Manufacturing Execution Systems Control and Compliance in the Pharmaceutical Industry\" as published by ISPE in 2010?\n   \n2. What disclaimer does ISPE include in their guide regarding the assurance of regulatory acceptance for systems managed according to their guide on Manufacturing Execution Systems in the pharmaceutical industry?\n\n3. What are the limitations on reproducing or copying any part of the ISPE's guide on Manufacturing Execution Systems, as stated in their copyright notice from 2010?", "prev_section_summary": "The section discusses the services offered by Halfmann Goetsch Peither AG (HGP) to healthcare industry partners for implementing paperless manufacturing solutions within a GMP-regulated environment. Key topics include MES feasibility studies, process analysis and improvement, global deployment strategies, project management, vendor assessments, computer system validation, and regulatory consulting. The section also highlights the contact information for Thomas Halfmann at HGP for expert consultation on MES implementation.", "excerpt_keywords": "Keywords: ISPE, Manufacturing Execution Systems, Control, Compliance, Pharmaceutical Industry"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "320e4d07-00e6-4efa-95b0-0d707ac08773", "node_type": "4", "metadata": {"page_label": "3", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "c571827cf5a2f127d276e49fb2e615434158508eb7fce75634242bd5d98c44e2", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "19425551-b537-499c-b556-a7926c9ddcb4", "node_type": "1", "metadata": {"page_label": "2", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "b1e8badf013359d70853307726d89fc9cbf19870afb50cf453b5375540ece8a0", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "28fb657f-da25-441b-aa34-8d94db519b7a", "node_type": "1", "metadata": {}, "hash": "246f9a3fc13d6a70031497f8fac21c109a5ccc4a42cb794d4416fdbed4aed7af", "class_name": "RelatedNodeInfo"}}, "text": "gamp good practice guide\n\nexecution systems manufacturing\n\ndisclaimer:\n\nprogram management - a strategic and approach\n\nthis guide is meant to assist pharmaceutical organizations and related industry organizations in determining a common understanding of the concept and principles of control and compliance of manufacturing execution systems. the international society for pharmaceutical engineering (ispe) cannot ensure and does not warrant that systems managed in accordance with this guide will be acceptable to regulatory authorities. further, this guide does not replace the need for hiring professional engineers or technicians.\n\nlimitation of liability\n\ninno event shall ispe or any of its affiliates, or the officers, directors, employees, members, or agents of each of them, be liable for any damages of any kind, including without limitation any special, incidental, indirect, or consequential damages, whether or not advised of the possibility of such damages, and on any theory of liability whatsoever, arising out of or in connection with the use of this information.\n\n(c) copyright ispe 2010. all rights reserved.\n\nall rights reserved. no part of this document may be reproduced or copied in any form or by any means - graphic, electronic, or mechanical, including photocopying, taping, or information storage and retrieval systems - without written permission of ispe.\n\nall trademarks used are acknowledged.\n\nisbn 1-931879-93-1", "start_char_idx": 0, "end_char_idx": 1442, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "28fb657f-da25-441b-aa34-8d94db519b7a": {"__data__": {"id_": "28fb657f-da25-441b-aa34-8d94db519b7a", "embedding": null, "metadata": {"page_label": "4", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "ISPE GAMP Good Practice Guide: Manufacturing Execution Systems - Strategic Program Management Approach and Integration with Process Control Systems", "questions_this_excerpt_can_answer": "1. How does the ISPE GAMP Good Practice Guide: Manufacturing Execution Systems approach the integration of MES with process control systems to support manufacturing in life sciences organizations?\n   \n2. What specific industry standard does the ISPE GAMP Good Practice Guide: Manufacturing Execution Systems leverage for the integration of manufacturing execution systems with enterprise systems, and what are the key components of this standard?\n\n3. In what ways does the ISPE GAMP Good Practice Guide: Manufacturing Execution Systems propose to manage the life cycles of integrated manufacturing environments, particularly in relation to the domain approach for categorizing system use and criticality?", "prev_section_summary": "The key topics of the section include the purpose of the ISPE guide on Manufacturing Execution Systems in the pharmaceutical industry, the disclaimer regarding regulatory acceptance of systems managed according to the guide, and the limitations on reproducing or copying any part of the guide. The entities mentioned in the section are the International Society for Pharmaceutical Engineering (ISPE) and pharmaceutical organizations. The section emphasizes the importance of understanding the principles of control and compliance in manufacturing execution systems and highlights the need for professional engineers or technicians in implementing these systems. Additionally, the section mentions the copyright notice from 2010 and the disclaimer of liability from ISPE.", "excerpt_keywords": "ISPE, GAMP, Manufacturing Execution Systems, Strategic Program Management, Process Control Systems"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "0a2c288a-1134-4014-9b92-7e1b7887cae7", "node_type": "4", "metadata": {"page_label": "4", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "8dda9f024159fedb6c0fcc474791a0bc10e75719cf06ed0ace1256243b6be072", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "22d70eef-e00d-4970-b19a-c9f972ecb99e", "node_type": "1", "metadata": {"page_label": "3", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "c571827cf5a2f127d276e49fb2e615434158508eb7fce75634242bd5d98c44e2", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "a4a47cb1-ef8f-4ec8-b37e-5c0103d28aaa", "node_type": "1", "metadata": {}, "hash": "e602c56f99726c9817416edf818a316d1c6fa2daa7a0f770faf19ce205af712c", "class_name": "RelatedNodeInfo"}}, "text": "## preface\n\nthe ispe gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach, was created to help to facilitate the planning, development, and testing of manufacturing execution systems (mes) that may be used to support manufacturing in life sciences organizations.\n\nthis guide is intended to help bridge the gap between the ispe gamp(r) good practice guide: global information systems control and compliance and the ispe gamp(r) good practice guide: validation of process control systems for supporting and maintaining mes environments. the ispe gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach should be read in conjunction with these guides.\n\ngamp(r) guidance aims to achieve computerized systems that are fit for intended use and meet current regulatory requirements, by building upon existing industry good practice in an efficient and effective manner. this guide has been developed by pharmaceutical industry professionals to meet these goals and principles.\n\nthis guide takes a life cycle approach to examining mes, not as an application, but as a collection or domain of manufacturing related functions that integrates business and process controls, information flow, and human interaction to facilitate the operation of an organization.\n\nas individual systems evolve to become broader in scope, a system considered to be business-oriented may have functionality which connects to manufacturing operations and potentially affects product quality. therefore, the integration of functions may require the application of testing principles for process control systems to a system considered to be business-oriented. the definition of a business system may become difficult, and it may become necessary to create logical boundaries around functionality across systems to define categories of use and criticality.\n\nthe domain approach presented in this guide provides an approach to manage life cycles for the integrated manufacturing environment.\n\nthe authors of this guide have built upon ansi/isa 95.00.01-2000, enterprise-control system integration, part 1; models and terminology, an industry independent standard for improved integration of manufacturing through communication that defines common terminology and a consistent set of models that emphasize good practices for integration of control systems with other enterprise systems.", "start_char_idx": 0, "end_char_idx": 2454, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "a4a47cb1-ef8f-4ec8-b37e-5c0103d28aaa": {"__data__": {"id_": "a4a47cb1-ef8f-4ec8-b37e-5c0103d28aaa", "embedding": null, "metadata": {"page_label": "5", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Collaborative Efforts and Acknowledgements in Developing the ISPE GAMP COP Guide: A Comprehensive Overview\"", "questions_this_excerpt_can_answer": "1. Who were the co-leaders of the ISPE GAMP CoP Special Interest Group responsible for developing the guide titled \"Collaborative Efforts and Acknowledgements in Developing the ISPE GAMP COP Guide: A Comprehensive Overview\"?\n\n2. Which companies supported their employees' efforts in authoring and reviewing the guide by providing special thanks in the acknowledgements section of the document?\n\n3. Can you list any individuals who were specifically thanked for their coaching and editorial contributions to the development of the ISPE GAMP CoP Guide?", "prev_section_summary": "The section discusses the ISPE GAMP Good Practice Guide for Manufacturing Execution Systems, focusing on the strategic program management approach and integration with process control systems in life sciences organizations. It emphasizes the importance of planning, development, and testing of MES to ensure compliance with regulatory requirements. The guide takes a life cycle approach to MES, viewing it as a collection of manufacturing functions that integrate business and process controls, information flow, and human interaction. It also addresses the challenges of integrating functions across systems and proposes a domain approach for categorizing system use and criticality. Additionally, the guide leverages the ANSI/ISA 95.00.01-2000 standard for improved integration of manufacturing systems through common terminology and models.", "excerpt_keywords": "ISPE, GAMP, Manufacturing Execution Systems, Task Team, Acknowledgements"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "899422ce-5072-412f-b698-20006ac5ff28", "node_type": "4", "metadata": {"page_label": "5", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "b55da61db9976a9853cb6aa33513caa4882a79291f13d75d5671eb2f601c9637", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "28fb657f-da25-441b-aa34-8d94db519b7a", "node_type": "1", "metadata": {"page_label": "4", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "8dda9f024159fedb6c0fcc474791a0bc10e75719cf06ed0ace1256243b6be072", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "96f76746-9256-49eb-a8c8-616c10cd53f3", "node_type": "1", "metadata": {}, "hash": "cc6173243d1cd66c07afa933b2460031b0c78fcc691709efe1dbccd04fbb729e", "class_name": "RelatedNodeInfo"}}, "text": "## acknowledgements\n\nthis guide was developed by a task team under the ispe gamp cop special interest group co-leadership of gregory ruklic and paul irving.\n\n### section writers and reviewers\n\n|joseph despautz|global life sciences|usa|\n|---|---|---|\n|karen donaldson|pfizer inc.|usa|\n|justin iovino|cognizant technology solutions|usa|\n|paul irving|aptitude uk limited|united kingdom|\n|ed kanczewski|process and compliance management|usa|\n|kenneth s. kovacs|independent|usa|\n|david lerner|pa consulting|usa|\n|allan pfitzenmaier|vectech pharmaceutical consultants, inc.|usa|\n|gregory ruklic|wyeth|usa|\n\nthe task team leaders would like to express their grateful thanks to the following team members for their contribution of additional materials and as technical reviewers of the guide:\n\n|stephen elms|novartis pharma ag|switzerland|\n|---|---|---|\n|david emerson|yokogawa|usa|\n|jeanette ewen|felten s.a.|luxembourg|\n|malcolm granger|mja international ltd.|united kingdom|\n|jerry hare|voice of compliance, llc|usa|\n|philip rees|cis ltd.|united kingdom|\n|dudley williams|vfms ltd.|united kingdom|\n\nthe task team leaders additionally wish to thank rockwell automation and glaxosmithkline for supporting employee efforts during authoring and review.\n\nspecial thanks go to chris clark, winnie cappucci, paige kane, and randy perez for their tireless support of this guide.\n\nspecial thanks also go to colin jones, tony margetts, and sion wyn for their coaching and editorial contributions.\n\nmany other individuals reviewed and provided comments during the preparation of this guide; although they are too numerous to list here, their input is greatly appreciated.", "start_char_idx": 0, "end_char_idx": 1655, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "96f76746-9256-49eb-a8c8-616c10cd53f3": {"__data__": {"id_": "96f76746-9256-49eb-a8c8-616c10cd53f3", "embedding": null, "metadata": {"page_label": "6", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "ISPE Global Headquarters and Regional Offices Locations and Contact Information", "questions_this_excerpt_can_answer": "1. What is the contact telephone number for the ISPE headquarters located in Tampa, Florida?\n2. How can someone reach the ISPE Asia Pacific office in Singapore via fax?\n3. What is the address of the ISPE European office in Brussels, Belgium, and how can it be contacted by telephone?", "prev_section_summary": "The section discusses the acknowledgements for the development of the ISPE GAMP CoP Guide, highlighting the co-leaders, section writers, reviewers, and companies that supported the efforts. Key topics include the individuals involved in the development process, the companies that provided support, and the specific acknowledgements for coaching and editorial contributions. Entities mentioned include the task team leaders, team members, companies like Rockwell Automation and GlaxoSmithKline, and individuals like Chris Clark, Winnie Cappucci, and others who contributed to the guide.", "excerpt_keywords": "ISPE, Manufacturing Execution Systems, Global Headquarters, Contact Information, Locations"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "e8b973fc-288f-458b-9e16-d85c39798357", "node_type": "4", "metadata": {"page_label": "6", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "1263a7831498ca7b6051a28a771fa77cc8994b8685291dbe4e746ad1eb2d8a48", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "a4a47cb1-ef8f-4ec8-b37e-5c0103d28aaa", "node_type": "1", "metadata": {"page_label": "5", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "b55da61db9976a9853cb6aa33513caa4882a79291f13d75d5671eb2f601c9637", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "4986aff8-d108-415d-b149-67cf1e795345", "node_type": "1", "metadata": {}, "hash": "8419c2a87c9b41583f66fc8a086eca21b8d18d8ced8277252ddb85e2ad95b6a4", "class_name": "RelatedNodeInfo"}}, "text": "## ispe headquarters\n\n3109 w. dr. martin luther king jr. blvd., suite 250, tampa, florida 33607 usa\n\ntel: +1-813-960-2105, fax: +1-813-264-2816\n\n## ispe asia pacific office\n\n73 bukit timah road, #04-01 rex house, singapore 229832\n\ntel: +65-6496-5502, fax: +65-6336-6449\n\n## ispe china office\n\nsuite 2302, wise logic international center\n\nno. 66 north shan xi road, shanghai, china 200041\n\ntel +86-21-5116-0265, fax +86-21-5116-0260\n\n## ispe european office\n\navenue de tervueren, 300, b-1150 brussels, belgium\n\ntel: +32-2-743-4422, fax: +32-2-743-1550\n\nwww.ispe.org", "start_char_idx": 0, "end_char_idx": 564, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "4986aff8-d108-415d-b149-67cf1e795345": {"__data__": {"id_": "4986aff8-d108-415d-b149-67cf1e795345", "embedding": null, "metadata": {"page_label": "7", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Management of Manufacturing Execution Systems: A Comprehensive Guide for Control, Compliance, and Operations", "questions_this_excerpt_can_answer": "1. What strategic approach does the GAMP\u00ae Good Practice Guide recommend for achieving control and compliance in the implementation of Manufacturing Execution Systems (MES) within the pharmaceutical industry?\n\n2. How does the document outline the MES life cycle, including key phases from planning through to operation, and what specific guidance does it provide for each phase to ensure successful implementation and compliance with regulatory standards?\n\n3. What are the detailed steps and considerations outlined in the document for conducting a periodic review of an MES to ensure ongoing compliance, operational efficiency, and alignment with business continuity and contingency planning?", "prev_section_summary": "The section provides contact information for ISPE headquarters in Tampa, Florida, the Asia Pacific office in Singapore, the China office in Shanghai, and the European office in Brussels, Belgium. It includes addresses, telephone numbers, and fax numbers for each office. The key entities mentioned are ISPE headquarters, ISPE Asia Pacific office, ISPE China office, and ISPE European office.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP Good Practice Guide, Compliance, Strategic Management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "8f26dba4-bb2b-44eb-8f95-966363103f6f", "node_type": "4", "metadata": {"page_label": "7", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "8fd22464158f73b928de1684735a1c251989e6c0a9c048171e59aca926eb1da7", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "96f76746-9256-49eb-a8c8-616c10cd53f3", "node_type": "1", "metadata": {"page_label": "6", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "1263a7831498ca7b6051a28a771fa77cc8994b8685291dbe4e746ad1eb2d8a48", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "b4dd4e6b-11c3-48ac-a9da-55d6b2dfb004", "node_type": "1", "metadata": {}, "hash": "e94cd4f433ca0f12810648b2a34e985b6ecbe4f68dc0b6547f0877820455afb8", "class_name": "RelatedNodeInfo"}}, "text": "# gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n|table of contents|page 5|\n|---|---|\n|1 introduction|9|\n|1.1 overview|9|\n|1.2 purpose|9|\n|1.3 scope|10|\n|1.4 benefits|10|\n|1.5 objectives|11|\n|1.6 key concepts|12|\n|1.7 structure of guidance|15|\n|2 approach to achieving control and compliance|17|\n|2.1 strategy for mes|17|\n|2.2 mes life cycle|19|\n|2.3 quality risk management|20|\n|3 project phase|21|\n|3.1 introduction|21|\n|3.2 planning|23|\n|3.3 requirements definition|28|\n|3.4 specification and design|29|\n|3.5 configuration and customization|30|\n|3.6 implementation|31|\n|3.7 verification|32|\n|3.8 data migration|35|\n|3.9 reporting and release|37|\n|3.10 supporting processes|38|\n|4 operation phase|43|\n|4.1 introduction|43|\n|4.2 operational change control and configuration management|43|\n|4.3 security|44|\n|4.4 performance monitoring|44|\n|4.5 backup and recovery of software and data|44|\n|4.6 record retention, archive, and retrieval|44|\n|4.7 business continuity and contingency planning|44|\n|4.8 periodic review|45|\n|5 appendix 1 - coordination of compliance, project, and operations activities for mes|47|\n|5.1 introduction|47|\n|5.2 structuring a program|47|\n|5.3 program responsibilities|48|", "start_char_idx": 0, "end_char_idx": 1257, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "b4dd4e6b-11c3-48ac-a9da-55d6b2dfb004": {"__data__": {"id_": "b4dd4e6b-11c3-48ac-a9da-55d6b2dfb004", "embedding": null, "metadata": {"page_label": "8", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Planning and Implementation of Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the key considerations and concepts involved in developing a Manufacturing Execution System (MES) implementation strategy as outlined in the ISPE Good Practice Guide?\n\n2. How does the document address the integration of MES with other systems such as ERP, process automation, and LIMS, and what specific interface issues are discussed in relation to electronic records and signatures?\n\n3. What strategic and program management approaches does the ISPE guide recommend for planning, selecting, and implementing MES in the pharmaceutical industry, particularly in terms of risk considerations, regulatory compliance, and system architecture?", "prev_section_summary": "The section discusses the strategic management of Manufacturing Execution Systems (MES) within the pharmaceutical industry, focusing on achieving control, compliance, and operational efficiency. Key topics include the GAMP\u00ae Good Practice Guide's recommended approach for MES implementation, the MES life cycle with phases from planning to operation, quality risk management, project and operation phases, security, performance monitoring, backup and recovery, record retention, business continuity planning, and periodic review. The section also outlines the structure of guidance, benefits, objectives, and key concepts related to MES.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Strategic Planning, Program Management, ISPE"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "267f0ded-08ac-4984-8286-568284e319a1", "node_type": "4", "metadata": {"page_label": "8", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "db2caaf9dc7b286cbc216a79fed32fb60344d72590ad517e253a4bcfd35d785c", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "4986aff8-d108-415d-b149-67cf1e795345", "node_type": "1", "metadata": {"page_label": "7", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "8fd22464158f73b928de1684735a1c251989e6c0a9c048171e59aca926eb1da7", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "2f2bccf9-306e-495e-b6df-d9c0f062feae", "node_type": "1", "metadata": {}, "hash": "97a8fcc59349cfe439347c620ac1e9cbfda1c919686486d30ee2ab2c72b2af6b", "class_name": "RelatedNodeInfo"}}, "text": "## manufacturing execution systems - a strategic and program management approach gamp(r) good practice guide:\n\n|appendix 2 - mes planning|51|\n|---|---|\n|6.1 introduction|51|\n|6.2 challenges|52|\n|6.3 business drivers|53|\n|6.4 program planning|54|\n|6.5 strategic planning|54|\n|6.6 functional domains|58|\n|6.7 application selection|58|\n|6.8 mes implementation plan|58|\n|6.9 risk considerations|58|\n|6.10 roles and responsibilities|58|\n|6.11 regulatory|60|\n|6.12 data management planning|60|\n|6.13 system architecture|60|\n|6.14 funding|61|\n\n## appendix 3 - domain approach\n\n|7.1 introduction|63|\n|---|---|\n|7.2 applying domains to systems design|64|\n|7.3 domain impact on risk management and verification|66|\n|7.4 domain approach implementation for existing systems|67|\n|7.5 summary of domain approach benefits|67|\n|7.6 expanding the genealogy example|68|\n\n## appendix 4 - developing an mes implementation strategy\n\n|8.1 introduction|69|\n|---|---|\n|8.2 considerations and concepts for strategy development|69|\n|8.3 horizontal implementation strategy|70|\n|8.4 vertical implementation strategy|71|\n|8.5 application control strategies|72|\n|8.6 core team activities|74|\n|8.7 deployment of mes core functionality|75|\n|8.8 phased deployment|76|\n|8.9 system controls during deployments|77|\n|8.10 other considerations|77|\n|8.11 life cycle phase relationships|77|\n\n## appendix 5 - an approach to application and system selection\n\n|9.1 introduction|79|\n|---|---|\n|9.2 development of the tactical approach|79|\n|9.3 scope and justification|82|\n\n## appendix 6 - system integration: interfaces and touch points\n\n|10.1 introduction|85|\n|---|---|\n|10.2 data|85|\n|10.3 middleware|85|\n|10.4 erp interface|86|\n|10.5 process automation|87|\n|10.6 batch systems|88|\n|10.7 lims|88|\n|10.8 interface issues for electronic records and signatures|89|", "start_char_idx": 0, "end_char_idx": 1819, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "2f2bccf9-306e-495e-b6df-d9c0f062feae": {"__data__": {"id_": "2f2bccf9-306e-495e-b6df-d9c0f062feae", "embedding": null, "metadata": {"page_label": "9", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Management of Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What specific strategies does the GAMP\u00ae Good Practice Guide suggest for establishing equivalent electronic functionality in manufacturing execution systems (MES), as outlined in Appendix 7 of the document \"Strategic Management of Manufacturing Execution Systems: A Comprehensive Guide\"?\n\n2. How does the document address the concept of \"review by exception\" in the context of MES, particularly in terms of definition, justification, and considerations for production report content, as detailed in Appendix 8?\n\n3. In the context of compliant work-in-progress (WIP) materials management within MES, what distinctions does the document make between accounting methods and GxP methods, and how does it suggest managing material inventory and status to ensure compliance, as discussed in Appendix 11?", "prev_section_summary": "The section discusses the strategic planning and implementation of Manufacturing Execution Systems (MES) in the pharmaceutical industry. Key topics include challenges, business drivers, program planning, strategic planning, functional domains, application selection, risk considerations, regulatory compliance, system architecture, funding, domain approach, system design, risk management, verification, application and system selection, system integration, interfaces, ERP integration, process automation, batch systems, LIMS integration, and interface issues related to electronic records and signatures. The document outlines considerations and concepts for developing an MES implementation strategy, as well as program management approaches for planning, selecting, and implementing MES.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP Good Practice Guide, Electronic Production Record Systems, Compliance"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "56b33d4d-2028-45fd-8981-359446fcc0dc", "node_type": "4", "metadata": {"page_label": "9", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "3d0b44a5652b7492ec465b6bd2578eb70a56a5dd384df6b58dac6a03312ae526", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "b4dd4e6b-11c3-48ac-a9da-55d6b2dfb004", "node_type": "1", "metadata": {"page_label": "8", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "db2caaf9dc7b286cbc216a79fed32fb60344d72590ad517e253a4bcfd35d785c", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "0045f183-d3cb-416f-97dd-f69ec036c3db", "node_type": "1", "metadata": {}, "hash": "56828229974b97c0c7e385e3ce6c31572571ad2d26ca626c484188d111f75a9f", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n|appendix 7 - electronic production record systems|91|\n|---|---|\n|11.1 introduction|91|\n|11.2 establishing equivalent electronic functionality|92|\n|11.3 ancillary records|94|\n|11.4 recipe management and testing|94|\n|11.5 eprs base functionality|96|\n|11.6 epr modules|97|\n|11.7 supplemental epr processes|98|\n|11.8 streamlining the process|98|\n|11.9 eprs approaches|99|\n|11.10 eprs advantages|101|\n\n|appendix 8 - review by exception|103|\n|---|---|\n|12.1 definition and justification|103|\n|12.2 production report content considerations|103|\n|12.3 considerations for new or upgraded systems|105|\n|12.4 phased deployment|106|\n|12.5 periodic systems reassessment|106|\n\n|appendix 9 - logon, identification, and signature methods|107|\n|---|---|\n|13.1 introduction|107|\n|13.2 physical aspects|107|\n|13.3 logical aspects|108|\n\n|appendix 10 - human and workflow considerations|111|\n|---|---|\n|14.1 introduction|111|\n|14.2 standard interface and enforced operational sequences|111|\n|14.3 psychological and cultural aspects|112|\n|14.4 user interface considerations|112|\n\n|appendix 11 - compliant wip materials management|115|\n|---|---|\n|15.1 accounting versus gxp methods|115|\n|15.2 managing material inventory and status|115|\n|15.3 dispensing (pharmacy) and material consumption considerations|116|\n\n|appendix 12 - configuration management|117|\n|---|---|\n|16.1 introduction|117|\n|16.2 operational definitions and key aspects|117|\n|16.3 mes domain ownership and life cycle|118|\n|16.4 functional and product configuration|119|\n|16.5 coordinated systems release processes|119|\n|16.6 configuration management in an mes domain|120|\n|16.7 system identification and nomenclature|121|\n|16.8 installation based nomenclature|124|\n|16.9 infrastructure tracking|125|\n|16.10 establishing rules for configuration|125|", "start_char_idx": 0, "end_char_idx": 1903, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "0045f183-d3cb-416f-97dd-f69ec036c3db": {"__data__": {"id_": "0045f183-d3cb-416f-97dd-f69ec036c3db", "embedding": null, "metadata": {"page_label": "10", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Standards, Models, and References for Manufacturing Execution Systems: A Comprehensive Exploration", "questions_this_excerpt_can_answer": "1. What specific standards and models are recommended for implementing Manufacturing Execution Systems (MES) in the pharmaceutical industry, as outlined in the GAMP\u00ae Good Practice Guide within the ISPE document?\n\n2. How does the ANSI/ISA-95 standard contribute to enterprise-control system integration in the context of Manufacturing Execution Systems, according to the comprehensive exploration provided in the ISPE document?\n\n3. What role does the Supply Chain Council SCOR model play in the context of Manufacturing Execution Systems, and how is it detailed in the appendix of the ISPE document focused on standards, models, and references for MES?", "prev_section_summary": "The section discusses various key topics related to Manufacturing Execution Systems (MES) as outlined in the document \"Strategic Management of Manufacturing Execution Systems: A Comprehensive Guide.\" These topics include establishing equivalent electronic functionality, review by exception, logon, identification, and signature methods, human and workflow considerations, compliant work-in-progress (WIP) materials management, and configuration management. The section addresses strategies for MES implementation, considerations for production report content, user interface considerations, material inventory management, and configuration management processes within an MES domain. It also highlights the importance of electronic production record systems, ancillary records, recipe management, and testing in MES operations.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP, ANSI/ISA-95, SCOR model"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "54b0ce89-37d6-4b9a-9c8f-1cc41a744527", "node_type": "4", "metadata": {"page_label": "10", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "3b4af81d15a977a8494d04746bb97ee46a4c8c864ae587ee10f70c5570c36859", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "2f2bccf9-306e-495e-b6df-d9c0f062feae", "node_type": "1", "metadata": {"page_label": "9", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "3d0b44a5652b7492ec465b6bd2578eb70a56a5dd384df6b58dac6a03312ae526", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "7e0ac5af-cfb1-4c6e-a8bb-4b28140a8cae", "node_type": "1", "metadata": {}, "hash": "255ff1b6920ea4af6ff5a13185db5592e5ee1dd7d3eb4c40b79801441576c14a", "class_name": "RelatedNodeInfo"}}, "text": "## manufacturing execution systems - a strategic and program management approach gamp(r) good practice guide:\n\nappendix 13 - standards and models for mes\n127\n17.1 introduction 127\n\n17.2 mes functions address industry profiles 128\n\n17.3 ansi/isa-95 enterprise-control system integration 128\n\n17.4 xml and b2mml 131\n\n17.5 ansi/isa-s88 131\n\n17.6 the supply chain council scor model 131\n\n17.7 mesa international 132\n\nappendix 14 - references\n133\n18.1 references 133\n\n18.2 bibliography 134\n\nappendix 15 - glossary\n135\n19.1 abbreviations and acronyms 135\n\n19.2 definitions 137", "start_char_idx": 0, "end_char_idx": 570, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "7e0ac5af-cfb1-4c6e-a8bb-4b28140a8cae": {"__data__": {"id_": "7e0ac5af-cfb1-4c6e-a8bb-4b28140a8cae", "embedding": null, "metadata": {"page_label": "11", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "GAMP (R) Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach", "questions_this_excerpt_can_answer": "1. How does the GAMP 5 framework facilitate the integration of Manufacturing Execution Systems (MES) within regulated pharmaceutical manufacturing environments, according to the ISPE Manufacturing Execution Systems guide?\n\n2. What specific benefits does the integration of MES offer to pharmaceutical organizations in terms of cost, quality, and efficiency, as outlined in the GAMP Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach?\n\n3. What role does the Manufacturing Execution Systems Special Interest Group (MES SIG) of the GAMP Community of Practice (CoP) play in the development of the guide for implementing MES in regulated environments, and what practical information does it provide to address the complexities of MES deployment?", "prev_section_summary": "The section discusses the standards, models, and references for Manufacturing Execution Systems (MES) in the pharmaceutical industry, as outlined in the GAMP\u00ae Good Practice Guide within the ISPE document. Key topics include the ANSI/ISA-95 standard for enterprise-control system integration, the role of the Supply Chain Council SCOR model, and references to other relevant organizations such as MESA International. The section also includes information on MES functions, XML and B2MML, ANSI/ISA-S88, and a glossary of abbreviations and definitions.", "excerpt_keywords": "Keywords: GAMP, Manufacturing Execution Systems, MES, ISPE, Pharmaceutical Industry"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "aeed8a35-086a-4615-9695-0c9eaf75cc86", "node_type": "4", "metadata": {"page_label": "11", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "fc64413ea1e4f7e6be1e81ec00b8ba273eef36a4f1957d34e6649a4f061e5062", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "0045f183-d3cb-416f-97dd-f69ec036c3db", "node_type": "1", "metadata": {"page_label": "10", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "3b4af81d15a977a8494d04746bb97ee46a4c8c864ae587ee10f70c5570c36859", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "c3e2fc0f-edba-4e09-85cf-bd7961d151a4", "node_type": "1", "metadata": {}, "hash": "20665af6829b22aa40f3cfc3921a9db3545f848f5bc365e8d3c4378a8cca426c", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### 1 introduction\n\n#### 1.1 overview\n\ncomputerized systems are used widely throughout healthcare manufacture as a result of the substantial automation of business processes and equipment that has occurred during the 1980s and 1990s. this automation typically has occurred in an incremental system-by-system approach, over an extended period of time, which has left many organizations with islands of automation and little or no strategy for systems integration.\n\na traditional view of manufacturing execution systems (mes) is of computerized systems designed to integrate with and extend the capabilities of other systems, e.g., by providing recipe management for process control equipment. the true potential of manufacturing execution lies in the integration of capabilities and functionality of systems through a well-designed mes domain, which can provide benefits, such as reduced cost, faster turnaround, and improved quality, through elimination of redundant data entry, transcription errors, etc.\n\nthis guide uses the framework of gamp 5, (reference 5, appendix 14), as a complete life cycle approach to the development and use of mes for regulated manufacturing. gamp 5 provides a framework to:\n\n- facilitate interpretation of regulatory requirements based on good practices\n- define the approach for planning and project activities\n- apply risk management to all aspects of the life cycle activities\n- identify roles and responsibilities to execute the life cycle\n- integrate existing and new systems\n- scale activities and documentation appropriately\n- leverage existing documentation and knowledge\n- identify boundaries and interfacing among the installed systems\n- develop an appropriate strategy for mes\n\nthis guide has been developed by the manufacturing execution systems special interest group (mes sig) of the gamp community of practice (cop), a technical subcommittee of ispe, to provide project teams with practical information to address the complex challenges of mes.\n\n#### 1.2 purpose\n\nthis guide is intended to provide regulated pharmaceutical organizations with the information to assist in achieving and maintaining compliant mes appropriate to the needs and capabilities of an organization. it collects and integrates information and knowledge from many disciplines and sources into a comprehensive guideline. regulatory requirements, industry standards, and gamp guidance are leveraged, and references to sources of additional information are provided.\n\nthe intended audience of this document includes:\n\n- systems and process development staff", "start_char_idx": 0, "end_char_idx": 2684, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "c3e2fc0f-edba-4e09-85cf-bd7961d151a4": {"__data__": {"id_": "c3e2fc0f-edba-4e09-85cf-bd7961d151a4", "embedding": null, "metadata": {"page_label": "12", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Optimizing Manufacturing Execution Systems in Regulated Industries: A Strategic Approach", "questions_this_excerpt_can_answer": "1. What specific industries does the GAMP Good Practice Guide: Manufacturing Execution Systems focus on for the application of its strategies and program management approach?\n   \n2. How does the GAMP Good Practice Guide: Manufacturing Execution Systems suggest it can benefit recipe-driven operations in regulated life science manufacturing industries?\n\n3. Where can additional information about managing global IT systems in the context of regulated life science manufacturing industries be found, as referenced in the GAMP Good Practice Guide: Manufacturing Execution Systems?", "prev_section_summary": "The section discusses the importance of integrating Manufacturing Execution Systems (MES) within regulated pharmaceutical manufacturing environments. It highlights the benefits of MES integration in terms of cost, quality, and efficiency, as well as the role of the Manufacturing Execution Systems Special Interest Group (MES SIG) of the GAMP Community of Practice (CoP) in providing practical information for implementing MES. The section also outlines the framework of GAMP 5 for developing and using MES, emphasizing the need for a well-designed MES domain to maximize the potential benefits of system integration. The guide aims to assist regulated pharmaceutical organizations in achieving and maintaining compliant MES by leveraging regulatory requirements, industry standards, and GAMP guidance.", "excerpt_keywords": "Manufacturing Execution Systems, GAMP, Regulated Industries, Program Management, Life Science Manufacturing"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "ccc9b89c-fe11-4437-ae96-728b6cde6f36", "node_type": "4", "metadata": {"page_label": "12", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "023cbb32dab55ccde5489a7723853cf1b60b6416231c3e2cd68271a7b68a7aca", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "7e0ac5af-cfb1-4c6e-a8bb-4b28140a8cae", "node_type": "1", "metadata": {"page_label": "11", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "fc64413ea1e4f7e6be1e81ec00b8ba273eef36a4f1957d34e6649a4f061e5062", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "1b832015-0e21-4e44-8c27-606221bbf12e", "node_type": "1", "metadata": {}, "hash": "5bd27e6fcd60945e12932a6153f23c5dbc63ce7e515296143f16b057a357186f", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n* manufacturing technology staff\n\n* information technology and engineering staff\n\n* regulatory, compliance, and quality staff\n\n* business process owners\n\n* data owners\n\n* suppliers of technology and systems to industry\n\n### 1.3 scope\n\nthis guide focuses on regulated life science manufacturing industries, including:\n\n* pharmaceuticals\n\n* diagnostics\n\n* biologics\n\n* medical devices\n\n* consumer products\n\nit is intended to be applied to the development of new systems, to extensions of existing systems, and to the operation of systems.\n\nadditional information about managing global it systems may be found in the ispe gamp good practice guide: global information systems control and compliance (reference 6, appendix 14).\n\nalthough applications and examples in this document may refer to batch manufacture, the concepts, strategies, approach, and implementation presented in this guide are applicable to manufacturing found in the medical device industry, consumer products, and packaging operations.\n\n### 1.4 benefits\n\nthe potential benefits of integrated manufacturing systems for recipe-driven operations include:\n\n* improved scheduling and resource utilization\n\n* improved manufacturing flexibility and process changeover\n\n* reduced work in progress (wip) and improved material tracking\n\n* shorter production cycles\n\n* enforced sequence of operations\n\n* reduced production record errors, electronic or hybrid", "start_char_idx": 0, "end_char_idx": 1524, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "1b832015-0e21-4e44-8c27-606221bbf12e": {"__data__": {"id_": "1b832015-0e21-4e44-8c27-606221bbf12e", "embedding": null, "metadata": {"page_label": "13", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Implementation of Manufacturing Execution Systems: A Comprehensive Guide for Success", "questions_this_excerpt_can_answer": "1. How does the GAMP (Good Automated Manufacturing Practice) guide propose to enhance the visibility, accuracy, and consistency of manufacturing data within the context of Manufacturing Execution Systems (MES)?\n   \n2. What specific strategies does the guide recommend for reducing the risk of project failure and balancing the costs of implementation and operation of MES, according to the strategic and program management approach outlined?\n\n3. In what ways does the guide suggest MES can support knowledge management and Process Analytical Technology (PAT), and what are the benefits of implementing electronic production records (EPR) and review by exception (RBE) as part of MES functionalities?", "prev_section_summary": "The section discusses the GAMP Good Practice Guide for Manufacturing Execution Systems, focusing on regulated life science manufacturing industries such as pharmaceuticals, diagnostics, biologics, medical devices, and consumer products. It outlines the scope of the guide, including the intended audience and the industries it applies to. The benefits of integrated manufacturing systems for recipe-driven operations are highlighted, such as improved scheduling, resource utilization, manufacturing flexibility, process changeover, reduced work in progress, improved material tracking, shorter production cycles, enforced sequence of operations, and reduced production record errors. Additional information on managing global IT systems in regulated industries is referenced in the ISPE GAMP Good Practice Guide for Global Information Systems Control and Compliance.", "excerpt_keywords": "Keywords: GAMP, Manufacturing Execution Systems, MES, Good Automated Manufacturing Practice, Process Analytical Technology"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "7b0e7527-ae6a-466b-bc7e-63b4595db20b", "node_type": "4", "metadata": {"page_label": "13", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "1d8caa6d61812b08e63762c23f71be730a65197bac33f02f23578d4078f1f361", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "c3e2fc0f-edba-4e09-85cf-bd7961d151a4", "node_type": "1", "metadata": {"page_label": "12", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "023cbb32dab55ccde5489a7723853cf1b60b6416231c3e2cd68271a7b68a7aca", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "9b3d63cc-d017-486e-94f7-d951fa327b45", "node_type": "1", "metadata": {}, "hash": "eef9185f1142657133462dc62e6596feef83d03f5cb2a34966c1d6dee4be03f1", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n- improved visibility, accuracy and consistency of manufacturing data, enhancing decision support, process analytical technology (pat), and investigations capabilities\n- minimized product recalls\n- increased plant reliability\n- realize paperless manufacturing\n- automated key performance indicator (kpi) generation and reporting, such as an overall equipment efficiency (oee) calculation\n- support knowledge management and pat\n- reduce quality unit resources required for day to day operations by providing functionality, such as electronic production records (epr) and review by exception (rbe)\n\nthis guide aims to enable organizations to:\n\n- shorten development and implementation times by leveraging industry experience\n- implement design and testing methods that improve life cycle activities\n- build compliance into the process\n- provide improved understanding and coordination of the complete manufacturing environment\n- reduce the risk of project failure\n- better balance costs of implementation and operation\n- clarify quality unit resources required for ongoing system operational support\n\n### objectives\n\nthis guide aims to provide guidance for the effective and efficient development and operation of mes by:\n\n- providing an understanding of mes\n- providing a practical framework for applying the principles and concepts of gamp 5 to mes\n- identifying regulatory and compliance aspects of mes\n- providing guidance for mes suppliers\n- addressing mes technical considerations", "start_char_idx": 0, "end_char_idx": 1596, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "9b3d63cc-d017-486e-94f7-d951fa327b45": {"__data__": {"id_": "9b3d63cc-d017-486e-94f7-d951fa327b45", "embedding": null, "metadata": {"page_label": "14", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Exploring MES Domain and Operational Definitions in Manufacturing Execution Systems\"", "questions_this_excerpt_can_answer": "1. How does the GAMP (Good Automated Manufacturing Practice) guide define the operational concept of a Manufacturing Execution System (MES) in the context of integrating human, electronic, and mechanized functionalities?\n   \n2. What methodology does the GAMP guide suggest for organizing and documenting computerized systems and functions within the MES domain, based on their attributes and goals?\n\n3. According to the GAMP guide, how is the MES domain constructed to ensure it encompasses the necessary functionality for production, and what criteria are used to determine the inclusion of existing or new systems within this domain?", "prev_section_summary": "The excerpt from the document discusses the GAMP (Good Automated Manufacturing Practice) guide's strategic and program management approach to Manufacturing Execution Systems (MES). Key topics include enhancing visibility, accuracy, and consistency of manufacturing data, reducing the risk of project failure, balancing implementation and operation costs, supporting knowledge management and Process Analytical Technology (PAT), and implementing electronic production records (EPR) and review by exception (RBE) functionalities. The guide aims to enable organizations to shorten development and implementation times, improve life cycle activities, build compliance into the process, and provide a better understanding of the manufacturing environment. Key entities mentioned include improved decision support, process analytical technology (PAT), investigations capabilities, paperless manufacturing, key performance indicator (KPI) generation, overall equipment efficiency (OEE) calculation, and compliance aspects of MES.", "excerpt_keywords": "MES, GAMP, manufacturing execution systems, operational definitions, domain concept"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "09e5f7b7-30a3-47bc-a568-1a8e08fa5037", "node_type": "4", "metadata": {"page_label": "14", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "168c5efbb3865cf4ff21173a2e4340ea2a37c408aa8c4d7179b4c099c73470c6", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "1b832015-0e21-4e44-8c27-606221bbf12e", "node_type": "1", "metadata": {"page_label": "13", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "1d8caa6d61812b08e63762c23f71be730a65197bac33f02f23578d4078f1f361", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "7df1da88-10e8-4a2e-b388-4acfee19062d", "node_type": "1", "metadata": {}, "hash": "249c0c1e642377e5ecb8dfe9e1677eda5ff5c887cd2aeb06b086d48d3b2a4c48", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n1.6 key concepts\n\n1.6.1 mes operational definition\n\nin this guide, mes is considered to be the complete interactive system of human, electronic, and mechanized functionality to execute manufacturing operations. this includes the necessary business and manufacturing computer applications and systems to optimize operations, manage data, and control information flow. this section further defines mes in the context of this guide. these concepts have been developed from industry standards (see appendix 13).\n\n1.6.2 mes domain concept\n\nthis guide considers the word domain to be a method for organizing and documenting computerized systems and functions into groups or domains, based on common attributes, business and manufacturing goals, intended use, or risks.\n\nthe mes domain is composed of computer systems, applications, and equipment functionality, along with any related data and information, which is used to produce desired intermediate results and final products.\n\nthe mes domain is constructed by defining functionality necessary for production, then determining which existing or new systems or functionality are needed for implementation. an mes domain includes functionality relevant to the intended scope of manufacturing activities; this may incorporate only the necessary functionality from systems components or applications as necessary to support the domain defined by an organization. see figure 1.1.\n\nfigure 1.1: an example view of mes domain", "start_char_idx": 0, "end_char_idx": 1576, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "7df1da88-10e8-4a2e-b388-4acfee19062d": {"__data__": {"id_": "7df1da88-10e8-4a2e-b388-4acfee19062d", "embedding": null, "metadata": {"page_label": "15", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Strategic Program and Risk Management in Manufacturing Execution Systems: A Comprehensive Approach to Functional Domain Concepts\"", "questions_this_excerpt_can_answer": "1. How does the GAMP Good Practice Guide suggest defining the MES domain for new systems versus existing systems, and what role does this domain play in aiding future implementations, testing, and system configuration management?\n\n2. According to the document, how can the modular nature of systems within the MES domain influence risk management activities, and what factors might affect the risk levels for various functionalities or between base products and their configurable or customized modules?\n\n3. What is the significance of functional domains in the context of manufacturing execution systems as described in the document, and how do they facilitate the interaction of information, personnel, materials, and equipment in identifying design requirements and testing activities related to manufacturing operations?", "prev_section_summary": "The section discusses key concepts related to Manufacturing Execution Systems (MES) as outlined in the GAMP (Good Automated Manufacturing Practice) guide. It defines MES as a system that integrates human, electronic, and mechanized functionalities to execute manufacturing operations efficiently. The MES domain concept is introduced as a method for organizing and documenting computerized systems and functions based on common attributes, goals, and intended use. The section also explains how the MES domain is constructed to include the necessary functionality for production, determining which systems or functionalities are needed for implementation. Overall, the section provides insights into the operational definitions and organizational aspects of MES within the manufacturing industry.", "excerpt_keywords": "MES, GAMP, manufacturing execution systems, functional domain, risk management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "9bbdcc48-133d-453b-9b5a-7b73f541e12a", "node_type": "4", "metadata": {"page_label": "15", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "55a5296fa3f33b4d4837d8efd4efbe631a0878517b6da19401102bd1cbe4c798", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "9b3d63cc-d017-486e-94f7-d951fa327b45", "node_type": "1", "metadata": {"page_label": "14", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "168c5efbb3865cf4ff21173a2e4340ea2a37c408aa8c4d7179b4c099c73470c6", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "8a5a46f6-2d20-49da-93a9-5904beabc527", "node_type": "1", "metadata": {}, "hash": "63d13171142e3de15603477402318906998c5348fcbf0ea5f68461b3bf051ea7", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\nsystems or applications, e.g., recipe management, may have all their functionality within the mes domain. some systems, such as mrp and erp, may have blocks of functionality within the mes domain which impact manufacturing, and other blocks, such as financial management, outside the mes domain. for new systems, the mes domain can be established during strategy and planning and further refined during implementation. for existing systems, the mes domain can be defined prior to or during expansions or modifications in order to aid future implementations, testing, and system configuration management. the mes domain is a design tool, and a high-level indicator of which functionality within systems will need to be verified for gxp operations. the mes domain also can be used to determine risk management activities, as the modular nature of systems can be a factor in determining risks at the functional level. systems and applications may have differing risk levels for various functionalities or between base products and their configurable or customized modules. the domain concept is further developed below and in appendix 3.\n\n### functional domain concept\n\nthe term function for this guide is a group of tasks that can be classified as having a common objective (reference isa-95 (part 1) (reference 3, appendix 14)). a functional domain is a defined boundary around a set of system or application functions related to a common business process or function, including where the functionality resides in different systems or applications, see material genealogy functional domain example in figure 1.2. the functions typically share common risks at the process level, but may have different risks based on other factors specific to the system in which that functionality resides, such as amount of customization verses standard equipment and software. functional domains are a tool to aid in defining interaction of the four major components related to manufacturing operations, i.e.: 1. information 2. personnel 3. materials 4. equipment. this helps to identify both design requirements and testing activities based on processes, information flow, and regulatory compliance activities. for further details on domains, see appendix 3.", "start_char_idx": 0, "end_char_idx": 2355, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "8a5a46f6-2d20-49da-93a9-5904beabc527": {"__data__": {"id_": "8a5a46f6-2d20-49da-93a9-5904beabc527", "embedding": null, "metadata": {"page_label": "16", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Comprehensive Guide to GxP Regulations in International Pharmaceutical Requirements", "questions_this_excerpt_can_answer": "1. How does the GAMP(r) Good Practice Guide suggest integrating risk management into the design and specifications of Manufacturing Execution Systems (MES) within the pharmaceutical industry?\n\n2. What specific international pharmaceutical regulations and practices are identified in the \"Comprehensive Guide to GxP Regulations in International Pharmaceutical Requirements\" as foundational to the operation of organizations within the pharmaceutical sector?\n\n3. What approach does the document recommend for ensuring the integrity and compliance of vendor or local quality systems in relation to Manufacturing Execution Systems, as per the audit and verification processes outlined in the context?", "prev_section_summary": "The section discusses the GAMP Good Practice Guide for Manufacturing Execution Systems, focusing on the strategic program and risk management approach. Key topics include defining the MES domain for new and existing systems, the modular nature of systems influencing risk management activities, and the significance of functional domains in facilitating interactions in manufacturing operations. Entities mentioned include the MES domain, functional domains, system functionality, risk management activities, and the interaction of information, personnel, materials, and equipment in manufacturing operations.", "excerpt_keywords": "GAMP, Manufacturing Execution Systems, GxP Regulations, Pharmaceutical Requirements, Risk Management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "024794a8-590e-4be1-b30d-0816648e181d", "node_type": "4", "metadata": {"page_label": "16", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "88711e15492f1fd0032be093472b59287095e052048f20682052d45791cf3337", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "7df1da88-10e8-4a2e-b388-4acfee19062d", "node_type": "1", "metadata": {"page_label": "15", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "55a5296fa3f33b4d4837d8efd4efbe631a0878517b6da19401102bd1cbe4c798", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "3d672aa8-9905-477e-91c7-4ec682de3196", "node_type": "1", "metadata": {}, "hash": "421ae1ead67c9de3e00843e6dd94d176a63514209d7aa3da6223f0e0095f94b8", "class_name": "RelatedNodeInfo"}}, "text": "## page 14\n\ngamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n|figure 1.2: example view of a functional domain for design and risk requirements (user/functional)|\n|---|\n|map to appropriate system functionality in specifications|\n|erp|weigh|lims|recipe|\n|risk for domain functions and data|\n|impact detection|frequency|data integrity|interfaces|\n|cots/custom; etc.|\n|audit: assure appropriate local or vendor quality systems, activities|\n|verification: add appropriate tests and criteria to verification|\n\n1.6.4 gxp regulation\n\nthe underlying international pharmaceutical requirements, such as those set forth in the us fd&c act, us phs act, fda regulations, eu directives, japanese regulations, or other applicable national legislation or regulations under which an organization operates.\n\nthese include, but are not limited to:\n\n- good manufacturing practice (gmp)\n- good clinical practice (gcp)\n- good laboratory practice (glp)\n- good distribution practice (gdp)\n- good quality practice (gqp)\n- good pharmacovigilance practice\n- medical device regulations", "start_char_idx": 0, "end_char_idx": 1115, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "3d672aa8-9905-477e-91c7-4ec682de3196": {"__data__": {"id_": "3d672aa8-9905-477e-91c7-4ec682de3196", "embedding": null, "metadata": {"page_label": "17", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Approach and Program Management for Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the three main sections outlined in the GAMP Good Practice Guide for Manufacturing Execution Systems, and what key concepts do they each focus on?\n   \n2. How does the GAMP Good Practice Guide suggest managing the lifecycle of a Manufacturing Execution System (MES) from planning to release, and what key supporting processes are emphasized?\n\n3. What types of documents and resources are included in the appendices of the GAMP Good Practice Guide for Manufacturing Execution Systems, and how do they support the main body of the guide in covering all aspects of computerized systems good practice and compliance?", "prev_section_summary": "The section discusses the integration of risk management into the design and specifications of Manufacturing Execution Systems (MES) in the pharmaceutical industry, as suggested by the GAMP(r) Good Practice Guide. It also identifies various international pharmaceutical regulations and practices that are foundational to the operation of organizations within the sector. The document recommends an approach for ensuring the integrity and compliance of vendor or local quality systems in relation to MES through audit and verification processes. Key topics include the strategic and program management approach to MES, functional domain design and risk requirements, and various GxP regulations such as GMP, GCP, GLP, GDP, GQP, pharmacovigilance practice, and medical device regulations.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP Good Practice Guide, Strategic Approach, Program Management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "5cbe5893-933b-464d-8256-525be6112cfc", "node_type": "4", "metadata": {"page_label": "17", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "98d5098ac14f4e0ebe6c72459a83e2a84d611678f65e3a2a69faa49e6e183b2c", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "8a5a46f6-2d20-49da-93a9-5904beabc527", "node_type": "1", "metadata": {"page_label": "16", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "88711e15492f1fd0032be093472b59287095e052048f20682052d45791cf3337", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "8413d2d5-6f5b-40a1-b949-754d049158cf", "node_type": "1", "metadata": {}, "hash": "f647c5aafaf48bc43dea123c979f1b5588bb55d4dedff70d8a48653228b2b316", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n|content|page number|\n|---|---|\n|structure of guidance|15|\n\nthis guide comprises a main body and a set of supporting appendices. the main body consists of three main sections:\n\n1. approach to achieving control and compliance\n\n- this section applies the gamp 5 key concepts and discusses the importance of developing a strategy for mes, following an mes life cycle, and applying quality risk management throughout.\n2. project life cycle phase\n\n- this section provides a scaleable life cycle approach to the project phase of an mes, from planning through to release. it also covers key supporting processes.\n3. operation phase\n\n- this section covers the key processes that are needed in order to maintain compliance and fitness for intended use throughout the operational life of an mes. for further information, see the ispe gamp good practice guide: a risk-based approach to operation of gxp computerized systems (reference 6, appendix 14).\n\nthe appendices consider a range of relevant mes topics that support topics considered in the main body, along with references and supporting materials. this guide forms part of a family of documents that together provide a powerful and comprehensive body of knowledge covering all aspects of computerized systems good practice and compliance.\n\nfigure 1.3: gamp document structure\n\ngamp 5 guide\nprinciples and framework\nappendices\nmanagement\ndevelopment\noperation\nspecial interest\ngeneral\ngood practice guides\nlaboratory\nglobal information systems\nprocess controls\ninfrastructure\ncalibration management\ntesting\nelectronic data archiving\nelectronic records and signatures\noper information\npapers and articles\ntemplates and examples\ntraining materials", "start_char_idx": 0, "end_char_idx": 1802, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "8413d2d5-6f5b-40a1-b949-754d049158cf": {"__data__": {"id_": "8413d2d5-6f5b-40a1-b949-754d049158cf", "embedding": null, "metadata": {"page_label": "18", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Empty Space: A Collection of Absences\"", "questions_this_excerpt_can_answer": "Based on the provided context, here are three questions that the context can provide specific answers to, which are unlikely to be found elsewhere:\n\n1. What is the file size of the \"ISPE Manufacturing Execution Systems\" PDF document stored in the PharmaWise Engineer directory within the PharmaWise CSV & Data Integrity project on MyDrive, and how does it relate to the document's content on manufacturing execution systems in the pharmaceutical industry?\n\n2. How does the document titled \"Empty Space: A Collection of Absences,\" which is seemingly unrelated to the typical content expected in a file named \"ISPE Manufacturing Execution Systems.pdf,\" contribute to the understanding of data integrity and system validation in the context of pharmaceutical manufacturing execution systems as stored in the PharmaWise CSV & Data Integrity raw data directory?\n\n3. Considering the creation and last modified dates of the \"ISPE Manufacturing Execution Systems\" PDF document are in April 2024, what implications does this have for the document's relevance and accuracy in discussing current trends and technologies in manufacturing execution systems within the pharmaceutical industry, especially in the context of development and compliance as outlined in the PharmaWise Engineer project?", "prev_section_summary": "The section discusses the GAMP Good Practice Guide for Manufacturing Execution Systems, outlining three main sections: approach to achieving control and compliance, project life cycle phase, and operation phase. It emphasizes the importance of developing a strategy for MES, following an MES life cycle, and applying quality risk management. The guide also covers key processes for maintaining compliance and fitness for intended use throughout the operational life of an MES. The supporting appendices provide additional resources and references to support the main body of the guide in covering all aspects of computerized systems good practice and compliance.", "excerpt_keywords": "manufacturing execution systems, pharmaceutical industry, GAMP Good Practice Guide, MES life cycle, quality risk management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "eefb8a9c-c3dd-4bd6-b134-71e738e3a443", "node_type": "4", "metadata": {"page_label": "18", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "cf7202f189876df3df0c7642ca6615e211822af264aacd3a778367ee74e2f28e", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "3d672aa8-9905-477e-91c7-4ec682de3196", "node_type": "1", "metadata": {"page_label": "17", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "98d5098ac14f4e0ebe6c72459a83e2a84d611678f65e3a2a69faa49e6e183b2c", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "7da3dc84-09b9-4e65-a9cd-11d0b3958520", "node_type": "1", "metadata": {}, "hash": "c4cd03053295bd0309b13715cb91f20fa706cd17dbbdc20830480641dedf0e2d", "class_name": "RelatedNodeInfo"}}, "text": "no_content_here", "start_char_idx": 0, "end_char_idx": 15, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "7da3dc84-09b9-4e65-a9cd-11d0b3958520": {"__data__": {"id_": "7da3dc84-09b9-4e65-a9cd-11d0b3958520", "embedding": null, "metadata": {"page_label": "19", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Implementation of Manufacturing Execution Systems (MES) in the Manufacturing Industry", "questions_this_excerpt_can_answer": "1. What are the key concepts of GAMP 5 that are applied to the strategic implementation of Manufacturing Execution Systems (MES) in the manufacturing industry, as outlined in the ISPE guide?\n   \n2. How does the ISPE guide recommend involving suppliers in the lifecycle of MES to leverage their knowledge, experience, and documentation for achieving and maintaining compliance?\n\n3. What framework does the ISPE guide propose for applying quality risk management throughout the lifecycle of MES, and how does it suggest planning and managing the implementation of MES within a business strategy?", "prev_section_summary": "The section provides metadata information about a PDF document titled \"ISPE Manufacturing Execution Systems\" stored in the PharmaWise Engineer project directory. It also mentions a document titled \"Empty Space: A Collection of Absences\" and raises questions about the relevance of the creation and last modified dates of the PDF document in discussing current trends and technologies in pharmaceutical manufacturing execution systems. The key topics include file details, document titles, data integrity, system validation, and relevance of document dates to industry trends.", "excerpt_keywords": "ISPE, Manufacturing Execution Systems, MES, GAMP 5, Quality Risk Management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "aa20ee54-fc94-4932-a23d-98da160186ef", "node_type": "4", "metadata": {"page_label": "19", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "105f8bb554fbda8445701f33503d6baca03b1f40a385af9e0961c2a7192a6992", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "8413d2d5-6f5b-40a1-b949-754d049158cf", "node_type": "1", "metadata": {"page_label": "18", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "cf7202f189876df3df0c7642ca6615e211822af264aacd3a778367ee74e2f28e", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "b2dd3034-7ba9-45cc-ae77-d1a8d5716d63", "node_type": "1", "metadata": {}, "hash": "42d9089ceee88890a077fe3a0fa771f5e226bccfd30d93dadb579a3c6f8d0881", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: page 17\n\nmanufacturing execution systems - a strategic and program management approach\n\n### approach to achieving control and compliance\n\nthe approach in this guide is based on application of the following gamp 5 key concepts:\n\n- process understanding\n- life cycle approach within a quality management system\n- scaleable life cycle activities\n- science-based quality risk management\n- leveraging supplier involvement\n\nbusiness processes should be understood thoroughly in order to specify, design, and verify mes. a computerized system life cycle approach, encompassing all activities from concept to retirement (see gamp 5 (reference 5, appendix 14)), which embraces manufacturing, engineering, quality, and it is considered a practical way of achieving and maintaining compliance. required activities and documentation should be scaled commensurate with risk. existing documentation (including supplier documentation) should be assessed to determine which may be used. subject matter experts (smes) from both the regulated organizations and suppliers should be involved, as required. application of quality risk management as an integral part of the lifecycle enables effort to be focused on critical aspects of mes in a controlled and justifiable manner. regulated organizations should seek to maximize supplier involvement throughout the system life cycle in order to leverage knowledge, experience, and documentation subject to satisfactory supplier assessment. for example, suppliers may assist with requirements gathering, risk assessments, the creation of functional and other specifications, system configuration, testing, support, and maintenance.\n\na practical framework for applying these concepts to an mes should include:\n\n- developing a strategy for mes\n- following a computerized system life cycle\n- applying quality risk management throughout\n\n### strategy for mes\n\nadopting mes is a significant undertaking that should be carefully planned. required activities and resources should be identified and funded. implementation of mes should also be planned and managed appropriately.\n\n#### business strategy\n\nthe business strategy for mes should identify the business need or drivers for mes, problems the mes should address, or business objectives mes are expected to achieve. a well-defined business strategy is considered essential for gaining executive understanding, support, and funding approval.", "start_char_idx": 0, "end_char_idx": 2448, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "b2dd3034-7ba9-45cc-ae77-d1a8d5716d63": {"__data__": {"id_": "b2dd3034-7ba9-45cc-ae77-d1a8d5716d63", "embedding": null, "metadata": {"page_label": "20", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Implementation of Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the key considerations for implementing a Manufacturing Execution System (MES) on a global scale, as outlined in the ISPE GAMP Good Practice Guide?\n   \n2. How does the document suggest addressing the apprehension among personnel regarding the introduction of new technology in the manufacturing environment, specifically in relation to MES implementation?\n\n3. What strategic planning aspects related to MES are detailed in Appendix 2 of the document, and how do they relate to the GAMP 5 key concept of product and process understanding?", "prev_section_summary": "The section discusses the strategic implementation of Manufacturing Execution Systems (MES) in the manufacturing industry, focusing on key concepts from GAMP 5 such as process understanding, life cycle approach, quality risk management, and supplier involvement. It emphasizes the importance of thorough understanding of business processes, involvement of subject matter experts from regulated organizations and suppliers, and application of quality risk management throughout the MES lifecycle. The section also highlights the need for developing a strategy for MES, following a computerized system life cycle, and aligning MES implementation with business strategy to address business needs and objectives.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP 5, Globalization, Implementation Strategy"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "1ab4ae2a-6aa2-405e-81d1-4a2362f04cdc", "node_type": "4", "metadata": {"page_label": "20", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "ba3aa53f7c445c3f30a19ea8ddc6f7671d59c49456488b166b6978b24578f664", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "7da3dc84-09b9-4e65-a9cd-11d0b3958520", "node_type": "1", "metadata": {"page_label": "19", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "105f8bb554fbda8445701f33503d6baca03b1f40a385af9e0961c2a7192a6992", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "98589a2d-e5d1-4591-9794-dd0abcb27338", "node_type": "1", "metadata": {}, "hash": "c4f20e352ec4040f24e9adc5a48d3c6a51fd9286e4b90f72ba6cdd2872735a92", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\nmes typically are linked with higher-order erp systems that focus on the economic aspects of business processes and also link with plcs on the automation level. this may result in the involvement of multiple groups, e.g. it, engineering, production, and quality. therefore, gaining management approval can be a complex and protracted process.\n\nappendix 2 describes strategic planning specifically related to mes. the gamp 5 key concept of product and process understanding as it relates to an mes is also fundamental to developing an mes business strategy.\n\n## globalization\n\nto maximize business benefits, an mes may be implemented globally as part of the mes business strategy. this may involve taking into account a range of factors, including:\n\n- definition of core and local needs for hardware, software, and infrastructure\n- cultural issues (e.g., language, organization, geographical, legal)\n- regulatory differences\n- data management\n- system architecture\n- managing global processes and procedures\n- verification approach\n- operational management\n\nfor further information, see the ispe gamp good practice guide: global information systems control and compliance (reference 6, appendix 14). for further information on mes specific considerations in relation to global systems, see appendix 4.\n\n## implementation strategy\n\nintroduction of mes typically has significant impact on manufacturing operations and related personnel, from operators to management. introducing mes requires careful planning to minimize production downtime and risks to business continuity. the development of an overall implementation strategy is outlined in appendix 4.\n\nin addition to the defined strategy, the implementation also should address the introduction of new systems and processes into the manufacturing environment.\n\n## implication of change on an organization\n\nthe introduction of new technology to a manufacturing environment may generate apprehension by many personnel within operations, management, and quality; this should be considered within the strategy. there are several effective mechanisms to help address this apprehension, including:\n\nmanagement approval of requirements\ninvolvement by key stakeholders in requirements and functional data gathering activities. stakeholders should include many levels of the organization, including manufacturing area personnel.\ncommunication throughout the planning, development, and implementation process", "start_char_idx": 0, "end_char_idx": 2561, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "98589a2d-e5d1-4591-9794-dd0abcb27338": {"__data__": {"id_": "98589a2d-e5d1-4591-9794-dd0abcb27338", "embedding": null, "metadata": {"page_label": "21", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Optimizing Manufacturing Execution Systems (MES) through a Lifecycle Approach and Supplier Involvement\"", "questions_this_excerpt_can_answer": "1. What strategic approach does the GAMP\u00ae Good Practice Guide recommend for optimizing Manufacturing Execution Systems (MES) through supplier involvement and lifecycle management?\n   \n2. How does the guide suggest handling the overlap of activities during the MES project phase to ensure effective systems integration and modular functionality release?\n\n3. What are the two levels of life cycle management proposed by the document to assure proper control of the manufacturing environment when implementing MES?", "prev_section_summary": "The section discusses the strategic implementation of Manufacturing Execution Systems (MES) and highlights key considerations for implementing MES on a global scale as outlined in the ISPE GAMP Good Practice Guide. It emphasizes the importance of strategic planning related to MES, addressing apprehension among personnel regarding the introduction of new technology, and the implications of change on an organization. The section also covers topics such as globalization, implementation strategy, and the involvement of multiple groups in the MES implementation process. Additionally, it mentions the importance of management approval, stakeholder involvement, and communication throughout the planning and implementation process.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP Good Practice Guide, Supplier Involvement, Lifecycle Management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "e975d48e-3c62-46ff-be89-759136590d90", "node_type": "4", "metadata": {"page_label": "21", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "f7ac6f61053158cdbe38bd32c1d330a646049dca5bbcdaaf4d17877cb5a13237", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "b2dd3034-7ba9-45cc-ae77-d1a8d5716d63", "node_type": "1", "metadata": {"page_label": "20", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "ba3aa53f7c445c3f30a19ea8ddc6f7671d59c49456488b166b6978b24578f664", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "1aa6c673-57cd-4d3d-8620-6e13991fef2d", "node_type": "1", "metadata": {}, "hash": "febe2a6c2b8311f24a2706274b88ac1bc77eff68bfdb6168ac448e53177b10f5", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n* participation in testing activities\n\n* substantive support presence during initial use\n\n* involvement by personnel in previous plant implementations\n\n* effective, hands-on training programs\n\n## mes life cycle\n\nthis guide provides a lifecycle approach to mes based on the computerized system life cycle approach discussed in gamp 5 (see reference 5, appendix 14). see figure 2.1.\n\n|figure 2.1: project stages and supporting processes within the life cycle|potential retention, migration, destruction, retirement|\n|---|---|\n|project stages| |\n|planning|changes|\n|specification| |\n|reporting| |\n|verification| |\n|supporting processes| |\n|risk management; design review; change and configuration management; traceability; document management| |\n\nsupplier involvement\n\nwhile the project phase consists of generally sequential stages, detailed activities may be performed in parallel or with some overlap. for example, verification activities may occur through several stages in the project phase. in particular, an mes approach to manufacturing typically involves various levels of systems integration and activities, which can be implemented in stages or phases, as required and as resources allow. within systems, functionality can be released as it is obtained and verified in a modular fashion if appropriate to systems, equipment, and application design. this may result in a significant overlap of activities. the application of the lifecycle should take account of the potential for mes and functional domains to span multiple systems.\n\ntwo levels of life cycle can be applied to assure proper control of the manufacturing environment:\n\n* mes domain life cycle", "start_char_idx": 0, "end_char_idx": 1776, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "1aa6c673-57cd-4d3d-8620-6e13991fef2d": {"__data__": {"id_": "1aa6c673-57cd-4d3d-8620-6e13991fef2d", "embedding": null, "metadata": {"page_label": "22", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Integration of Manufacturing Execution Systems and Quality Risk Management in Manufacturing Operations", "questions_this_excerpt_can_answer": "1. How does the GAMP(r) Good Practice Guide suggest integrating individual system life cycles within the MES domain to enhance manufacturing operations, and what specific management structures are recommended for coordinating these systems?\n\n2. What are the key components of the quality risk management process as outlined in the GAMP 5 framework, specifically in relation to the complete lifecycle of computerized systems in manufacturing environments?\n\n3. Can you detail the structured approach recommended for implementing risk management within MES domains, including how risk assessments and decisions are integrated at various stages of the MES lifecycle, as per the guidance provided in the document?", "prev_section_summary": "The section discusses the strategic approach recommended by the GAMP\u00ae Good Practice Guide for optimizing Manufacturing Execution Systems (MES) through supplier involvement and lifecycle management. It outlines the MES life cycle based on the computerized system life cycle approach, including project stages and supporting processes. The guide emphasizes the importance of supplier involvement and handling the overlap of activities during the MES project phase to ensure effective systems integration and modular functionality release. Additionally, it introduces two levels of life cycle management, the MES domain life cycle, to assure proper control of the manufacturing environment when implementing MES.", "excerpt_keywords": "Manufacturing Execution Systems, Quality Risk Management, GAMP, MES domain, Risk-based decision making"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "1afd683e-7a64-4917-a0e8-611472a019b3", "node_type": "4", "metadata": {"page_label": "22", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "5a0c88a2051929559f4d343ca7afc45f83f11df86af94e29ef969d23c7fa65aa", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "98589a2d-e5d1-4591-9794-dd0abcb27338", "node_type": "1", "metadata": {"page_label": "21", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "f7ac6f61053158cdbe38bd32c1d330a646049dca5bbcdaaf4d17877cb5a13237", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "38561274-168f-42f3-b972-5411c139a871", "node_type": "1", "metadata": {}, "hash": "97a08d172130b8dbcb4eea4d98d09196225169df0bf18eb472fdf45d13e4814f", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n* individual system life cycles within the mes domain\nthe mes domain life cycle along with an appropriate management structure should coordinate the manufacturing environment with each system in the mes domain controlled and tracked to a system life cycle. for further information, see appendix 12.\nto accommodate these types of approaches, the relationships between the life cycle activities and supporting processes become critical to success. configuration management and underlying processes for change control are particularly important for phased implementations to ensure control of release/gate points for systems, components, modules, equipment, and software versions.\nfurther specific guidance on developing mes through the project stages is provided in section 3 of this guide.\nfurther guidance on mes operation is provided in section 4 of this guide.\n\n## quality risk management\n\nquality risk management is a systematic process for the assessment, control, communication, and review of risks. the evaluation of the risk to quality is based on scientific process knowledge linked to protection of the patient. it is an iterative process used throughout the entire computerized system life cycle from concept to retirement.\ngamp 5 describes a generic science-based quality risk management process applicable to the complete lifecycle as shown in figure 2.2.\n\n| |risk-based decision making|\n|---|---|\n|r1|initial risk assessment|\n|r2|risk-based decisions during planning|\n|r3|functional risk assessments|\n|r4|risk-based decisions during test planning|\n|r5|risk-based decisions during planning of operational activities|\n|r6|functional risk assessments in change control|\n|r7|risk-based decisions when planning system retirement|\n\nfor mes, risk management may be structured around defined mes domains. for further information, see section 3 of this guide.", "start_char_idx": 0, "end_char_idx": 1974, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "38561274-168f-42f3-b972-5411c139a871": {"__data__": {"id_": "38561274-168f-42f3-b972-5411c139a871", "embedding": null, "metadata": {"page_label": "23", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "GAMP 5 Project Phases for Implementing Manufacturing Execution Systems", "questions_this_excerpt_can_answer": "1. What is the GAMP 5 approach to categorizing software in the context of implementing Manufacturing Execution Systems, and how does it differentiate between the levels of risk associated with each category?\n   \n2. How does the GAMP Good Practice Guide define the scope of non-configured products (Category 3) in terms of user-set parameters and their implications for manufacturing execution systems implementation?\n\n3. What specific examples of parameters are mentioned that might be included in a Category 3 non-configured product to allow it to perform built-in functions within a specific organizational IT or technical environment?", "prev_section_summary": "This section discusses the strategic integration of Manufacturing Execution Systems (MES) and Quality Risk Management in manufacturing operations. It covers the integration of individual system life cycles within the MES domain, the key components of the quality risk management process outlined in the GAMP 5 framework, and the structured approach recommended for implementing risk management within MES domains. The section emphasizes the importance of coordination, configuration management, and risk-based decision making throughout the entire computerized system life cycle in manufacturing environments.", "excerpt_keywords": "GAMP 5, Manufacturing Execution Systems, Quality Risk Management, Software Categories, Project Phases"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "d498772d-d8c7-4837-95c2-f527dd609a65", "node_type": "4", "metadata": {"page_label": "23", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "3d655c9d8843a7fdbe5ed794b883aed5bbade4959392d48401738a17b3488e00", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "1aa6c673-57cd-4d3d-8620-6e13991fef2d", "node_type": "1", "metadata": {"page_label": "22", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "5a0c88a2051929559f4d343ca7afc45f83f11df86af94e29ef969d23c7fa65aa", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "591d6f45-80c1-4820-bc88-e125c794aaca", "node_type": "1", "metadata": {}, "hash": "0b22ad835e760e336e531662b350ada8ec5730e466817b2e125875a254c0a547", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n|content|page number|\n|---|---|\n|project phase|21|\n\n### 3 project phase\n\n### 3.1 introduction\n\ngamp 5 provides a scaleable approach to projects using the systems life cycle based on the following software and hardware categories with increasing risk as the category number increases. note that an application may have a combination of functions with different categories that may incur different levels of risk.\n\nsoftware:\n\n- infrastructure software (category 1):\n- not considered in this guide, reference gamp 5 (reference 5, appendix 14)\n- non-configured products (category 3):\n- this category should not be misinterpreted as having no user-set parameters. category 3 specifically does not include configuring software to meet unique user business processes or practices, but can include parameters that select operations from among predetermined or programmed functionality, or parameters that allow software to perform the built-in functions in a specific organization it or other technical environment, such as database aliases, network addresses, and communication with peripheral equipment.\n- configured products (category 4):\n- includes configuration of pre-existing modules or functionality to meet user business processes or practices\n- custom applications (category 5):\n- includes creation or addition of new or non-standard functionality\n\nhardware:\n\n- standard hardware components (category 1)\n- custom-built hardware components (category 2)\n\nfigure 3.1 shows the gamp 5 project stages for a typical configured product (category 4).", "start_char_idx": 0, "end_char_idx": 1656, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "591d6f45-80c1-4820-bc88-e125c794aaca": {"__data__": {"id_": "591d6f45-80c1-4820-bc88-e125c794aaca", "embedding": null, "metadata": {"page_label": "24", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Approach for Configured Product in MES Project Implementations: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What specific approach does the GAMP (Good Automated Manufacturing Practice) recommend for managing the complexity of designs or implementations in MES (Manufacturing Execution Systems) project implementations, particularly regarding configured products?\n\n2. How does the document suggest handling the documentation and activities for lower risk systems and equipment within MES project implementations, according to the ASTM 2500-07 reference?\n\n3. What categories of MES project implementations are identified in the document, and how are they differentiated in terms of integration and application within manufacturing environments?", "prev_section_summary": "This section discusses the GAMP 5 approach to categorizing software in the context of implementing Manufacturing Execution Systems. It outlines the different levels of risk associated with software categories, including infrastructure software, non-configured products, configured products, and custom applications. The section also defines the scope of non-configured products (Category 3) in terms of user-set parameters and their implications for manufacturing execution systems implementation. Specific examples of parameters that might be included in a Category 3 non-configured product are mentioned, such as database aliases, network addresses, and communication with peripheral equipment. The section provides a strategic and program management approach to project phases, emphasizing the importance of understanding the risk levels associated with different software and hardware categories.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, configured product, project implementations"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "626fef4c-b8ae-4bf8-b2c7-c947faec081e", "node_type": "4", "metadata": {"page_label": "24", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "2ea6a1a4fd1c581e6335076ab6df42a5d7725c0e2ec128e209f315f32378f8b4", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "38561274-168f-42f3-b972-5411c139a871", "node_type": "1", "metadata": {"page_label": "23", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "3d655c9d8843a7fdbe5ed794b883aed5bbade4959392d48401738a17b3488e00", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "0f3a47b4-7931-436c-aa8a-c83be289ea59", "node_type": "1", "metadata": {}, "hash": "d1bc33b619088899c6d4288e1ca362ea541d93e4eae4a47907a9e8f722fe0801", "class_name": "RelatedNodeInfo"}}, "text": "## figure 3.1: typical approach for a configured product\n\n|planning|user requirements specification|reporting|primary responsibility|\n|---|---|---|---|\n|functional planning and specification|functional specification|configuration testing|regulated company|\n|planning and specification|configuration specification|configure product testing|supplier|\n|supporting processes| |configurable product testing|supplier qms|\n\nnote: the gamp approach in figure 3.1 defines a set of activities that support complex designs or implementations. lower risk systems and equipment may not have all of the documentation and activities shown. activities and documentation can be combined whenever appropriate. assessed risk can determine the scope and rigor of life cycle activities, which in turn can determine the content and format of documentation (see astm 2500-07 (reference 8, appendix 14)). integrated manufacturing environments often include equipment built into facilities production infrastructure that is driven by higher level supervisory control and data acquisition (scada) and recipes to coordinate equipment and operations. risk assessments should examine the complete assembly of equipment and systems to determine the verification approach.\n\nthis section uses the typical approach for a configured model as the overall model for the project phase. typical mes project implementations may include:\n\n- self-contained commercial applications that have application programming interface (api) communications (category 3)\n- standalone modules that are integrated by manual data entry (category 4)\n- custom or bespoke software to address specific business processes (category 5)\n- kernel product applications that are supplied by a systems integrator (category 3)", "start_char_idx": 0, "end_char_idx": 1758, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "0f3a47b4-7931-436c-aa8a-c83be289ea59": {"__data__": {"id_": "0f3a47b4-7931-436c-aa8a-c83be289ea59", "embedding": null, "metadata": {"page_label": "25", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Comprehensive Title: Strategic Risk Management and Planning for Manufacturing Execution Systems (MES): A Guide for Effective Implementation and Maintenance", "questions_this_excerpt_can_answer": "1. How does the GAMP (Good Automated Manufacturing Practice) guide categorize software applications used in manufacturing execution systems (MES), and what examples are provided for add-on configurable software packages within these categories?\n\n2. What factors should be considered during the planning phase to ensure an MES project meets compliant specifications and verification, according to the strategic risk management and planning guide for MES implementation?\n\n3. What steps are recommended for conducting an initial risk assessment in the context of implementing a Manufacturing Execution System (MES) in the life sciences sector, including the types of regulatory environments that should be considered?", "prev_section_summary": "The section discusses the approach for configured products in MES project implementations, as recommended by GAMP. It outlines the typical activities and documentation required for managing the complexity of designs or implementations, particularly for lower risk systems and equipment. The document identifies different categories of MES project implementations based on integration and application within manufacturing environments. It also highlights the importance of risk assessments in determining the scope and rigor of life cycle activities, as well as the verification approach for equipment and systems in integrated manufacturing environments. Key topics include planning, user requirements specification, reporting, primary responsibilities, and different categories of MES project implementations. Key entities mentioned are GAMP, ASTM 2500-07, configured products, documentation, activities, risk assessments, and integrated manufacturing environments.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, Risk Management, Strategic Planning"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "83b30181-a9f4-48d4-9c1a-8fb8f7fd3ea2", "node_type": "4", "metadata": {"page_label": "25", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "dd9b19725232ed7267010a58be2f1beb26188ac4d409f4c67073b4b699ec88f9", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "591d6f45-80c1-4820-bc88-e125c794aaca", "node_type": "1", "metadata": {"page_label": "24", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "2ea6a1a4fd1c581e6335076ab6df42a5d7725c0e2ec128e209f315f32378f8b4", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "4ed5f1e0-b997-4cfb-bf08-4764d33f214c", "node_type": "1", "metadata": {}, "hash": "c6be4962af69fa9182106c9ee846706a77fa9b7dbb1ef0962791b9c4b300fef6", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\napplications used to model business or manufacturing processes that could include all three categories (category 3, 4, and 5)\n\nadd-on configurable software packages, e.g., historian, scada, batch/processing engines, or multivariate analytical tools that would be used to develop pat enhancements (category 3)\n\na single category for entire systems or applications may not be appropriate. careful planning is required to ensure that an efficient and effective approach is taken for each component or module (see section 3.2 for further details).\n\nthe application of this general approach will vary widely depending on the risk, complexity, and novelty of individual systems. the specifications shown in the figure 3.1 are not necessarily separate documents; thus, the life cycle activities and related documentation are adjusted to fit the determined risk of the subject system or component.\n\nfor example, standard equipment is addressed with a simplified approach with high dependency on supplier documentation and quality systems.\n\n### planning\n\nplanning should focus on activities required to achieve compliant specification and verification during the project phase, which should form an integral part of project planning for the mes domain.\n\nlife cycle activities should be scaled in scope and rigor for factors such as:\n\n- system impact on patient safety, product quality, and data integrity (initial risk assessment)\n- system complexity and novelty (architecture and categorization of system components)\n- outcome of supplier assessment (supplier capability)\n\ntechnical personnel should be capable of assessing risks of systems failing to meet requirements and specifications. impact on patient safety and product quality requires cross-functional risk management of which technical risk management is a part.\n\nplanning should include appropriate activities to ensure that technical risks are properly addressed in overall safety and quality risk programs. the impact of technical failures should be understood and addressed by those quality risk programs. the risks to safety and quality are then factored back into design and implementation of systems to assure acceptable mitigation.\n\n### initial risk assessment\n\nas part of planning an mes domain, an initial risk assessment should be performed based on:\n\n- an understanding of business processes and business risk assessments\n- user requirements\n- regulatory requirements\n- known functional areas\n\neither prior to, or as part of, the initial risk assessment, an analysis should be performed to determine which regulatory environments are associated with a system, such as life sciences (e.g., gxp), environmental, safety, and controlled substances and materials. any relevant previous assessments may provide useful input that can be referenced in an updated document without repeating the activity if the information, data, and system context is still relevant.", "start_char_idx": 0, "end_char_idx": 3034, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "4ed5f1e0-b997-4cfb-bf08-4764d33f214c": {"__data__": {"id_": "4ed5f1e0-b997-4cfb-bf08-4764d33f214c", "embedding": null, "metadata": {"page_label": "26", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Comprehensive Guide to Risk Assessment, GAMP Categorization, Supplier Assessment, and Validation Planning in Manufacturing Execution Systems", "questions_this_excerpt_can_answer": "1. How does the GAMP categorization approach allow for the differentiation of risk levels within the components of a Manufacturing Execution System (MES), and what examples are provided to illustrate how different software or system components might be categorized?\n\n2. What considerations should be taken into account during the supplier assessment phase for MES components, especially regarding the use of supplier documentation and the assessment of supplier quality management systems across multiple locations?\n\n3. In the context of validation planning for MES, how is the creation of a computerized system validation plan approached, particularly in terms of incorporating individual plans for systems and processes within the MES domain?", "prev_section_summary": "The section discusses the strategic risk management and planning for Manufacturing Execution Systems (MES) according to the GAMP guide. Key topics include categorization of software applications in MES, factors to consider during planning for compliant specifications and verification, steps for conducting an initial risk assessment, and the importance of addressing technical risks in overall safety and quality risk programs. Entities mentioned include add-on configurable software packages, system impact on patient safety and product quality, supplier assessment, technical risk management, and regulatory environments in the life sciences sector.", "excerpt_keywords": "Manufacturing Execution Systems, Risk Assessment, GAMP Categorization, Supplier Assessment, Validation Planning"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "e1394254-9084-485a-b8a5-46188edb8815", "node_type": "4", "metadata": {"page_label": "26", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "f3174d1a58982aa6def32a56ada4e02557f9fccda350bea0f4818bae30d900ea", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "0f3a47b4-7931-436c-aa8a-c83be289ea59", "node_type": "1", "metadata": {"page_label": "25", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "dd9b19725232ed7267010a58be2f1beb26188ac4d409f4c67073b4b699ec88f9", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "1e60cff7-52cc-42f5-8fe4-b46231a7430a", "node_type": "1", "metadata": {}, "hash": "c9ca6af677036883732272c381aaf5814b021d5b125519409fa50be41a873957", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\nthe results of this initial risk assessment should confirm whether the system is gxp regulated and which regulations apply. it should also include an overall assessment of system impact. the level of effort, formality, and documentation of subsequent risk management activities should be determined based on the level of risk and system impact. stages at which risk assessment will be performed should be identified. any specific quality risk management procedures or standards to be followed should be defined.\n\n3.2.2 gamp categorization\n\nwhere the default configuration is being used, applications may be considered as non-configured product (category 3), e.g., where an original equipment manufacturer (oem) supplier has delivered a package that is not modified by the end user, such as equipment with an embedded control system. in these cases, risk mitigating factors, such as large user base and low complexity may help to determine the categorization. some applications, such as scada, require complex configuration activities and may be considered category 4. custom software, such as new interfaces, should be considered as category 5, for which increased levels of specification and verification are required. however, the functional domain approach encourages examination of systems at a functional level to determine risks associated with system modules, components, or specific functionality. in this manner, gamp categories can be applied directly to components of systems, preventing overestimating or underestimating risk for an entire system. functional domains may contain different categories of software. for example, a supplied product may be considered category 3, while additional customized or new software modules may be considered category 4 or 5. these may be grouped together into higher risk functional domains. additional testing and rigor can then be applied to the higher risk functionality without necessarily increasing the effort for the entire system. care should be taken in specification and verification to understand how functions interact within a system, and whether functionality can be assessed individually, in groups, or simply as an entire system for gamp categorization.\n\n3.2.3 supplier assessment\n\nthe need for a supplier assessment is typically based on the category selected for the required functionality. planning should determine how best to use supplier documentation, including existing test documentation, to avoid wasted effort and duplication. justification for the use of supplier documentation should be provided by the satisfactory outcome of supplier assessments, which may include a supplier audit based on risk factors such as complexity. supplier documentation should be assessed for suitability, accuracy, and completeness. there should be flexibility regarding acceptable format, structure, and documentation practices. large software and system suppliers may operate from multiple locations with a base product being developed at a central location and regional centers working with end users to develop configuration and customizations. there may be multiple or different quality management systems in each location. the supplier assessment should consider all pertinent locations and focus on how responsibilities are divided among the locations with a special emphasis on how patches and upgrades are assessed and tested against any prior end user customization. commercially available hardware, software, and documentation should be exploited to take advantage of reduced specification and verification activities. for further information, see gamp 5, appendix m2 (reference 5, appendix 14).\n\n3.2.4 validation planning\n\na computerized system validation plan should be produced for the overall mes domain, typically referencing individual plans for systems and processes within the mes domain.", "start_char_idx": 0, "end_char_idx": 3976, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "1e60cff7-52cc-42f5-8fe4-b46231a7430a": {"__data__": {"id_": "1e60cff7-52cc-42f5-8fe4-b46231a7430a", "embedding": null, "metadata": {"page_label": "27", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Execution Systems Validation and Compliance Roles and Responsibilities Document", "questions_this_excerpt_can_answer": "1. What specific criteria and considerations should be included in a computerized system validation plan for Manufacturing Execution Systems (MES) according to the GAMP good practice guide?\n   \n2. How does the GAMP good practice guide recommend handling the documentation and change control strategy for MES domains that span multiple sites, and what are the implications for central validation strategies?\n\n3. What are the defined roles and responsibilities for ensuring MES compliance, particularly in relation to the process owner, as outlined in the ISPE Manufacturing Execution Systems Validation and Compliance Roles and Responsibilities Document?", "prev_section_summary": "The section discusses the importance of risk assessment, GAMP categorization, supplier assessment, and validation planning in Manufacturing Execution Systems (MES). Key topics include the initial risk assessment to determine system impact, GAMP categorization for different software components, considerations for supplier assessment such as using supplier documentation and assessing supplier quality management systems, and the creation of a computerized system validation plan for the MES domain. Entities mentioned include GAMP categories, supplier documentation, supplier quality management systems, and individual validation plans for systems and processes within the MES domain.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP, Validation, Compliance"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "28aa163d-a2df-4b4f-8794-f86f64f19833", "node_type": "4", "metadata": {"page_label": "27", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "571efd8e7aa99a2aaca5a231434b3696eccaf33ffe3e59ca8746c2616b69d205", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "4ed5f1e0-b997-4cfb-bf08-4764d33f214c", "node_type": "1", "metadata": {"page_label": "26", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "f3174d1a58982aa6def32a56ada4e02557f9fccda350bea0f4818bae30d900ea", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "c28b7626-324a-46d5-878b-ea5a283dbb9e", "node_type": "1", "metadata": {}, "hash": "e30055c6f10a916df9c07543c46095cb71d71c9111dcf1ce853e420a6335e34e", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\ncomputerized system validation plans should define or reference documentation for:\n\n- what activities are required?\n- methods for implementing and controlling activities and who is responsible. this includes how the system will be released for each stage of verification and for production use, such as any phased release or other techniques to be used. (see appendix 12.)\n- what are the outputs and results of activities and related deliverables, such as documentation?\n- critical criteria\n\nthe level of detail in the validation plan should reflect the outcome of the initial risk assessment, gamp categorization, and supplier assessment.\n\nthe mes domain may comprise multi-site systems; thus, the location and change control strategy, including documentation, should be addressed early in the project phase.\n\nwhen a central validation strategy is chosen for a standard configuration distributed by a central control organization, deployment sites should have access to supporting documentation for audits and inspections. local representatives should be familiar with the documentation and document structure and interrelationships to support an internal or external audit. for further information, see the ispe gamp good practice guide: global information systems control and compliance (reference 6, appendix 14).\n\n### key roles and responsibilities\n\nthe following are key roles and responsibilities when achieving mes compliance and should be assigned during validation planning. designated individuals should have sufficient experience and training to perform the respective role.\n\nspecific activities may be delegated to appropriate nominated representatives. for further information, see gamp 5, section 6.2.3 (reference 5, appendix 14).\n\nprocess owner\n\nthe owner of the business process or processes being managed should be identified. where multiple process owners are responsible for the mes domain, a principle process owner should be identified. in addition to the responsibilities below, they also should have responsibility for appropriate consultation with the other business process owners. the process owner is ultimately responsible for ensuring that the mes and its operation is in compliance and fit for intended use in accordance with applicable standard operating procedures (sops). the process owner also may be the system owner. specific activities may include:\n\n- approval of key documentation as defined by plans and sops\n- providing adequate resources (personnel, including smes, and financial resources) to support development and operation of a system\n- ensuring adequate training for end users\n- ensuring that sops required for operation of the system exist, are followed, and are reviewed periodically\n- ensuring changes are approved and managed", "start_char_idx": 0, "end_char_idx": 2889, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "c28b7626-324a-46d5-878b-ea5a283dbb9e": {"__data__": {"id_": "c28b7626-324a-46d5-878b-ea5a283dbb9e", "embedding": null, "metadata": {"page_label": "28", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Roles and Responsibilities in Manufacturing Execution Systems (MES) Governance and Compliance", "questions_this_excerpt_can_answer": "1. What specific responsibilities does the system owner have in ensuring the Manufacturing Execution System (MES) meets GxP compliance and operational efficiency according to the GAMP\u00ae Good Practice Guide?\n   \n2. How does the quality unit contribute to the governance and compliance of MES, particularly in relation to patient safety, product quality, and data integrity, as outlined in the document?\n\n3. What are the defined roles and activities of Subject Matter Experts (SMEs) in the context of defining requirements and ensuring the effectiveness of MES, according to the GAMP\u00ae Good Practice Guide on Manufacturing Execution Systems?", "prev_section_summary": "This section discusses the criteria and considerations for creating a computerized system validation plan for Manufacturing Execution Systems (MES) according to the GAMP good practice guide. It also covers the documentation and change control strategy for MES domains that span multiple sites, as well as the defined roles and responsibilities for ensuring MES compliance, particularly focusing on the process owner. Key topics include validation plan details, multi-site system considerations, central validation strategies, and the responsibilities of the process owner in ensuring compliance and system operation. Key entities mentioned are the process owner, business process owners, system owner, and end users.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, compliance, governance"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "439727de-8e10-4a3b-8ab7-01a1f5d177ca", "node_type": "4", "metadata": {"page_label": "28", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "f73619a524bc7867c8feae18e6ffec442a0abfefa31167327307d0298d45849e", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "1e60cff7-52cc-42f5-8fe4-b46231a7430a", "node_type": "1", "metadata": {"page_label": "27", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "571efd8e7aa99a2aaca5a231434b3696eccaf33ffe3e59ca8746c2616b69d205", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "3c1fdc4b-1535-41de-8085-e32d7b7bbd8d", "node_type": "1", "metadata": {}, "hash": "5ecb3be8cf48d92b6bdc0cb44b628617b6bc21d08a518be0f296332f46a4b9e6", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\nsystem owner\n\nthe system owner is responsible for the availability and support and maintenance of the mes and for the security of the data residing on that system. where multiple systems make up the mes domain, mechanisms should be established to coordinate the responsibilities and activities of the various system owners.\n\nthe system owner should act on behalf of the end users. global mes may have a global system owner and local system owners to manage local implementation.\n\nspecific activities may include:\n\n- ensuring that sops required for maintenance of the system exist and are followed\n- ensuring adequate training for maintenance and support staff\n- ensuring changes are managed\n- ensuring the availability of information for the system inventory and configuration management\n- providing adequate resources (personnel including smes and financial resources) to support the system\n- reviewing audit reports, responding to findings, and taking appropriate actions to ensure gxp-compliance\n- coordinating input from other groups (e.g., finance, information security, health, safety, and environment, legal)\n- ensuring that governance structures exist to allow escalation of issues, decision making and drive business process harmonization\n\nquality unit\n\nthe quality unit has a key role to play in successfully planning and managing the compliance and fitness for intended use of mes, and provides an independent role in the following:\n\napproval or audit of key documentation, such as policies, procedures, acceptance criteria, plans, reports\nfocus on quality critical aspects\napproval of changes that potentially affect patient safety, product quality, or data integrity\naudit processes and supporting documentary evidence to verify that compliance activities are effective\nacts as the sme for gxp compliance aspects\n\nsubject matter expert\n\nqualified and experienced smes have a key role in:\n\n- defining the requirements of the mes", "start_char_idx": 0, "end_char_idx": 2051, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "3c1fdc4b-1535-41de-8085-e32d7b7bbd8d": {"__data__": {"id_": "3c1fdc4b-1535-41de-8085-e32d7b7bbd8d", "embedding": null, "metadata": {"page_label": "29", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Roles and Responsibilities in Manufacturing Execution Systems (MES) Implementation Guide", "questions_this_excerpt_can_answer": "1. What specific roles do Subject Matter Experts (SMEs) play in the verification process of Manufacturing Execution Systems (MES) according to the GAMP Good Practice Guide?\n   \n2. How does the document outline the responsibilities of suppliers, including internal suppliers like IT or engineering departments, in supporting the compliance and fitness for intended use of MES?\n\n3. What activities are end users of MES expected to be involved in throughout the system's life cycle as per the ISPE Manufacturing Execution Systems Implementation Guide?", "prev_section_summary": "The section discusses the roles and responsibilities of key entities in Manufacturing Execution Systems (MES) governance and compliance. It covers the responsibilities of the system owner in ensuring MES meets GxP compliance and operational efficiency, the contribution of the quality unit in ensuring patient safety, product quality, and data integrity, and the defined roles and activities of Subject Matter Experts (SMEs) in defining requirements and ensuring the effectiveness of MES. Key topics include system ownership, quality unit involvement, and SME contributions to MES governance and compliance.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP Good Practice Guide, Subject Matter Experts, Compliance"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "4e5b4198-f277-40f9-822e-097a40c0c0ac", "node_type": "4", "metadata": {"page_label": "29", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "5abf29e500ce67086f8960637d60839275f7b38f153437e6e7ae3452c7b0d20a", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "c28b7626-324a-46d5-878b-ea5a283dbb9e", "node_type": "1", "metadata": {"page_label": "28", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "f73619a524bc7867c8feae18e6ffec442a0abfefa31167327307d0298d45849e", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "d5ca4be9-751e-49c0-ba48-cd57801942b9", "node_type": "1", "metadata": {}, "hash": "7fbcd7f011b2bfada3792946006c9f3bd574a63d025ad54bc5daa0a292c03966", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\nperforming reviews and assessments\n\ntaking technical decisions, using science-based process and product understanding, and sound engineering principles\n\ndifferent smes may be involved with different activities, e.g., during specification and verification. smes should take the lead role in the verification of mes. responsibilities include planning and defining verification strategies, defining acceptance criteria, selection of appropriate test methods, execution of verification tests, and reviewing results. smes may come from a wide range of backgrounds as required, including business process, engineering, it, supplier, quality, and testing disciplines.\n\nsupplier suppliers (including internal suppliers, such as it or engineering) should provide support for achieving and maintaining system compliance and fitness for intended use. specific activities may include:\n\n- provision of product documentation\n- preparation and review of specific documentation\n- acting as subject matter expert for technical aspects, such as configuration and design options\n- performing and supporting testing\n- change and configuration management\n- supporting processes geared toward maintaining system compliance, e.g., by providing software patches, providing second-tier support for problem resolution processes\n- supporting requirements analysis for system customization\n- supporting audits by customers to facilitate understanding of supplier quality systems\n\nend user in addition to using the system in accordance with approved procedures, end users also may be involved in the following activities throughout the life cycle:\n\ninput to user requirements and specifications\nevaluation of prototypes\ntesting\nacceptance of the system and handover\ninput to development of standard operating procedures for use of the system\nreporting defects (incidents and problem reporting)\nidentifying opportunities for improvement", "start_char_idx": 0, "end_char_idx": 2018, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "d5ca4be9-751e-49c0-ba48-cd57801942b9": {"__data__": {"id_": "d5ca4be9-751e-49c0-ba48-cd57801942b9", "embedding": null, "metadata": {"page_label": "30", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "A Comprehensive Guide to Developing Manufacturing Execution Systems: Prototypes, Requirements, and Domain Approach", "questions_this_excerpt_can_answer": "1. How does the GAMP(r) Good Practice Guide define the use of prototype systems in the development and verification of manufacturing execution systems (MES), and what are the specific purposes for maintaining prototype systems as training simulators?\n\n2. What considerations does the guide suggest when testing software fixes or upgrades in a production system that is already online for GxP use, especially in continuous process environments or those with high levels of integration?\n\n3. According to the guide, how should user requirements for MES be gathered, and what role does the MES domain approach play in identifying risks and ensuring comprehensive coverage of business processes and regulatory requirements?", "prev_section_summary": "The section discusses the roles and responsibilities of Subject Matter Experts (SMEs) in the verification process of Manufacturing Execution Systems (MES) according to the GAMP Good Practice Guide. It also outlines the responsibilities of suppliers, including internal suppliers like IT or engineering departments, in supporting the compliance and fitness for intended use of MES. Additionally, it highlights the activities that end users of MES are expected to be involved in throughout the system's life cycle, such as providing input to user requirements, evaluating prototypes, testing, accepting the system, and identifying opportunities for improvement.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP Good Practice Guide, Prototype Systems, User Requirements"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "ab6d6a45-7fbd-45d8-961a-d5c9a7f8b48c", "node_type": "4", "metadata": {"page_label": "30", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "c71bb9c4008754434a38167599cf9c931cd829fda9bfe9d494cfafcd00f57bb3", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "3c1fdc4b-1535-41de-8085-e32d7b7bbd8d", "node_type": "1", "metadata": {"page_label": "29", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "5abf29e500ce67086f8960637d60839275f7b38f153437e6e7ae3452c7b0d20a", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "0a185f31-ad06-45f1-83a2-c91de6e5638d", "node_type": "1", "metadata": {}, "hash": "febe864181669d628f7b6e7a81ad6541783cc743183304bb8b7d49ff467b1f7d", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n3.2.6 use of prototype systems\n\nprojects involving integrated systems may make use of representative smaller versions of systems to facilitate development, as well as verification testing and other uses. in this guide, the term prototype system is used in place of pilot, development, or reference system. the term test system is used for the formal testing (or quality assurance) environment.\n\none or more prototype systems can be constructed on a small scale and used for verification of hardware, software, and integration functionality in a simulated production environment. prototype systems may be maintained as training simulators provided that equivalent production system functionality and realistic master data are maintained. use of a common system for prototyping, training, and testing may help to justify the costs of maintenance over extended time periods. it should be noted that if testing is to be performed on a common system to support quality systems, such as change control, the common system needs to be maintained in a known, verified state that is an equivalent of the production system.\n\nwhen a new facility or area is being constructed, the production system may be used for testing the complete set of functionality. however, once a production system is on-line for gxp use, testing of software fixes or upgrades prior to use in production becomes difficult without a separate system. this is particularly true where organizations run continuous processes without much down time, or with higher levels of integration where different applications require different shutdown schedules to meet business needs. in such cases, it is considered preferable to have representative test versions of interfaces and systems to perform verification activities away from the production environment. where cost or complexity are prohibitive, verified and controlled simulations for interface input and output, such as sql scripts or other tools, may be used instead of interfaces. for further information, see appendix 4.\n\n3.3 requirements definition\n\nuser requirements should be clearly and completely understood. the extent and detail of requirements gathering and specification should be sufficient to support risk assessment, further specification, and development of a system, and verification. comparison of available solutions may result in refinement of the requirements.\n\nfor mes, a full understanding of relevant business processes and regulatory requirements is significant. the mes should be capable of complying with the organizations quality management system. specific product process requirements and critical process parameters (cpps) should be addressed in the creation of the product recipes rather than system design.\n\nuser requirements are the responsibility of the user community and should be maintained and controlled. users of mes typically are not representative of a single business group. the mes domain approach recognizes that usage may not be satisfied by a single application, but may be split across multiple applications and systems in the mes domain. identification of risks for specific processes or functions can be simplified by using the mes domain approach. trace matrices or other cross-reference techniques should be used early in the requirements and design phases to ensure that gaps and overlaps are prevented.\n\na data flow design should be developed during requirements definition indicating data ownership and access and transfer requirements. such information is a major factor in choosing applications and systems appropriate to the mes project, and will assist with subsequent specification and design.\n\ndepending on the mes strategy and the scope, requirements should be compiled from across an organization under the guidance of an mes program. there may be more than one requirements document depending on the strategy chosen. in the case of multiple requirements documents, a high-level document should provide a clear map of the scope and relationship of the various requirements documentation. strategy documents may provide high-level requirements that are used to guide the development of detailed requirements. for further information, see gamp 5, appendix d1 (reference 5, appendix 14).", "start_char_idx": 0, "end_char_idx": 4371, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "0a185f31-ad06-45f1-83a2-c91de6e5638d": {"__data__": {"id_": "0a185f31-ad06-45f1-83a2-c91de6e5638d", "embedding": null, "metadata": {"page_label": "31", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Approach to Manufacturing Execution Systems: Ensuring Compliance and Risk Management in Manufacturing Operations", "questions_this_excerpt_can_answer": "1. What specific benefit does the implementation of MES (Manufacturing Execution Systems) provide in relation to RBE (Risk-Based Engineering), and where can one find detailed information about this benefit within the ISPE GAMP Good Practice Guide?\n   \n2. How does the ISPE document suggest handling the security of logon and signature entries for MES, and what are the recommended methods for identifying an individual based on the system design?\n\n3. What approach does the document recommend for conducting risk assessments during the purchase of complex systems like MES, and how should these assessments address functional risks according to the identified functional domains?", "prev_section_summary": "This section discusses the use of prototype systems in the development and verification of manufacturing execution systems (MES), considerations for testing software fixes or upgrades in production systems, and the gathering of user requirements for MES. Key topics include the definition and maintenance of prototype systems, the importance of understanding user requirements, the MES domain approach for identifying risks, and the development of data flow designs during requirements definition. Entities mentioned include GAMP(r) Good Practice Guide, prototype systems, production systems, user requirements, business processes, regulatory requirements, critical process parameters (CPPs), data flow design, and MES program.", "excerpt_keywords": "MES, Manufacturing Execution Systems, Risk-Based Engineering, ISPE, GAMP"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "cf4be52a-675e-4aee-a487-3fe0cae9c022", "node_type": "4", "metadata": {"page_label": "31", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "ea58d88d7ac35933616299c9a348338eca295e0c28befd1992161be8c72ffbba", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "d5ca4be9-751e-49c0-ba48-cd57801942b9", "node_type": "1", "metadata": {"page_label": "30", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "c71bb9c4008754434a38167599cf9c931cd829fda9bfe9d494cfafcd00f57bb3", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "55083db6-5d67-4a17-829b-8709035a580c", "node_type": "1", "metadata": {}, "hash": "39bbf5dbf5b8c5c5364d21e5739b35a59c4888fc4b06f7d9acfe589d83095c09", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\nspecific considerations for mes include:\n\n- a key mes benefit is that it is an enabler of rbe (see appendix 8).\n- use of electronic records and signatures and compliance with relevant regulations (see appendix 7), e.g.:\n- security of logon and signature entries may use combinations of electronic, biometric, or manual methods for identifying an individual depending on system design.\n- confirmation of manual entry steps\n\nfor further information, see the ispe gamp good practice guide: a risk-based approach to compliant electronic records and signatures (reference 6, appendix 14).\n\n- data interfaces between different systems, e.g., transactional business systems may need to support continuous processing taking place in manufacturing area systems. risk assessments should take into account loss of communications.\n\nfor further information, see appendix 7 and appendix 10.\n\n### risk assessments\n\ntypically, high-level risk assessments alone are not adequate for the purchase of complex systems, as they do not reflect workflow details.\n\nfurther risk assessments, commencing during requirements definition, should address functional risks. these risk assessments should be based on the identified functional domains.\n\neach major user of the different functionality should be a principle contributor to defining risks and the resulting requirements.\n\n### specification and design\n\n#### system specification and design\n\nmes may be implemented using several approaches; therefore, the structure of the specifications may vary. as with requirements, multiple specifications may be required, and may trace to one or more requirements documents that cross business group, application, or system boundaries. risk management should take into account the structure of the requirements. upon examining existing and new applications and systems, a functional map can be created so that risks may be assigned to required functions and various systems, taking into consideration the benefits for standard or customized integration.\n\ndesign documentation for mes should relate the application of the hardware and software to the manufacturing process. for further information on aspects of specification and design, see gamp 5 appendices d1 through d7 (reference 5, appendix 14).\n\nexample of a system specification approach for mes\n\nan example of a system specification approach that is hierarchical and traceable includes:\n\n- the root specification describes and provides cross-references to individual systems and applications, integration, infrastructure, and equipment that comprise the mes implementation.", "start_char_idx": 0, "end_char_idx": 2711, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "55083db6-5d67-4a17-829b-8709035a580c": {"__data__": {"id_": "55083db6-5d67-4a17-829b-8709035a580c", "embedding": null, "metadata": {"page_label": "32", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Design and Configuration of Manufacturing Execution Systems: A Comprehensive Approach", "questions_this_excerpt_can_answer": "1. What specific aspects should be reviewed during the design review phase to ensure a Manufacturing Execution System (MES) meets its intended use and complies with GMP and other applicable regulations, according to the GAMP(r) Good Practice Guide?\n\n2. How does the GAMP(r) Good Practice Guide suggest handling the balance between system specification and design customization for MES to ensure both compliance and functionality, particularly in relation to supplier-developed products?\n\n3. What role does risk management play in the selection of hardware and infrastructure for MES, as outlined in the GAMP(r) Good Practice Guide, and what specific appendix provides further information on this process?", "prev_section_summary": "This section discusses the strategic approach to Manufacturing Execution Systems (MES) with a focus on ensuring compliance and risk management in manufacturing operations. Key topics covered include the benefits of MES in relation to Risk-Based Engineering (RBE), handling security of logon and signature entries, conducting risk assessments during the purchase of complex systems like MES, and specification and design considerations for MES implementation. The section emphasizes the importance of addressing functional risks, involving major users in defining risks and requirements, and creating a hierarchical and traceable system specification approach for MES. It also references the ISPE GAMP Good Practice Guide for further information on electronic records and signatures compliance and risk assessments.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP Good Practice Guide, Risk Management, System Configuration"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "4bb6c97e-c9bd-4773-9f60-43e4eab27032", "node_type": "4", "metadata": {"page_label": "32", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "a76c8db96a1fe46b9bcb1cefc2be2a87c3ee636a8e761f90130c20b5deda9ce4", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "0a185f31-ad06-45f1-83a2-c91de6e5638d", "node_type": "1", "metadata": {"page_label": "31", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "ea58d88d7ac35933616299c9a348338eca295e0c28befd1992161be8c72ffbba", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "1cff1862-d811-4cc3-9c6f-f994988be2d7", "node_type": "1", "metadata": {}, "hash": "19abbddeede63dc62a5dd84f8eb371245f4f9e29c164eecd204749cd368f3a00", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\nthe root specification may include specifications for common functionality, such as user interface, data conventions across applications and systems, and self-contained functionality from a supplier.\n\nindividual system specifications focus on each mes domain component.\n\ndesign and configuration specifications detail how the system is built and configured for use at each location. how a system implements a requirement is important to manufacturing operations and often directly affects the required labor and systems integration related to unit operations. time spent reworking specifications during implementation may reduce available resources and time required for adequate testing.\n\n### design review\n\nsystem specification and design should be reviewed to confirm that proposed or ongoing designs will result in systems that are capable of executing the required business processes including data management. design review may be performed once or in phased or cyclical approaches depending on the implementation methods and the level of risk and impact potential of the planned system. these activities involve reviewing the system specifications, and prototype if applicable, against the user requirements, design practices and guidelines, applicable regulatory requirements, and identified risks. the purpose is to ensure and document:\n\n- the adequacy of the design and configuration specifications for development or purchase\n- that the design will meet the intended use of the system and business process requirements\n- that the system, as designed, will comply with gmp and other applicable regulations\n- that identified risks are adequately controlled\n- that adequate traceability among systems specifications and test documentation is established\n\nfor mes, which are based on configured products, a significant part of the design review activities should have been performed by the supplier during their development of the product. this should be verified during supplier assessment. user design review activities should focus on the configuration activities. design reviews should be performed by appropriate smes. for further information, see gamp 5, appendix m5 (reference 5, appendix 14).\n\n### configuration and customization\n\n#### system build, installation, and configuration\n\nsystem build, installation, and configuration involves developing or procuring new hardware or software modules, configuring any hardware and software, and building the overall system. decisions for the selection of hardware, infrastructure, and applications should be based on a risk management approach for the approved design. for further information, see appendix 12.\n\n#### configuration\n\nconfiguration typically involves setting system parameters to match an organizations business processes using standard system functionality.", "start_char_idx": 0, "end_char_idx": 2942, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "1cff1862-d811-4cc3-9c6f-f994988be2d7": {"__data__": {"id_": "1cff1862-d811-4cc3-9c6f-f994988be2d7", "embedding": null, "metadata": {"page_label": "33", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Customization and Implementation of Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the specific categories designated for software and hardware customization within the context of Manufacturing Execution Systems (MES) implementation, and how do these categories influence the required level of testing and validation strategy?\n\n2. How does the GAMP (Good Automated Manufacturing Practice) guide suggest assessing the risks associated with customization of software, infrastructure, or system hardware in MES, and what factors should be considered in determining the impact of these customizations on production and system functionality?\n\n3. What factors should be considered in the approach to implementing an MES domain to ensure an effective validation strategy, and what are the recommended steps for resolving issues related to the rollout of additional functionality within an MES environment?", "prev_section_summary": "This section discusses the strategic design and configuration of Manufacturing Execution Systems (MES) according to the GAMP(r) Good Practice Guide. Key topics include the importance of design review to ensure compliance with regulations and intended use, the balance between system specification and design customization, risk management in selecting hardware and infrastructure, and the role of suppliers in design review activities. The section also covers system build, installation, and configuration, as well as the configuration of system parameters to align with business processes. Key entities mentioned include system specifications, design practices, user requirements, regulatory requirements, risks, suppliers, and hardware and infrastructure selection.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Customization, GAMP, Validation Strategy"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "97c2dd1e-3713-44a6-b609-b8aaac93cf4b", "node_type": "4", "metadata": {"page_label": "33", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "f0a7b0cbed91617f6c673c677207a59c7a81d08e4b4a8c6ddff1113b6d606558", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "55083db6-5d67-4a17-829b-8709035a580c", "node_type": "1", "metadata": {"page_label": "32", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "a76c8db96a1fe46b9bcb1cefc2be2a87c3ee636a8e761f90130c20b5deda9ce4", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "7b57e779-f2d4-4bd1-9dcb-5b95df366ff4", "node_type": "1", "metadata": {}, "hash": "449d002d6e3056069c6539c8cbdb7ddb7d7f716f65634b9dc7ce9c18187ac60a", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n3.5.3 customization\n\ncustomization involves altering or adding to standard or supplier delivered systems and equipment functionality. end users take on responsibility for added risk by requesting alterations or implementing their own changes. assessment of risks for customized software, infrastructure, or system hardware should determine the impact on production, as well as on systems functionality, including assessment of impact that may cross system boundaries. customized items can be grouped into one or more functional domains and the appropriate risk-based approaches applied to specification and verification based upon risk assessments for those functional domains, mitigated by individual function and hardware factors, such as lower complexity or impact. software examples include:\n\n- software code changes\n- new applications or programs\n- new modules that link into applications\n- complex scripting that modifies system functionality\n\nsoftware customization is designated as software category 5, requiring more extensive testing based on risk, and should be identified as part of the validation strategy. customized hardware is designated as hardware category 2.\n\n3.6 implementation\n\nthe approach to implementation of an mes domain will affect the validation strategy and should be considered in advance. factors to consider typically include:\n\n- establishing control responsibilities for hardware and software environments\n- determining single verses multiple process or site rollouts\n- defining testing in controlled offline test environments verses production environments\n- training\n- future development\n\nthe following should be appropriately reviewed and resolved:\n\n- how and when additional functionality is to be rolled out", "start_char_idx": 0, "end_char_idx": 1857, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "7b57e779-f2d4-4bd1-9dcb-5b95df366ff4": {"__data__": {"id_": "7b57e779-f2d4-4bd1-9dcb-5b95df366ff4", "embedding": null, "metadata": {"page_label": "34", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Deployment and Verification of Manufacturing Execution Systems: A Comprehensive Approach", "questions_this_excerpt_can_answer": "1. What are the recommended approaches for deploying Manufacturing Execution Systems (MES) across multiple sites, including how to manage configuration, verification, and support according to the GAMP\u00ae Good Practice Guide?\n   \n2. How does the GAMP\u00ae Good Practice Guide suggest maintaining validated MES when integrating and validating new functionalities, especially in terms of data management and migration strategies?\n\n3. What specific guidance does the GAMP\u00ae Good Practice Guide provide regarding the development of a test strategy for MES, including considerations for supplier documentation, the involvement of subject matter experts (SMEs), and the handling of suppliers performing non-routine activities?", "prev_section_summary": "The section discusses the customization and implementation of Manufacturing Execution Systems (MES) with a focus on risk assessment, validation strategy, and impact on production and system functionality. Key topics include the GAMP guide's recommendations for assessing risks associated with customization, categorization of software and hardware customization, factors to consider in implementing an MES domain, and steps for resolving issues related to the rollout of additional functionality within an MES environment. Entities mentioned include software customization categories, risk-based approaches, validation strategies, hardware categories, control responsibilities, testing environments, training, and future development.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP Good Practice Guide, Verification, Test Strategy"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "40d92323-2c48-4af3-a974-0f01bc540d65", "node_type": "4", "metadata": {"page_label": "34", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "a193355ca660429ea9a14ddac7d800003dd7ebba86f428ad1e10697ab12ca1c1", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "1cff1862-d811-4cc3-9c6f-f994988be2d7", "node_type": "1", "metadata": {"page_label": "33", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "f0a7b0cbed91617f6c673c677207a59c7a81d08e4b4a8c6ddff1113b6d606558", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "e547bd29-0631-4c35-8f33-1998d2247310", "node_type": "1", "metadata": {}, "hash": "f0e5afb90366b7458ef5aa583dc4aba61e1f293301678a0b93458a10c63fc3fe", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n* how and when additional sites are to be rolled out\n\n* how are phase and functionality additions going to be supported at both the new and existing sites\n\n* ownership of the configuration, verification, and support at all the sites\n\n* how to maintain validated systems when new functionality needs to be integrated and validated\n\n* data management and migration, e.g., paper to electronic, existing system to new system, site to site\n\nmes projects are typically deployed in one of the following ways:\n\n- central control of applications\n- a central organization is responsible for specifying, developing, and controlling versions of applications in the mes domain.\n- changes requested by sites are implemented by the central organization.\n- site control of applications\n- sites are responsible for specifying, developing, and controlling versions of applications in the mes domain.\n- combination of central and site control\n- a central organization is responsible for core applications or functionality with sites responsible for the remainder.\n\nfor further information, see appendix 4.\n\n### verification\n\nverification confirms that specifications have been met and that systems are fit for the intended use. verification encompasses factory acceptance tests, site acceptance tests, commissioning and testing, to identify defects, confirm installation, and demonstrate the system meets its requirements.\n\nthis section contains a summary of testing requirements for mes. for further information, including detailed checklists, see gamp 5, appendix d5 (reference 5, appendix 14) and the ispe gamp good practice guide: testing of gxp systems (reference 6, appendix 14).\n\n#### test strategy\n\nan appropriate test strategy should be developed covering all required stages based on the risk, complexity, and novelty of systems. supplier documentation should be assessed and used if suitable and the supplier is prepared to make the documentation available. the strategy should define which types of testing are required and the number and purpose of test specifications. the test strategy should be reviewed and approved by appropriate smes. the test strategy should take into account the number of suppliers involved and whether suppliers are performing standard or specialized activities. for example, more rigorous testing may be required if a supplier is not following routine or well-established procedures.", "start_char_idx": 0, "end_char_idx": 2516, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "e547bd29-0631-4c35-8f33-1998d2247310": {"__data__": {"id_": "e547bd29-0631-4c35-8f33-1998d2247310", "embedding": null, "metadata": {"page_label": "35", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Testing Approach for Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the GAMP(r) Good Practice Guide suggest addressing the diverse functionality span of MES between process control, operational control, and business systems in terms of testing strategy?\n   \n2. What specific steps does the document recommend for establishing traceability within the MES domain to define the scope of testing, and how does it suggest linking various specifications to testing across the MES domain's components?\n\n3. According to the document, what are the stages of testing recommended for MES systems classified as GAMP category 4, and how should the testing focus be adjusted based on the complexity and impact of the system?", "prev_section_summary": "The section discusses the strategic deployment and verification of Manufacturing Execution Systems (MES) according to the GAMP\u00ae Good Practice Guide. Key topics include approaches for deploying MES across multiple sites, ownership of configuration and support, maintaining validated systems when integrating new functionalities, data management and migration strategies, and verification processes such as factory acceptance tests and site acceptance tests. The section also emphasizes the importance of developing a test strategy for MES, considering factors such as risk, complexity, supplier documentation, involvement of subject matter experts (SMEs), and handling of suppliers performing non-routine activities.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, testing strategy, traceability"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "5ad7a32e-dacd-442b-8a92-749ea0c937d3", "node_type": "4", "metadata": {"page_label": "35", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "a4904d2f37c37e6fb9b4562eb4d75dd6b6edaea5fb838888fd1e5b67918b3695", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "7b57e779-f2d4-4bd1-9dcb-5b95df366ff4", "node_type": "1", "metadata": {"page_label": "34", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "a193355ca660429ea9a14ddac7d800003dd7ebba86f428ad1e10697ab12ca1c1", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "9d6fae7d-4a85-4671-8564-e7f24329a8b7", "node_type": "1", "metadata": {}, "hash": "001683f1f408fc8a667de123d3ce69d50d2d40b48eada8553c8864f49af3849c", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\nsince mes spans functionality between process control, operational control, and business systems, the test strategy should be defined to address all types of functionality. business systems may tend to be transactional, maintained by an it organization, and be enterprise or facility-wide. process control systems tend to be real-time, maintained by operations or engineering with designs based upon unit operations. the functional domain-based approach focuses the test strategy on the appropriate testing of functionality, regardless of the system or application within which the functionality resides.\n\n### 3.7.2 use of traceability\n\nthe source and ownership of the data elements that are used within the mes domain should be identified in order to define the scope of testing. a process should be established to link user requirements through functional specifications, design specifications, and configuration specifications to testing across the applications and systems, databases, and integration components that make up the defined mes domain. traceability should be confirmed during design review. key parameters to consider include:\n\n- identifying data or information elements as well as the source of the data (e.g., materials)\n- defining the process that will convert the data or information (e.g., convert materials from erp inventory formats to shop-floor work order formats)\n- identifying outputs from the conversion process, (e.g., material lots, production quantities, or other created information)\n- defining the destination of the converted data or information\n- defining the timing and delivery requirements\n\nwithin the mes domain, the typical testing steps should then be applied as they relate to functional domain elements. for further information, see appendix 6.\n\n### 3.7.3 stages of testing\n\nmes typically involves the configuration of commercially available software products running on standard hardware components. software products which are configured for a specific business process are typically classified as gamp category 4. in such cases, and based on satisfactory supplier and risk assessments, a testing approach based on the three levels of configuration, functionality, and requirements is typically applicable. the number of test documents required to cover these three levels will depend on the complexity and impact of the system. testing should focus on:\n\ninstallation testing - tests should verify and document that system components are combined and installed in accordance with specifications, supplier documentation, and local and global requirements.\nconfiguration testing - tests should verify that the package has been configured in accordance with the relevant specification. the tests may take the form of inspections or check of supplier documentation.\nfunctional testing - functionality that supports the specific business process based on risk and supplier assessments (this is an area where supplier documentation may be leveraged).\nrequirements testing that demonstrate fitness for intended use; this may include testing the system functionality against requirements depending on risk.", "start_char_idx": 0, "end_char_idx": 3255, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "9d6fae7d-4a85-4671-8564-e7f24329a8b7": {"__data__": {"id_": "9d6fae7d-4a85-4671-8564-e7f24329a8b7", "embedding": null, "metadata": {"page_label": "36", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Testing Considerations for Manufacturing Execution Systems (MES) in the Manufacturing Industry", "questions_this_excerpt_can_answer": "1. What specific tests are recommended for Manufacturing Execution Systems (MES) to ensure they meet contractual acceptance before and after delivery, according to the GAMP (r) Good Practice Guide?\n   \n2. How does the GAMP (r) Good Practice Guide categorize custom software required as part of MES in terms of testing rigor, and what appendix provides detailed information on test strategy, execution, reporting, supplier, and automated testing?\n\n3. What are the key aspects that require particular consideration to ensure adequate testing of MES to prevent critical data loss, ensure system security, and maintain operational integrity, as outlined in the GAMP (r) Good Practice Guide?", "prev_section_summary": "The section discusses the strategic testing approach for Manufacturing Execution Systems (MES) as outlined in the GAMP(r) Good Practice Guide. It covers the need to address the diverse functionality span of MES between process control, operational control, and business systems in testing strategy. The use of traceability is emphasized to define the scope of testing within the MES domain, linking user requirements to testing across applications, systems, databases, and integration components. The stages of testing for MES systems classified as GAMP category 4 are outlined, including installation testing, configuration testing, functional testing, and requirements testing. The focus is on ensuring system components are installed correctly, configurations are accurate, functionality supports business processes, and requirements are met for intended use.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP, Testing Considerations, Data Integrity"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "9964a8b8-efcc-45c0-80a4-0ca7addc4122", "node_type": "4", "metadata": {"page_label": "36", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "a928a90ea005dd327ba8e25615ad574690c199052227a366cc11355720b158d9", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "e547bd29-0631-4c35-8f33-1998d2247310", "node_type": "1", "metadata": {"page_label": "35", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "a4904d2f37c37e6fb9b4562eb4d75dd6b6edaea5fb838888fd1e5b67918b3695", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "1a56a5f2-33b4-4825-aa48-092cc7e095d1", "node_type": "1", "metadata": {}, "hash": "999c2d850811bbe946e39208b8796ca057d572c6114eb5da787dddd93342ec2f", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\nrequirements testing should include delivery and acceptance of the final documentation set from the supplier, including specifications, manuals, and drawings, if not already covered.\n\nany further or more rigorous tests as a result of risk and supplier assessments.\n\nwhen working with suppliers, tests are often structured to allow contractual acceptance, e.g.:\n\n- factory acceptance tests (fats) are performed at the supplier site before delivery to show that the system is working sufficiently well to be installed and tested on-site.\n- site acceptance tests (sats), sometimes called system acceptance testing, show that the system is working in its operational environment and interfaces correctly with other systems and peripherals.\n\nany custom software required as part of mes, such as new interfaces, should be considered category 5, requiring more rigorous testing. for more information on test strategy, execution, reporting, supplier, and automated testing, see gamp 5, appendix d5.\n\n### specific aspects to consider\n\nfor mes, aspects that require particular consideration to ensure adequate testing include:\n\n- power failure testing, especially brownout (low voltage situations without complete power loss). brownouts can result in some systems resetting with possible data and sequence synchronization issues.\n- prevention against loss of critical data or loss of control action.\n- ease of controlled restart.\n- system access and security features.\n- audit trails and logging of critical actions, including manual interactions.\n- manual data entry features and testing methods.\n- electronic signature integrity.\n- alarms and error messages.\n- critical calculations.\n- critical transactions.\n- transfer of critical data into other packages or systems for further processing.\n- interfaces and data transfers.\n- backup and restore.\n- data archival and retrieval.\n- ability to deal with high volume loads, especially if the system is accessed by many users as part of a network application.", "start_char_idx": 0, "end_char_idx": 2108, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "1a56a5f2-33b4-4825-aa48-092cc7e095d1": {"__data__": {"id_": "1a56a5f2-33b4-4825-aa48-092cc7e095d1", "embedding": null, "metadata": {"page_label": "37", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Testing and Data Migration in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the key considerations for planning integration and interface testing within the Manufacturing Execution Systems (MES) domain as outlined in the GAMP Good Practice Guide?\n   \n2. How does the document suggest handling the verification of interfaces once installed in a production environment, especially concerning data integrity, performance under load, and error reporting?\n\n3. What specific guidance does the document provide for planning and executing data migration projects in MES, including the use of data migration tools and the development of scripts?", "prev_section_summary": "The section discusses testing considerations for Manufacturing Execution Systems (MES) in the manufacturing industry, as outlined in the GAMP (r) Good Practice Guide. It covers specific tests recommended for MES to ensure contractual acceptance, categorization of custom software in terms of testing rigor, key aspects requiring consideration for adequate testing to prevent data loss and ensure system security, and operational integrity. Topics include delivery and acceptance of documentation, factory acceptance tests (FATs), site acceptance tests (SATs), custom software testing, power failure testing, data integrity, system access and security features, audit trails, electronic signatures, alarms and error messages, data transfers, backup and restore, data archival and retrieval, and handling high volume loads.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Integration Testing, Data Migration, GAMP Good Practice Guide"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "a54b2868-70e1-45a3-93f1-3c85c38ae1a9", "node_type": "4", "metadata": {"page_label": "37", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "61e54facb60a711c45725d73bcee7b70c1198016c7dc6ba3deb63403a3dc077f", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "9d6fae7d-4a85-4671-8564-e7f24329a8b7", "node_type": "1", "metadata": {"page_label": "36", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "a928a90ea005dd327ba8e25615ad574690c199052227a366cc11355720b158d9", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "b8e96097-b775-45a0-ba97-49fb14a57ec1", "node_type": "1", "metadata": {}, "hash": "956a218f72670e5a70358fbc98341e1b99e35e5fe67a0da0a54fbdab174cddbe", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\ntest data\n\nnormalization of data\n\nin addition, mes may involve substantial integration and interface activities.\n\n### integration and interface testing\n\nplanning should identify clearly how systems and components in the mes domain need to be integrated. for an integrated testing approach to be feasible, it is important that the implementation program is under change management to ensure there is no adverse impact on previously tested components. this includes having a unified process if different project change control approaches are being used for various components of the mes domain. this is particularly important for mes and equipment that are verified in a modular fashion by system, function, room, area, or site.\n\nthe test strategy should define the approach to testing of interfaces. interfaces may be documented and managed as independent systems, or as a component of one of the source data systems. the approach should consider:\n\n- whether a particular system is dominant in generating or storing data\n- whether data transmission flow is one-way or duplex\n- whether one system previously exists or is installed first and the interface can be assigned to it\n- whether the interface is comprised of middleware (non-configured, configured, or custom) or the interface is a constituent part of one system or database\n\ninterface testing should include tests for data integrity, performance under load, and error reporting at a minimum. tests should cover each data flow transfer (e.g., daily download, batched data transfer, or real-time data). once installed in a production environment, the interface should be verified to have the correct connectivity to applications and databases. see appendix 3 and appendix 6.\n\n### data migration\n\n#### data migration planning\n\nmigration or the transfer of data from one system to another is a key issue when planning and executing mes projects. data migration plans should be based on risk and developed to describe execution and verification activities for transferring permanent, historical, or live real-time data from existing systems to test or production systems. for further information, see gamp 5, appendix d7 (reference 5, appendix 14).\n\nmigrating system data from existing corporate or site systems involves planning for:\n\navailability of data migration tools\ndevelopment of scripts\ncurrent state of site-based systems (active, retired, archived, under revision, or upgrade)\ncutover strategy from test to production systems", "start_char_idx": 0, "end_char_idx": 2600, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "b8e96097-b775-45a0-ba97-49fb14a57ec1": {"__data__": {"id_": "b8e96097-b775-45a0-ba97-49fb14a57ec1", "embedding": null, "metadata": {"page_label": "38", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Data Migration and Verification in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What specific steps and considerations are outlined in the GAMP(r) Good Practice Guide for ensuring data and referential integrity during the migration of data to a Manufacturing Execution System (MES)?\n\n2. How does the document recommend verifying migrated data in a Manufacturing Execution System environment, including the tools and approaches for ensuring the accuracy and integrity of the data post-migration?\n\n3. What procedural and technical controls does the guide suggest implementing to prevent unauthorized modification of data during the migration process to a Manufacturing Execution System, especially in the context of static versus dynamic data types?", "prev_section_summary": "This section discusses key considerations for integration and interface testing within Manufacturing Execution Systems (MES), including the importance of change management, test strategy for interfaces, and testing for data integrity, performance, and error reporting. It also covers data migration planning, including the use of data migration tools, development of scripts, and cutover strategy from test to production systems. The section emphasizes the need for a comprehensive approach to testing and data migration in MES projects.", "excerpt_keywords": "Data Migration, Manufacturing Execution Systems, GAMP, Data Integrity, Verification"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "6ed9cd22-e81d-4d35-b28f-71964c582828", "node_type": "4", "metadata": {"page_label": "38", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "2d51024de033fe8ce51c9d5b022b58d8555528bd51da436a98db790c681ac08f", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "1a56a5f2-33b4-4825-aa48-092cc7e095d1", "node_type": "1", "metadata": {"page_label": "37", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "61e54facb60a711c45725d73bcee7b70c1198016c7dc6ba3deb63403a3dc077f", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "72843d1b-3cff-4354-a474-cd1a48dd4d86", "node_type": "1", "metadata": {}, "hash": "29b4413248176f99b9079e0e00ea84ae902061ab723f44acc4a2a50b5147f5cf", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n* access times to operational systems and applications\n\n* electronic data conversion or move\n\n* verification\n\n* backup and archiving of data sets\n\nexisting systems may be staged to become obsolete or may become part of an mes domain. for systems that will become part of an mes domain, the data should be examined for compatibility of format and structure. migration plans should address any internal reformatting or schema changes required for access by other systems.\n\n### data migration execution and verification\n\nmigration may involve changing data to a different format during the process to fit new system constructs or standards. in some cases, this entails transferring data from paper to electronic format. migration from one electronic system to another may involve script or code development. development of these should consider the requirements for ensuring data and referential integrity.\n\nverification of migrated data includes:\n\n* confirmation the correct number of data records were transferred\n\n* verification of data values and format\n\n* verification of scripts or code used to translate data\n\n* appropriate data sampling and comparison of migrated data to original data whether the original data is paper or electronic format\n\n* review and approval of migration results by appropriate quality unit representatives for test or production systems\n\nthe verification of data should be performed by reviewing the data directly in the database using software utilities (e.g., sql) or indirectly through the use of the applications involved in the migration. data review may be performed manually or via a controlled software utility or tool.\n\nthe verification of data using a sampling approach should be performed based on an approved procedure or established standards (e.g., ansi/asqc).\n\ndepending on test and implementation methods, historical data may have to be migrated to test systems to ensure a realistic and appropriate test environment.\n\na data migration report should be generated and may be part of associated system documentation.\n\n### migration data types\n\nspecific data may be loaded in advance (static data), but other data cannot as it may be subject to continuous change (dynamic data).\n\nmigration and its verification should be carefully planned during the start-up and cut-over period. procedural and technical controls to prevent modification by users, administrators, or other electronic systems should be established prior to migration. data types to support the migration and verification procedures may be described by some broad categories, such as:", "start_char_idx": 0, "end_char_idx": 2702, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "72843d1b-3cff-4354-a474-cd1a48dd4d86": {"__data__": {"id_": "72843d1b-3cff-4354-a474-cd1a48dd4d86", "embedding": null, "metadata": {"page_label": "39", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Execution Systems: Strategic Program Management and System Release Best Practices Guide", "questions_this_excerpt_can_answer": "1. What specific types of data tables are identified in the GAMP Good Practice Guide for Manufacturing Execution Systems, and how are they categorized in terms of their dynamic or static nature?\n\n2. According to the document, what are the essential components and considerations for a well-managed system handover from the project team to the operational users in the context of Manufacturing Execution Systems?\n\n3. What criteria and documentation are emphasized for ensuring a controlled and documented cutover process from development and testing to production within the framework of Manufacturing Execution Systems as outlined in the guide?", "prev_section_summary": "This section discusses the importance of data migration and verification in Manufacturing Execution Systems (MES). It outlines specific steps and considerations outlined in the GAMP(r) Good Practice Guide for ensuring data and referential integrity during data migration. The document recommends verifying migrated data in MES environments, including tools and approaches for ensuring accuracy and integrity post-migration. It also discusses procedural and technical controls to prevent unauthorized modification of data during migration, especially in the context of static versus dynamic data types. Key topics include data migration execution and verification, data types, and procedural and technical controls for ensuring data integrity during migration.", "excerpt_keywords": "Manufacturing Execution Systems, GAMP, System Handover, Data Migration, Cutover Process"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "502f302a-03ca-41fc-bf1e-ab1e4e9dabdc", "node_type": "4", "metadata": {"page_label": "39", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "2f0f0e0588e8c6c6cbbe93e7763e3aa7845c79f40486724e6a8fabf46bba91ce", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "b8e96097-b775-45a0-ba97-49fb14a57ec1", "node_type": "1", "metadata": {"page_label": "38", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "2d51024de033fe8ce51c9d5b022b58d8555528bd51da436a98db790c681ac08f", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "8367a2c6-236b-4352-a6f6-45989fee9a8e", "node_type": "1", "metadata": {}, "hash": "76ffb9ae80366bbeb621c647b37273fe11b65d227a481f93266e07103b1dc2a1", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide:\n\nmanufacturing execution systems - a strategic and program management approach\n\n- static system specification nomenclature, abbreviations, symbols, and dimensional conversions\n- static specification tables, which contain the parameter data that will not change from process to process\n- dynamic specification tables are typically business process and product specific that are updated at the beginning of execution to define materials, processes, process equipment, and assets like scales, instruments, and storage containers for use in the process to be run.\n- dynamic status tables are updated as a result of executing the business process rules or recording information about non-automated operations.\n- dynamic application specific data is created from business operations, consumption of materials, and production creation.\n- dynamic history (logs or tables) data are the data that becomes the audit trails and internal transaction logs.\n\n## reporting and release\n\nprojects often require different stages of hardware and infrastructure availability (e.g., development, testing, and production environment) in preparation for system release.\n\nproviding effective environments may be very difficult or costly due to the number of systems and technologies involved. as a result, projects may need to consider the use of simulation (test) environments.\n\nwell managed system handover from the project team to the process owner, system owner, and operational users is a pre-requisite for effectively maintaining the compliance of a system.\n\ntherefore, reports should be produced summarizing:\n\n- activities performed\n- deviations from the plan\n- outstanding or corrective actions\n- statement of fitness for intended use of the system\n- systems and resources to support ongoing maintenance are in place and tested\n- disaster recovery and business continuity measures are in place and tested\n\nfor further information, see gamp 5, appendix m7 (reference 5, appendix 14).\n\norganizations should ensure a controlled and documented cutover process from development and testing to production with documentation demonstrating that release criteria have been met. planning should allow for any phased cutover steps and the time and resources to perform them. cutover criteria should include the following, as appropriate:\n\n- confirmation of completion of verification activities\n- outstanding actions or deviations have been addressed. this may include risk-based decisions for:\n- corrective and preventive action (capa) or other closeout requirements and criteria", "start_char_idx": 0, "end_char_idx": 2585, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "8367a2c6-236b-4352-a6f6-45989fee9a8e": {"__data__": {"id_": "8367a2c6-236b-4352-a6f6-45989fee9a8e", "embedding": null, "metadata": {"page_label": "40", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Execution Systems: Strategic Risk Management and Supporting Processes in Manufacturing Operations", "questions_this_excerpt_can_answer": "1. What are the key steps outlined in the GAMP(r) Good Practice Guide for ensuring data integrity and system efficiency in the context of Manufacturing Execution Systems (MES)?\n   \n2. How does the document describe the role of risk management in the development and implementation of Manufacturing Execution Systems, specifically in relation to patient safety, product quality, and data integrity?\n\n3. What specific methodologies or frameworks does the document recommend for conducting risk assessments within the MES project lifecycle, and how are these assessments integrated into the overall system development process?", "prev_section_summary": "The section discusses the GAMP Good Practice Guide for Manufacturing Execution Systems, focusing on static and dynamic system specifications, reporting and release processes, system handover, and cutover criteria. Key topics include static and dynamic specification tables, system handover considerations, reporting requirements, and cutover criteria such as verification activities, addressing outstanding actions, and closeout requirements. The section emphasizes the importance of a well-managed system handover and a controlled cutover process for ensuring compliance and system integrity in Manufacturing Execution Systems.", "excerpt_keywords": "Manufacturing Execution Systems, GAMP, Risk Management, Data Integrity, System Efficiency"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "6c781fd6-d3ee-40d6-8094-e231fe53c5a6", "node_type": "4", "metadata": {"page_label": "40", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "6aa7f26e807deb67cf8ae32959363dc8112c8d83184088dc4faa5e592958ac7c", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "72843d1b-3cff-4354-a474-cd1a48dd4d86", "node_type": "1", "metadata": {"page_label": "39", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "2f0f0e0588e8c6c6cbbe93e7763e3aa7845c79f40486724e6a8fabf46bba91ce", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "57723f8a-3147-4206-bc9f-4e1545fc7d90", "node_type": "1", "metadata": {}, "hash": "e51145f2b83428873a3c308ddcd9264d0ec79680ca31d42cac24f3b480e51e2e", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n- planned, on-going verification in the production environment\n\n- data archiving for obsolete legacy systems has been executed. future data retrieval methods have been developed.\n- existing test data has been removed from production systems.\n- data migration to production systems has been successful.\n\n### supporting processes\n\nthe key supporting activities for mes project development are:\n\n1. risk management\n2. configuration management, including project change control\n3. release management\n\n#### risk management\n\nquality risk management is a systematic process for the assessment, control, communication, and review of risks to patient safety, product quality, and data integrity, based on a framework consistent with ich q9 (reference 1, appendix 14). it is used:\n\n- to identify risks and to remove or reduce them to an acceptable level\n- as part of a scaleable approach that enables regulated organizations to select the appropriate lifecycle activities for a specific system\n\nfor mes, an initial risk assessment is required to understand the overall system impact as described in section 3.2.1. this should be followed by one or more functional risk assessments as the system specification and design are developed, as described in section 3.3.1.", "start_char_idx": 0, "end_char_idx": 1366, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "57723f8a-3147-4206-bc9f-4e1545fc7d90": {"__data__": {"id_": "57723f8a-3147-4206-bc9f-4e1545fc7d90", "embedding": null, "metadata": {"page_label": "41", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Risk Assessment and Management in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the GAMP (Good Automated Manufacturing Practice) guide suggest managing risks for configured products in the context of Manufacturing Execution Systems (MES)?\n   \n2. What is the difference between an MES domain and a functional domain as outlined in the \"Risk Assessment and Management in Manufacturing Execution Systems: A Comprehensive Guide,\" and how does this distinction aid in risk management?\n\n3. What are the key considerations outlined in the guide for assessing risks associated with a functional domain within MES implementations, and how does the guide suggest using a matrix to facilitate this process?", "prev_section_summary": "The excerpt discusses the key steps outlined in the GAMP(r) Good Practice Guide for ensuring data integrity and system efficiency in Manufacturing Execution Systems (MES). It emphasizes the importance of risk management in the development and implementation of MES, particularly in relation to patient safety, product quality, and data integrity. The document recommends specific methodologies and frameworks for conducting risk assessments within the MES project lifecycle, integrating them into the overall system development process. Key supporting processes for MES project development include risk management, configuration management, and release management. Quality risk management is highlighted as a systematic process for assessing, controlling, communicating, and reviewing risks, with a focus on identifying and reducing risks to an acceptable level. The excerpt also mentions the importance of an initial risk assessment followed by functional risk assessments as the system specification and design progress.", "excerpt_keywords": "Keywords: GAMP, Manufacturing Execution Systems, Risk Assessment, MES Domain, Functional Domain"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "d1ab3221-0c6e-4e95-ab29-c76f6f6dc4e0", "node_type": "4", "metadata": {"page_label": "41", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "be5cbb1472639369cd8a1a65cb6ef5974b3a9fd61ece59ad0ae33cb821355fa0", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "8367a2c6-236b-4352-a6f6-45989fee9a8e", "node_type": "1", "metadata": {"page_label": "40", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "6aa7f26e807deb67cf8ae32959363dc8112c8d83184088dc4faa5e592958ac7c", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "273bbdaf-2f0c-40ca-ac00-20bd501e490e", "node_type": "1", "metadata": {}, "hash": "a3a6a5dfeb970889c12d542b66081920db2561438ce9415237d7d8f9a0b33de7", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\nfigure 3.2: risk-based approach for configured product (category 4)\n\nwhat are the overall risks to the business?\n\nsystem gxp determination\n\nwhat is the overall impact of the system?\n\nare more detailed risk assessments required?\n\nconsider user testing of controls and procedures\n\n|iteration as required|user requirements specification testing|requirements testing|functional specification testing|functional testing of system controls|\n|---|---|---|---|---|\n|identify and define| | | | |\n|identify risks to specific processes| | | | |\n|identify risks to specific functions| | | | |\n|define controls to reduce risks| | | | |\n\nmes functionality poses particular challenges during the project life cycle, in that they may be complex and found on multiple systems with extensive interfaces. the mes domain approach provides a practical framework for assessing and managing risks associated with these challenges.\n\n### mes and functional domain approach and risk management\n\nthere is a distinction between an mes domain and a functional domain. an mes domain may be viewed as all the functionality related to manufacturing operations and management, and a functional domain may be viewed as a list of related functions that perform a particular set of tasks within the overall mes domain. individual functions may reside in more than one functional domain.\n\nthe mes and functional domain approach facilitates identification and grouping of related functions and data, including across system boundaries, which can be assessed together for risk. this helps ensure a consistent assignment of risk attributes to functionality that may be physically or logically separated in the systems architecture.\n\nmes implementations typically have a relatively high level of risk because of the likely impact on product quality and the difficulty of adequately documenting processes, requirements, and design because of complex data pathways through a number of related functions and common tasks.\n\nusing an mes and functional domain approach, a matrix can be developed from requirements and specifications to show which functionality across systems is linked to a common task or data. each matrix can become a functional domain, or related functions within the matrix may be grouped into one or more functional domains. risk assessments may be made for each of these functional domains. testing methods and criteria may then be developed and applied to items in the functional domain as described in this guide. see appendix 3.\n\n### considerations when assessing risks\n\nimportant points to consider when assessing the risks associated with a functional domain include:", "start_char_idx": 0, "end_char_idx": 2761, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "273bbdaf-2f0c-40ca-ac00-20bd501e490e": {"__data__": {"id_": "273bbdaf-2f0c-40ca-ac00-20bd501e490e", "embedding": null, "metadata": {"page_label": "42", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Configuration Management in Manufacturing Execution Systems: Ensuring Reliability and Control", "questions_this_excerpt_can_answer": "1. How does the GAMP (Good Automated Manufacturing Practice) guide suggest handling the increased risk associated with custom components, such as scripts or linked code, in Manufacturing Execution Systems (MES)?\n   \n2. What specific example risk controls does the GAMP guide recommend for ensuring the reliability and availability of MES and their data, particularly in the face of system or communications interruptions?\n\n3. What are the key activities involved in configuration management for MES as outlined in the GAMP guide, and how do these activities contribute to the control and documentation of MES components throughout their life cycles?", "prev_section_summary": "This section discusses the risk assessment and management in Manufacturing Execution Systems (MES) using a comprehensive guide. It covers the GAMP guide's suggestions for managing risks for configured products, the distinction between MES domain and functional domain for risk management, and key considerations for assessing risks associated with functional domains within MES implementations. The section also highlights the challenges posed by MES functionality during the project life cycle and the use of a matrix to facilitate risk assessment and management. Key topics include system impact assessment, user testing of controls and procedures, grouping related functions and data, and developing risk assessments for functional domains.", "excerpt_keywords": "Keywords: GAMP, Manufacturing Execution Systems, Configuration Management, Risk Controls, Functional Domain"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "4429682f-8611-4e07-969d-a9e9c3b780b0", "node_type": "4", "metadata": {"page_label": "42", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "4bf2261044f05b758e0f88a96df5ecb56b41b56ea09acb5509615b223acf93da", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "57723f8a-3147-4206-bc9f-4e1545fc7d90", "node_type": "1", "metadata": {"page_label": "41", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "be5cbb1472639369cd8a1a65cb6ef5974b3a9fd61ece59ad0ae33cb821355fa0", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "6ddbe8f6-6754-45ee-9bfc-1fbd37e93d38", "node_type": "1", "metadata": {}, "hash": "6af60a334ea40c456c319c560c5fa255e234fba53793068baea725074d514fcb", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n- understanding customization verses configuration\n- working with suppliers or system integrators to create matrices of components, such as scripts or linked code (e.g., visual basic for applications (vba)), that is not in the standard system or application. this item list requires additional attention in testing because of increased risk. high-risk components may not be concentrated in any one functional domain. an additional use of a functional domain approach can be to group all functionality with a common set of risk attributes into a functional domain for which a consistent approach for specification and verification is established.\n- understanding how code types differ. for example, ladder logic functionality is simpler and more controlled than custom programming using programming languages such as vba and c++.\n- understanding how the intended use of a system or component may affect the product or process. for example, a simple device with large potential impact to product may warrant more rigorous supplier assessment and verification.\n- understanding critical steps in the manufacturing of products, such as weighing components, order of addition, manual instructions, in-process product sampling and testing, and verification of actual results to process limits. issues encountered with these operations may impact the quality, efficacy, and safety of the product, as well as the safety of operations personnel near processing equipment.\n- understanding the levels of complexity and integration of interfaces\n- understanding functionality used for execution of quality assurance and quality control activities, e.g., product disposition, rbe (see appendix 8).\n\n### example risk controls\n\nexample controls for identified risks associated with mes include:\n\n- design of redundancies in systems and infrastructure to assure high overall reliability and availability of systems and data\n- storage area networks\n- making more than one workstation available in a work area\n- operational recovery from backup systems through technical and procedural methods across multiple systems\n- sops for pausing and restarting production operations to minimize impact on processes and data\n- automatic recovery from fail-safe conditions, where possible\n- automatic or manual (procedural) update and resynchronization of data after a system or communications interruption, including data and transaction buffering\n\n### configuration management\n\nconfiguration management provides the necessary policies, guidelines, and procedures to document and control the components of the mes domain systems and supporting networks (hardware, software, and related documentation) throughout their life cycles. during project implementation, the configuration management activities typically consist of:\n\n- identification and documentation of system elements", "start_char_idx": 0, "end_char_idx": 2961, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "6ddbe8f6-6754-45ee-9bfc-1fbd37e93d38": {"__data__": {"id_": "6ddbe8f6-6754-45ee-9bfc-1fbd37e93d38", "embedding": null, "metadata": {"page_label": "43", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Comprehensive Title: \"Optimizing Configuration and Release Management Processes for Manufacturing Execution Systems\"", "questions_this_excerpt_can_answer": "1. What specific guidance does the GAMP (Good Automated Manufacturing Practice) provide for managing the configuration of Manufacturing Execution Systems (MES) and ensuring their compliance with required characteristics?\n\n2. How does the document suggest handling the complexity of configuration management when multiple suppliers and integrators are involved in the MES or integrated systems setup?\n\n3. What are the recommended practices for release management in the context of MES implementation, particularly regarding the determination of system boundaries and interfaces to assess the impact of new or altered components?", "prev_section_summary": "This section discusses the importance of configuration management in Manufacturing Execution Systems (MES) to ensure reliability and control. It covers topics such as understanding customization versus configuration, handling custom components like scripts or linked code, and the risks associated with MES. The section also provides examples of risk controls for ensuring the reliability and availability of MES and their data, such as redundancies in systems, operational recovery, and automatic data resynchronization. Additionally, it outlines the key activities involved in configuration management for MES, including the identification and documentation of system elements throughout their life cycles.", "excerpt_keywords": "MES, Manufacturing Execution Systems, Configuration Management, Release Management, GAMP"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "24223b8d-779d-4814-a317-b1abbe19ecc1", "node_type": "4", "metadata": {"page_label": "43", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "09cccd7b697980c8950e0e0f59e1b8fb85956ee76266a339834375f9a85e8a56", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "273bbdaf-2f0c-40ca-ac00-20bd501e490e", "node_type": "1", "metadata": {"page_label": "42", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "4bf2261044f05b758e0f88a96df5ecb56b41b56ea09acb5509615b223acf93da", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "69de20d2-5106-4d95-9037-20d02efecd2b", "node_type": "1", "metadata": {}, "hash": "f647c5aafaf48bc43dea123c979f1b5588bb55d4dedff70d8a48653228b2b316", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n- status accounting of system configuration items\n- reconciliation of system configuration versus required characteristics\n- controlling change via project change control\n\nany involvement of the supplier in these processes should be defined and contractually agreed. for further information, see gamp 5, appendix m8 (reference 5, appendix 14).\n\nestablishing a configuration baseline for each rollout of the mes program should provide a baseline reference point for operational change control, ongoing evaluations, maintenance, and future system assessments or periodic reviews.\n\nperiodic system quality audits should continue to verify current mes configurations and conformance with specifications to ensure ongoing regulatory compliance.\n\nthe following should be considered for components being integrated within a phased mes implementation:\n\n- definitions of status nomenclature, such as \"installed, configured, commissioned, operationally tested, released to operations\"\n- criteria to be met for each status to be achieved\n- a status management process whereby each milestone is defined, status achievement is recorded and updated as appropriate, and communicated to all concerned\n\nconfiguration management becomes particularly difficult when multiple suppliers and integrators are working on different parts of an mes or an integrated set of systems. procedures should be developed to ensure accurate and timely communications and scheduling that prevent completed work from being affected by ongoing implementation and testing. for further information, see appendix 12.\n\n### release management\n\nrelease management provides methods for defining criteria and responsibilities for releasing equipment, applications, system modules, and systems at each stage of implementation. processes should include consideration of system boundaries and interfaces to determine the impact of new or altered components on the mes domain implementation.\n\nfor further information, see appendix 12.", "start_char_idx": 0, "end_char_idx": 2096, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "69de20d2-5106-4d95-9037-20d02efecd2b": {"__data__": {"id_": "69de20d2-5106-4d95-9037-20d02efecd2b", "embedding": null, "metadata": {"page_label": "44", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Blank Canvas: A Collection of Diverse Entities\"", "questions_this_excerpt_can_answer": "Based on the provided context, here are three questions that the context can provide specific answers to, which are unlikely to be found elsewhere:\n\n1. **What is the specific file size of the \"ISPE Manufacturing Execution Systems\" document stored in the PharmaWise Engineer project within the PharmaWise CSV & Data Integrity raw data directory?**\n   - This question targets the unique attribute of the document's file size, which is detailed in the context.\n\n2. **What are the creation and last modification dates of the document titled \"Blank Canvas: A Collection of Diverse Entities\" found in the PharmaWise Engineer project's raw data directory?**\n   - This question seeks information on the document's metadata, specifically its creation and last modification dates, which are explicitly mentioned in the context.\n\n3. **Under what file name and path can the \"ISPE Manufacturing Execution Systems\" PDF be located within the PharmaWise Engineer project's directory structure, and what is its relevance to the project?**\n   - This question is designed to extract detailed information about the document's storage location and its potential relevance or role within the broader PharmaWise Engineer project, inferred from its detailed file path and name. The context provides specific details about the file's location and its format, which might hint at its importance within the project's scope.\n\nThese questions are tailored to extract unique information provided in the context, which would be difficult to find in other sources without access to the specific document or project details mentioned.", "prev_section_summary": "The section discusses the importance of configuration and release management processes for Manufacturing Execution Systems (MES). Key topics include status accounting of system configuration items, reconciliation of system configuration versus required characteristics, controlling change via project change control, establishing a configuration baseline for each rollout of the MES program, periodic system quality audits, definitions of status nomenclature, criteria for status achievement, status management processes, challenges of configuration management with multiple suppliers and integrators, and release management methods for defining criteria and responsibilities for releasing equipment, applications, system modules, and systems at each stage of implementation. Key entities mentioned include GAMP (Good Automated Manufacturing Practice), suppliers, integrators, and system boundaries.", "excerpt_keywords": "MES, Configuration Management, Release Management, GAMP, Suppliers"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "b0d65257-6718-4695-93ac-5cdd31e55ce6", "node_type": "4", "metadata": {"page_label": "44", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "ef62ded4d296008599e018d0780f679a37808ab2c819756ba152f9702b546362", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "6ddbe8f6-6754-45ee-9bfc-1fbd37e93d38", "node_type": "1", "metadata": {"page_label": "43", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "09cccd7b697980c8950e0e0f59e1b8fb85956ee76266a339834375f9a85e8a56", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "ae32f035-2eb6-4753-aa00-a60aa0fb38ec", "node_type": "1", "metadata": {}, "hash": "c22d39fa7bff931a59a090c69df36f1a0390688053ffbeab3b802e5b88e37bf7", "class_name": "RelatedNodeInfo"}}, "text": "no_content_here", "start_char_idx": 0, "end_char_idx": 15, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "ae32f035-2eb6-4753-aa00-a60aa0fb38ec": {"__data__": {"id_": "ae32f035-2eb6-4753-aa00-a60aa0fb38ec", "embedding": null, "metadata": {"page_label": "45", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Operational Change Control and Configuration Management in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the operational phase of Manufacturing Execution Systems (MES) ensure compliance and fitness for intended use throughout the systems' operational life, according to the GAMP\u00ae Good Practice Guide?\n   \n2. What specific steps and considerations does the formal change control process entail for operational changes in MES, as outlined in the document?\n\n3. How is configuration management defined in the context of MES lifecycle, and what are the procedures for managing configuration items as per the guidelines provided in the document?", "prev_section_summary": "The section provides metadata details about a document titled \"Blank Canvas: A Collection of Diverse Entities\" within the PharmaWise Engineer project's raw data directory. It includes information such as the file size, creation date, last modification date, file name, file path, and relevance to the project. The section also outlines specific questions that can be answered based on the context provided, focusing on unique attributes of the document and its storage location within the project directory.", "excerpt_keywords": "Operational Change Control, Configuration Management, Manufacturing Execution Systems, GAMP Good Practice Guide, Compliance"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "547825fd-11de-410e-8470-c3f008bd2d01", "node_type": "4", "metadata": {"page_label": "45", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "186aa40d3ae42bc03daf5aa010d9496f022d78675118810f14833c7d9dfb115b", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "69de20d2-5106-4d95-9037-20d02efecd2b", "node_type": "1", "metadata": {"page_label": "44", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "ef62ded4d296008599e018d0780f679a37808ab2c819756ba152f9702b546362", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "e5123704-9e5b-4bc3-90b7-191c348cc6f5", "node_type": "1", "metadata": {}, "hash": "934792f64bba1275b27328325151b2734072e82a46710fc7dece1e7d440560e7", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### operation phase\n\n4.1 introduction\n\ncompliance and fitness for intended use throughout the operational life of systems and equipment is achieved by the use of up to date documented procedures and training that cover use, maintenance, and management. the operation phase of mes typically has to account for changes to software, hardware, the business processes, and regulatory requirements. the integrity of the mes and their data is maintained at all times and verified as part of periodic review. this section considers aspects of the operation phase that are of particular relevance to mes. for further information, see gamp 5 section 4 (reference 5, appendix 14).\n\n### 4.2 operational change control and configuration management\n\n#### 4.2.1 change control\n\noperational change control is a critical activity that is fundamental to maintaining the compliant status of the mes. all changes that are proposed during the operation phase, whether related to software (including middleware), hardware, infrastructure, configuration, static data, or use of the mes, should be subject to a formal change control process. this process should ensure that all proposed changes are appropriately reviewed to assess impact and risk of implementing the change. the process should ensure that changes are suitably evaluated, authorized, documented, tested, and approved before implementation, and subsequently closed. the process should allow the rigor of the approach, including extent of documentation and verification, to be scaled based on the nature, risk, and complexity of the change. some activities, such as replacements and routine system administration tasks, should be covered by appropriate repair or system administration processes. change control teams or committees should have appropriate representation from the system users, process owners, system owners, and technical smes. changes involving process specifications also require process smes and personnel qualified to assess risks to product and patients. relationships between mes or otherwise interfaced systems and equipment should be specified to aid change control teams in determining the scope and impact that a change to one system or piece of equipment has on other related systems.\n\n#### 4.2.2 configuration management\n\nconfiguration management are those activities necessary to be able to precisely define a computerized system at any point during its life cycle, from the initial steps of development through to retirement. a configuration item is a component of the system which does not change as a result of the normal operation of the system. configuration items should be modified only by application of a change control process. formal procedures should be established to identify, define, and baseline configuration items and to control and record modifications and releases of configuration items, including updates and patches.", "start_char_idx": 0, "end_char_idx": 3020, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "e5123704-9e5b-4bc3-90b7-191c348cc6f5": {"__data__": {"id_": "e5123704-9e5b-4bc3-90b7-191c348cc6f5", "embedding": null, "metadata": {"page_label": "46", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Best Practices for Managing Manufacturing Execution Systems: Security, Performance Monitoring, Backup and Recovery, Record Retention, and Business Continuity", "questions_this_excerpt_can_answer": "1. What specific security measures are recommended for aseptic production lines, parenteral manufacturing, and cell culture production areas within the context of Manufacturing Execution Systems (MES) to ensure both personnel and system security?\n   \n2. How does the document suggest handling the backup and recovery of software, records, and data within MES to comply with regulatory requirements, and what specific guides does it refer to for further information on establishing, testing, and documenting restore procedures?\n\n3. What are the key components and considerations outlined in the document for effective business continuity and contingency planning in the context of Manufacturing Execution Systems, and how does it suggest organizations prepare to respond to failures and disruptions?", "prev_section_summary": "The section discusses the operational phase of Manufacturing Execution Systems (MES) and focuses on operational change control and configuration management. Key topics include the importance of compliance and fitness for intended use throughout the operational life of MES, the formal change control process for operational changes, and the definition and procedures of configuration management in the context of MES lifecycle. Entities mentioned include change control teams or committees, system users, process owners, system owners, technical subject matter experts (SMEs), process SMEs, and personnel qualified to assess risks to product and patients.", "excerpt_keywords": "Manufacturing Execution Systems, Security, Performance Monitoring, Backup and Recovery, Record Retention, Business Continuity"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "4462e2c6-dd74-49bf-8180-453e8ccf6a94", "node_type": "4", "metadata": {"page_label": "46", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "d16fe3015849c455b0606911a069261c75751c2cd1d0be803f21f4f55a967cf7", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "ae32f035-2eb6-4753-aa00-a60aa0fb38ec", "node_type": "1", "metadata": {"page_label": "45", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "186aa40d3ae42bc03daf5aa010d9496f022d78675118810f14833c7d9dfb115b", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "4fe2f75f-543e-4802-ab7f-14e6fb3772cb", "node_type": "1", "metadata": {}, "hash": "3fbb510aa1951f204ccf398e202d35b7b75fdd226108d79148408b2d31055e0b", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### 4.3 security\n\nsystems and equipment access levels, personnel qualifications, and groups should be defined and documented for all users of mes. security controls for multi-use systems that may have gxp and non-gxp modules, such as erp, require special attention to ensure that non-gxp access is the same security level or otherwise configured to ensure that gxp operations are protected. for example, within an integrated automated environment, gxp operations could be segregated by firewall from non-gxp applications to safeguard all data generated.\n\naseptic production lines, parenteral manufacturing, and cell culture production are operational areas that may need special personnel and system security, such as system lockouts, room access controls, or biometric devices for personal security and operational access level definitions.\n\nphysical as well as logical security should be appropriate for the accessible functionality in production areas. physical security can affect the needs for logical security. see appendix 9.\n\n### 4.4 performance monitoring\n\nsystem performance monitoring processes should ensure that adequate operation is maintained. for further information, see the ispe gamp good practice guide: global information systems control and compliance (reference 6, appendix 14).\n\n### 4.5 backup and recovery of software and data\n\nprocesses and procedures should be established to ensure that backup copies of software, records, and data are made, maintained, and retained for a defined period within safe and secure areas. restore procedures should also be established, tested, and the results of that testing documented. for further information, see the ispe gamp good practice guide: global information systems control and compliance (reference 6, appendix 14).\n\n### 4.6 record retention, archive, and retrieval\n\npolicies for retention of regulated records should be established, based on a clear understanding of regulatory requirements, and existing corporate policies, standards, and guidelines. retention periods should be defined as part of this process. archiving is the process of taking records and data offline by moving them to a different location or system, and potentially protecting them against further changes. procedures for archiving and retrieval of records should be established based on a clear understanding of regulatory requirements. for further information, see the ispe gamp good practice guide: global information systems control and compliance and the ispe gamp good practice guide: electronic data archiving (reference 6, appendix 14).\n\n### 4.7 business continuity and contingency planning\n\nbusiness continuity planning is a series of related activities and processes concerned with ensuring that an organization is fully prepared to respond effectively in the event of failures and disruptions.", "start_char_idx": 0, "end_char_idx": 2959, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "4fe2f75f-543e-4802-ab7f-14e6fb3772cb": {"__data__": {"id_": "4fe2f75f-543e-4802-ab7f-14e6fb3772cb", "embedding": null, "metadata": {"page_label": "47", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Comprehensive Business Continuity Planning and Periodic Reviews for Manufacturing Execution Systems", "questions_this_excerpt_can_answer": "1. What specific strategies does the GAMP\u00ae Good Practice Guide recommend for ensuring the continuity of critical business processes and systems in the event of a failure or disruption within Manufacturing Execution Systems (MES)?\n\n2. How does the document suggest handling data generated during a system outage or disruption, particularly in relation to business continuity planning (BCP) and the resumption of MES operations?\n\n3. What are the key considerations and recommended practices for conducting periodic reviews of MES to ensure compliance with regulatory requirements, fitness for intended use, and adherence to organizational policies and procedures, as outlined in the document?", "prev_section_summary": "The section discusses key topics related to managing Manufacturing Execution Systems (MES), including security measures for aseptic production lines, parenteral manufacturing, and cell culture production areas, performance monitoring, backup and recovery of software and data, record retention, archive, and retrieval, and business continuity and contingency planning. It emphasizes the importance of defining security controls, monitoring system performance, establishing backup and recovery procedures, defining record retention policies, and preparing for business continuity in the event of failures and disruptions. The section also references the ISPE GAMP Good Practice Guide for further information on these topics.", "excerpt_keywords": "Manufacturing Execution Systems, Business Continuity Planning, GAMP Good Practice Guide, Periodic Reviews, Regulatory Compliance"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "81deb07c-763c-4690-820f-cf027ea1c7f2", "node_type": "4", "metadata": {"page_label": "47", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "57160eec65de1b39c43bfaa3003c4860e2bfcad7bcbc6f78193be5d742eb04bc", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "e5123704-9e5b-4bc3-90b7-191c348cc6f5", "node_type": "1", "metadata": {"page_label": "46", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "d16fe3015849c455b0606911a069261c75751c2cd1d0be803f21f4f55a967cf7", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "a9583643-f037-420b-8df2-f0b7dcef988d", "node_type": "1", "metadata": {}, "hash": "f647c5aafaf48bc43dea123c979f1b5588bb55d4dedff70d8a48653228b2b316", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\ncritical business processes and systems supporting these processes should be identified and the risks to each assessed. plans should be established and exercised to ensure the timely and effective resumption of these critical business processes and systems.\n\na business continuity plan (bcp) defines how the business may continue to function and handle data following failure or disruption. it also defines the steps required to restore business processes following a disruption, and where appropriate, how data generated during the disruption should be managed.\n\nthe bcp also identifies the triggers for invoking the bcp, roles and responsibilities, and required communication.\n\nany paper or other records generated during systems outages should be maintained as the original records for the required archive periods, and also may be used to update the mes after recovery.\n\nthe use of hot standby systems for important systems should be considered.\n\nreverting to manual paper-based procedures and/or production records can allow processes to continue. however, the complexity of resynchronization of automated systems increases rapidly with the scope and volume of manual emergency activities. any manual activities should be limited to critical operations that cannot be interrupted. the following are important considerations when planning manual operation:\n\n- manual procedures should be maintained in a current state to match systems and processes.\n- although operating personnel may be fully trained on manual procedures, they may not have executed them in operations or rehearsal for long periods of time, which can result in errors.\n\nre-synchronizing data collected on paper with systems data can be difficult, and the original record is in two distinct types of media that may need to be archived. procedural controls are required to manage processing, storage, cross-referencing, and recovery of original records.\n\ncontingency planning and business continuity is also covered in section 4.6 \"business continuity and disaster recovery\" of the ispe gamp good practice guide: global information systems control and compliance (reference 6, appendix 14).\n\n## periodic review\n\nperiodic reviews are used throughout the operational life of the mes to verify that they remain compliant with regulatory requirements, fit for intended use, and meet organizational policies and procedures. the reviews should confirm that, for all components of the system, the required support and maintenance processes and expected regulatory controls (plans, procedures, and records) are established.\n\nfor mes, periodic reviews should consider the effects of cumulative changes on related systems including interfaces and data management. since mes involves direct interaction with manufacturing operations, impact of systems changes on processes, as well as process change impact on systems should be available for examination during the reviews.\n\nreview of calibration and maintenance records, incident records, change records, and configuration records should be included in system reviews. the training of personnel affecting system operation should be audited on a periodic basis, including expert groups supporting mes. the content and extent of reviews, as well as the intervals between reviews are based on an assessment of all the risks for the mes domain as well as constituent functional domains.\n\naudit findings should be addressed and closed by appropriate, documented, corrective, and preventative actions.", "start_char_idx": 0, "end_char_idx": 3616, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "a9583643-f037-420b-8df2-f0b7dcef988d": {"__data__": {"id_": "a9583643-f037-420b-8df2-f0b7dcef988d", "embedding": null, "metadata": {"page_label": "48", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Blank Canvas: A Collection of Absence\"", "questions_this_excerpt_can_answer": "Based on the provided context, here are three questions that this specific context can provide specific answers to, which are unlikely to be found elsewhere:\n\n1. **What is the file size of the \"ISPE Manufacturing Execution Systems\" PDF document stored in the PharmaWise Engineer project within the PharmaWise CSV & Data Integrity raw data directory?**\n   - This question is specific to the document's metadata, including its file size, which is detailed in the provided context.\n\n2. **What are the creation and last modification dates of the document titled \"Blank Canvas: A Collection of Absence\" found in the PharmaWise Engineer project's raw data directory?**\n   - The context provides unique information regarding the document's creation and last modification dates, which is not likely to be found in other sources.\n\n3. **How does the document titled \"Blank Canvas: A Collection of Absence\" relate to the ISPE Manufacturing Execution Systems within the context of the PharmaWise Engineer project?**\n   - This question seeks to understand the relationship or relevance between the document's content (or lack thereof, as suggested by the title and the \"no_content_here\" excerpt) and its placement within a collection that includes a document on Manufacturing Execution Systems, specifically within a pharmaceutical development context. This is a unique inquiry that combines the document's metadata with its thematic or content-based placement within a specific project directory.", "prev_section_summary": "The section discusses the importance of comprehensive business continuity planning for Manufacturing Execution Systems (MES), including the identification of critical business processes, establishment of a business continuity plan (BCP), management of data during system outages, and considerations for manual operation. It also covers the use of hot standby systems, periodic reviews of MES to ensure compliance with regulatory requirements, and the auditing of calibration, maintenance, incident, and change records. The section emphasizes the need for proactive measures to ensure the continuity and effectiveness of MES operations in the event of disruptions or failures.", "excerpt_keywords": "Keywords: ISPE, Manufacturing Execution Systems, business continuity planning, MES operations, regulatory compliance"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "70f19e9b-0546-4abd-98ab-8a088a1463ea", "node_type": "4", "metadata": {"page_label": "48", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "0d5e6167fd92a487042d8e7bf48ceb3797493304cae91e6bcfebc10faf380ed6", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "4fe2f75f-543e-4802-ab7f-14e6fb3772cb", "node_type": "1", "metadata": {"page_label": "47", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "57160eec65de1b39c43bfaa3003c4860e2bfcad7bcbc6f78193be5d742eb04bc", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "9e864463-75b6-472e-9559-28a8001ca310", "node_type": "1", "metadata": {}, "hash": "cb4368db4980ed8510b22a62b01a5162ce2eb4c644412727471d13622e45edbf", "class_name": "RelatedNodeInfo"}}, "text": "no_content_here", "start_char_idx": 0, "end_char_idx": 15, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "9e864463-75b6-472e-9559-28a8001ca310": {"__data__": {"id_": "9e864463-75b6-472e-9559-28a8001ca310", "embedding": null, "metadata": {"page_label": "49", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Ensuring Effective Governance and Oversight for MES Implementation in the Life Sciences Industry\"", "questions_this_excerpt_can_answer": "1. What are the three major foundation models that MES programs are designed to coordinate within the life sciences industry, as outlined in the document?\n   \n2. How does the document recommend ensuring that MES systems remain compliant with regulations and evolve with organizational requirements and the business environment in the life sciences sector?\n\n3. What methodologies does the document suggest for relating elements of program foundation models during the implementation of MES in the life sciences industry?", "prev_section_summary": "The section provides metadata information about a PDF document titled \"ISPE Manufacturing Execution Systems\" stored in the PharmaWise Engineer project within the PharmaWise CSV & Data Integrity raw data directory. It includes details such as file size, creation date, and last modification date. Additionally, it mentions a document titled \"Blank Canvas: A Collection of Absence\" and poses questions about the relationship between this document and the ISPE Manufacturing Execution Systems document within the project context. The section focuses on document metadata and their thematic relevance within a pharmaceutical development project.", "excerpt_keywords": "MES, governance, oversight, compliance, life sciences, implementation"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "c455a66f-da42-40c3-bf6f-0e8774fd70a5", "node_type": "4", "metadata": {"page_label": "49", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "aa92e803380acc62e3d589739cd4b38edb9f41b81c5d2358c4ef285336bc7a03", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "a9583643-f037-420b-8df2-f0b7dcef988d", "node_type": "1", "metadata": {"page_label": "48", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "0d5e6167fd92a487042d8e7bf48ceb3797493304cae91e6bcfebc10faf380ed6", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "0cb81ed9-5912-4dc1-a158-21182452aaf1", "node_type": "1", "metadata": {}, "hash": "e3df3cb694494246fd2aa84c35ed453a322c5f9f087848dc1b7c0c7db81fa75d", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 1 - coordination of compliance, project, and operations activities for mes\n\n5.1 introduction\n\nimplementation of mes requires coordinated governance, oversight, auditing, operations, and maintenance across multiple groups within organizations with responsibilities across system boundaries. typically, a program is established to oversee initial planning and implementation, as well as creating a permanent structure, such as a program management office (pmo) to coordinate activities among the systems within the mes domain to ensure systems remain compliant with regulations and evolve with organizational requirements and the business environment for life sciences. see appendix 12 configuration management.\n\n5.2 structuring a program\n\nmes programs are designed to supplement quality systems where necessary to accommodate control of multiple systems as a unified manufacturing environment. risk-based approaches are created or modified to be systemic and coordinated within technical and quality systems supporting the mes domain. the three major concepts (or foundation models) of mes programs are:\n\n- life cycle\n- quality systems\n- execution\n\nmes programs should be based on coordinating these concepts into a cohesive structure with activity-driven responsibilities which are clearly defined. the use of gamp, ieee, astm, and other guidance is recommended. figure 5.1 provides an example approach to relating elements of program foundation models, where there is overlap in many of the activities. this is based on the sequence and timing of intra-system or inter-system staged or phased implementation using a common life cycle approach. alternative methods that may be used for relating elements include:\n\n- rapid application development (rad)\n- dynamic system development (dsd)\n- structured analysis and design (sa/sde)\n\na standard set of operational definitions for the concepts, such as that shown in figure 5.1, can be established to harmonize documentation for computer systems, quality systems, and the life cycle. a phased or staged plan may be used to specify, verify, and release systems or functionality in the mes domain to operations in manageable subsets of the intended domain. during implementation, the current life cycle phase, specification and verification status of systems and equipment in the mes domain should be established at intervals, as part of a design review process which ensures that designs meet the intended use.", "start_char_idx": 0, "end_char_idx": 2466, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "0cb81ed9-5912-4dc1-a158-21182452aaf1": {"__data__": {"id_": "0cb81ed9-5912-4dc1-a158-21182452aaf1", "embedding": null, "metadata": {"page_label": "50", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Execution Systems Program Management and Responsibilities Guide", "questions_this_excerpt_can_answer": "1. What specific roles and responsibilities does GAMP 5 and the ISPE GAMP Good Practice Guide assign to technical organizations in the context of managing quality systems for computerized systems in life sciences regulation?\n\n2. How does the document define the relationship and division of responsibilities between process owners and system owners within the framework of Manufacturing Execution Systems (MES) program management?\n\n3. What are the responsibilities of technical SMEs (Subject Matter Experts) in ensuring the reliability and compliance of MES, according to the guidelines provided in the document?", "prev_section_summary": "This section discusses the importance of effective governance and oversight for MES implementation in the life sciences industry. It emphasizes the need for coordinated activities across compliance, project, and operations functions within organizations. The document suggests structuring a program to oversee planning, implementation, and ongoing maintenance of MES systems, with a focus on remaining compliant with regulations and evolving with organizational requirements. The three major foundation models for MES programs are identified as life cycle, quality systems, and execution. The document recommends using methodologies such as GAMP, IEEE, and ASTM guidance to coordinate these concepts into a cohesive structure. It also mentions alternative methods for relating elements of program foundation models, such as rapid application development and structured analysis and design. The section highlights the importance of establishing operational definitions and using a phased or staged plan for implementing MES systems in manageable subsets.", "excerpt_keywords": "Manufacturing Execution Systems, Program Management, Responsibilities, GAMP 5, ISPE GAMP Good Practice Guide"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "b5f0cae3-6a76-4181-9730-cc8e800d1963", "node_type": "4", "metadata": {"page_label": "50", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "eab601ec105cc450516c91e900c4f2dbc7b454ee201989f46a6815815f3ab11e", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "9e864463-75b6-472e-9559-28a8001ca310", "node_type": "1", "metadata": {"page_label": "49", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "aa92e803380acc62e3d589739cd4b38edb9f41b81c5d2358c4ef285336bc7a03", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "d5d58316-f9f8-44d9-af98-a0fe83adbfdd", "node_type": "1", "metadata": {}, "hash": "c6280ece6111db7a38adffed2110a39af67fcb2f763e0d769fd7cdc66b46638d", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 1: manufacturing execution systems - a strategic and program management approach\n\n5.3 program responsibilities\n\ngamp 5 (reference 5, appendix 14) and the ispe gamp good practice guide: global information systems control and compliance (reference 6, appendix 14) define roles for technical organizations in defining and managing quality systems related to their functional responsibilities for designing, testing, and maintaining computerized systems. quality units provide independent assessment or auditing of quality systems and technical programs where systems may affect product quality or are otherwise subject to life sciences regulation.\n\nprocess owners\n\nprocess owners should have ultimate responsibility for ensuring that the systems used in operations are in compliance and fit for intended use. while not typical, the process owner also may be the system owner where department expertise and capability permits. regardless of the owner department affiliation, responsibility structures should be established to utilize smes across department boundaries whenever all necessary skills are not present in the owner department. for example, it is typical for it and engineering to share appropriate responsibilities for mes programs, and either can be appropriate as system owner depending on the particular expertise in each group.\n\nsystem owners\n\nsystem ownership and maintenance responsibilities should be established explicitly. system ownership may be divided among computer systems or applications within mes; however, it is considered advantageous to have an overall mes domain owner to assure coordination of all supporting organizations and system owners. a system owner should have overall responsibility for systems security, maintenance, and reliability.\n\ndomain owner\n\nthe focus of the domain is to assure manufacturing and business functions are of primary importance in serving the critical needs of the business. while technical organizations can function as domain owners, process owners may be the appropriate domain owner, supported by technical organizations in the overall mes program domain management structure.\n\ntechnical smes\n\ntechnical smes, such as automation, engineering, maintenance, and it should have the expertise and the responsibility to establish system designs, testing methods, and maintenance practices based on geps and it guidance and standards. technical smes also can establish and maintain the required technical quality systems, e.g., document, drawing, software, and hardware version control that should be audited by the quality unit. technical smes have overall responsibility to provide and maintain reliable systems in a state of control for hardware, software, and documentation.", "start_char_idx": 0, "end_char_idx": 2749, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "d5d58316-f9f8-44d9-af98-a0fe83adbfdd": {"__data__": {"id_": "d5d58316-f9f8-44d9-af98-a0fe83adbfdd", "embedding": null, "metadata": {"page_label": "51", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Program Management for Manufacturing Execution Systems Lifecycle and Quality Systems Governance Strategy Document", "questions_this_excerpt_can_answer": "1. How does the document outline the integration of document control within the lifecycle of Manufacturing Execution Systems (MES) as part of its strategic program management approach?\n\n2. What specific strategies does the document propose for managing the transition and retirement phases of MES within the context of quality systems and governance?\n\n3. In the context of executing MES projects, how does the document detail the process for conducting independent program compliance auditing, and how is this integrated with configuration management and change control processes?", "prev_section_summary": "The section discusses the program responsibilities related to Manufacturing Execution Systems (MES) program management, as defined by GAMP 5 and the ISPE GAMP Good Practice Guide. It outlines the roles and responsibilities of process owners, system owners, domain owners, and technical Subject Matter Experts (SMEs) in ensuring compliance, reliability, and quality of MES systems. Key topics include defining responsibilities, division of responsibilities between process and system owners, and the importance of technical SMEs in maintaining reliable systems.", "excerpt_keywords": "Manufacturing Execution Systems, Strategic Program Management, Lifecycle, Quality Systems Governance, Compliance Auditing"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "818c84de-463d-47a9-b561-d6587b6ce5a4", "node_type": "4", "metadata": {"page_label": "51", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "bc738cbfd41692219887ef842662cf1c26f56410fb27ef7e0474167d888424e2", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "0cb81ed9-5912-4dc1-a158-21182452aaf1", "node_type": "1", "metadata": {"page_label": "50", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "eab601ec105cc450516c91e900c4f2dbc7b454ee201989f46a6815815f3ab11e", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "c9e1ebca-87cc-4bfc-bdda-bb52335caa8f", "node_type": "1", "metadata": {}, "hash": "804053874673bff8c8cc44221fc663f1eb19b2cc09e74190afaeb06aabbbb7aa", "class_name": "RelatedNodeInfo"}}, "text": "## manufacturing execution systems - a strategic and program management approach\n\n|projects|plan|specify|implement|\n|---|---|---|---|\n|life cycle| | | |\n| | | |operations|\n| | | |retirement|\n| | | | |\n| | | |independent program compliance auditing|\n| | | |document control (linked into configuration management)|\n|quality systems and governance| | | |\n| | | |configuration management/change management|\n| | | |project change control|\n| | | |operational change control|\n| | | |retirement|\n| | | | |\n| | | |development|\n| | | |design review|\n| | | |periodic review|\n| | | |policy/procedure|\n|execution| | | |\n| | | |testing - fat - sat/commissioning/testing release|\n| | | |change and release|\n| | | |de-commission/archive|", "start_char_idx": 0, "end_char_idx": 721, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "c9e1ebca-87cc-4bfc-bdda-bb52335caa8f": {"__data__": {"id_": "c9e1ebca-87cc-4bfc-bdda-bb52335caa8f", "embedding": null, "metadata": {"page_label": "52", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Integrated Life Cycle Management Strategies for Manufacturing Execution Systems\"", "questions_this_excerpt_can_answer": "1. How does the ASTM life cycle integrate with the GAMP 5 life cycle for manufacturing execution systems, particularly in the context of project activities and changes during the operation phase?\n   \n2. What specific guidance does the unified approach, as described in the document, offer for developing life cycle policies and procedures for manufacturing execution systems using ASTM terminology within GAMP 5 framework?\n\n3. How does the document describe the application of unified risk management concepts from ASTM 2500-07 and GAMP 5 in the development of specifications and verifications for manufacturing execution systems, particularly in terms of assessing risks based on novelty, complexity, and supplier quality?", "prev_section_summary": "The section outlines a strategic program management approach for Manufacturing Execution Systems (MES) lifecycle and quality systems governance. It discusses the integration of document control within the MES lifecycle, strategies for managing transition and retirement phases, conducting independent program compliance auditing, and integrating document control with configuration management. Key topics include project planning, implementation, quality systems, governance, configuration management, change control, testing, and decommissioning. Key entities mentioned are operations, retirement, compliance auditing, document control, configuration management, project change control, operational change control, development, design review, testing, release, and decommissioning.", "excerpt_keywords": "Manufacturing Execution Systems, ASTM, GAMP 5, life cycle management, risk management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "5994e642-2977-4149-ba58-c98d123c3446", "node_type": "4", "metadata": {"page_label": "52", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "54894757d3b8fda08a8e45416b41b39589d9e3b4898c7e099d99376885d64837", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "d5d58316-f9f8-44d9-af98-a0fe83adbfdd", "node_type": "1", "metadata": {"page_label": "51", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "bc738cbfd41692219887ef842662cf1c26f56410fb27ef7e0474167d888424e2", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "a49624dc-e514-4109-9a42-fa51f45f011f", "node_type": "1", "metadata": {}, "hash": "3f8102de17f9a8e1208dd1f273503ba37577c193c639e6329651c3be05f16abc", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 1: manufacturing execution systems - a strategic and program management approach\n\nfigure 5.2 shows a possible mapping of activities described by astm and gamp guidance to provide a unified approach for life cycle management.\n\n|astm| | | | | |\n|---|---|---|---|---|---|\n|2500-07 product knowledge| | | | | |\n|process knowledge|acceptance and release|operation and continuous improvement| | | |\n|regulatory requirements| | | | | |\n|company quality requirements| | | | | |\n|gamp 5| | | | | |\n|planning|reporting| | | | |\n|product and process knowledge|verification|changes| | | |\n|concept|project|operation|retirement| | |\n\nnotes on figure 5.2:\n\n- the astm life cycle is project oriented and fits into the overall gamp 5 life cycle project phase (reference 5, appendix 14). project activities within the gamp operation phase, e.g., for changes, also conform to this process as noted in gamp 5.\n- organizations can define life cycle policies and procedures based on the overall gamp life cycle, while utilizing astm terminology within projects.\n- the unified risk management concepts in the astm 2500-07 (reference 8, appendix 14) and gamp 5 guidance allow development of a standard approach to specification and verification based on establishment/assessment of risk-based on novelty, complexity, and supplier quality whether for equipment of systems or applications and constituent functionality.\n- risk approaches define the contents and rigor of activities.", "start_char_idx": 0, "end_char_idx": 1469, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "a49624dc-e514-4109-9a42-fa51f45f011f": {"__data__": {"id_": "a49624dc-e514-4109-9a42-fa51f45f011f", "embedding": null, "metadata": {"page_label": "53", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Strategic MES Planning Process: A Comprehensive Approach and Implementation Guidance\"", "questions_this_excerpt_can_answer": "1. What are the key factors that should guide the focus of an MES (Manufacturing Execution System) project according to the \"Strategic MES Planning Process: A Comprehensive Approach and Implementation Guidance\" document?\n\n2. How does the document suggest organizations should manage risks during the development and implementation of MES strategies?\n\n3. What tools and exercises does the \"Strategic MES Planning Process: A Comprehensive Approach and Implementation Guidance\" recommend for identifying an organization's relevant business drivers and the associated functional areas for MES implementation?", "prev_section_summary": "The section discusses the integration of ASTM and GAMP 5 life cycle approaches for manufacturing execution systems, focusing on project activities, changes during operation, and risk management concepts. It provides a mapping of activities from both standards to create a unified approach for life cycle management. The section emphasizes the project-oriented nature of the ASTM life cycle within the GAMP 5 framework, the development of life cycle policies using ASTM terminology, and the application of unified risk management concepts for specification and verification based on risk assessment criteria such as novelty, complexity, and supplier quality.", "excerpt_keywords": "MES, Planning Process, Implementation Guidance, Risk Management, Business Drivers"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "85c40455-cd98-4fe5-80eb-1b401672bc6c", "node_type": "4", "metadata": {"page_label": "53", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "261e5afb0c9bc052df147e90fd1a808fd46e79f8242c326b90c11156685bfe8a", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "c9e1ebca-87cc-4bfc-bdda-bb52335caa8f", "node_type": "1", "metadata": {"page_label": "52", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "54894757d3b8fda08a8e45416b41b39589d9e3b4898c7e099d99376885d64837", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "38acbe58-aaba-43db-88b4-9894d3e25606", "node_type": "1", "metadata": {}, "hash": "fd78a21d303717f5c4dc1043fd9b68ef7809166716a3c199999e12e3e2fe3876", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 2 - mes planning\n\n6.1 introduction\n\nthis appendix provides guidance for the mes planning process, including aspects of program, strategic, and implementation planning.\n\nmes projects should provide benefits based upon an organizations objectives and priorities, e.g., lowering costs, improving quality, and reducing time-to-market. the focus of the mes effort will depend on an organizations business drivers, regulatory environments, and customer demands. business drivers and mes strategies can be used to determine beneficial mes functions. risk management principles should be applied throughout development and implementation of strategies to ensure that risks are understood and mitigated appropriately throughout an mes project. organizations may choose which elements of functional domains to include as part of an implementation strategy. complexity, cost, compliance, culture, or resource constraints may drive a phased approach to mes implementation to spread limited budgets and resources over time or provide proof of concepts before attempting a large-scale implementation. business planning exercises should identify an organizations relevant business drivers, along with the associated functional areas, that can provide a positive business impact. these exercises may use several tools, e.g., gap analysis, audits and assessments, or \"brown paper\" flowcharting. quantifiable benefit metrics should be identified for business drivers. these metrics should determine the mes domain functionality to be implemented. an mes-based strategy exercise should provide a recommended project strategy for submission to management. figure 6.1 shows strategic planning functions and approach.", "start_char_idx": 0, "end_char_idx": 1707, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "38acbe58-aaba-43db-88b4-9894d3e25606": {"__data__": {"id_": "38acbe58-aaba-43db-88b4-9894d3e25606", "embedding": null, "metadata": {"page_label": "54", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Planning Functions and Challenges of MES in Manufacturing Pharmaceutical and Life Sciences Organizations", "questions_this_excerpt_can_answer": "1. How does the document outline the strategic planning functions necessary for implementing Manufacturing Execution Systems (MES) in pharmaceutical and life sciences organizations, specifically in terms of existing organizational models and business drivers?\n\n2. What specific challenges related to manufacturing processes, patent management, and compliance requirements are highlighted for pharmaceutical and life sciences organizations in the adoption of MES, as per the document?\n\n3. How does the document propose to address the gap between current and desired processes within pharmaceutical and life sciences organizations through MES strategic and tactical planning, including the consideration of global standards and best practices?", "prev_section_summary": "The section provides guidance on the MES planning process, including program, strategic, and implementation planning. It emphasizes the importance of aligning MES projects with organizational objectives and priorities such as cost reduction, quality improvement, and time-to-market reduction. The focus of the MES effort should be determined by business drivers, regulatory environments, and customer demands. Risk management principles should be applied throughout development and implementation to mitigate risks effectively. Organizations may choose elements of functional domains to include in their implementation strategy based on factors like complexity, cost, compliance, culture, or resource constraints. Business planning exercises should identify relevant business drivers and associated functional areas using tools like gap analysis, audits, and flowcharting. Quantifiable benefit metrics should be identified to determine the MES domain functionality to be implemented. Finally, a recommended project strategy should be developed for submission to management.", "excerpt_keywords": "MES, strategic planning, pharmaceutical, life sciences, challenges"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "54ea8ad7-5b13-418d-8c5b-c360aa6906d9", "node_type": "4", "metadata": {"page_label": "54", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "f57aafeb0e8e82fdea0369cbeb0881b7d30cc7bc2fb5c6aacf6d7e40a6213283", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "a49624dc-e514-4109-9a42-fa51f45f011f", "node_type": "1", "metadata": {"page_label": "53", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "261e5afb0c9bc052df147e90fd1a808fd46e79f8242c326b90c11156685bfe8a", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "dc67aeb2-d0e9-4235-86da-5a57a9b657e7", "node_type": "1", "metadata": {}, "hash": "a6b4f608ef10bb5104242fdb4b3a716e785d0a2128512ac18407771a812a68d7", "class_name": "RelatedNodeInfo"}}, "text": "## figure 6.1: mes strategic planning functions\n\n|existing organizational model|strategic assessment|business drivers|\n|---|---|---|\n|organizational policies and procedures|documented current corporate and site processes|benchmarks and best practices|\n|quality and compliance|desired corporate and site processes|business drivers models and standards|\n|business/mfg process definitions|strategic business plan includes gap analysis|same industry best practice, other industry best practice, internal development best practice|\n|technology|mes strategic plan|implementation and deployment, method options|\n| |mes tactical implementation plan|mes benefits, globalization|\n\n## 6.2 challenges\n\ntypical challenges for manufacturing pharmaceutical and life sciences organizations include:\n\n- accommodating different manufacturing processes: batch, continuous, discrete\n- patent expiration and exclusivity\n- extensive record and audit trail requirements\n- extensive material tracking and genealogy requirements", "start_char_idx": 0, "end_char_idx": 1003, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "dc67aeb2-d0e9-4235-86da-5a57a9b657e7": {"__data__": {"id_": "dc67aeb2-d0e9-4235-86da-5a57a9b657e7", "embedding": null, "metadata": {"page_label": "55", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Business Drivers and Key Performance Indicators in Manufacturing Execution Systems Strategy: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the GAMP (Good Automated Manufacturing Practice) guide suggest Manufacturing Execution Systems (MES) can address the challenge of increasing regulatory impacts on specification and verification activities within the pharmaceutical industry?\n\n2. What specific business drivers are identified in the document as critical for senior management to agree upon when developing a Manufacturing Execution Systems (MES) strategy to enhance operational efficiency and regulatory compliance in the pharmaceutical sector?\n\n3. According to the document, how are Key Performance Indicators (KPIs) and business drivers integrated within the ANSI/ISA-95 framework to justify the investment in MES projects, and what benefits are highlighted as being derived from MES implementations that align with these business drivers?", "prev_section_summary": "The section discusses the strategic planning functions necessary for implementing Manufacturing Execution Systems (MES) in pharmaceutical and life sciences organizations. It outlines existing organizational models, business drivers, challenges related to manufacturing processes, patent management, and compliance requirements. The document also proposes addressing the gap between current and desired processes through MES strategic and tactical planning, considering global standards and best practices. Key topics include strategic assessment, business drivers, technology, challenges in accommodating different manufacturing processes, patent expiration, record and audit trail requirements, and material tracking. Key entities mentioned are organizational policies and procedures, quality and compliance, business/mfg process definitions, and MES strategic and tactical plans.", "excerpt_keywords": "GAMP, Manufacturing Execution Systems, Strategic Business Drivers, Key Performance Indicators, Regulatory Compliance"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "e5238ab0-3dec-4c15-8c43-149594147fc4", "node_type": "4", "metadata": {"page_label": "55", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "766a23d95556e198a90fd9d1fb2b85503d617482c97fea5dbbb3654661831fa1", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "38acbe58-aaba-43db-88b4-9894d3e25606", "node_type": "1", "metadata": {"page_label": "54", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "f57aafeb0e8e82fdea0369cbeb0881b7d30cc7bc2fb5c6aacf6d7e40a6213283", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "e4b2c4ed-e2ba-41e0-80ae-9c8d7e859e9c", "node_type": "1", "metadata": {}, "hash": "3cefb7f520e36c36c7b70bb95aecb521a33aacc79d8a87cf0e51529d74382703", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: page 53\n\n## manufacturing execution systems - a strategic and program management approach appendix 2\n\n- increasing value of products, lowering cost of goods\n- the regulatory impact on specification and verification activities\n- complexity of forecasting and scheduling\n- time required for regulatory approvals\n- need for approvals from multiple regulatory agencies\n- cost of non-compliance (recalls, consent decrees, injunctions, warning letters)\n- requirements for trained and qualified staff\n- increasing costs of production\n\n### business drivers\n\nthese challenges influence business drivers, which should be stated concisely and agreed by senior management. examples of business drivers include:\n\n- reducing production cost\n- improving customer service\n- maintaining product quality conformance\n- implementing manufacturing and supply chain efficiencies, integration, and optimization\n- managing new product development and approval\n- reducing product time to market\n- minimization of waste\n- reduction of cycle times\n- increasing resource utilization\n- improving asset management and efficiency\n- maintaining regulatory compliance\n\nbusiness drivers and key performance indicators (kpis) (also called critical success factors) are defined and used as potential touch points into business processes in ansi/isa-95 (reference 3, appendix 14). see appendix 13. business drivers should be understood and addressed during development of an mes strategy. benefits derived from mes implementations that address business drivers can provide the basis for justification of mes projects.", "start_char_idx": 0, "end_char_idx": 1613, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "e4b2c4ed-e2ba-41e0-80ae-9c8d7e859e9c": {"__data__": {"id_": "e4b2c4ed-e2ba-41e0-80ae-9c8d7e859e9c", "embedding": null, "metadata": {"page_label": "56", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Planning for MES Implementation in Manufacturing Operations: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the key components that should be included in an MES tactical implementation plan according to the GAMP(r) Good Practice Guide?\n   \n2. How does the GAMP(r) Good Practice Guide suggest organizations should approach the identification and planning of MES projects within their strategic and program management framework?\n\n3. What process does the GAMP(r) Good Practice Guide recommend for capturing current and evolving information regarding business objectives and manufacturing operations in the context of strategic planning for MES implementation?", "prev_section_summary": "The section discusses the strategic business drivers and key performance indicators in Manufacturing Execution Systems (MES) strategy within the pharmaceutical industry. It highlights the challenges faced, such as increasing regulatory impacts, complexity of forecasting, and the need for regulatory approvals. The document identifies specific business drivers critical for senior management to agree upon, including reducing production costs, improving customer service, and maintaining regulatory compliance. It also emphasizes the integration of Key Performance Indicators (KPIs) and business drivers within the ANSI/ISA-95 framework to justify MES investments and outlines the benefits derived from MES implementations aligned with these drivers.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, strategic planning, program management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "3888fc2b-e016-478e-8305-42b31f7b8a3a", "node_type": "4", "metadata": {"page_label": "56", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "e44190d5b88a20b9ae3dd659f686c0c72de19850e71a4e26c83b8fca251392ae", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "dc67aeb2-d0e9-4235-86da-5a57a9b657e7", "node_type": "1", "metadata": {"page_label": "55", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "766a23d95556e198a90fd9d1fb2b85503d617482c97fea5dbbb3654661831fa1", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "57307ebc-92ef-469d-b042-183cbed8bd55", "node_type": "1", "metadata": {}, "hash": "53cbff066d118af5b5dc9e5dbff57603d6b573f949d1b41946ac3a4b17996ce1", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: appendix 2\n\n### manufacturing execution systems - a strategic and program management approach\n\n#### 6.4 program planning\n\nmes business and strategic plans should be developed into an mes tactical implementation plan. project goals and business objectives should be achieved by methodically identifying options and addressing complexities of a targeted solution. the program planning process should include the following project goals:\n\n- establishing a corporate structure required for governance and implementation\n- defining which mes projects consisting of functional domains are needed to accomplish the mes strategy\n- preparing master project and validation plans\n- establishing high-level timelines for each of the identified mes projects\n- determining overall internal and external resources required for the desired scope\n\nconsideration should be given to:\n\n- strategic planning\n- identification of functional domains\n- application selection\n- mes implementation planning\n- risk management\n- roles and responsibilities\n- regulatory compliance\n- data management planning\n- system architecture\n- funding\n\n#### 6.5 strategic planning\n\n##### 6.5.1 functions and concepts\n\nstrategic analysis and planning should determine business needs for developing strategic business and mes plans. figure 6.1 shows a process which can be used to capture both current and evolving information regarding business objectives, business benefits, manufacturing operations, along with knowledge of organizational capabilities, such as resources and skill levels.\n\nstrategic planning includes an assessment process to provide an understanding of the manufacturing operations so that requirements may be appropriately addressed throughout the development life cycle. these plans should include the regulatory compliance requirements needed to further define components of an mes validation plan.\n\nthe development of strategic plans provides a basis for corporate and local organizations to define individual project plans in a consistent and synergistic manner. mes strategic plans enable organizations to develop:", "start_char_idx": 0, "end_char_idx": 2129, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "57307ebc-92ef-469d-b042-183cbed8bd55": {"__data__": {"id_": "57307ebc-92ef-469d-b042-183cbed8bd55", "embedding": null, "metadata": {"page_label": "57", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Business Planning and Gap Analysis for MES Implementation", "questions_this_excerpt_can_answer": "1. How does the GAMP Good Practice Guide suggest integrating existing organizational business drivers and best practices into the strategic assessment for MES project goals?\n   \n2. What are the key components of a business strategy as outlined in the context, and how do they contribute to the successful implementation of a Manufacturing Execution System (MES) in regulated organizations?\n\n3. How does the document propose using gap analysis in the context of MES implementation, and what specific steps are recommended for identifying and addressing gaps in the supply chain?", "prev_section_summary": "This section discusses the strategic planning and program management approach for implementing Manufacturing Execution Systems (MES) in manufacturing operations. Key topics include program planning, strategic planning, functions and concepts, and considerations such as governance, project goals, resource requirements, risk management, regulatory compliance, data management planning, system architecture, and funding. The section emphasizes the importance of developing strategic business and MES plans, capturing current and evolving information regarding business objectives and manufacturing operations, and aligning individual project plans with corporate goals. The GAMP(r) Good Practice Guide provides guidance on identifying options, addressing complexities, and establishing a structured approach to MES implementation.", "excerpt_keywords": "MES, Manufacturing Execution Systems, Strategic Business Planning, Program Management, GAMP Good Practice Guide"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "5be321be-fbfd-46c9-84e1-eec91033c2f1", "node_type": "4", "metadata": {"page_label": "57", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "45e845e51ba9026f4b8868f0a94e6cd704e5b1d0e9fbdefddf06382d67d648da", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "e4b2c4ed-e2ba-41e0-80ae-9c8d7e859e9c", "node_type": "1", "metadata": {"page_label": "56", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "e44190d5b88a20b9ae3dd659f686c0c72de19850e71a4e26c83b8fca251392ae", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "fcaade37-870e-4bd9-9b37-f0b46174c99c", "node_type": "1", "metadata": {}, "hash": "4cea175a6743ab2c329b82a6975ee24fce370a033856555427e5594ffe8cdc11", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 2\n\n* implementation and rollout functional domains containing specific workflow activities\n\n* initial functional and design specification requirements\n\n* development and acceptance testing rationales\n\n* commissioning and qualification techniques\n\nexisting organizational business drivers and best practices can be identified through a strategic assessment and used to address business objectives and to achieve mes project goals.\n\n### 6.5.2 strategic business planning\n\na business strategy for regulated organizations may be considered as the combination of competitive actions and business approaches employed to meet regulatory requirements, satisfy customers, and compete successfully, while achieving organizational objectives.\n\nstrategies should be developed by specifying the vision and objectives of an organization. the primary objective is to put the organization into a position to carry out its mission effectively and efficiently. a corporate strategy should:\n\n- integrate goals and policies cohesively to provide guidance for developing action sequences (tactics) for successful implementation\n- be appropriate for an organizations resources and circumstances\n- apply strategic advantages to the business environment\n\ncomponents of a business strategy include:\n\n- vision - an outline of the future of an organization, providing direction about customer focus, the geographic and product markets to be pursued, the capabilities the organization plans to develop, and the type of organization that management is trying to maintain or create.\n- objectives - goals that strengthen the overall business position and competitive vitality of an organization.\n- plan - the deliverable of strategic planning, consisting of an organizations mission and future direction, near-term and long-term performance targets and metrics, and high-level guidance to achieve the vision and objectives.\n\na strategic business plan may be driven by other organizational initiatives, but serves as guidance for an mes program. an mes program may become a driver to establish a well-documented plan if none exists, or update an existing plan.\n\na gap analysis may be used to identify where gaps exist by creating a set of documents or a matrix of facts discerned from an examination of current and future states. separate gap analysis documents may be created for elements of the supply chain that are subsequently summarized in a parent document or report.", "start_char_idx": 0, "end_char_idx": 2567, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "fcaade37-870e-4bd9-9b37-f0b46174c99c": {"__data__": {"id_": "fcaade37-870e-4bd9-9b37-f0b46174c99c", "embedding": null, "metadata": {"page_label": "58", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Strategic Planning for Manufacturing Execution Systems: A Holistic Approach to Achieving Business Goals\"", "questions_this_excerpt_can_answer": "1. How does the GAMP (Good Automated Manufacturing Practice) guide suggest MES (Manufacturing Execution Systems) strategic planning should align with business objectives, and what specific areas of impact are considered crucial in this alignment?\n   \n2. What are the key components and strategies outlined in the GAMP guide for developing an MES strategic plan, particularly in terms of organizational and technology strategies, to improve supply chain operations?\n\n3. According to the GAMP guide, what process should be initiated to justify the implementation of an MES solution, and how should the benefits of executing the MES strategic plan be quantified in relation to business objectives?", "prev_section_summary": "This section discusses the strategic business planning and gap analysis for MES implementation in regulated organizations. It covers the integration of organizational business drivers and best practices into the strategic assessment for MES project goals, key components of a business strategy, such as vision, objectives, and plan, and the use of gap analysis to identify and address gaps in the supply chain. The section emphasizes the importance of developing a cohesive corporate strategy that aligns with organizational resources and circumstances to successfully implement an MES program.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, strategic planning, supply chain operations"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "1278a942-95bb-4665-99a9-ec9964a054b9", "node_type": "4", "metadata": {"page_label": "58", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "82797efecb3f543e7deaf824860d3ed6ae6014dbe57cf09eed97c6a20cee08bc", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "57307ebc-92ef-469d-b042-183cbed8bd55", "node_type": "1", "metadata": {"page_label": "57", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "45e845e51ba9026f4b8868f0a94e6cd704e5b1d0e9fbdefddf06382d67d648da", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "b8dffd39-d7a2-49d5-a22c-7b219df9581a", "node_type": "1", "metadata": {}, "hash": "62c5a0b3adebeb0aadbee3db2b4ef98959fe42f95bd0713f3d3237287a45ff7a", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: appendix 2\n\n### manufacturing execution systems - a strategic and program management approach\n\n6.5.3 mes strategic planning\n\nan mes strategic plan, that includes project scope and high-level requirements for technology, human resources, and budgets, forms the foundation of an mes program. development of the mes strategic plan typically is iterative and based on successive levels of definition from corporate and site organizations. depending on the size and complexity of the activities, the mes strategic plan may be a single document, or may be comprised of various corporate and site planning documents.\n\nthe plan should be written for a broad audience; it should contain much of the information required to gain approval for mes projects. approval to proceed may occur at various points during strategic development, or approval may be achieved sequentially only after successful completion of each stage of the strategic development.\n\nthe mes strategic planning process should be initiated by mapping the gap analysis to the relevant business objectives to define and quantify the benefits of executing or implementing the mes strategic plan. this should determine the impact on the business, and may be related to:\n\n- economy\n- efficiency\n- safety\n- reliability\n- consistency\n- quality\n- regulatory compliance\n\nin order to merit implementation, the gap analysis should demonstrate how an mes solution would make a significant contribution to addressing business objectives.\n\nstrategic planning should provide a high-level compilation of methods and requirements to improve supply chain operations. the mes strategic plan typically includes appropriate requirements for:\n\n- organizational strategy:\n- reorganization of departments or functional areas to better match the corporate vision. this will result in functional domains to achieve the most important goals or achieve the largest benefits.\n- expected scope of re-engineering human activities to perform the functional domain activities. this will include the interaction of technology in an efficient manner, taking advantage of the strengths of each.\n- technology strategy:\n- types of technologies to include in mes\n- definition of functional domains integrating business activities with technology to perform the activities\n- implementation and deployment overview\n- priorities for implementation of the functional domains for largest or most important benefits", "start_char_idx": 0, "end_char_idx": 2461, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "b8dffd39-d7a2-49d5-a22c-7b219df9581a": {"__data__": {"id_": "b8dffd39-d7a2-49d5-a22c-7b219df9581a", "embedding": null, "metadata": {"page_label": "59", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Strategic Planning and Implementation for Manufacturing Execution Systems: A Comprehensive Approach\"", "questions_this_excerpt_can_answer": "1. What are the three major groups into which the benefits of implementing a Manufacturing Execution System (MES) can be organized according to the GAMP Good Practice Guide, and what are examples of benefits in each group?\n\n2. How does the GAMP Good Practice Guide suggest addressing the challenges of globalization in the strategic planning for MES, including specific aspects like culture, language, and regulatory environments?\n\n3. What are the recommended steps for creating an MES strategic plan as outlined in the GAMP Good Practice Guide, including the approach to risk analysis and the prioritization of implementation methods?", "prev_section_summary": "The section discusses the strategic planning process for Manufacturing Execution Systems (MES) as outlined in the GAMP guide. Key topics include the development of an MES strategic plan, alignment with business objectives, gap analysis, organizational and technology strategies, and quantifying the benefits of implementing the plan. The section emphasizes the importance of considering economy, efficiency, safety, reliability, consistency, quality, and regulatory compliance in the strategic planning process. It also highlights the need for reorganization of departments, re-engineering human activities, and prioritizing technology integration to improve supply chain operations.", "excerpt_keywords": "MES, Manufacturing Execution Systems, Strategic Planning, GAMP Good Practice Guide, Globalization"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "a956128c-3972-42d3-af85-44c759c22364", "node_type": "4", "metadata": {"page_label": "59", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "471c099aa9a52d8831f56e27b292073c1101d175f9c7097e30d9580b92e58b4e", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "fcaade37-870e-4bd9-9b37-f0b46174c99c", "node_type": "1", "metadata": {"page_label": "58", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "82797efecb3f543e7deaf824860d3ed6ae6014dbe57cf09eed97c6a20cee08bc", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "37dd367e-5f2e-41fe-a989-de108641cf11", "node_type": "1", "metadata": {}, "hash": "a175b71f5b42b2b74651a929b7a3df2aa6d4f8d84ea35050c6a5495ef92628e5", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 2\n\nmes strategic plans typically address the following topics:\n\n- benefits - determined by evaluating the impact of the mes-based functionality on an organization. benefits can be organized into three major groups:\n- primary - direct impact on operations, e.g., shorter production cycles, improved product consistency, enhanced level of compliance, and fewer errors in process execution.\n- secondary - indirect impact on operations, e.g., improved record accuracy and reduction in undocumented processes and practices.\n- strategic - further the corporate vision, e.g., improved business reputation and enhanced management decision support.\n- degree of globalization:\n- current and future site usage, regional and global organization.\n- culture and language impact.\n- regulatory environments.\n- governance of regional and global issues for shared, as well as distributed systems.\n- for further guidance on global issues, see appendix 4. for further guidance on global issues, see the ispe gamp good practice guide: global information systems control and compliance (reference 6, appendix 14).\n- implementation and deployment options:\n- central verses site systems supervision and control.\n- purchase verses development philosophy.\n- internal verses external resources.\n- prioritization of benefits applied to deployment: horizontal, vertical, or combination approach, concurrent or sequential deployment.\n- prototype systems or facilities for development, testing, and training (see appendix 4).\n- data management:\n- distribution, ownership, and repository issues.\n\nthe mes strategic plan should be created by reviewing the strategic business plan to establish the long term scope of the mes program for site, regional, or global targets.\n\na risk analysis should be performed for each of the gaps. risks should be prioritized and subsequently controlled during implementation of mes functional domains. timeline goals and available resources and skill levels should be balanced to achieve the selected implementation and deployment methods.\n\nthe mes strategic plan should be documented for review, distribution, and approval. the mes strategic plan is a key deliverable from the mes planning process.", "start_char_idx": 0, "end_char_idx": 2324, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "37dd367e-5f2e-41fe-a989-de108641cf11": {"__data__": {"id_": "37dd367e-5f2e-41fe-a989-de108641cf11", "embedding": null, "metadata": {"page_label": "60", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Best Practices for Implementing MES Programs", "questions_this_excerpt_can_answer": "1. What are the key considerations for selecting applications and systems during the implementation of a Manufacturing Execution System (MES) according to the ISPE guide?\n   \n2. How does the ISPE guide recommend managing risks associated with MES implementation to ensure patient safety, product quality, data integrity, and organizational integrity?\n\n3. According to the ISPE guide, what strategies are suggested for establishing roles and responsibilities within an MES program, including the management of contract personnel involved in critical functions?", "prev_section_summary": "The section discusses the strategic planning and implementation of Manufacturing Execution Systems (MES) according to the GAMP Good Practice Guide. Key topics include the benefits of implementing MES, addressing challenges of globalization, creating an MES strategic plan, degree of globalization, governance, implementation and deployment options, data management, risk analysis, and documentation. The section emphasizes the importance of evaluating benefits, considering global factors, prioritizing deployment methods, and documenting the MES strategic plan for review and approval.", "excerpt_keywords": "MES, Manufacturing Execution Systems, ISPE, implementation, risk management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "0a242e3c-db5c-43b9-9231-3b7f6f9ee936", "node_type": "4", "metadata": {"page_label": "60", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "427cce280de2077afc1b88159ab6716d675b827af69759c093873709b03df06e", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "b8dffd39-d7a2-49d5-a22c-7b219df9581a", "node_type": "1", "metadata": {"page_label": "59", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "471c099aa9a52d8831f56e27b292073c1101d175f9c7097e30d9580b92e58b4e", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "e8cab95b-78ce-4f3c-93b5-8face600b1bb", "node_type": "1", "metadata": {}, "hash": "924e66c2311667a25c66f865c60b492b1179e27ab759876b146569f7d44ba782", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: appendix 2\n\n|6.6|functional domains|\n|---|---|\n| |functional domains should be identified and described for the mes program. for further information, see appendix 3.|\n|6.7|application selection|\n| |implementation of an mes solution typically comprises a combination of applications and systems, and therefore, entails a level of systems integration. the selection of applications and systems should be based on production and process requirements, as well as individual business needs and risk management. for additional information regarding application selection, see appendix 5.|\n|6.8|mes implementation plan|\n| |considerations and concepts for strategy development should be identified along with business drivers and associated mes functional domains that provide a positive business impact suitable for project justification. for additional information, see appendix 4.|\n|6.9|risk considerations|\n| |risks to patient safety, product quality, data integrity, and the organization should be considered when developing and implementing mes functionality. potential risks should be assessed and controlled as an integral part of the project. the identification and management of risk throughout the project lifecycle can simplify the verification effort, while lowering project cost and time to completion. the identification and control of risk allows appropriate planning for the reduction of risk to an acceptable level in order to optimize resources and enable achievement of project objectives. properly managing risk can positively impact other project areas, including scope and overall quality of the implementation. mes projects can pose risks to an organization. business systems generally have contingency plans to address system outages and ensure business continuity. integration with the manufacturing area can increase the impact on the business process of process control failures. during the design phase of the mes project, processes should be analyzed to determine the vulnerability of process steps to unanticipated interruptions (partial or full) of enterprise systems, as well as automation. some operations cannot be interrupted without significant impact on product or product data. the impact of the expected period of interruption of service should be evaluated for each operation. appropriate risk management tools or methods can be applied to each process and operation, e.g., fmea, haccp, or hazop. fault tree analysis (fta) also can be used to analyze the connections between functional domains to enable more meaningful results.|\n|6.10|roles and responsibilities|\n| |management should assign personnel to develop the mes program and establish program milestones for planning, budgeting, resource allocation, and execution. appropriate roles and responsibilities should be documented. contract personnel executing critical functions, such as change management and control, are expected to have documented training on an organizations or equivalent procedures.|", "start_char_idx": 0, "end_char_idx": 3024, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "e8cab95b-78ce-4f3c-93b5-8face600b1bb": {"__data__": {"id_": "e8cab95b-78ce-4f3c-93b5-8face600b1bb", "embedding": null, "metadata": {"page_label": "61", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Team Organization and Quality Unit Responsibilities in MES Projects: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the key roles and responsibilities identified for a team involved in MES (Manufacturing Execution Systems) projects, and how do they contribute to the project's success according to the document from ISPE Manufacturing Execution Systems?\n\n2. How does the document describe the importance of cross-functional team organization in MES projects, and what specific examples does it provide to illustrate the need for such a team structure?\n\n3. What specific responsibilities does the quality unit have in MES projects, especially concerning electronic production records (EPRs), as outlined in the document from ISPE Manufacturing Execution Systems?", "prev_section_summary": "The key topics covered in this section include functional domains, application selection, MES implementation plan, risk considerations, and roles and responsibilities in implementing a Manufacturing Execution System (MES) according to the ISPE guide. The section emphasizes the importance of identifying functional domains, selecting applications and systems based on production and process requirements, managing risks to patient safety, product quality, data integrity, and the organization, and establishing roles and responsibilities within an MES program. It also highlights the need for proper planning, risk assessment, and control throughout the project lifecycle to optimize resources and achieve project objectives. Additionally, the section mentions the use of risk management tools such as FMEA, HACCP, and HAZOP, as well as the importance of documenting roles and responsibilities, especially for contract personnel involved in critical functions.", "excerpt_keywords": "Manufacturing Execution Systems, MES projects, Team organization, Quality unit responsibilities, Electronic production records"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "32b42e4a-47a6-44b9-93b1-70e6048610db", "node_type": "4", "metadata": {"page_label": "61", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "380c899f39ce47b8cffd3052f59b7dd67f6c077d95e236d0584b5754023f7504", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "37dd367e-5f2e-41fe-a989-de108641cf11", "node_type": "1", "metadata": {"page_label": "60", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "427cce280de2077afc1b88159ab6716d675b827af69759c093873709b03df06e", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "441a094a-6ed9-425a-adbd-e7ec873f1c33", "node_type": "1", "metadata": {}, "hash": "d451980d95e519889d843fe89be86c51e4dffe0640e627f39a5dea5b9f3dd60b", "class_name": "RelatedNodeInfo"}}, "text": "## manufacturing execution systems - a strategic and program management approach\n\n### appendix 2\n\nroles and responsibilities may include categories such as:\n\n- executive sponsor(s)\n- steering or supervisory committee\n- project management office (pmo)\n- corporate and site responsible department leaders and representatives\n- project leaders and managers\n- smes\n- external organizations, e.g. suppliers, consultants, and systems integrators\n\n### team organization\n\na team that represents the appropriate areas of an organization should be established and should be appropriately documented. the team structure may be dependent on the mes domain segmentation that typically crosses functional areas and organizational groups. for example, erp systems typically are managed by it and have a broad user community. factory automation related systems may be owned by automation, engineering, or maintenance organizations and have a more specific user community. other systems, such as lims, may be jointly owned by it and the quality unit. an mes approach to production bridges the gaps between factory floor operations, it, business, and quality unit communities.\n\na team that has cross-functional representation and well-defined roles and responsibilities should be defined early in an mes project to help minimize project delays and disruptions by ensuring that the implementation plan has buy-in from appropriate functional groups. as part of the team, it representation should ensure that data transportation, communication, and security issues are well defined and understood. input from users of an mes should be obtained during requirements definition and during final testing. engineering personnel who are team members should assess feasibility, particularly since much of the data and operational functionality is based on the factory floor.\n\ncompliance roles within it, engineering, and operations should be defined explicitly, scoped, and coordinated to prevent overlap and ensure there are no gaps. the quality unit should provide quality supervision, input to tasks, and documentation as determined by the risk-based approach, and as a key user group; therefore, quality unit involvement from the beginning of an mes project is critical to overall success. the quality unit can be a major contributor to a successful mes implementation.\n\nproject management roles should be separate from technical, development, compliance, and quality roles, except where directly managing quality attributes of implementation. the role of project managers is critical in addressing the complexity of mes implementations and experienced professional project management should be applied to mes implementations. where customization of software and interfaces is required, personnel with experience in handling software development should be involved in project management.\n\n### quality unit responsibilities\n\nthe quality unit typically has multiple roles during mes projects, especially when electronic production records (eprs), such as electronic batch record (ebr) or electronic device history record (edhr) functionality, is included. the quality unit typically acts as:", "start_char_idx": 0, "end_char_idx": 3165, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "441a094a-6ed9-425a-adbd-e7ec873f1c33": {"__data__": {"id_": "441a094a-6ed9-425a-adbd-e7ec873f1c33", "embedding": null, "metadata": {"page_label": "62", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Planning Guide for Successful Manufacturing Execution Systems (MES) Implementation", "questions_this_excerpt_can_answer": "1. What role does the quality unit play in the implementation of a Manufacturing Execution System (MES) according to the Strategic Planning Guide for Successful Manufacturing Execution Systems Implementation?\n\n2. How does the document suggest handling regulatory compliance issues when implementing an MES solution, particularly in relation to GMP relevant production records and data management?\n\n3. What approach does the document recommend for data management planning and system architecture in the context of MES implementation, including the use of data modeling practices and consideration of system architectures?", "prev_section_summary": "The section discusses the key roles and responsibilities in Manufacturing Execution Systems (MES) projects, emphasizing the importance of cross-functional team organization. It outlines various roles such as executive sponsors, project managers, subject matter experts, and external organizations involved in MES projects. The document highlights the need for a team structure that bridges functional areas and organizational groups to ensure project success. Additionally, it emphasizes the quality unit's responsibilities in MES projects, particularly concerning electronic production records (EPRs) like electronic batch records (EBRs) or electronic device history records (EDHRs). The quality unit is described as providing quality supervision, input to tasks, and documentation, playing a crucial role in the overall success of MES implementations.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Strategic Planning, Regulatory Compliance, Data Management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "27df8cbe-0a57-41b5-b9e9-6ae5bfcbcd10", "node_type": "4", "metadata": {"page_label": "62", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "2d298853cf12f757952512e0ead50189736c9b19057377aabe80b263a33b6bed", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "e8cab95b-78ce-4f3c-93b5-8face600b1bb", "node_type": "1", "metadata": {"page_label": "61", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "380c899f39ce47b8cffd3052f59b7dd67f6c077d95e236d0584b5754023f7504", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "626abba2-e0ca-4d6e-b0b6-71b62efede7a", "node_type": "1", "metadata": {}, "hash": "af0c891c3c29dbc9bdc011a2b09d871010e00354756869be1f1f5bb521fa49ef", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 2: manufacturing execution systems - a strategic and program management approach\n\n* client (end user) for system services\n\n* design team participant\n\n* design approver (quality unit functions)\n\n* design approver (overall system functionality)\n\nthe quality unit should act as the supervisory and approval body for documents and methods for the complete implementation, as determined by the risk-based approach. the quality unit should address separation of responsibilities to prevent real or perceived conflicts of interest. within a quality unit, roles can be defined to assure that objective review and approval processes are defined and executed. the quality unit may delegate specific technical and compliance roles to other groups, such as it or engineering compliance.\n\n### regulatory\n\nwhen planning the implementation of an mes solution, all relevant regulatory compliance issues must be considered, including:\n\n- how various workflow processes will be managed, e.g., review and approval of production steps and intermediate and product release\n- how and where gmp relevant production records and data will be created, maintained, and stored, or integrated with other systems\n- whether or not epr functionality will be used\n\ndecisions made regarding regulatory issues will have a direct impact on the system architecture, design, and implementation, as well as associated verification activities. for example, if data from a manufacturing area control system were planned to be archived on a network server on the corporate intranet, this would require qualification of the relevant infrastructure elements and verification of compliance with electronic record and signature requirements.\n\n### data management planning\n\nplans should be developed to employ data modeling practices and tools to capture the required definition and flow of data. master data and dynamic data should be identified to support systems architecture and functionality decisions regarding data types, ownership and management, transfer and communication, and test data set definition. data modeling is an iterative process, beginning with the basic organization-required data, with augmentation driven by process and systems functionality design to meet organizational goals. additional detailed modeling should provide support for risk analysis of systems architecture to ensure critical data is protected and available to critical processes and systems in a timely fashion. for further information, see appendix 6.\n\n### system architecture\n\na multitude of system architectures can be considered when planning an mes implementation. the consideration of standards and associated models in defining system architectures and implementation provides a perspective on how the mes domain of functions can productively meet an organizations business goals. for further information on modeling system architectures, see appendix 13.", "start_char_idx": 0, "end_char_idx": 2919, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "626abba2-e0ca-4d6e-b0b6-71b62efede7a": {"__data__": {"id_": "626abba2-e0ca-4d6e-b0b6-71b62efede7a", "embedding": null, "metadata": {"page_label": "63", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Securing Funding for Manufacturing Execution Systems: A Strategic Approach", "questions_this_excerpt_can_answer": "1. What is the primary strategy recommended by the ISPE Good Practice Guide for securing funding for Manufacturing Execution Systems (MES) projects?\n   \n2. According to the document titled \"Securing Funding for Manufacturing Execution Systems: A Strategic Approach,\" what is considered essential for the completion of a successful MES project?\n\n3. In the context of the ISPE Manufacturing Execution Systems guide, what is the basis for obtaining approval for funding as outlined in Appendix 2, section 6.14?", "prev_section_summary": "The section discusses the strategic and program management approach to implementing Manufacturing Execution Systems (MES). Key topics include the role of the quality unit in MES implementation, handling regulatory compliance issues, data management planning, and system architecture considerations. The quality unit is highlighted as the supervisory and approval body for documents and methods in the implementation process. Regulatory compliance issues such as managing workflow processes, creating and storing GMP relevant production records, and using EPR functionality are emphasized. Data management planning involves employing data modeling practices and tools to capture data flow, while system architecture considerations involve choosing the appropriate architecture to meet organizational goals. The section provides guidance on addressing these key topics to ensure successful MES implementation.", "excerpt_keywords": "ISPE, Manufacturing Execution Systems, MES, funding, strategic approach"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "551558c4-a2a8-471d-8759-a1e5241adcfd", "node_type": "4", "metadata": {"page_label": "63", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "fff6833db34c373e7c8161a53bf32237cb910c3047b1b786e14eb2dbd45129de", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "441a094a-6ed9-425a-adbd-e7ec873f1c33", "node_type": "1", "metadata": {"page_label": "62", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "2d298853cf12f757952512e0ead50189736c9b19057377aabe80b263a33b6bed", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "84e6080c-bc9a-485b-90cc-f2735b3fbb44", "node_type": "1", "metadata": {}, "hash": "f647c5aafaf48bc43dea123c979f1b5588bb55d4dedff70d8a48653228b2b316", "class_name": "RelatedNodeInfo"}}, "text": "# gamp (r)good practice guide:\n\nmanufacturing execution systems - a strategic and program management approach\n\n## appendix 2\n\n6.14 funding\n\nobtaining adequate funding to ensure the completion of a successful project is considered essential. the basis for obtaining funding approval can be a strong business case with justification for requested funds.", "start_char_idx": 0, "end_char_idx": 351, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "84e6080c-bc9a-485b-90cc-f2735b3fbb44": {"__data__": {"id_": "84e6080c-bc9a-485b-90cc-f2735b3fbb44", "embedding": null, "metadata": {"page_label": "64", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Blank Canvas: A Collection of Absence\"", "questions_this_excerpt_can_answer": "Based on the provided context, here are three questions that the context can provide specific answers to, which are unlikely to be found elsewhere:\n\n1. **What is the file size of the \"ISPE Manufacturing Execution Systems\" PDF document stored in the PharmaWise Engineer project within the PharmaWise CSV & Data Integrity raw data directory?**\n   - This question is specific to the metadata provided in the context, such as the file size, which is detailed as 7322258 bytes. This information is unique to this document and its storage specifics, making it unlikely to be found in other sources.\n\n2. **What are the creation and last modification dates of the document titled \"Blank Canvas: A Collection of Absence\" found in the ISPE Manufacturing Execution Systems PDF?**\n   - The context provides specific dates for the creation and last modification of the document, which are April 7, 2024, and April 4, 2024, respectively. These details are unique to this document's version and revision history, making them highly specific and not likely to be available from other sources without access to the document's metadata.\n\n3. **Under what directory path is the \"ISPE Manufacturing Execution Systems\" PDF located within the PharmaWise Engineer project, and what is its significance in the context of PharmaWise CSV & Data Integrity raw data?**\n   - The question targets the specific file path provided (/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf) and asks for its significance. This question assumes that the document plays a role within the broader context of the PharmaWise Engineer project's focus on CSV (Computer System Validation) & Data Integrity within the pharmaceutical development sector. The specificity of the file path and its contextual relevance to the project's goals are details not likely to be found outside of this particular context.\n\nThese questions are tailored to extract information that is uniquely available from the provided context, leveraging the specific details about the document's metadata and its placement within a larger project framework.", "prev_section_summary": "The section discusses the importance of securing funding for Manufacturing Execution Systems (MES) projects, as outlined in the ISPE Good Practice Guide. It emphasizes the need for a strong business case with justification for requested funds to ensure the successful completion of the project. The document provides strategic and program management approaches for obtaining adequate funding for MES projects.", "excerpt_keywords": "Keywords: ISPE, Manufacturing Execution Systems, MES, funding, business case"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "da00acf9-e55e-447f-8538-fa6305f31bbf", "node_type": "4", "metadata": {"page_label": "64", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "1f5acc835d0835cc5870da4b65bfb967b9c61aca52582feef2a5dd8c027f47d6", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "626abba2-e0ca-4d6e-b0b6-71b62efede7a", "node_type": "1", "metadata": {"page_label": "63", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "fff6833db34c373e7c8161a53bf32237cb910c3047b1b786e14eb2dbd45129de", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "cb8e1c1c-a419-4d5c-9566-d461fb83c78c", "node_type": "1", "metadata": {}, "hash": "a7cdb080fda484c383f937d5116af48ac76b13f38befca78e1c36d57b5e48eca", "class_name": "RelatedNodeInfo"}}, "text": "no_content_here", "start_char_idx": 0, "end_char_idx": 15, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "cb8e1c1c-a419-4d5c-9566-d461fb83c78c": {"__data__": {"id_": "cb8e1c1c-a419-4d5c-9566-d461fb83c78c", "embedding": null, "metadata": {"page_label": "65", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "The Domain Approach in Manufacturing Execution Systems: Enhancing Specification, Risk Assessment, and Systems Management", "questions_this_excerpt_can_answer": "1. How does the domain approach within the GAMP good practice guide for manufacturing execution systems (MES) redefine the relationship between MES and traditional ISA functional hierarchy levels?\n   \n2. What are the key benefits of adopting a domain approach in the specification, risk assessment, verification, and systems management of MES, as outlined in the GAMP good practice guide?\n\n3. How does the GAMP good practice guide suggest handling the variability in GxP impact across different functionalities within a single computer system or MES, particularly in relation to risk assessment and lifecycle activities?", "prev_section_summary": "The key topics of this section include the metadata of a PDF document titled \"ISPE Manufacturing Execution Systems\" stored in the PharmaWise Engineer project within the PharmaWise CSV & Data Integrity raw data directory. The section provides information on the file size, creation date, last modification date, document title, and file path of the PDF document. The entities mentioned in the section are the document title, file size, creation date, last modification date, and file path, all of which are specific to the context of the document within the PharmaWise Engineer project.", "excerpt_keywords": "GAMP, Manufacturing Execution Systems, Domain Approach, Risk Assessment, Systems Management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "78ba35dd-c7df-4d64-95c1-24f08ee56f57", "node_type": "4", "metadata": {"page_label": "65", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "e210366cc5403f8778a7786218471ac71f75e29587de678ca0ca92f72e2e9504", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "84e6080c-bc9a-485b-90cc-f2735b3fbb44", "node_type": "1", "metadata": {"page_label": "64", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "1f5acc835d0835cc5870da4b65bfb967b9c61aca52582feef2a5dd8c027f47d6", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "80cdb8b8-438d-4a76-8ccf-7a54ab264158", "node_type": "1", "metadata": {}, "hash": "5cbc21386e16b6237cc8e543d3c8d409296c67b5014bbe454b02ebcae99c2a4f", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 3\n\n#### appendix 3 - domain approach\n\n7.1 introduction\n\ncomputer system applications may contain feature-rich functionality that spans an organization, as well as control levels presented by isa [ref isa-95 part 1]. particular software applications or systems may be fitted into one of the levels (1 through 4) depicted in the isa functional hierarchy model. specific functions within a single computer system or application may fall into different levels of the isa functional hierarchy model.\n\ncommon descriptive application terms, such as \"business system\" (e.g., erp), \"manufacturing execution system,\" or \"automation\" may no longer fit applications and equipment in which various functions reside. the domain approach is a tool to describe complex systems in a way that enhances specification, risk assessment, verification, and systems management activities for complex systems. the approach is based on defining an mes domain encompassing systems functionality related to or otherwise supporting manufacturing operations.\n\neach functional domain within a system can be assigned the appropriate risk value or level to ensure that adequate and appropriate design, specification, and verification activities are applied.\n\nfor example, an mrp/erp computer system may have functionality that is non-gxp, as well as functionality with varying levels of gxp impact. a single risk level is not appropriate as a basis for defining life cycle activities for many systems and some equipment. for further information, see gamp 5. the concept of domain recognizes that inherent functionality within applications and systems often spans the isa enterprise-control system integration layers.\n\nthe traditional view of mes is that of a layer comprising one or more applications that bridge business systems to automation, even though there are many definitions of the term automation. examples of these applications include recipe management, wip, material management, and epr reporting.\n\nthis guide uses the term automation to describe the creation and application of technology to monitor and control the production of goods and services. intrinsic to automation is instrumentation and basic control (reference 9, appendix 14) dedicated to establishing and maintaining a specific state of equipment or process condition.\n\nsome of this functionality can also be implemented in more advanced scada or dcs functions, such as batch and asset management, and production and data analysis and reporting. an organization may possess systems with duplicate functionality that is disabled or not used.\n\nadvantages in design and testing methods can be achieved by using a higher level view of mes: that of the mes domain, comprising the entire manufacturing system of processes, computer systems and equipment, materials, and human activities.\n\nas the domain approach is independent of technology, it avoids designs linked to a specific application, and allows an organization to combine existing systems and add new systems functionalities to create a systems-based manufacturing environment.\n\nnote: this does not change the isa functional hierarchy model. an mes domain model makes no assumption that an entire application or computer system resides in only one level of the model (although that may occur depending on specific application capabilities). complex applications can have functionality within them mapped to the isa model as necessary to fulfill overall mes domain requirements.\n\nan application described as an mes may fulfill some of the requirements defined by the complete mes domain when the functionality is not available in other applications or is superior in capabilities or design.", "start_char_idx": 0, "end_char_idx": 3812, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "80cdb8b8-438d-4a76-8ccf-7a54ab264158": {"__data__": {"id_": "80cdb8b8-438d-4a76-8ccf-7a54ab264158", "embedding": null, "metadata": {"page_label": "66", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "A Comprehensive Approach to Designing Manufacturing Execution Systems Using Functional Domains", "questions_this_excerpt_can_answer": "1. How does the domain approach in designing Manufacturing Execution Systems (MES) facilitate the integration of new and existing systems to meet the requirements of an MES domain?\n   \n2. In what ways does the domain approach assist in the coordination of computer systems and related quality systems throughout the overall facility lifecycle, particularly in the context of Manufacturing Execution Systems?\n\n3. How can organizations leverage the domain approach to mitigate risks associated with the implementation of new technologies or methods of manufacturing within the MES framework?", "prev_section_summary": "The section discusses the domain approach in Manufacturing Execution Systems (MES) as outlined in the GAMP good practice guide. Key topics include the redefinition of the relationship between MES and traditional ISA functional hierarchy levels, the benefits of adopting a domain approach in specification, risk assessment, verification, and systems management of MES, and handling variability in GxP impact across different functionalities within a single computer system or MES. The section emphasizes the importance of defining an MES domain to enhance activities related to complex systems, such as specification, risk assessment, and verification. It also highlights the advantages of taking a higher-level view of MES as a domain encompassing the entire manufacturing system, including processes, computer systems, equipment, materials, and human activities. The domain approach allows for flexibility in combining existing systems and adding new functionalities to create a systems-based manufacturing environment.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Domain Approach, Systems Design, Functional Domains"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "7fcfbeff-20e9-4ed1-9dc8-1bc609d19488", "node_type": "4", "metadata": {"page_label": "66", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "5000cc99f73a7fac08d923280678b3c43bb05b0ffea2cfe925ef115cac63b0e6", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "cb8e1c1c-a419-4d5c-9566-d461fb83c78c", "node_type": "1", "metadata": {"page_label": "65", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "e210366cc5403f8778a7786218471ac71f75e29587de678ca0ca92f72e2e9504", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "a77ad469-a0d6-4c98-a1da-f991babed245", "node_type": "1", "metadata": {}, "hash": "02db6fef0b308092089e3dc73b2dfb0fa9621f80905457d334ad79cca1b8bab5", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: appendix 3\n\n### manufacturing execution systems - a strategic and program management approach\n\n7.2 applying domains to systems design\n\nscenarios which describe typical mes domain implementations include:\n\n- first-time implementation for an organization or facility using systems and applications new to the organization\n- integration of existing applications and systems to fulfill requirements (all or in part) of an mes domain\n- use of a combination of new and existing systems integrated to provide required functionality for an mes domain\n\nin the domain approach, requirements are developed for the overall domain, inclusive of functionality supporting business requirements, manufacturing processes, ancillary processes, and controls, e.g., regulatory requirements and geps. individual system requirements are developed as subsets of the mes domain requirements. this allows the relationships of system functionality across the domain to be properly understood, allowing best use of technology and activities for implementation of the domain.\n\nthe domain approach does not replace standard systems development and deployment models, but does help to ensure the coordination of computer systems and related quality systems throughout an overall facility lifecycle. activities such as data definition and flow modeling are based on the domain and applied to constituent systems during specification.\n\nfor new technologies or methods of manufacturing, organizations may choose to limit the scope of initial implementations to reduce risks of production delays. defining in requirements the necessary manufacturing-related functionality as a functional domain without regard to any particular application or system enables an objective description of what is needed for manufacturing. a design can then be achieved using existing systems, alone or in combination with new technology, to execute an initial implementation.\n\nby describing required functionality for mes using a domain approach, the functionality can be assigned to the most appropriate application or system as part of the specification process. see figure 7.1.\n\nfunctional domains can be defined by identifying common attributes, business and manufacturing goals, related activities (manual or systems functions), related data, or risks. functional domains may be implemented across system boundaries, modules, components, or equipment within a system. see figure 1.2 in section 1.6.\n\nthe complete mes domain becomes the combined set of these functional domains required to execute the intended business and manufacturing processes. the mes domain logically describes the manufacturing environment showing the interrelationships among needs and activities for business, process and systems owners within an organization, but without specific systems sme knowledge.\n\nnote: requirements and specification documentation for systems and applications can be similar to that used without a domain approach. separate documents for each functional domain are not required. documentation for each system may be generated with an identified system owner and cross-referencing of the requirements and specifications for each functional domain. the complexity of systems and functionality may determine which method or combination is more efficient.", "start_char_idx": 0, "end_char_idx": 3336, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "a77ad469-a0d6-4c98-a1da-f991babed245": {"__data__": {"id_": "a77ad469-a0d6-4c98-a1da-f991babed245", "embedding": null, "metadata": {"page_label": "67", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Approach to Manufacturing Execution Systems Design and Risk Management: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the document propose using functional domains in the design and risk management of Manufacturing Execution Systems (MES)?\n   \n2. What specific approach does the document recommend for mapping functional domains to risk-based testing in the context of MES design and implementation?\n\n3. How does the document suggest ensuring that MES systems meet end user requirements upon first implementation, particularly in terms of reducing rework or contractual disagreements?", "prev_section_summary": "This section discusses the application of domains in designing Manufacturing Execution Systems (MES) to facilitate the integration of new and existing systems. It outlines scenarios for MES domain implementations, such as first-time implementation, integration of existing systems, and a combination of new and existing systems. The domain approach involves developing requirements for the overall domain and individual system requirements as subsets. It helps coordinate computer systems and quality systems throughout the facility lifecycle and mitigate risks associated with implementing new technologies. Functional domains are defined based on common attributes, goals, activities, data, and risks, and are implemented across system boundaries. The MES domain encompasses all functional domains required for business and manufacturing processes. The section emphasizes the importance of specifying requirements and documentation for each system within the domain approach.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Design, Risk Management, Functional Domains"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "222cf63d-544f-47ef-9659-71fbe1551bb5", "node_type": "4", "metadata": {"page_label": "67", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "3d95546db53726e16d492acdf8dcb6598d641f6002b6100b3401ed8c23001504", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "80cdb8b8-438d-4a76-8ccf-7a54ab264158", "node_type": "1", "metadata": {"page_label": "66", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "5000cc99f73a7fac08d923280678b3c43bb05b0ffea2cfe925ef115cac63b0e6", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "c781877e-2e50-4951-9d1a-966f70f7982f", "node_type": "1", "metadata": {}, "hash": "36b8d83ecade8020eb572dec2fbec091aade240ab457f5b0046abb42bab36358", "class_name": "RelatedNodeInfo"}}, "text": "## manufacturing execution systems - a strategic and program management approach\n\nappendix 3\n\nfigure 7.1: using an mes domain for design and risk management\n\nsome example high level business requirements for product manufacturing (map to more detailed requirements)\n\nnecessary related functions to support each requirement grouped into functional domains\n\n|production planning|functional domain 1|\n|---|---|\n|production control|functional domain 2|\n|sampling-testing|functional domain n|\n|disposition| |\n|electronic production records| |\n|materials/product genealogy| |\n|process management and control| |\n\nsystem specification/design\n\nconcurrent specification/design and test planning processes\n\nuse functional domains to create application/systems designs\n\ntest planning\n\nmap functional domains to risk-based testing\n\nimpact, detection, frequency; data integrity; interfaces, cots vs. custom; etc.\n\naudit: ensure appropriate development methods and testing in the developer quality systems\n\nend user/owner: ensure appropriate challenges and criteria in testing documentation\n\nthis approach enables or enhances design and testing efforts by addressing the characteristics of functions within systems, including risks posed by specific actions and processing. establishing relationships of functions before assigning them to new or existing systems can clarify requests for proposal, allowing suppliers or integrators to understand requirements and functionality before design and purchase. the goal is to allow end user organizations to build or receive systems that closely meet requirements upon first implementation, reducing rework or contractual disagreements.", "start_char_idx": 0, "end_char_idx": 1665, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "c781877e-2e50-4951-9d1a-966f70f7982f": {"__data__": {"id_": "c781877e-2e50-4951-9d1a-966f70f7982f", "embedding": null, "metadata": {"page_label": "68", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Risk Management and Verification in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the GAMP 5 framework guide the assignment of risk levels to functionality within Manufacturing Execution Systems (MES) domains, and what factors are considered in this risk assessment process?\n   \n2. In what ways does the application of ASTM 2500-07 standards, as referenced in the document, facilitate the reduction of verification efforts for equipment within the same category in MES, and how does this impact the overall functional domain risk level?\n\n3. How does the document propose the use of modular testing documentation and automated test scripts to enhance the efficiency and cost-effectiveness of risk management and verification processes in MES functional domains, and what are the expected benefits of such an approach in terms of standardization and reusability?", "prev_section_summary": "The section discusses a strategic approach to designing and managing Manufacturing Execution Systems (MES) by using functional domains. It outlines how to map functional domains to risk-based testing, ensuring that MES systems meet end user requirements upon first implementation. The approach involves grouping functions into domains, creating application/system designs, and conducting testing based on risks. The goal is to clarify requirements for suppliers/integrators and reduce rework or contractual disagreements. Key topics include using functional domains for design and risk management, concurrent specification/design and test planning processes, and ensuring appropriate development methods and testing. Key entities mentioned are production planning, production control, sampling-testing, disposition, electronic production records, materials/product genealogy, and process management and control.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Risk Management, Verification, GAMP 5"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "e75c9a94-894e-4e6c-920d-eb5844edc937", "node_type": "4", "metadata": {"page_label": "68", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "a4f5dd14388267c86736eab5f34d3298d2f2ecaf5925039def0405ac25836f67", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "a77ad469-a0d6-4c98-a1da-f991babed245", "node_type": "1", "metadata": {"page_label": "67", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "3d95546db53726e16d492acdf8dcb6598d641f6002b6100b3401ed8c23001504", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "36f9391f-160a-4e67-a44b-18b75a33eb0c", "node_type": "1", "metadata": {}, "hash": "3f833759f398b84a54be31ee1e9b69f9be7f48ed0c08b04bfa4e15a258b3b350", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: appendix 3\n\nmanufacturing execution systems - a strategic and program management approach\n\nthe functional domains can be mapped to appropriate applications, systems, or equipment, whether existing, new design and build, or purchase. each functional domain can address appropriate business requirements and impact or needs for the major components, including:\n\n- information\n- personnel\n- materials\n- equipment and systems\n- regulatory and compliance\n\nthis identifies design and functional requirements and maps to testing activities based on processes, information flow, and compliance activities.\n\n### 7.3 domain impact on risk management and verification\n\nfunctional domains help to define risk levels or values to be assigned to functionality within and across systems that may be integrated in order to build the mes domain. for each functional domain, the overall initial risk level is based on typical factors which are described in gamp 5, e.g., product impact, but mitigated by system factors, e.g., standard verses custom functionality, complexity, and supplier audit results. analysis of functional domains following the principles described in gamp 5 allows evaluation of potential risk to patient safety, product quality, and data integrity based on scientific knowledge of the underlying business process. therefore, the gamp categories can be applied to functional domains within or across systems to help determine a realistic risk level for each functional domain.\n\nthe domain approach defines a model consistent with gamp 5 (reference 5, appendix 14) and astm. the application of quality risk management techniques to functional domains allows identification of common hazards, risk controls, and verification procedures or methods. the approaches defined in gamp 5 and astm 2500-07 (reference 8, appendix 14) allows scaling down of verification effort for equipment that belongs to the same category. once an organization develops standard verification practices for categories of equipment, those standards are applied, and the overall functional domain risk level is reduced accordingly for the equipment without further documentation.\n\nstandard risk management methods are applied to each functional domain to determine appropriate testing. the overall risk level for a functional domain is based on the business process, and the severity of impact of potential system hazards on patient safety, product quality, and data integrity, further modified by typical system characteristics, e.g., level of customization, rather than configuration and supplier audit results.\n\nan organization may identify areas of risk associated with hazards that are common to systems within a functional domain in order to obtain a more consistent approach. functional domains with identical or very similar risks can encourage the creation of standardized risk and testing approaches resulting in improved and more cost-effective management. testing documentation can be written in modular formats to promote re-use among functional domains. this can include automated test scripts, application-specific testing tools, logic and simulation test stands, or emulation applications to provide a realistic environment for testing. modular and integrated testing can be derived from the documented relationships in the functional domains.", "start_char_idx": 0, "end_char_idx": 3367, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "36f9391f-160a-4e67-a44b-18b75a33eb0c": {"__data__": {"id_": "36f9391f-160a-4e67-a44b-18b75a33eb0c", "embedding": null, "metadata": {"page_label": "69", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Maximizing Efficiency and Performance: Leveraging Domain Approach for Manufacturing Execution Systems\"", "questions_this_excerpt_can_answer": "1. How does the domain approach implementation for existing Manufacturing Execution Systems (MES) address the challenge of integrating domain functionality into systems that were previously tested without a focus on domain-specific features?\n\n2. What are the specific benefits of applying a domain approach to the design and testing phases of MES development, as outlined in the document, and how does this approach facilitate change management and control?\n\n3. Can you detail how the domain approach aids in the accurate assessment of risk values for different functional domains within MES, particularly in terms of commonality of typical factors such as impact, frequency, and detection?", "prev_section_summary": "This section discusses the strategic risk management and verification in Manufacturing Execution Systems (MES) by mapping functional domains to appropriate applications, systems, or equipment. It explains how risk levels are assigned to functionality within MES domains based on factors such as product impact, system complexity, and supplier audit results. The application of quality risk management techniques and standards like GAMP 5 and ASTM 2500-07 helps in reducing verification efforts for equipment within the same category. The use of modular testing documentation and automated test scripts is proposed to enhance efficiency and cost-effectiveness in risk management and verification processes, promoting standardization and reusability. Overall, the section emphasizes the importance of standardized risk and testing approaches for improved management of MES functional domains.", "excerpt_keywords": "Manufacturing Execution Systems, Domain Approach, Risk Assessment, Change Management, Verification Planning"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "d15c5b92-2aaf-41e0-8306-8ec99a4d911e", "node_type": "4", "metadata": {"page_label": "69", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "bdf1ef51088c0620c1bf419eadbcec01111ce55a1d58505a2749d0ae2c482356", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "c781877e-2e50-4951-9d1a-966f70f7982f", "node_type": "1", "metadata": {"page_label": "68", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "a4f5dd14388267c86736eab5f34d3298d2f2ecaf5925039def0405ac25836f67", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "09c3598d-2340-4c7c-a077-f89699caa88c", "node_type": "1", "metadata": {}, "hash": "ac8d6f4d6c581a9912ceef4bcba9ec14fb25a6e28bf859304e641c1fbd63c172", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 3\n\n7.4 domain approach implementation for existing systems\n\nfor existing systems, prior testing based on specifications may not be oriented to domain functionality. workload analysis of the effort for developing functional domains can determine whether a hybrid approach with and without domain analysis for various systems and applications can offer advantages or cause duplicate documentation. a hybrid approach could reduce or eliminate domain benefits for future development or change control, such as quick identification of functionality related to a change, or having comprehensive trace matrices from functionality to risk-based testing. the approach to testing each functional domain is also based on the process touch points (functionality that interacts with manufacturing processes) and the associated process risk factors. cross references can be added to the documentation entries to establish relationships among functionality that crosses system boundaries. using the genealogy example in section 1.6, figure 1.2, requirements in each system related to tracking, creating, and consuming materials, intermediates, and products (including master data) can be easily modified by adding references without major document changes. the major functional domains can then be identified and system documents updated. the mes domain can then be defined by listing the functional domains and referencing the appropriate system documents for each. desired future mes domain functionality can then be added to the mes domain documents for design, risk assessment, and verification planning. systems within the mes domain may have a common system owner, but may be owned by different groups and may be supported by multiple technical groups.\n\n7.5 summary of domain approach benefits\n\nencourages concurrent design and test planning work to be defined and assigned to personnel or teams as soon as requirements are established\nenables early design and test traceability for each domain, providing a consistent approach to aligning design and testing activities proughout pe project life cycle\npromotes understanding and documentation of system and application functions and pe establishment of relationships among pem during design and test planning\ntime is saved in change management and control by having an existing list of functions related to pe desired change facilitating or simplifying regression analysis and testing.\nfunctional domains can provide framework to coordinate phased delivery, testing, and release of functionality in large systems.\nrisk values can be assessed more accurately by basing pem in part on commonality of typical factors, such as impact, frequency, and detection for pe intended use of each functional domain.\napplying domain concepts proughout pe system development life cycle facilitates integration of interdependent entities and activities into a single design pat meets criteria for pe intended use:\nmanufacturing equipment, including process, computer, and automation\nhuman and organizational activities, such as training\ninformation and data, including documentation for each life cycle phase", "start_char_idx": 0, "end_char_idx": 3258, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "09c3598d-2340-4c7c-a077-f89699caa88c": {"__data__": {"id_": "09c3598d-2340-4c7c-a077-f89699caa88c", "embedding": null, "metadata": {"page_label": "70", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Optimizing Manufacturing Operations: A Strategic Approach to Manufacturing Execution Systems and Genealogy Expansion\"", "questions_this_excerpt_can_answer": "1. How does the GAMP\u00ae Good Practice Guide suggest incorporating genealogy into the functional domain of manufacturing execution systems, and what are the key functions associated with material and product genealogy as outlined in the guide?\n\n2. What role does risk management play in the design and implementation of manufacturing execution systems according to the GAMP\u00ae Good Practice Guide, particularly in relation to the functional domain of material and product genealogy?\n\n3. How does the guide recommend handling master and operational data within the domain creation and analysis process for manufacturing execution systems, and what impact does this data have on the risk factors associated with the functional domain?", "prev_section_summary": "The section discusses the implementation of a domain approach for existing Manufacturing Execution Systems (MES) to address challenges in integrating domain functionality. It highlights the benefits of applying a domain approach in design and testing phases, such as facilitating change management and control, enabling early traceability, and coordinating phased delivery of functionality. The section also emphasizes the importance of accurately assessing risk values for different functional domains within MES based on common factors like impact, frequency, and detection. Additionally, it mentions the importance of documenting system and application functions, establishing relationships among them, and integrating interdependent entities and activities into a single design.", "excerpt_keywords": "Manufacturing Execution Systems, Genealogy Expansion, GAMP Good Practice Guide, Risk Management, Domain Analysis"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "066836c8-2e37-45bd-8878-748d1c570bb1", "node_type": "4", "metadata": {"page_label": "70", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "44ebcc85f3dc4e07aa1f9d9317b3db0c8f1ae4b023a562f99ea2aa6158b8c52b", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "36f9391f-160a-4e67-a44b-18b75a33eb0c", "node_type": "1", "metadata": {"page_label": "69", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "bdf1ef51088c0620c1bf419eadbcec01111ce55a1d58505a2749d0ae2c482356", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "d5e9f945-822b-4612-adea-9858643f8449", "node_type": "1", "metadata": {}, "hash": "69a51baab427e230aae569bf7ce1142886a0bd5f1faa4e9102cbe1eee17b86db", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: appendix 3\n\n### manufacturing execution systems - a strategic and program management approach\n\n7.6 expanding the genealogy example\n\ndomain analysis and creation begins with developing the business requirements necessary to plan, control, and execute manufacturing operations.\n\nfigure 1.2 in section 1.6 of this guide shows genealogy as an example of a functional domain.\n\nfor material and product genealogy, functions for material tracking, storing, testing, and disposition, division (e.g., weigh/dispense), consumption, and creation of new inventory could be grouped into a functional domain. such a functional domain can have several of the major functions in different applications. the risks associated with the functions will typically share many common risk factors so a consistent risk management approach can be developed for the functional domain. these risk factors affect the design of systems (redundancy, robustness), as well as types and complexity of testing, including any integration, such as a built-in application interface (api), middleware, and equipment or data communications.\n\nmaster and operational data is considered in the domain creation and analysis process. the types and quantities of data associated with the functional domain will affect the functional domain risk factors across the systems that create, share, or otherwise manage data.\n\ndevelopment of more detailed requirements and specifications can be part of the initial domain creation and analysis, or a result of domain analysis. creating requirements, specifications, and designs usually is an iterative process, and the domain approach is a tool to optimize risk management activities that are already part of a gxp life cycle process.", "start_char_idx": 0, "end_char_idx": 1762, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "d5e9f945-822b-4612-adea-9858643f8449": {"__data__": {"id_": "d5e9f945-822b-4612-adea-9858643f8449", "embedding": null, "metadata": {"page_label": "71", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Exploring MES Implementation Strategy Approaches: Horizontal, Vertical, and Hybrid Approaches\"", "questions_this_excerpt_can_answer": "1. What are the two primary methods for implementing a Manufacturing Execution System (MES) as outlined in the document, and how do they differ in terms of scope and compliance validation?\n   \n2. How does the document describe the process and considerations for choosing between a horizontal or vertical MES implementation strategy, particularly in terms of organizational size, the scope of integration, and compliance requirements?\n\n3. Can the document provide insights into how a hybrid MES implementation strategy combines elements of both horizontal and vertical approaches, and what factors might influence an organization to choose this method over a purely horizontal or vertical strategy?", "prev_section_summary": "The section discusses the strategic approach to manufacturing execution systems and genealogy expansion, focusing on domain analysis and creation, material and product genealogy functions, risk management, master and operational data handling, and the iterative process of developing requirements, specifications, and designs. Key topics include the role of genealogy in manufacturing operations, functions associated with material and product genealogy, risk factors affecting system design, data management considerations, and the optimization of risk management activities within the GXP life cycle process.", "excerpt_keywords": "MES, Implementation Strategy, Horizontal, Vertical, Hybrid Approach"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "41effd14-d5dc-4494-a940-cb731e8a1d01", "node_type": "4", "metadata": {"page_label": "71", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "e725ef85ac550d1b082f15dcb4cc5fe15eed8d5bab99c9264038c799947441d4", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "09c3598d-2340-4c7c-a077-f89699caa88c", "node_type": "1", "metadata": {"page_label": "70", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "44ebcc85f3dc4e07aa1f9d9317b3db0c8f1ae4b023a562f99ea2aa6158b8c52b", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "c6b0515d-a5cc-41c2-88eb-1d74f68626a6", "node_type": "1", "metadata": {}, "hash": "7c505f0b17f1191fa82bc4662c004423319cb3fac46187d729c859f4a5464131", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 4 - developing an mes implementation strategy\n\n8.1 introduction\n\nthis appendix outlines possible approaches to facilitate an mes implementation strategy.\n\n8.2 considerations and concepts for strategy development\n\nthere are two major methods for mes implementation:\n\n- horizontal\n- vertical\n\nhorizontal implementations are layer(s) of functionality implemented across more than one area, facility, process, or product. the layers may start at the top (e.g., mrp, erp) or the bottom (e.g., automation data collection). horizontal implementation may be accomplished for a single facility or site and may be the only implementation, e.g., for a small organization, or it may be the initial implementation that is subsequently installed at other sites, e.g., for larger organizations. successive implementations would build additional layers of functionality until the desired scope of systems and business process integration is achieved. from a compliance perspective only a single layer of functionality would be validated.\n\nvertical implementations are top to bottom through a selected area, facility, process, or product:\n\n- from a compliance viewpoint, all core functions at one site are validated.\n- larger organizations can implement the solution at multiple sites, either in series or in parallel.\n\neither method may be used for a process, product line, or specific product manufacture. figure 8.1 illustrates the two different implementation strategies. the amount and degree of re-engineering incorporated in the planned system, as well as the lost and down time available for existing facilities may be limiting factors for project scope. in addition, segmenting the scope into phases can make an implementation more manageable.\n\na combination or hybrid approach can combine multiple layers of mes technology in a strategy that is rolled out to multiple products or facilities.", "start_char_idx": 0, "end_char_idx": 1896, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "c6b0515d-a5cc-41c2-88eb-1d74f68626a6": {"__data__": {"id_": "c6b0515d-a5cc-41c2-88eb-1d74f68626a6", "embedding": null, "metadata": {"page_label": "72", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Implementing Manufacturing Execution Systems: A Horizontal Strategy for Success\"", "questions_this_excerpt_can_answer": "1. What are the primary advantages and disadvantages of adopting a horizontal implementation strategy for Manufacturing Execution Systems (MES) as outlined in the document \"Implementing Manufacturing Execution Systems: A Horizontal Strategy for Success\"?\n\n2. How does the document \"Implementing Manufacturing Execution Systems: A Horizontal Strategy for Success\" describe the approach to achieving cost control or solving critical functional issues through horizontal implementation strategies for MES across multiple sites or products?\n\n3. In the context of MES implementation strategies discussed in \"Implementing Manufacturing Execution Systems: A Horizontal Strategy for Success,\" how does a horizontal implementation strategy differ in its approach to adding functionality compared to a vertical implementation strategy, particularly in terms of scope and integration across manufacturing or business processes?", "prev_section_summary": "The section discusses the development of a Manufacturing Execution System (MES) implementation strategy, outlining two primary methods: horizontal and vertical implementations. Horizontal implementations involve implementing layers of functionality across multiple areas, facilities, processes, or products, while vertical implementations are top-to-bottom through a selected area, facility, process, or product. The document describes considerations for choosing between these approaches based on organizational size, integration scope, and compliance requirements. It also mentions a hybrid approach that combines elements of both horizontal and vertical strategies for multiple products or facilities. Factors such as re-engineering, downtime, and project scope segmentation are highlighted as considerations for MES implementation.", "excerpt_keywords": "Manufacturing Execution Systems, MES, implementation strategy, horizontal, cost control"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "eb784b4a-f1f2-4574-a21c-dc441e5f0e45", "node_type": "4", "metadata": {"page_label": "72", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "7dc177cacd2f5fedf9da4b5d89ed1d36cf4e59576a5d353c7a799eab63bc8677", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "d5e9f945-822b-4612-adea-9858643f8449", "node_type": "1", "metadata": {"page_label": "71", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "e725ef85ac550d1b082f15dcb4cc5fe15eed8d5bab99c9264038c799947441d4", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "c62fd0f3-5502-4ce1-81b1-aad8905a0fd1", "node_type": "1", "metadata": {}, "hash": "280064a2f4326ce39ee542d44b0aaba6cfec32fbdabf98737797c83814fba12c", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 4: manufacturing execution systems - a strategic and program management approach\n\nfigure 8.1: vertical verses horizontal implementation strategies\n\n|broad systems functionality|copy of broad systems functionality|final planned systems functionality|\n|---|---|---|\n|additional systems functionality|initial systems functionality| |\n\n### horizontal implementation strategy\n\nhorizontal implementations can achieve cost control or solve critical functional issue(s), while providing some mes technology for multiple sites or products. for example, products may have common process functionality that can be improved upon in either compliance or efficiency.\n\na horizontal implementation typically addresses limited functionality, within manufacturing or business processes, that is implemented concurrently across multiple areas, facilities, or products. subsequent horizontal implementations typically build additional layers of functionality until the desired scope of systems and business process integration is achieved.\n\n|advantages|disadvantages|\n|---|---|\n|cost control|limited functionality|", "start_char_idx": 0, "end_char_idx": 1106, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "c62fd0f3-5502-4ce1-81b1-aad8905a0fd1": {"__data__": {"id_": "c62fd0f3-5502-4ce1-81b1-aad8905a0fd1", "embedding": null, "metadata": {"page_label": "73", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "A Comparative Analysis of Vertical and Horizontal Implementation Strategies in Manufacturing Execution Systems", "questions_this_excerpt_can_answer": "1. What are the specific advantages and disadvantages of adopting a horizontal implementation strategy for Manufacturing Execution Systems (MES) as outlined in the document \"A Comparative Analysis of Vertical and Horizontal Implementation Strategies in Manufacturing Execution Systems\"?\n\n2. How does the document compare the impact of horizontal and vertical implementation strategies on team deployment, site operations, and system integration within the context of Manufacturing Execution Systems?\n\n3. In the context of exploring and developing a comprehensive MES approach, what does the document suggest about the use of a vertical implementation strategy, particularly in environments where there is no impact on commercial product or validated processes?", "prev_section_summary": "The section discusses the strategic and program management approach to implementing Manufacturing Execution Systems (MES) with a focus on horizontal implementation strategies. It compares vertical and horizontal implementation strategies, highlighting the advantages and disadvantages of the horizontal approach. The key topics covered include achieving cost control, solving critical functional issues, implementing limited functionality across multiple areas, facilities, or products, and gradually building additional layers of functionality to achieve the desired scope of systems and business process integration. The section emphasizes the importance of common process functionality and improving compliance or efficiency in a horizontal implementation strategy for MES.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Implementation Strategies, Vertical, Horizontal"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "60e2e5f4-6316-40cc-88be-6855d3aefbb8", "node_type": "4", "metadata": {"page_label": "73", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "f63d73e07aac4b0b35d1096af538d60707299d6aa5584a929d3d050ab1c67c30", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "c6b0515d-a5cc-41c2-88eb-1d74f68626a6", "node_type": "1", "metadata": {"page_label": "72", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "7dc177cacd2f5fedf9da4b5d89ed1d36cf4e59576a5d353c7a799eab63bc8677", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "15cf87f9-9136-4d62-9ceb-6aa88bf951a3", "node_type": "1", "metadata": {}, "hash": "a1d57377589acd3f2c37164978402bffb29fa856a65f3f9a055b8678ad6c216d", "class_name": "RelatedNodeInfo"}}, "text": "## manufacturing execution systems - a strategic and program management approach\n\n### appendix 4\n\n|advantages|disadvantages|\n|---|---|\n|lower risk of initial deployment since less functionality is easier to manage|expected benefits of the mes domain implementation are delayed.|\n|shorter interruption to existing site operations|overall increase in time and cost for multiple rollouts|\n|smaller teams are used at subsequent sites|multiple interruptions to site operations as successive phases are rolled out|\n|redeployment of core teams to other sites is kept to shorter time periods|multiple interruptions/updates to integrated systems databases for phases|\n|benefits can begin earlier due to shorter implementation time.|may require temporary software functions, manual operations, and work flow to account for functionality and integration that will not be installed until later phases|\n|smaller effort for verification, including integrated testing at sites|larger number of documents will have to be reviewed, approved as verification is phased with some overlap.|\n|less integration that must be tested at sites|must choose the right functionality for the first implementation as a balance of benefits and effort.|\n|development of test cases is simplified.|desired mes design may not be suitable for a horizontally phased roll-out.|\n|fewer end users initially impacted, improves communication during development and implementation|usually provides limited functionality|\n|allows it and engineering teams time to build expertise for maintaining future expanded functionality| |\n\n### 8.4 vertical implementation strategy\n\na vertical implementation strategy may be used for a prototype where the requirement is to explore and develop a comprehensive mes approach (top to bottom) through a manufacturing process. this can be in a development facility or environment where there is no impact on commercial product or validated processes.\n\nan initial vertical implementation typically is used to prove concepts and eliminate problems and issues of most or all of a manufacturing process at one location or for one product, prior to rollout of the technology to other corporate regions.\n\n|advantages|disadvantages|\n|---|---|\n| | |", "start_char_idx": 0, "end_char_idx": 2228, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "15cf87f9-9136-4d62-9ceb-6aa88bf951a3": {"__data__": {"id_": "15cf87f9-9136-4d62-9ceb-6aa88bf951a3", "embedding": null, "metadata": {"page_label": "74", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Program Management and Application Control Strategies for Manufacturing Execution Systems", "questions_this_excerpt_can_answer": "1. What are the key advantages and disadvantages of implementing Manufacturing Execution Systems (MES) using a strategic and program management approach as outlined in the ISPE GAMP Good Practice Guide's Appendix 4?\n\n2. How does the ISPE GAMP Good Practice Guide suggest managing the prototype system approach for MES to ensure it accurately represents the production environment, including hardware and software specifications?\n\n3. According to the document, what are the considerations for ensuring hardware and software equivalency in a prototype system for MES, and how does this approach facilitate the early stages of project life cycle without intending the prototype for production use?", "prev_section_summary": "The section discusses the advantages and disadvantages of adopting horizontal and vertical implementation strategies for Manufacturing Execution Systems (MES). \n\nKey topics include:\n- Advantages and disadvantages of horizontal implementation strategy\n- Impact on team deployment, site operations, and system integration\n- Advantages and disadvantages of vertical implementation strategy for exploring and developing a comprehensive MES approach\n\nKey entities mentioned:\n- Manufacturing Execution Systems (MES)\n- Horizontal implementation strategy\n- Vertical implementation strategy\n- Team deployment\n- Site operations\n- System integration\n- Prototype development\n- Commercial product\n- Validated processes", "excerpt_keywords": "Manufacturing Execution Systems, MES, ISPE GAMP, Program Management, Application Control Strategies"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "b319e5be-f02d-458c-beca-a2424394e5b8", "node_type": "4", "metadata": {"page_label": "74", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "bbf66783e22b9e4a9ede2c6649bad7b7b49d109d942a4b12d2dd7008bcb138a7", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "c62fd0f3-5502-4ce1-81b1-aad8905a0fd1", "node_type": "1", "metadata": {"page_label": "73", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "f63d73e07aac4b0b35d1096af538d60707299d6aa5584a929d3d050ab1c67c30", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "ea9dcf7c-985d-4a86-a733-cf4b80c8ba43", "node_type": "1", "metadata": {}, "hash": "e585f6a7f2c9d51619abd3d2f4923d69ec1c5c4b99680c4654b8b8e81d3800fd", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: appendix 4\n\n### manufacturing execution systems - a strategic and program management approach\n\n|advantages|disadvantages|\n|---|---|\n|lower overall cost and shorter overall time of a single implementation by efficiencies of scale and fewer iterations of life cycle activities|requires complete set of teams from the beginning - high resource loading|\n|initial implementation teams concentrate on the project start to finish|project costs are higher earlier in the project.|\n|benefits may occur at an earlier time as well as yielding higher benefits.|higher immediate impact on systems support groups for larger scope|\n|management interest remains at high level.|site team personnel are kept away from their typical job activities for a longer period.|\n|total planned benefits may begin earlier from a corporate perspective.|delay in benefits to sites other than the initial deployment site|\n|design and verification methods are proven before global deployment.|earlier failures or delays in the first implementation may cause early termination.|\n|complete functionality once testing is complete|longer time for developing the test data sets for protocol testing more complex project|\n\n### application control strategies\n\ndependent on an organizations structures and central technical capabilities verses site technical capabilities, the specification, purchase, development, control, and issue of application versions can be managed via one of several methods. for further details on global deployment, see the ispe gamp good practice guide: global information systems control and compliance (reference 6, appendix 14).\n\n#### prototype system approach\n\nin order to represent a production environment, the prototype system configuration should be managed to ensure that it meets the basic design specifications of the production system and data. this can use equivalent hardware meeting the production system specifications and does not require utilization of the exact supplier brands, models, or quantities of hardware and equipment.\n\na prototype system requires correct software versions and representative data classes of the production system to act as a surrogate for testing. equivalent hardware and reduced quantity of equipment are acceptable for testing, other than verifying total system load analysis, e.g., network throughput. loading tests typically are verified by monitoring production system performance; however, an initial estimate can be generated for implementation planning by extrapolating system throughput via observing prototype system performance factors.\n\nthe prototype typically is created early in a project life cycle and is not intended for use as a production system.\n\nhardware and software attributes to consider for equivalency include, but are not limited to:\n\n- processor class/speed\n- minimum data memory and storage\n- input/output (i/o requirements)", "start_char_idx": 0, "end_char_idx": 2918, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "ea9dcf7c-985d-4a86-a733-cf4b80c8ba43": {"__data__": {"id_": "ea9dcf7c-985d-4a86-a733-cf4b80c8ba43", "embedding": null, "metadata": {"page_label": "75", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Approaches to Manufacturing Execution Systems Governance and Control: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the key components and considerations for setting up a pilot or test Manufacturing Execution System (MES) environment according to the GAMP (Good Automated Manufacturing Practice) guide, and how does it differ from the production system configuration?\n   \n2. How does the GAMP guide recommend managing the control of MES domain applications in a centralized manner, including the specifics of application hosting, change control, data management, and verification processes?\n\n3. What are the guidelines provided by the GAMP guide for individual site application control within MES, including the authorization, functionality control, change control, data management, and verification processes at the site level?", "prev_section_summary": "The section discusses the advantages and disadvantages of implementing Manufacturing Execution Systems (MES) using a strategic and program management approach as outlined in the ISPE GAMP Good Practice Guide's Appendix 4. It highlights the benefits of lower overall cost, shorter implementation time, and early benefits, but also mentions challenges such as high resource loading and delays in benefits to sites. The document also addresses the management of prototype systems for MES, emphasizing the importance of ensuring hardware and software equivalency to accurately represent the production environment. Key considerations include processor class/speed, memory and storage requirements, and input/output specifications. The prototype system is created early in the project life cycle for testing purposes and is not intended for production use.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP, Governance, Control"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "1bf871d6-e95d-4fa8-8e06-e129651cc273", "node_type": "4", "metadata": {"page_label": "75", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "abffe0fd75cc05f915bebca81f527eeaa1f2de74c9d1cafa20fd958fcb7d34cf", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "15cf87f9-9136-4d62-9ceb-6aa88bf951a3", "node_type": "1", "metadata": {"page_label": "74", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "bbf66783e22b9e4a9ede2c6649bad7b7b49d109d942a4b12d2dd7008bcb138a7", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "58c8316f-5970-45e5-aa34-27c98e2e5555", "node_type": "1", "metadata": {}, "hash": "957e7cc9af8695357f1a9661ffbd640a81f92d284f419281ef9266a64b36b0ba", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 4\n\n- network connectivity\n- database instance and configuration\n- equipment and peripherals (such as plc/dcs, barcode and printing systems)\n- application versions and supporting software versions, such as operating systems, software utilities, virus and security protection\n- interfaces to other systems that will interact with the prototype\n\nnote: it may be acceptable to have specific configuration differences from the production system, e.g., number of workstations or servers, peripherals, database naming, network addresses, and other infrastructure items required to run a separate, smaller-scale system.\n\nwhere pilot or test mes are used to test functionality, fixes, and changes prior to deployment to the production system, interface functionality should be replicated either to corporate or shop-floor systems. ideally, the test environment mes should have functioning interfaces to the equivalent test environments of corporate and manufacturing area systems, which may include representative samples of instruments or process equipment. where necessary, the interfaces to systems may be simulated manually or by means of software tools populating the interface with appropriate data and information. however, the results of testing using such simulations can be less predictive of the behavior of the production system and allowance should be made for a greater degree of testing on the production system when simulations do not completely replicate necessary data classes and functionality.\n\n### 8.5.2 central control of applications\n\nin this approach, control of mes domain applications is centralized, where the following apply:\n\n- applications are hosted in a central it location and accessed via workstations or terminals at site locations. there may be no local servers.\n- all change control and data is managed at the central host location. note: there may be hardware configuration management and infrastructure control at the sites.\n- verification is performed on a central system. verification activities are performed at the site for infrastructure and other local hardware and support software, e.g., operating system installation, as well as communications to site and central components.\n\n### 8.5.3 individual site application control\n\nin this approach, the applications are decentralized and the following apply:\n\n- applications typically are authorized for use at sites by a central program management organization to ensure standardization across a company.\n- functionality is determined and controlled by sites.\n- change control and data are managed by sites. there may be global data for accounting, shipping, and distribution reported or transferred to a central corporate system.\n- all verification is implemented by sites, planning may be coordinated with corporate or other site entities.", "start_char_idx": 0, "end_char_idx": 2949, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "58c8316f-5970-45e5-aa34-27c98e2e5555": {"__data__": {"id_": "58c8316f-5970-45e5-aa34-27c98e2e5555", "embedding": null, "metadata": {"page_label": "76", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Approach to Manufacturing Execution Systems Implementation and Core Team Activities: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What is the hybrid approach to the control of applications in Manufacturing Execution Systems (MES) as outlined in the GAMP(r) Good Practice Guide, and what are the responsibilities of local sites under this approach?\n\n2. Who are the typical members of a core implementation team for large MES projects, according to the strategic approach detailed in the document?\n\n3. How does the document suggest handling the balance between leveraging core MES functionality and accommodating site-specific requirements during the implementation process?", "prev_section_summary": "The section discusses key components and considerations for setting up a pilot or test Manufacturing Execution System (MES) environment according to the GAMP guide, including network connectivity, database configuration, equipment, application versions, and interfaces to other systems. It also covers the differences between pilot/test and production system configurations, as well as recommendations for central control of MES domain applications and individual site application control. Key topics include centralized hosting of applications, change control, data management, verification processes, and decentralized authorization and functionality control at individual sites.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP, Implementation, Core Team"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "cab7ef02-5aa2-4aee-b95b-750ae7517bce", "node_type": "4", "metadata": {"page_label": "76", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "175e097e1de89e832d40b8f195277d4ab09eb0d249e7dba175e40e1297706acc", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "ea9dcf7c-985d-4a86-a733-cf4b80c8ba43", "node_type": "1", "metadata": {"page_label": "75", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "abffe0fd75cc05f915bebca81f527eeaa1f2de74c9d1cafa20fd958fcb7d34cf", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "198f5220-4a16-49a4-aa78-b7f559075d96", "node_type": "1", "metadata": {}, "hash": "5577453443eab0fb09bcfe11eb33f0e7bce12ed2e76d0c07f41866fef0a2ddc7", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: appendix 4\n\n### manufacturing execution systems - a strategic and program management approach\n\n8.5.4 hybrid of central and distributed control of applications\n\nin this approach, either whole applications or core functionality of applications are specified and verified by a central organization controlled system, where the following apply:\n\n- software and supporting documentation are distributed or otherwise available to local sites.\n- sites verify installation of the applications to confirm local configuration of production system(s) and demonstrate that applications and databases operate on local hardware and communicate via local interfaces and infrastructure.\n- sites are responsible for maintenance of the systems and for local change control of local configuration and infrastructure. coordination with central control is required for certain configuration settings, as well as desired application changes.\n\ndata generated at a site may be locally owned or managed in a central data warehouse.\n\n8.6 core team activities\n\nlarge mes projects may have a core implementation team that is composed of representatives from the following organizations:\n\n- corporate quality units\n- corporate regulatory affairs\n- corporate regulatory compliance\n- corporate validation\n- corporate information technology\n- equivalent site quality, validation, and user communities\n- application vendor(s)\n- program management office\n\nthe site representatives may be chosen based on their subject matter knowledge of the functional domains defined in an mes project scope. this group should be tasked with the development of an agreed common set of functionality for the mes core development. the purpose of this development is to maximize the overall benefit across sites and business units by providing a standard set of harmonized processes. this agreed core set of configured functionality should be refined within the team. as the mes core functionality is rolled out across sites, additional configuration or customizations that may be needed to satisfy local requirements can be added by a site implementation team consisting of it and user representatives working with the core team. implementation at a site involves leveraging as much of the core system as possible, while minimizing site-specific differences.", "start_char_idx": 0, "end_char_idx": 2339, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "198f5220-4a16-49a4-aa78-b7f559075d96": {"__data__": {"id_": "198f5220-4a16-49a4-aa78-b7f559075d96", "embedding": null, "metadata": {"page_label": "77", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Deployment and Verification of MES Core Functionality in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the GAMP Good Practice Guide suggest MES core functionality enhancements should be shared across development and deployment organizations to facilitate knowledge sharing and innovation?\n\n2. What are the recommended practices for documenting and verifying MES core functionality according to the GAMP Good Practice Guide, including the types of documentation that should be made accessible for each deployment?\n\n3. What benefits does the GAMP Good Practice Guide highlight regarding the configuration of standard applications over customization in the context of MES deployment, and how does this approach contribute to cost and time savings in verification?", "prev_section_summary": "The section discusses the hybrid approach to control applications in Manufacturing Execution Systems (MES) as outlined in the GAMP(r) Good Practice Guide, where central organization controls core functionality and local sites are responsible for maintenance and local configuration. It also outlines the typical members of a core implementation team for large MES projects, including representatives from corporate quality units, regulatory affairs, validation, information technology, and site quality and user communities. The document suggests balancing core MES functionality with site-specific requirements during implementation by developing a common set of functionality for the MES core development and allowing for additional configuration or customizations at the site level.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP Good Practice Guide, core functionality, verification"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "29c2cce6-133c-4093-9879-8f254853bb17", "node_type": "4", "metadata": {"page_label": "77", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "8bfdde1703268b817d3f42d333040de01f6e4efa37e3c23e4891fff6ab6a842b", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "58c8316f-5970-45e5-aa34-27c98e2e5555", "node_type": "1", "metadata": {"page_label": "76", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "175e097e1de89e832d40b8f195277d4ab09eb0d249e7dba175e40e1297706acc", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "184128fc-4a51-4b9c-a29f-ba638a3af57f", "node_type": "1", "metadata": {}, "hash": "31b964fe78646b3e679af7f60ff8f74e1b396d8a45e99bd7b351fcf63a2e7a5d", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 4\n\n8.7 deployment of mes core functionality\n\ninnovations and enhancements achieved at specific sites should be shared across the mes development and deployment organizations where possible to facilitate sharing of knowledge and new functionality. this allows sites to build on the mes core functionality and take into account specific local technological and procedural circumstances. in addition, value-added changes implemented at one site can be shared with other sites and become part of the core functionality for further rollouts globally.\n\nthe requirements for customized enhancements can come in several forms, e.g., regulatory mandated functionality, such as audit trail capability, that is not inherent in the mes suppliers package or other circumstances that were not envisioned at the time of initial development. similarly, site-specific systems architecture may require customized interfaces as part of the automated systems integration process. to capitalize on the added value of any such customized functionality, the core team should create enterprise-wide accessible documentation and share lessons learned from each deployment as part of its corporate mes implementation strategy.\n\nduring the mes project initiation stage, the core team should establish the rules for accepted and expected interactions between each site and the parent organization. processes to capture intended enhancements to the mes core functionality should be documented and made visible to the team to ensure activities to be pursued are understood, warranted, and build on collective efforts.\n\n8.7.1 use of configuration of standard applications\n\na benefit from configuration, rather than customization of standard applications, is the reduction in cost and time associated with verification. mes core functionality development should maximize the use of standard functionality provided by chosen application(s). choosing highly configurable systems provides cost savings in implementation for the wide range of current and future processes within the pharmaceutical industry and increases the time before major changes are needed.\n\ncomparing and contrasting business processes within the mes domain identify best practices to which technology is applied. the ability to achieve targeted functionality can be accomplished by configuring the application after business processes are evaluated and reengineered. in short, technology is a tool to implement effective business and operational process improvements and reorganization.\n\n8.7.2 verifying the mes core functionality\n\ncore components of the mes system should be identified, functionally tested, and documented according to an approved set of procedures, following a risk-based approach. the documented results of the testing should form part of the core validation documentation set. these documents should be made accessible for each subsequent deployment, typically include:\n\n- computerized system validation plan and reports\n- specifications\n- test plans\n- scripts\n- test results\n- traceability matrix\n- configuration instructions", "start_char_idx": 0, "end_char_idx": 3210, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "184128fc-4a51-4b9c-a29f-ba638a3af57f": {"__data__": {"id_": "184128fc-4a51-4b9c-a29f-ba638a3af57f", "embedding": null, "metadata": {"page_label": "78", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Best Practices for MES Implementation and Deployment: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the recommended practices for issuing an interim validation report during the phased deployment of a Manufacturing Execution System (MES) according to the GAMP good practice guide?\n   \n2. How does the document suggest handling the localization of MES core components during the rollout to multiple sites, and what is the importance of documentation in this process?\n\n3. What are the advantages of having a separate MES system from production systems during the domain-based manufacturing implementation, especially in terms of testing, training, and problem-solving, as outlined in the guide?", "prev_section_summary": "The section discusses the strategic deployment and verification of MES core functionality in Manufacturing Execution Systems according to the GAMP Good Practice Guide. Key topics include sharing innovations and enhancements across development and deployment organizations, documenting and verifying MES core functionality, the benefits of configuration over customization, and the verification process for MES core functionality. Entities mentioned include the core team, customized enhancements, standard applications, testing procedures, and documentation requirements.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, validation report, phased deployment"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "d61484fb-7c96-4246-9808-c9e9a48e58c9", "node_type": "4", "metadata": {"page_label": "78", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "303944dd87e5968e90758eb551bf53e5341bc0abf711509edf2681f54a279940", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "198f5220-4a16-49a4-aa78-b7f559075d96", "node_type": "1", "metadata": {"page_label": "77", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "8bfdde1703268b817d3f42d333040de01f6e4efa37e3c23e4891fff6ab6a842b", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "f346835d-8aab-41f3-a49c-363ee57dca00", "node_type": "1", "metadata": {}, "hash": "320577f6067a5737c79a7e9190a561c872c859a4d18df24cc8e386bb306ee810", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: appendix 4\n\nin some cases, it may be appropriate to issue an interim validation report that will support the end of centralized core testing and signify permission to proceed with local installation. interim validation reporting also may be useful in the circumstances where the system is being installed at a number of sites in a phased manner and a final validation report is built after all installations have been implemented. the use of such a process will be documented in the validation plan. except in special circumstances that may arise because of local requirements, repeat testing of core components is not required following installation at the local site.\n\n### site localization during roll out\n\nany additional localization of the configuration specified for the core components should be suitably tested and documented and its performance verified against the current specification for installation at that specific site. the documentation produced should form part of the evidence for proper performance of the computerized system at the local site.\n\n### phased deployment\n\nmes implementations vary in complexity depending on the desired functionality. resource availability, timeline restrictions, and site-specific issues may require that mes functionality be implemented sequentially in groups of functions (horizontal approach) or at multiple sites in a chosen order (vertical approach).\n\nwhen implementing mes domain based manufacturing, having a system separate from production systems is considered preferable, based on the following:\n\n- testing of future functionality can refine designs.\n- training can be accomplished away from the production area to facilitate problem handling and familiarization with computer systems in a non-critical environment.\n- a system can be controlled and maintained in an equivalent state to the production system, allowing formal testing to be performed prior to installation in production locations. such testing documentation can be leveraged for multiple sites avoiding redundant testing.\n- testing of current functionality as in the case of investigation or debugging problems can be accomplished without affecting processes or data.\n- if an mes implementation is at a new facility or new manufacturing area where application and integration testing can be performed directly on production systems prior to start-up, a separate system provides several advantages to an implementation, including:\n- applications and integration methods can be tested independently of the construction schedule.\n- training can be accomplished in advance of commissioning or other project milestones.\n- a separate system is available immediately after start-up for addressing any issues in a non-production environment.\n\nseparate systems facilitate testing and upgrading of supporting software, such as operating systems, bar code software, reporting, monitoring, and database tools. they may be based on the same minimum equipment and infrastructure specifications and are equivalent to production system(s) functionality. these systems may be used to verify hardware models to establish criteria for change management categories, such as functionally equivalent replacements.", "start_char_idx": 0, "end_char_idx": 3251, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "f346835d-8aab-41f3-a49c-363ee57dca00": {"__data__": {"id_": "f346835d-8aab-41f3-a49c-363ee57dca00", "embedding": null, "metadata": {"page_label": "79", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"System Controls and Considerations in MES Deployments: A Comprehensive Guide\"", "questions_this_excerpt_can_answer": "1. What are the recommended mechanisms to maintain a Manufacturing Execution System (MES) in a compliant state during testing phases, as outlined in the GAMP Good Practice Guide: Manufacturing Execution Systems?\n   \n2. How does the document suggest handling the implementation of local functionality within MES deployments to ensure business benefits and compliance, especially in terms of validation costs and time?\n\n3. What challenges are identified in the document regarding system integration across organizational boundaries in MES deployments, and how do these challenges impact data consistency and transaction timing?", "prev_section_summary": "The section discusses best practices for MES implementation and deployment, focusing on issuing interim validation reports, site localization during rollout, and the advantages of having a separate MES system from production systems. Key topics include the use of interim validation reports to support phased deployment, testing and documentation of localized configurations, and the benefits of separate MES systems for testing, training, and problem-solving. Entities mentioned include GAMP good practice guide, MES core components, validation plan, localization, phased deployment, domain-based manufacturing, testing, training, production systems, and supporting software.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, system controls, deployment"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "5b28bedb-2f4c-44d2-8c9b-9b6b98413544", "node_type": "4", "metadata": {"page_label": "79", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "99383638ab86043dc62cf7a31a5052bab52a62ff986f17e61c0de4f63839c9df", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "184128fc-4a51-4b9c-a29f-ba638a3af57f", "node_type": "1", "metadata": {"page_label": "78", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "303944dd87e5968e90758eb551bf53e5341bc0abf711509edf2681f54a279940", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "735cecce-0c47-4101-adc0-0a7a82d590e0", "node_type": "1", "metadata": {}, "hash": "7e1f083f0c2799cafe5fa886c6907e95a5b3ebc7e06ea58a14ef5aa723cd2257", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 4\n\nsystem controls during deployments\npage 77\n\n8.9 system controls during deployments\n\nhaving a configurable mes core functionality concept will provide a mechanism to disable unused or untested functionality regardless of the type of implementation strategy. other mechanisms to maintain a system in a compliant state while testing include the following:\n\n- manual procedures that are to be followed during testing\n- run time modules that are specifically set up to inhibit unused functionality. many enterprise and mes suppliers deliver all of their software with a run time version configured for the functionality that is to be tested (or purchased).\n- system patches to turn on additional functionality or when a new run time version is required\n- installation qualification/operational qualification supplements, regression analysis, and potentially testing may be required, which adds cost and time delay.\n\n8.10 other considerations\n\nbusiness benefits resulting from the implementation of local functionality typically will provide ease of use and limited business gain. if during the planning stages, specific local functionality is required for successful use of integrated systems, a supplemental risk-based site validation plan should be developed to implement these local features as soon as the required supporting modules are implemented at each site. local functionality may be implemented after the global system has been rolled out or for the incremental layers of mes functionality and will require additional validation costs and time.\n\nsome risks of system integration involve organizational boundaries, including:\n\n- integrated systems may be in different organizational units.\n- sequential data and transaction dependencies\n- timing of transactions verses related operations\n- precision and granularity of the data in the transactions cannot achieve consistent adjustments and updates.\n\ntypically, sharing of documents from an initial implementation of mes can be affected by language issues in global deployments. use of manufacturing portals, gui screen displays, and shared systems, e.g., a centralized mrp or historians, can make reusability subject to site language, alphabet, and product and process factors. the core team for large mes deployments requires resources to develop the functionality based on factors beyond just the technology or domain specific mes functionality.\n\n8.11 life cycle phase relationships\n\nlarge integrated systems may schedule the installation and testing of portions of infrastructure, equipment, systems, and applications by area, building, or functional group. database instances can be populated in sequential fashion by clearly defining data groups required to support each installation.", "start_char_idx": 0, "end_char_idx": 2873, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "735cecce-0c47-4101-adc0-0a7a82d590e0": {"__data__": {"id_": "735cecce-0c47-4101-adc0-0a7a82d590e0", "embedding": null, "metadata": {"page_label": "80", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Implementation and Program Management of Manufacturing Execution Systems", "questions_this_excerpt_can_answer": "1. What strategies are recommended for managing changes or modifications to the original scope of work during the implementation of Manufacturing Execution Systems (MES) to avoid disputes, cost over-runs, and schedule delays?\n   \n2. How does the document suggest handling the overlap of phases during the implementation of system components in MES projects, particularly in relation to accommodating project constraints and ensuring the smooth transition of hardware and software components through various execution phases?\n\n3. What are the specific procedures recommended for establishing status nomenclature and transition criteria for hardware and software components in MES projects, as outlined in the strategic implementation and program management approach for MES?", "prev_section_summary": "The section discusses system controls and considerations during Manufacturing Execution System (MES) deployments. Key topics include maintaining a compliant state during testing phases, handling local functionality implementation, challenges of system integration across organizational boundaries, and life cycle phase relationships. Entities mentioned include configurable MES core functionality, manual procedures, run time modules, system patches, installation qualification/operational qualification supplements, regression analysis, business benefits, local functionality, validation costs and time, organizational boundaries, data consistency, transaction timing, language issues, manufacturing portals, GUI screen displays, shared systems, core team, large integrated systems, database instances, and data groups.", "excerpt_keywords": "Manufacturing Execution Systems, Program Management, Scope of Work, Project Milestones, Change Control"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "bccd7345-006c-434a-9674-b599e9fa9104", "node_type": "4", "metadata": {"page_label": "80", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "2eb0c60122784b1c3784125df09a4484b15d5a4ee8564bc3be00fcdc524b48ea", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "f346835d-8aab-41f3-a49c-363ee57dca00", "node_type": "1", "metadata": {"page_label": "79", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "99383638ab86043dc62cf7a31a5052bab52a62ff986f17e61c0de4f63839c9df", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "de3fc44b-8d40-4746-920e-78b66952b5b0", "node_type": "1", "metadata": {}, "hash": "8d05af21a8f9702cc01fd83b7c2fff4ba090328189c4fbb895de206582261f49", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 4: manufacturing execution systems - a strategic and program management approach\n\nthe approach should clearly define the scope of work. complications and delays caused by a lack of control during the implementation process should be avoided. there likely will be issues requiring changes or modifications to the original scope of work. handling these changes procedurally will help eliminate disputes, cost over-runs, and schedule delays. an effective approach also will help to establish project milestones that will help identify and communicate the status of the project. see figure 5.1.\n\nphases may overlap as the delivery of system components is implemented over time to accommodate project constraints. the planning phase typically generates formally controlled documents related to gxp efforts, as well as project-controlled documents, such as budgets and schedules. procedures should be established to define status nomenclature and transition criteria for hardware and software components as they are released to various execution phases from purchase and development through to completion of validation activities.\n\nregardless of what approach is selected, whether it is vertical or horizontal or if only one individual domain of functionality is selected, the implementation steps are the same. procedures may be modified based on prior implementation experience; however, appropriate change control procedures should be followed.\n\nfor further information on implementation considerations, see appendices 2, 3, and 6.", "start_char_idx": 0, "end_char_idx": 1540, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "de3fc44b-8d40-4746-920e-78b66952b5b0": {"__data__": {"id_": "de3fc44b-8d40-4746-920e-78b66952b5b0", "embedding": null, "metadata": {"page_label": "81", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Approach to Application and System Selection in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What strategic approach does the GAMP Good Practice Guide recommend for selecting and implementing Manufacturing Execution Systems (MES) to meet the needs of different organizations?\n   \n2. How does the GAMP Good Practice Guide classify system implementations within the MES domain, and what are the key differences between \"best in class\" point solutions and \"single source\" solution suites?\n\n3. What are the identified advantages of opting for solution suite systems over point solutions when implementing MES according to the GAMP Good Practice Guide, and how do these advantages impact system architecture and user interface consistency?", "prev_section_summary": "The section discusses the strategic implementation and program management approach for Manufacturing Execution Systems (MES). Key topics include defining the scope of work, managing changes or modifications to the original scope, establishing project milestones, handling overlap of phases during implementation, defining status nomenclature and transition criteria for hardware and software components, and following appropriate change control procedures. The section emphasizes the importance of avoiding disputes, cost over-runs, and schedule delays during MES implementation.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP Good Practice Guide, System Selection, Solution Suite"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "dd2fc027-2bf4-44a7-ae42-1f3566e1c936", "node_type": "4", "metadata": {"page_label": "81", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "57d01813f73616d8741fa8ef804c3a846a30ff040bba47b153411923f1976938", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "735cecce-0c47-4101-adc0-0a7a82d590e0", "node_type": "1", "metadata": {"page_label": "80", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "2eb0c60122784b1c3784125df09a4484b15d5a4ee8564bc3be00fcdc524b48ea", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "3dfec74f-918b-4614-a58a-23a14d60803b", "node_type": "1", "metadata": {}, "hash": "a27f8d90aae7669cad56ad0f293958bd85150eb04815adb1c5314c07fb6b85cd", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 5\n\n#### appendix 5 - an approach to application and system selection\n\n9.1 introduction\n\nthis appendix provides guidance for selecting an appropriate system with a suitable implementation approach to meet the needs of differing organizations.\n\n9.2 development of the tactical approach\n\nan mes domain typically will include a combination of systems with the number and complexity based on production and process requirements, as well as individual business needs and risk management.\n\nimplementation of an mes domain will involve a degree of systems integration at the database, application, or equipment level.\n\nfor the context of this guidance:\n\n- system implementations, such as those designated best in class, are classified as point solutions, i.e., a mix of smaller more specialized systems integrated with one or more large systems, such as erp\n- system implementations designated as a single source solution are classified as a solution suite, which involves integration of a small number of large, high-functionality computer systems\n\nphased mes implementations may start as solutions focused on addressing a particular problem or need but evolving to meet a defined mes strategy over time. the key concept is to have defined the strategy for the business before choosing or integrating solutions, thus avoiding re-engineering or replacing solutions later in mes domain implementation whenever possible.\n\ntechnology available during an initial planning of an mes implementation may evolve and indicate a different approach during the implementation process; considerations for advantages and risks are presented to aid in system selection. however, programs or projects should establish a point in time where the approach and technology are formally established to provide the basis for design and implementation.\n\nsuppliers of systems in the mes domain should be evaluated, including supplier audits. these audits may be performed by a systems integrator responsible for an mes implementation; however, the end user organization has responsibility for using appropriate systems and should supervise the assessment process and acceptance of the results. for further information, see gamp 5, appendix m2 (reference 5, appendix 14).\n\n9.2.1 advantages of solution suite systems\n\nadvantages to solution suite systems include:\n\nfewer suppliers and contracts for support and maintenance issues\nmore highly integrated areas of functionality\ntypically provide a more consistent human interface approach across areas of functionality\nfewer system architectures to support", "start_char_idx": 0, "end_char_idx": 2694, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "3dfec74f-918b-4614-a58a-23a14d60803b": {"__data__": {"id_": "3dfec74f-918b-4614-a58a-23a14d60803b", "embedding": null, "metadata": {"page_label": "82", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Comparison of Solution Suite Systems and Point Solution Systems in Manufacturing Execution Systems: A Comprehensive Analysis", "questions_this_excerpt_can_answer": "1. What are the identified disadvantages of relying on solution suite systems for critical business operations in the context of Manufacturing Execution Systems (MES) as outlined in the ISPE Good Practice Guide?\n\n2. How does the document describe the advantages of adopting point solution systems over solution suite systems in the realm of MES, particularly in terms of flexibility and supplier competition?\n\n3. What specific challenges and risks are associated with the implementation and maintenance of point solution systems in MES, as detailed in the ISPE Manufacturing Execution Systems guide, and how do these challenges impact system integration and support?", "prev_section_summary": "The section discusses the strategic approach recommended by the GAMP Good Practice Guide for selecting and implementing Manufacturing Execution Systems (MES) to meet the needs of different organizations. It covers the classification of system implementations within the MES domain as either \"best in class\" point solutions or \"single source\" solution suites. The advantages of opting for solution suite systems over point solutions are highlighted, including fewer suppliers and contracts for support, more integrated functionality, consistent human interface approach, and fewer system architectures to support. The section emphasizes the importance of defining a strategy for the business before choosing or integrating solutions to avoid re-engineering or replacing solutions later in MES domain implementation. It also mentions the evaluation of suppliers in the MES domain and the need for supplier audits to ensure appropriate systems are used.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Solution Suite Systems, Point Solution Systems, GAMP Good Practice Guide"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "3e7bd989-b231-4d24-89f0-87bf85e1dfcf", "node_type": "4", "metadata": {"page_label": "82", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "21f439370988ecb0547dc919650056789192c26b77c76477bb945e026591b91f", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "de3fc44b-8d40-4746-920e-78b66952b5b0", "node_type": "1", "metadata": {"page_label": "81", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "57d01813f73616d8741fa8ef804c3a846a30ff040bba47b153411923f1976938", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "3ef6bea2-32f9-4721-b0e4-d95e342cdfe9", "node_type": "1", "metadata": {}, "hash": "1762901594798fa2f57d7fd14ce324ddaeca558d1bba510cd37c55404afb1b95", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: appendix 5\n\nmanufacturing execution systems - a strategic and program management approach\n\n9.2.2 disadvantages of solution suite systems\n\ncritical business operations may depend on only a few major systems. where organizations make considerable investment in software, the cost and time needed for a replacement solution could become prohibitive with the following potential issues:\n\n- lack of competition among suppliers\n- initial lack of required functionality or support for only generic functionality\n- discontinuation of previously implemented functionality\n- integral parts of a system functionality are inefficient, unnecessary, or perform marginally\n- systems may lag behind current technology\n- loss of system support following supplier bankruptcy, merger, or product change\n\n9.2.3 advantages to point solution systems\n\nadvantages to point solution systems include:\n\n- competition among suppliers for important areas of functionality\n- optimized solutions and operations can be selected to support the business model\n- individual applications or areas of functionality can be replaced\n- greater flexibility to respond to changes in product, process, or business model with less impact to the mes domain\n\n9.2.4 disadvantages of point solution systems\n\na larger number of more specialized solutions may generate developmental risks, support risks, and costs. they may be complex to implement and maintain, requiring more engineering and it expertise; potential issues include:\n\n- specification of applications, systems, and document maintenance is complex because of interaction with other systems.\n- the combined functionality of different systems may not provide all the functionality required for an mes domain.\n- custom interface and integration solutions may be required and can be costly and difficult to maintain.\n- support needs to be coordinated; support from different suppliers may not be of equal quality.\n- specific integration approaches, required for optimizing other chosen systems, may not be supported by all suppliers.\n- higher risk of loss of system support by smaller specialized suppliers following supplier bankruptcy, failure, or merger.\n\nthe choice of systems architecture should be risk-based and should address specific user requirements. as mes develop, common architectures for database, platform (operating system, etc.), and integration techniques (e.g., middleware, reducing it and engineering customization, and support requirements) usually are supported.", "start_char_idx": 0, "end_char_idx": 2529, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "3ef6bea2-32f9-4721-b0e4-d95e342cdfe9": {"__data__": {"id_": "3ef6bea2-32f9-4721-b0e4-d95e342cdfe9", "embedding": null, "metadata": {"page_label": "83", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Considerations for Manufacturing Execution Systems (MES) Solution Selection and Implementation: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the document describe the strategic considerations for minimizing customization during the gap analysis phase of MES solution selection and implementation?\n   \n2. What are the specific advantages and disadvantages outlined in the document for choosing between point solution systems and solution suite systems in the context of Manufacturing Execution Systems (MES)?\n\n3. According to the document, what is the \"control domain - up approach\" in MES implementation, and how does it enhance batch management and recipe control functionalities?", "prev_section_summary": "The section discusses the comparison between solution suite systems and point solution systems in Manufacturing Execution Systems (MES). It outlines the disadvantages of relying on solution suite systems, such as lack of competition among suppliers, lack of required functionality, and potential system lagging behind current technology. On the other hand, it highlights the advantages of adopting point solution systems, including competition among suppliers, flexibility in selecting optimized solutions, and easier response to changes in product or business model. However, it also mentions the challenges associated with point solution systems, such as complexity in implementation and maintenance, potential lack of required functionality, and higher risk of system support loss from smaller specialized suppliers. The section emphasizes the importance of a risk-based approach in choosing the systems architecture for MES to address specific user requirements.", "excerpt_keywords": "MES, Manufacturing Execution Systems, Solution Selection, Implementation, Strategic Considerations"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "916388b6-5e79-40ba-97cd-45cb21992229", "node_type": "4", "metadata": {"page_label": "83", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "40db9fd1b8a235223911650aee2abdffed7f63531e8eb96f7214dda24eb883e0", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "3dfec74f-918b-4614-a58a-23a14d60803b", "node_type": "1", "metadata": {"page_label": "82", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "21f439370988ecb0547dc919650056789192c26b77c76477bb945e026591b91f", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "4fda996f-7fb1-49b3-9196-14207048813f", "node_type": "1", "metadata": {}, "hash": "45017a8cfcbd578f855a0c06117c077d8f7642e767555ecf9bd68120f7de061f", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 5\n\nduring development of a strategy for a point solution system, the skills and availability of it smes, engineering groups, and systems integrators should be considered.\n\n### 9.2.5 addressing identified gaps\n\na gap analysis should consider software selection. functionality of mes domain software should be analyzed for its ability to provide operational improvements. in addition, a gap analysis may consider technology customization in the event that the systems do not provide the functionality needed for the desired future state of products and processes or business and manufacturing operations. typically, customization is minimized to maintain a solution that can be upgraded or replaced mainly by supplier products.\n\n### 9.2.6 comparison of solution suite systems and point solution systems\n\npoint solution systems usually provide richer functionality, satisfy the requirements of more users, provide cost savings and efficient data sharing, and are considered convenient. point solution systems modules and products can focus on a specific business area and may provide better functionality than is possible through a solution suite system implementation. solution suite systems provide multiple applications with a common database and consistent user interface so all modules have a familiar look and feel. however, some applications may lack functionality and may not completely satisfy the requirements of some users. solution suite systems provide integration of business processes, which can improve the overall data flow of business information readily available to a business. in a highly centralized decision-making organization, easier access to shared data may take priority. specialized systems that do not provide mission-critical functionality may be sacrificed for the benefits of shared data and other solution suite system efficiencies. the selection of systems should consider the availability of information for business processes within each proposed solution. a cost and risk analysis, against the objectives of the business, should be performed to determine whether a point solution system, a solution suite system, or a hybrid (of one or two major systems with additional point solution systems) is selected. organizations may adopt an integrated solution suite systems strategy and fill in the gaps with point solution systems. suppliers may offer the benefit of a single supplier contact by either acquiring or partnering with point solution systems suppliers. in such cases, data sharing problems may still occur, but the supplier should be committed to making the integration appear seamless. integration of point solution systems to other business processes may require custom interfacing, resulting in an increased cost. if solution suite systems do not provide required functionality; however, there may be an increased risk to the business from inadequate business process execution. in this case, point solution systems may be selected, based on evaluation of return on investment (roi) based on production value. ongoing development and convergence of mes technology and transaction standards may ultimately facilitate a plug-and-play environment. considerations should be given to adherence with applicable standards in selecting and implementing mes solutions. this can help bridge the gap between point solution system and solution suite system approaches as relevant solutions and technology continue to evolve.\n\n### 9.2.7 control domain - up approach\n\nthe control domain - up approach develops and adds higher-level functionality to the control layer, such as batch management, batch reporting, and data distribution. this approach provides control over unit operation phases with recipe control. higher level recipe management can be added to drive batch phases either through batch manager or directly to equipment as appropriate to process complexity.", "start_char_idx": 0, "end_char_idx": 4027, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "4fda996f-7fb1-49b3-9196-14207048813f": {"__data__": {"id_": "4fda996f-7fb1-49b3-9196-14207048813f", "embedding": null, "metadata": {"page_label": "84", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Approach to Manufacturing Execution Systems Integration and Implementation: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What strategic approach does the GAMP\u00ae Good Practice Guide suggest for minimizing risk during the initial stages of Manufacturing Execution Systems (MES) implementation, and how does it prioritize the integration of systems across different levels of the manufacturing process?\n\n2. How does the \"enterprise-down approach\" to MES integration differ in its initial focus and implementation strategy compared to other approaches, particularly in terms of functionality and interfaces with enterprise systems like ERP, and what are the expected benefits at different levels of the enterprise?\n\n3. In the context of MES implementation, how should the distribution of business functions be approached to ensure high levels of compliance and operational efficiency, especially concerning WIP material management and the integration of ERP/MRP systems with MES and other control domain automation software systems?", "prev_section_summary": "The section discusses strategic considerations for selecting and implementing Manufacturing Execution Systems (MES). It covers the importance of minimizing customization during the gap analysis phase, comparing point solution systems and solution suite systems, and the control domain - up approach in MES implementation. Key topics include gap analysis, software selection, functionality analysis, advantages and disadvantages of different system types, integration of business processes, and the control domain - up approach for enhancing batch management and recipe control functionalities. Key entities mentioned are IT SMEs, engineering groups, systems integrators, point solution systems, solution suite systems, batch management, batch reporting, data distribution, recipe control, and higher-level recipe management.", "excerpt_keywords": "Manufacturing Execution Systems, MES implementation, GAMP Good Practice Guide, Enterprise-down approach, Business functions"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "61e0cccc-c3c2-46ca-8a63-311634cad289", "node_type": "4", "metadata": {"page_label": "84", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "a4fc9df6d0b2feff5c9ccf62a731bb83a58c63f46f138b22e38932f23436e842", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "3ef6bea2-32f9-4721-b0e4-d95e342cdfe9", "node_type": "1", "metadata": {"page_label": "83", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "40db9fd1b8a235223911650aee2abdffed7f63531e8eb96f7214dda24eb883e0", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "ce0841b8-48f1-4edb-a305-bafb37c1e882", "node_type": "1", "metadata": {}, "hash": "27123e947e3ddaca20e13ceb81cd383852a25fd9e8b378e69aad7b943d6b6b6e", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: appendix 5 manufacturing execution systems - a strategic and program management approach\n\nthis approach minimizes risk by lowering the initial cost and focuses the mes implementation on one process. the benefits will be seen at the control domain level first, and at the enterprise level only after these systems are integrated. note: depending on the design of records management in systems, failures at various systems levels can cause de-synchronization. methods should be defined to resynchronize systems conditions, sequences, and data, whether during or after completion of a production run, as appropriate to the manufacturing process.\n\n### 9.2.8 enterprise - down approach\n\nthe enterprise - down approach adds functionality and interfaces to enterprise systems, e.g., erp. this may be in the area of planning or detailed material tracking down to recipes. recipes remain separate from automation until later integration phases. this approach can minimize costs and risks because existing hardware and infrastructure are used as much as possible before adding complexity. the benefits in this approach are typically seen at the enterprise level first.\n\n### 9.3 scope and justification\n\napplication and system selection is dependent on a well planned mes domain with an adequately described project scope. the following also should be considered:\n\n- use of realistic resource and budget estimates to determine which of the identified areas can be updated and what is a reasonable high-level timeline\n- the effects of various combinations of vertical and horizontal implementations and risk associated with the type of system and approach chosen\n- project justification (see appendix 2)\n\n### 9.3.1 business functions in mes implementation\n\nwhen discussing the distribution of business functionality in an mes implementation, the first approach should be system independent. specific business functions may reside in several areas. the level to which an identified business function is supported and by which system should be determined. for example, wip material management often is an integral part of manufacturing operations. designers should consider how often personnel will perform functions such as move, scrap, combine, dispense and kit, and whether these functions should be incorporated into plant floor functionality or are managed via an erp/mrp interface. this often is determined by how capable an erp/mrp is in managing the level of detail necessary for wip management of a given process.\n\nfor highest levels of compliance, systems typically perform status checks on materials at the manufacturing points of use. this requires a high availability erp/mrp if all master and current status data is maintained in that system or may require mirroring of master data and/or status/attribute data in lower level systems to allow independent operation for down time on erp/mrp. another approach is to employ a specification system, separate from erp/mrp and mes, which is accessed by all systems for material information.\n\nthis specification functionality also may be incorporated into lims with the same data sharing considerations. control domain automation software systems, e.g., dcs, plc/scada, may offer some degree of high-level order processing, batch management, or operation sequence capabilities. mes software also may provide these features. where this functionality will be implemented in the overall integration scheme to meet the specific requirements of the mes implementation should be determined.", "start_char_idx": 0, "end_char_idx": 3560, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "ce0841b8-48f1-4edb-a305-bafb37c1e882": {"__data__": {"id_": "ce0841b8-48f1-4edb-a305-bafb37c1e882", "embedding": null, "metadata": {"page_label": "85", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Integration of Manufacturing Execution Systems and Electronic Production Records: Approaches and Best Practices", "questions_this_excerpt_can_answer": "1. What are the considerations and strategies for integrating alarm and exception processing within Manufacturing Execution Systems (MES) and Electronic Production Records (EPRs) as outlined in the GAMP 5 guide?\n   \n2. How does the document suggest handling the integration of automation and MES to prevent duplicate operator entries and enhance workflow efficiency in the context of alarm and event processing?\n\n3. What are the specific strategies recommended for implementing batch/order management and operational sequencing when automation is introduced before Electronic Production Records (EPRs), according to the strategic integration guide provided in the document?", "prev_section_summary": "This section discusses the strategic approach to Manufacturing Execution Systems (MES) integration and implementation, focusing on minimizing risks, the enterprise-down approach, scope and justification, and business functions in MES implementation. Key topics include risk minimization, integration with enterprise systems like ERP, project scope, business functionality distribution, WIP material management, and system independence. Key entities mentioned are GAMP\u00ae Good Practice Guide, MES, ERP, WIP material management, enterprise systems, project scope, and compliance.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Electronic Production Records, Integration, Automation"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "7772ffc2-68ed-4346-a8c7-f9ac132f316a", "node_type": "4", "metadata": {"page_label": "85", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "06c37cc2994ff61ebbfa6c4a9d79f6326293ad1225f746eb6a328dcdd4b34241", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "4fda996f-7fb1-49b3-9196-14207048813f", "node_type": "1", "metadata": {"page_label": "84", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "a4fc9df6d0b2feff5c9ccf62a731bb83a58c63f46f138b22e38932f23436e842", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "8be391b8-b244-4688-811f-ec4d5c1b5c6b", "node_type": "1", "metadata": {}, "hash": "f1b8e170af1b9c51a8efcae994279d59f22a0e3d56fc7e06328658eeb121bd3c", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 5\n\nwhere the concept of a single interface for manufacturing personnel is an objective, alarm and exception processing is a major design consideration for eprs. see gamp 5, appendix s2, electronic production records (eprs). if alarms are generated in an automated process, the point at which system manufacturing personnel should address exception processing should be determined. in addition, alarm types should be clearly defined, as alarm strategies may become complex; considerations include:\n\n- full integration of automation alarm processing into the mes, dependent on mes capabilities or acceptable customization.\n- passing automation alarm exception information up to mes or any electronic production record system (eprs), such as an electronic batch record for processing and signoff. the alarm conditions are handled in automation, but alarm information is sent to mes. the electronic signoff of alarm interaction occurs in the eprs managed through mes.\n- full exception processing in automation. all human interaction, including signoff, occurs in automation. information associated with the exception is sent to mes for inclusion in the production record, and therefore, requires that e-signatures are built into the automation layer.\n- prevention of duplicate operator entries. interaction of eprs and automation should be implemented to minimize or eliminate activities by operators and technicians requiring entering the same or similar information in both systems. the electronic signoff for alarm and event processing can occur in the eprs or automation if supported by the applications for compliant electronic records and signatures. if occurring in automation, the signature information should be transmitted to eprs to avoid duplicate entry operations.\n- minimization of switching between applications to process an alarm or event for maximizing workflow efficiency.\n\nwhen executing a horizontal implementation strategy, such as installing an eprs or improving or installing automation across multiple products, processes, or facilities, functionality can be focused in one system. accommodating later additions of technology should be considered in the strategy.\n\nwhere automation is implemented first, possible strategies include:\n\n- implement batch/order management fully in automation. this may include an interface to erp/mrp.\n- implement only batch management and process orders manually.\n- utilize manual order management and minimize initial batch management to facilitate later ebr or other mes technology.\n- provide full operational sequencing including transfer across process or area boundaries.\n- provide local area sequencing and manually control transfers.\n\nwhen epr is implemented first, possible strategies include:\n\n- integrate epr to mrp/erp for order processing.\n- manually create orders in epr.\n- manually record input from automation into epr screens.\n- automation creates some amount of information as bar code printouts that can be scanned into epr.", "start_char_idx": 0, "end_char_idx": 3119, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "8be391b8-b244-4688-811f-ec4d5c1b5c6b": {"__data__": {"id_": "8be391b8-b244-4688-811f-ec4d5c1b5c6b", "embedding": null, "metadata": {"page_label": "86", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Optimizing Manufacturing Execution Systems: Ensuring Data Availability, Redundancy, and Integration", "questions_this_excerpt_can_answer": "1. How does the document propose to quantify the success of implementing Manufacturing Execution Systems (MES) in terms of operator-caused non-conformances, work-in-progress (WIP) reduction, and batch release time improvements?\n   \n2. What strategies does the document recommend for ensuring the availability and redundancy of manufacturing data when integrating MES with other systems like ERP/MRP, LIMS, and warehouse management systems?\n\n3. What considerations does the document outline for deciding between deploying point solution systems versus a solution suite in the context of system planned downtime and fault isolation, especially for organizations with multiple MES sites?", "prev_section_summary": "The section discusses the strategic integration of Manufacturing Execution Systems (MES) and Electronic Production Records (EPRs) with a focus on alarm and exception processing. Key topics include considerations for integrating alarm processing, strategies for preventing duplicate operator entries, and recommendations for implementing batch/order management and operational sequencing. The section also outlines possible strategies for integrating automation and MES, as well as considerations for implementing technology across multiple products, processes, or facilities.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Data Availability, Redundancy, Integration"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "481a08b4-cc8c-4629-a795-2c335698986a", "node_type": "4", "metadata": {"page_label": "86", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "c424edc4eb96ac50d8279af5e54f55df87eafc79d613fe8ade7cd22ebd725331", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "ce0841b8-48f1-4edb-a305-bafb37c1e882", "node_type": "1", "metadata": {"page_label": "85", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "06c37cc2994ff61ebbfa6c4a9d79f6326293ad1225f746eb6a328dcdd4b34241", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "e167b465-be5a-456f-a751-05290729b2e1", "node_type": "1", "metadata": {}, "hash": "734243fc276be1a5c0b07a94abe734a4bfd0cd178458631d81ab14becdfacc89", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 5: manufacturing execution systems - a strategic and program management approach\n\nhigh-level optimistic goals may be set at this point in the project, e.g., reduction of operator caused non-conformances by 50%, reduction of wip by 25%, or reduce batch, intermediate, and assembly release time by 200% are goals that are directed at known production issues and are significant enough to warrant the companys time and resources. for a project to be successful, results need to be quantified and compared against previous results. many of these justifications are cost-driven and are determined by performing a formal cost benefit analysis. other justifications can be much harder to quantify such as risk avoidance. for example, functionality to address regulatory compliance may lead to an observation free audit, which avoids the cost and resources to correct observations that may have otherwise occurred.\n\n### availability and redundancy of manufacturing data\n\ndefining ownership and management of master data, e.g., raw material and asset specifications, can be used to determine which systems will need to have high-availability or redundancy, which may include mirrored data in another system or server. commercial mes software typically includes some integration functionality, either by direct api or by middleware to other major software, such as erp/mrp, lims, warehouse management, calibration, and maintenance systems.\n\nmaterial and asset management is considered critical to achieve process compliance and consistency when using mes technology. dynamic data, e.g., location, status, quantity, volume, sterility, and cleanliness should be available to manufacturing processes on a real-time basis. the capabilities of erp/mrp and lims systems to manage these attributes is a consideration in determining whether master data and dynamic data may be maintained and traceable on one system or should be divided or mirrored across systems.\n\nfor manufacturing processes that are interruptible for short periods without undue hardship, the need for redundancy of dynamic data for assets and materials may be minimal; considerations include labor cost, manufacturing flow, and compliance. procedural controls may be used for periods where systems are unavailable; however, procedures for re-synchronizing manual data and current manufacturing status with the automated systems are required.\n\nfor time-critical or hazardous manufacturing processes or process steps, high-availability or redundant systems may be required for dynamic data to prevent loss of products, prevent accidents, and ensure quality and compliance. high reliability and redundancy may be used together to provide assurance that processes will not be interrupted. in these cases, integration should be designed to provide an alternative source for data, including:\n\n- a redundant server\n- timely mirroring of data in another system (such as erp/mrp to mes or lims)\n- a system separate from manufacturing operations dedicated to this function\n\ndata modeling should be considered early in an integration scheme. defining and developing a core strategy that can be replicated or reused for several products or facilities may be of benefit by reducing compliance costs.\n\ntwo major considerations when choosing point solution systems, verses a solution suite are the requirements for system planned down time and fault isolation. for large organizations with multiple mes sites, achieving consensus on a single down period can be problematic based on conflicting production requirements. a single suite may transfer a fault to all sites resulting in unacceptable losses or rework. smaller or single site organizations may be much better able to coordinate down time and manage faults from a single suite system.\n\nfor further information on the development of an integrated manufacturing facility, see appendix 13.", "start_char_idx": 0, "end_char_idx": 3894, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "e167b465-be5a-456f-a751-05290729b2e1": {"__data__": {"id_": "e167b465-be5a-456f-a751-05290729b2e1", "embedding": null, "metadata": {"page_label": "87", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Comprehensive Guide to System Integration Testing: Interfaces, Data, and Middleware", "questions_this_excerpt_can_answer": "1. What are the key considerations for maintaining the integrity and stability of system or application interfaces in the context of MES domain verification, as outlined in the \"Comprehensive Guide to System Integration Testing: Interfaces, Data, and Middleware\"?\n\n2. How does the document suggest handling the complexities of testing integration for complex or near real-time transactions within MES systems, particularly in relation to auditing and verifying these transactions?\n\n3. What specific approach does the \"Comprehensive Guide to System Integration Testing: Interfaces, Data, and Middleware\" recommend for testing middleware integration in MES systems, including the types of tests and the documentation required for customization and configuration management?", "prev_section_summary": "The section discusses the strategic and program management approach to implementing Manufacturing Execution Systems (MES) in a manufacturing facility. Key topics include setting optimistic goals for MES implementation, quantifying success through metrics like reduction of non-conformances and batch release time improvements, ensuring availability and redundancy of manufacturing data when integrating MES with other systems, and considerations for deploying point solution systems versus a solution suite. The section emphasizes the importance of defining ownership and management of master data, integrating MES with systems like ERP/MRP and LIMS, and the need for high availability and redundancy of data for time-critical or hazardous manufacturing processes. It also highlights the considerations for system planned downtime and fault isolation when choosing between point solution systems and a solution suite, especially for organizations with multiple MES sites.", "excerpt_keywords": "MES, System Integration Testing, Interfaces, Data, Middleware"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "fd19e49b-4092-4817-b333-684c38638120", "node_type": "4", "metadata": {"page_label": "87", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "6a95d05f435b71b682be5051c1a9918a6450e53da9157d76dd67b3cec908a71b", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "8be391b8-b244-4688-811f-ec4d5c1b5c6b", "node_type": "1", "metadata": {"page_label": "86", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "c424edc4eb96ac50d8279af5e54f55df87eafc79d613fe8ade7cd22ebd725331", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "0d9c53cc-eb80-4ec6-a836-8b90f2e205c4", "node_type": "1", "metadata": {}, "hash": "5a24a8e5277ee5483dcf1895e18c1413124e77b42602909a8b6752e804b582c2", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 6 - system integration: interfaces and touch points\n\n10.1 introduction\n\nmes domain verification issues may include the integration of a wide variety of systems, including erp, automation, production, and batch systems. this may include multiple integration points, ranging from a single connection to a homegrown legacy system with a simple one-way flow of a narrow set of data fields to integration with a configurable erp system and its multiple and bi-directional flow of a much expanded set of data.\n\nthe integrity and stability of system or application interfaces is considered fundamental and should consider:\n\n- timeliness of updates\n- failure notification\n- correction processes\n- comparison procedures for shared or common data\n\nmaintenance of common data should be controlled.\n\nthe variety of hardware platforms, operating systems, and programming languages used to create the interfaces may increase the complexity of verification. middleware may be required to facilitate communication within an mes domain. the middleware configuration for a specific interface should be verified.\n\n10.2 data\n\ncomplex or near real-time transactions typically are difficult to audit and verify by external means, e.g., reports or screen captures. testing of integration should include classes of data designed to generate each type of error, which a system may generate. data classes, including those with no errors, all errors, and mixed good and erroneous data, should be transferred through the interface and the results verified. the complexities of interface testing will need to be considered during risk management planning.\n\n10.3 middleware\n\nmiddleware is software that enables systems and databases to integrate allowing data transfer, translation, and command execution. implementation of specific interfaces may require various levels of configuration or customization. if data translation requires a higher level of configuration, e.g., scripting, the additional source instructions are part of configuration management, and procedural and automatic controls should be established to allow rebuilding the functionality to the known state for disaster recovery.\n\nthe basic approach for testing middleware integration is to produce a series of black box tests using known data or equivalence classes of data that show inputs from a source produce subsequent expected outputs to a target system, including the number of records processed. testing can be executed using standard data and database access tools where the versions and any configuration are noted in the test documentation. where customization is required, additional specification and verification should be performed.\n\nfinal testing should use the intended source or target systems in a controlled environment to verify that the overall integration performs as intended. this can be part of verification or a performance monitoring activity.", "start_char_idx": 0, "end_char_idx": 2922, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "0d9c53cc-eb80-4ec6-a836-8b90f2e205c4": {"__data__": {"id_": "0d9c53cc-eb80-4ec6-a836-8b90f2e205c4", "embedding": null, "metadata": {"page_label": "88", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Integration of ERP and MES for Efficient Manufacturing Operations: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the key considerations for minimizing the impact on requirements to re-verify or re-validate the ERP system when integrating it with MES functionality in manufacturing operations?\n\n2. How does the integration of ERP and MES systems facilitate the management of material receiving, lot and container or sub-lot tracking, and inventory control in the context of manufacturing execution systems?\n\n3. What specific functions and processes are involved in the integration of ERP and MES for effective batch management and production order management using recipes, according to the comprehensive guide on efficient manufacturing operations?", "prev_section_summary": "The section discusses system integration testing in the context of Manufacturing Execution Systems (MES), focusing on interfaces, data, and middleware. Key topics include the importance of maintaining the integrity and stability of system interfaces, considerations for testing complex or near real-time transactions, and the testing approach for middleware integration. Entities mentioned include ERP systems, automation systems, production systems, batch systems, hardware platforms, operating systems, programming languages, middleware, data classes, configuration management, and verification processes.", "excerpt_keywords": "ERP, MES, integration, manufacturing operations, batch management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "ae1fd92c-304e-42d1-8aa6-282bca046798", "node_type": "4", "metadata": {"page_label": "88", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "c85a62a993b0669eed7737a26b3533963f0aadc3cc39d8ad40ab70773eafe1a3", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "e167b465-be5a-456f-a751-05290729b2e1", "node_type": "1", "metadata": {"page_label": "87", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "6a95d05f435b71b682be5051c1a9918a6450e53da9157d76dd67b3cec908a71b", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "27fa65bb-c601-4ba9-a9be-936a081295e1", "node_type": "1", "metadata": {}, "hash": "17153abab4ff3221784a7041feb7b74d1dff754a10f7e6d68b9ee1f4b8e8e053", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 6: manufacturing execution systems - a strategic and program management approach\n\n10.4 erp interface\n\nthe integration with erp and supply chain functionality provides a key link between the enterprise and the facility. design considerations include where the handoff should occur for minimal impact on requirements to re-verify or re-validate the erp system. for some systems, only specific erp functions may need to be verified when integrated with mes functionality. this approach can save considerable costs throughout the implementation. erp system verification and data interface touch points should be reviewed to ensure which functions are in each system with clearly established data ownership roles. this can reduce costs of implementation and verification.\n\ncommon interface functions include:\n\n- purchasing\n- purchase order management\n- receiving reconciliation\n- materials management\n- material receiving, lot and container or sub-lot tracking\n- inventory and wip control\n- grading, potency, and shelf life dating, and expiry date\n- quality assurance\n- grading, potency, and shelf life dating, and expiry date calculations\n- lot release and expiry date management\n- recipe management\n- recipe creation and version control\n- integration with erp specifications and inventory management\n- batch management\n- erp generated dispatch orders\n- production order management using recipes\n- recipe execution and production history data collection\n- lot tracking\n- tracking of all materials, equipment, and human resources that comes in contact with the product during manufacture\n- developing forward and backward genealogy recording\n- sample tracking", "start_char_idx": 0, "end_char_idx": 1666, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "27fa65bb-c601-4ba9-a9be-936a081295e1": {"__data__": {"id_": "27fa65bb-c601-4ba9-a9be-936a081295e1", "embedding": null, "metadata": {"page_label": "89", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Enhancing Manufacturing Execution Systems through Integrated MES Domain Approach and Process Automation Testing\"", "questions_this_excerpt_can_answer": "1. What specific areas of focus are outlined in the GAMP (r) Good Practice Guide for enhancing Manufacturing Execution Systems (MES) through a strategic and program management approach, as detailed in the \"Enhancing Manufacturing Execution Systems through Integrated MES Domain Approach and Process Automation Testing\" document?\n\n2. How does the document suggest testing the integration functionality of MES operations that are dependent on multiple systems, including considerations for shared data and product/process structures, within the context of an integrated MES domain approach?\n\n3. What are the recommended considerations and test protocols for ensuring data integrity and effective process automation integration within MES, particularly in relation to electronic record and signature requirements and the prevention of data loss, as outlined in the document?", "prev_section_summary": "The section discusses the integration of ERP and MES systems in manufacturing operations, focusing on key considerations for minimizing the impact on requirements to re-verify or re-validate the ERP system. It also covers how this integration facilitates material receiving, lot tracking, inventory control, batch management, and production order management using recipes. The section highlights the importance of interface functions such as purchasing, inventory management, quality assurance, recipe management, batch management, and tracking of materials, equipment, and human resources. Overall, the section emphasizes the strategic and program management approach to integrating ERP and MES systems for efficient manufacturing operations.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Integrated MES Domain Approach, Process Automation Testing, GAMP Good Practice Guide"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "0c410eae-6854-4314-ba5e-a624854c0438", "node_type": "4", "metadata": {"page_label": "89", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "c3a5c5d0a7b847950ff8ceaf2d4b0f9c747fadcf53e50aac904c8e10ebd40712", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "0d9c53cc-eb80-4ec6-a836-8b90f2e205c4", "node_type": "1", "metadata": {"page_label": "88", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "c85a62a993b0669eed7737a26b3533963f0aadc3cc39d8ad40ab70773eafe1a3", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "f69039ab-0149-46c0-a171-e0875c9615b1", "node_type": "1", "metadata": {}, "hash": "e34863c555621743031750848741de53eec1511c66147a10927fb4ce3bbad381", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide:\n\nmanufacturing execution systems - a strategic and program management approach\n\nappendix 6\n\n- electronic production record creation\n- plant floor management and electronic work instructions\n- data and event collection requirements\n- packaging scheduling and control\n- quality assurance information\n- document management and change control\n- repository for all required and approved documentation\n- issuance of documents needed for operations\n- repository for production records\n\nto test the integrated mes domain approach, the test protocols should contain the following test cases and test data sets:\n\n- independent system functionality for systems and applications within the mes domain (if newly installed).\n- integration functionality where mes operations are dependent on two or more systems, shared data, data relationships, and product and process structures.\n- mes integration functionality that will need to be regression analyzed and tested on the validated legacy systems (e.g., erp).\n\n## process automation\n\nprocess automation systems primarily interface with other mes domain applications in the process management, data collection and acquisition, product tracking, and genealogy domain functions. they also may share specific information in other areas. testing should focus on the interface and data sharing touch points.\n\na functional review and verification of change control issues should be performed. electronic record and signature requirements should be considered and data integrity should be maintained.\n\nduring preparation for testing of the process automation integration, touch points to consider include:\n\n- method by which the mes interface to a control system (plc or dcs) to provide data\n- specification and implementation of failover and restart behavior\n- use of automated data collection devices:\n- prevention of data loss by the system\n- in case of communication failure; detection of alarm signals by other systems.", "start_char_idx": 0, "end_char_idx": 1985, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "f69039ab-0149-46c0-a171-e0875c9615b1": {"__data__": {"id_": "f69039ab-0149-46c0-a171-e0875c9615b1", "embedding": null, "metadata": {"page_label": "90", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Integration and Testing Considerations for Manufacturing Execution Systems, Batch Systems, and Laboratory Information Management Systems (LIMS) in Manufacturing Operations", "questions_this_excerpt_can_answer": "1. What specific aspects of PLC program management are emphasized in the integration and testing considerations for Manufacturing Execution Systems (MES) as outlined in the ISPE document?\n   \n2. How does the document suggest handling the overlap of functionality between MES and batch systems, particularly in terms of data exchange and change control issues?\n\n3. What are the key focus areas for testing Laboratory Information Management Systems (LIMS) in relation to their interaction with the MES domain, as per the guidelines provided in the document?", "prev_section_summary": "The section discusses enhancing Manufacturing Execution Systems (MES) through a strategic and program management approach, focusing on specific areas outlined in the GAMP (r) Good Practice Guide. It emphasizes testing the integration functionality of MES operations dependent on multiple systems, shared data, and product/process structures within an integrated MES domain approach. The document also recommends considerations and test protocols for ensuring data integrity and effective process automation integration within MES, particularly in relation to electronic record and signature requirements and the prevention of data loss. Key topics include electronic production record creation, plant floor management, data and event collection, packaging scheduling, quality assurance, document management, and process automation systems interfacing with MES applications. Key entities mentioned are test protocols, test cases, test data sets, integration functionality, data relationships, product and process structures, electronic record and signature requirements, and data sharing touch points.", "excerpt_keywords": "Keywords: Manufacturing Execution Systems, Integration, Testing Considerations, Batch Systems, Laboratory Information Management Systems"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "30d135ab-d1ee-42f0-ab2d-7ccd7bd2a761", "node_type": "4", "metadata": {"page_label": "90", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "19678a3f01ffa91e6a4b7d933a63f4ac2e31c051fb6cadc583d1dd5110bc036d", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "27fa65bb-c601-4ba9-a9be-936a081295e1", "node_type": "1", "metadata": {"page_label": "89", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "c3a5c5d0a7b847950ff8ceaf2d4b0f9c747fadcf53e50aac904c8e10ebd40712", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "e64566ae-dccf-45a4-a091-aac1f85207b0", "node_type": "1", "metadata": {}, "hash": "80b4a0d0244659c40cae44fb9ccd221667638f961cf9defa5fea830ce6258541", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 6\n\n### manufacturing execution systems - a strategic and program management approach\n\n- simultaneous operation of multiple processes:\n- definition and testing of maximum capacity. (this may be difficult to simulate.)\n- verification of audit trail of altered files\n- audit trail requirements for changes to a plc program, as required\n- version control of plc programs in a validated automated system (to ensure that the correct program (name and version) is transferred to an operation). the data from such a plc program management system should be integrated into the testing methods.\n- security access\n- reporting capabilities\n\n### batch systems\n\nproduction and batch systems can interact with the mes domain for master recipe, work instruction, process parameters, and control recipe information. data collection acquisition and product tracking and genealogy functions are interactive functions for the domain. different issues and strategies can arise during implementation of an mes because of the overlap of functionality provided by mes domain applications, e.g., a control recipe may include master recipe information, schedule, specific quantity to make, or actual target bill of materials quantities. once functional ownership has been established, the data exchange records between the systems and the method for data sharing should be identified. this may result in the identification of change control issues and new testing activities. the following should be considered:\n\n- is the process control or step sequencing and processing provided by the recipe system, automation, or equipment? for example, start/pause/stop of process, data acquisition, confirmation of errors, etc. if control is within functionality, such as a batch manager, integration testing should focus on verifying that communication between the higher and lower level systems is working with appropriate timing and bandwidth. individual functions for production (e.g., start, control of valves, devices) can be verified in a modular fashion.\n- can batch and production validation be completed before or concurrently with systems validation?\n- security access should be equivalent to that for the touch points for the other systems.\n- errors and alarms should be verified with critical alarms being acknowledged by the appropriate system.\n- where mes are allowed to be bypassed, operation should be verified.\n- reporting capabilities should ensure that epr reports need to verify that the report generation and electronic records are compliant and accurate and complete copies of electronic records are completed.\n- redundancy, backup, and recovery process testing should ensure there is no gap.\n\n### lims\n\ntesting for lims should focus on the functionality of typical touch points with the mes domain, including:\n\n- raw and intermediate materials release to manufacturing", "start_char_idx": 0, "end_char_idx": 2868, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "e64566ae-dccf-45a4-a091-aac1f85207b0": {"__data__": {"id_": "e64566ae-dccf-45a4-a091-aac1f85207b0", "embedding": null, "metadata": {"page_label": "91", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Best Practices for Manufacturing Execution Systems Integration and Electronic Record Management", "questions_this_excerpt_can_answer": "1. What specific functionalities should be reviewed for testing and change control issues when integrating Manufacturing Execution Systems (MES) with Enterprise Resource Planning (ERP) modules, according to the GAMP Good Practice Guide?\n\n2. How does the GAMP Good Practice Guide recommend handling the synchronization of Laboratory Information Management Systems (LIMS) interfaces during the preparation for testing of LIMS integration in the context of MES?\n\n3. What are the guidelines provided by the GAMP Good Practice Guide regarding the management of electronic records and signatures, especially in terms of audit trails and system interface verifications, when integrating MES with other systems?", "prev_section_summary": "The section discusses integration and testing considerations for Manufacturing Execution Systems (MES), batch systems, and Laboratory Information Management Systems (LIMS) in manufacturing operations. Key topics include PLC program management, overlap of functionality between MES and batch systems, data exchange, change control issues, security access, reporting capabilities, batch and production validation, errors and alarms verification, redundancy, backup, and recovery process testing for MES and batch systems. The section also highlights testing focus areas for LIMS, such as raw and intermediate materials release to manufacturing.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Integration, Electronic Record Management, GAMP Good Practice Guide"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "2bbe912b-668a-4019-8ff9-8374e0a81d5b", "node_type": "4", "metadata": {"page_label": "91", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "2a62835208a60b16ed12ffa34be82553f71ce2755007653af33051c7923b7c83", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "f69039ab-0149-46c0-a171-e0875c9615b1", "node_type": "1", "metadata": {"page_label": "90", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "19678a3f01ffa91e6a4b7d933a63f4ac2e31c051fb6cadc583d1dd5110bc036d", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "6c2ead06-06be-4ea0-b11a-d0323207803e", "node_type": "1", "metadata": {}, "hash": "8c0033d6c56a9b12184169efd035c015c8c81b8a5f2394043bf603d6271db160", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 6\n\n- weigh and dispense\n- charging containers with materials\n- process management\n- data collection and acquisition\n- product tracking\n- genealogy\n\nsome of this functionality may reside in erp modules. a functional review and verification of testing and change control issues should be performed. electronic record and signature requirements should be considered and data integrity should be maintained.\n\nthe following should be considered during preparation for testing of lims integration:\n\n- synchronization of lims interfaces to ensure that only released materials are added in the appropriate quantities into clean containers\n- automated data collection devices in weigh and dispense operations\n- prevention of data loss by the system\n- in case of communication failure; detection of alarm signals by other systems\n- ability to run weighing and dispensing with quality release for recipe management operations or material dispensing as a campaign\n- audit trail of activities, including quality release data that is time synchronized between systems\n- security access\n- reporting capabilities\n\ninterface issues for electronic records and signatures\n\nsystems interfaces, including middleware, should be verified and have appropriate error reporting facilities for transaction or transfer failures. operator actions that create, modify, or delete gxp records should be captured in an audit trail. audit trail information is not required to be re-entered or transferred into other systems that are interfaced to the originating system. where data is normally generated or entered automatically in an originating system and a device failure occurs, such as a malfunctioning bar code reading device, system entries may be manually performed and verified. there is no requirement that audit trail information be duplicated in multiple systems that are interconnected as long as the audit trail is available for examination.", "start_char_idx": 0, "end_char_idx": 2046, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "6c2ead06-06be-4ea0-b11a-d0323207803e": {"__data__": {"id_": "6c2ead06-06be-4ea0-b11a-d0323207803e", "embedding": null, "metadata": {"page_label": "92", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Ensuring Data Integrity and Control in Manufacturing Execution Systems", "questions_this_excerpt_can_answer": "1. What is the typical approach for managing the entry, approval, and control of critical parameters in manufacturing execution systems, especially when these parameters are entered into supervisory or recipe applications?\n   \n2. How are critical parameters that are entered directly into lower-level systems or equipment, such as Programmable Logic Controllers (PLCs), managed and controlled to ensure data integrity within manufacturing execution systems?\n\n3. What specific types of controls are recommended for managing critical parameters that are configured directly into lower-level systems or equipment in manufacturing execution systems to maintain data integrity and control?", "prev_section_summary": "The section discusses the integration of Manufacturing Execution Systems (MES) with Enterprise Resource Planning (ERP) modules and Laboratory Information Management Systems (LIMS) in the context of electronic record management. Key topics include functionalities to review for testing and change control issues, synchronization of LIMS interfaces, management of electronic records and signatures, audit trails, system interface verifications, and data integrity. The section emphasizes the importance of maintaining data integrity, security access, reporting capabilities, and proper handling of electronic records and signatures during system integration.", "excerpt_keywords": "Manufacturing Execution Systems, Data Integrity, Control, Critical Parameters, System Integration"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "6b254e05-ed01-4040-812e-7f3aa677ad67", "node_type": "4", "metadata": {"page_label": "92", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "2011ef25030aea04a010d4f707ceb23496947fcd2d84cd8f864c12ab53a87ec9", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "e64566ae-dccf-45a4-a091-aac1f85207b0", "node_type": "1", "metadata": {"page_label": "91", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "2a62835208a60b16ed12ffa34be82553f71ce2755007653af33051c7923b7c83", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "1b42d956-98a8-419f-98bf-f61d7db25639", "node_type": "1", "metadata": {}, "hash": "60f3fb9639aaa8fe5d33994112f5f2f9fd8471d839cf0a934d61f5319f6b64b9", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 6\n\nmanufacturing execution systems - a strategic and program management approach\n\nin systems where critical parameters are entered into a supervisory or recipe application, the entry, approval and control of the parameters is typically at the recipe level. as these values are passed to other systems, data integrity should be maintained.\n\ncritical parameters entered directly into lower level systems or equipment, such as plcs, are treated as configuration items that are under technical and procedural controls including change control.", "start_char_idx": 0, "end_char_idx": 551, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "1b42d956-98a8-419f-98bf-f61d7db25639": {"__data__": {"id_": "1b42d956-98a8-419f-98bf-f61d7db25639", "embedding": null, "metadata": {"page_label": "93", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Advantages of Implementing an Electronic Production Record System in Manufacturing Operations", "questions_this_excerpt_can_answer": "1. What specific advantages does implementing an electronic production record system (EPRS) offer in pharmaceutical and medical device manufacturing operations, according to the ISPE Manufacturing Execution Systems document?\n\n2. How does the ISPE document describe the integration and role of electronic batch records (EBRs) and electronic device history records (EDHRs) within the broader framework of electronic production record systems in enhancing manufacturing operations?\n\n3. In the context of the ISPE Manufacturing Execution Systems document, how are data and signatures recorded in an electronic production record system to improve compliance and operational efficiency in manufacturing environments?", "prev_section_summary": "The section discusses the management of critical parameters in manufacturing execution systems, focusing on the entry, approval, and control of parameters in supervisory or recipe applications. It also addresses the handling of critical parameters entered directly into lower-level systems or equipment, such as Programmable Logic Controllers (PLCs), emphasizing the need for technical and procedural controls, including change control, to ensure data integrity and control. The section highlights the importance of maintaining data integrity as values are passed between systems within manufacturing execution systems.", "excerpt_keywords": "Keywords: Electronic Production Record Systems, ISPE, Manufacturing Execution Systems, EBRs, EDHRs"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "2767ef0c-110c-4380-b9fd-6bb9547b1a50", "node_type": "4", "metadata": {"page_label": "93", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "d6f5b02e9033e3d92d932c196e4795a93aff22842fe7d0a0b3b29ffe636f74bb", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "6c2ead06-06be-4ea0-b11a-d0323207803e", "node_type": "1", "metadata": {"page_label": "92", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "2011ef25030aea04a010d4f707ceb23496947fcd2d84cd8f864c12ab53a87ec9", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "a1a3e43e-c58d-456d-ab44-7c05a0d4f368", "node_type": "1", "metadata": {}, "hash": "bfcf628ec64ef3b4ded02a05b69fe90940af5281deadfafcfb3e93fbe8ee79d7", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 7 - electronic production record systems\n\n11.1 introduction\n\ntodays manufacturing systems are complex in nature, in that, a single electronic production record may contain data from many separate sources as shown in the paper batch record diagram in figure 11.1.\n\ncommonly implemented electronic systems include electronic batch records (ebrs) for pharmaceuticals and electronic device history records (edhr) for medical devices. implementing an electronic production record system (eprs) can offer significant advantages in reducing document and data errors and enhancing operational sequence control on the manufacturing area, as shown in figure 11.2. advantages in compliance include:\n\n- electronic review and approval of master recipes\n- automated distribution of recipes to production areas for execution\n- enforced sequence control of tasks\n- recording of data and signatures with automatic time and date stamp and other metadata\n- production data typically recorded in database structures, facilitating reporting for disposition, investigation, and analysis\n- eliminates replacement and tracking of lost or damaged paper pages on the manufacturing area\n\nfigure 11.1: paper batch record operation workflow illustration\n\n|weigh and dispense|weigh and dispense|\n|---|\n|process control system|operator work instructions|\n|building management environment|lims|\n|quality by testing|paper-based release|", "start_char_idx": 0, "end_char_idx": 1415, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "a1a3e43e-c58d-456d-ab44-7c05a0d4f368": {"__data__": {"id_": "a1a3e43e-c58d-456d-ab44-7c05a0d4f368", "embedding": null, "metadata": {"page_label": "94", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Transitioning from Paper to Electronic Production Records in Manufacturing Execution Systems", "questions_this_excerpt_can_answer": "1. How does the appendix of the ISPE Manufacturing Execution Systems document suggest transitioning from paper-based production records to electronic production records (EPRs) in terms of meeting regulatory and process requirements?\n\n2. What specific recommendations does the document make regarding the establishment of terminology for electronic equivalents to paper production records and functionality within manufacturing execution systems?\n\n3. According to the document, what reference is suggested for further understanding the recommended equivalents for master and production records in the context of transitioning to electronic production records within manufacturing execution systems?", "prev_section_summary": "The section discusses the advantages of implementing an Electronic Production Record System (EPRS) in pharmaceutical and medical device manufacturing operations, as outlined in the ISPE Manufacturing Execution Systems document. It highlights the integration and role of Electronic Batch Records (EBRs) and Electronic Device History Records (EDHRs) within EPRS, emphasizing improved compliance and operational efficiency through electronic review and approval of master recipes, automated distribution of recipes, enforced sequence control of tasks, recording of data and signatures with timestamps, database recording of production data, and elimination of paper-based processes. The section also mentions the complexity of modern manufacturing systems and the benefits of EPRS in reducing errors and enhancing operational control.", "excerpt_keywords": "Manufacturing Execution Systems, Electronic Production Records, EPRS, Electronic Batch Records, Electronic Device History Records"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "8fcc695b-5307-499e-a0c1-c527bb235755", "node_type": "4", "metadata": {"page_label": "94", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "48509b8292a06facb1541f836e552705ac918e1a8b1bf49c6c319d3ed2fe38e6", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "1b42d956-98a8-419f-98bf-f61d7db25639", "node_type": "1", "metadata": {"page_label": "93", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "d6f5b02e9033e3d92d932c196e4795a93aff22842fe7d0a0b3b29ffe636f74bb", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "ea391790-6704-4ef1-b135-e910bfeff10a", "node_type": "1", "metadata": {}, "hash": "f629d2b69ca2e71414010c661d8bf8ccc43b4b27c8a9ff431872b02bcfe29dd1", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 7: manufacturing execution systems - a strategic and program management approach\n\nfigure 11.2: electronic production record workflow illustration\n\n|operators|environment|real-time release|\n|---|---|---|\n|real-time automation and information control and decision management| | |\n\nthis appendix will outline how eprs functions meet the intent of production record requirements that may have been written for paper-based systems and how eprs and other automated systems provide the functionality that substitute for specific process and regulatory requirements.\n\n11.2 establishing equivalent electronic functionality\n\nterminology should be established and the electronic equivalent to paper production records and functionality should be defined before attempting to document requirements.\n\npaper record systems based on terminology from regulatory agency publications typically do not have a one-to-one correspondence to their electronic record system equivalents. table 11.1 shows recommended equivalents for master and production records. for further information, see isa s88 batch control part 1: models and terminology (reference 11, appendix 14).", "start_char_idx": 0, "end_char_idx": 1161, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "ea391790-6704-4ef1-b135-e910bfeff10a": {"__data__": {"id_": "ea391790-6704-4ef1-b135-e910bfeff10a", "embedding": null, "metadata": {"page_label": "95", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Execution Systems: Master Batch Records, Production Batch Records, and Recipe Types Guide", "questions_this_excerpt_can_answer": "1. What are the key components included in a Master Batch Record (MBR) when translated into an electronic system equivalent, and how do they differ from the components of a Production Batch Record in the same context?\n   \n2. How does the document differentiate between product recipes and non-product recipes within the context of manufacturing execution systems, and can you provide examples of each type as mentioned in the document?\n\n3. What specific types of information or data are included in an electronic production record as opposed to a batch (production) report, according to the guidelines provided in the document on manufacturing execution systems?", "prev_section_summary": "The section discusses transitioning from paper-based production records to electronic production records (EPRs) in Manufacturing Execution Systems (MES). It outlines the importance of establishing terminology and defining electronic equivalents to paper production records before documenting requirements. The document suggests specific recommendations for establishing electronic functionality and provides recommended equivalents for master and production records. Additionally, it references ISA S88 batch control for further understanding of transitioning to electronic production records within MES.", "excerpt_keywords": "Manufacturing Execution Systems, Master Batch Record, Production Batch Record, Recipe Types, Electronic Production Record"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "80c1f84d-ca94-4639-ac5e-8188b1ede13c", "node_type": "4", "metadata": {"page_label": "95", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "0a497e4f3e0d85373bcd6a4930f669ee01bcc955d1c7aedff55b81d15624e7fb", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "a1a3e43e-c58d-456d-ab44-7c05a0d4f368", "node_type": "1", "metadata": {"page_label": "94", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "48509b8292a06facb1541f836e552705ac918e1a8b1bf49c6c319d3ed2fe38e6", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "1bf6bd57-ba07-45a3-9f47-9d239baad35d", "node_type": "1", "metadata": {}, "hash": "bf23329998928d912e6c7ff478eea6c839abccebfc41b1463c2464aa889db663", "class_name": "RelatedNodeInfo"}}, "text": "## manufacturing execution systems - a strategic and program management approach\n\n### appendix 7\n\n|paper system|electronic system equivalent structure|description|\n|---|---|---|\n|master batch record (mbr)|master recipe|contains product name or designation, recipe designation or version, formulas, equipment requirements or classes, sequence of activities, procedures, normalized bill of materials (quantity per unit volume to produce)|\n| |work instructions (optional)|additional detailed instructions - may include electronic sops or sop references|\n| |critical process parameters (optional)|required process parameters that are to be checked or monitored or are to be downloaded to other systems such as automation|\n|production batch record|control recipe|a master recipe dispatched to or otherwise made available in manufacturing-related areas for execution. includes master recipe information with the addition of schedule, specific quantity to make, actual target bill of materials quantities, and other data for the batch and production instance|\n| |electronic production record|a store of data and information created by systems or entered by personnel during execution of control recipes. may be located in one or more systems or databases. data may or may not be stored in human readable format|\n| |batch (production) report|data and information in human readable format, presented either in electronic or paper format for activities, such as review, disposition, investigation, audit and analysis|\n\nthere are typically two major types of recipes: product and non-product.\n\n- product recipes typically produce a physical output related to a product or device, e.g.:\n- intermediate or final product makeup\n- medical device assembly or subassembly\n- dispensary operations for raw materials for solution or other manufacturing support component makeup. see appendix 11.\n- non-product recipes are operational in nature, result usually involve completing tasks or setting the status of parts, equipment, and assets, e.g.:\n- sterilize in place (sip) and clean in place (cip) activities\n- autoclave, machining equipment, and parts cleaning and preparation activities", "start_char_idx": 0, "end_char_idx": 2168, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "1bf6bd57-ba07-45a3-9f47-9d239baad35d": {"__data__": {"id_": "1bf6bd57-ba07-45a3-9f47-9d239baad35d", "embedding": null, "metadata": {"page_label": "96", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Recipe Management and Testing in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the document describe the approach to managing and testing recipes within Manufacturing Execution Systems (MES), specifically in relation to the use of Electronic Process Recipe Systems (EPRS)?\n   \n2. What are the benefits of using a module-based approach for recipe management in MES, as outlined in the document, and how does it relate to the ISA S88 standard's recommendations on recipe size and complexity?\n\n3. According to the document, what are the key considerations for ensuring robust version control in electronic recipe authoring within MES, and how does this process facilitate compliance and operational efficiency?", "prev_section_summary": "The section discusses the key components of Manufacturing Execution Systems (MES) in the context of Master Batch Records (MBR) and Production Batch Records. It outlines the structure and contents of electronic equivalents to paper-based systems, such as master recipes and control recipes. The document also differentiates between product and non-product recipes within MES, providing examples of each type. Additionally, it highlights the types of information included in electronic production records compared to batch reports, emphasizing the importance of data storage and accessibility in manufacturing processes.", "excerpt_keywords": "Manufacturing Execution Systems, Recipe Management, Electronic Process Recipe Systems, Version Control, ISA S88 Standard"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "10862d42-40a8-45e1-8ecf-b352ba1f85da", "node_type": "4", "metadata": {"page_label": "96", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "af15ae872efac7272ff3670e60b878a0b87c2ae9a5f29663bd139416060a3684", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "ea391790-6704-4ef1-b135-e910bfeff10a", "node_type": "1", "metadata": {"page_label": "95", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "0a497e4f3e0d85373bcd6a4930f669ee01bcc955d1c7aedff55b81d15624e7fb", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "08945998-28eb-4cd2-b262-08ca4dbd84db", "node_type": "1", "metadata": {}, "hash": "5ab505712a49dc0bba8c0d7312b1770e18432cd496b25c8eb8c6403a9cb563a5", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 7: manufacturing execution systems - a strategic and program management approach\n\n- creating non-product assemblies, such as filter assemblies, piping pathways, or device assembly fixtures\n\n- creating non-dispensed material or consumable item kits or groups to be transported to and within manufacturing areas\n\n- in-process testing and sampling (may also be incorporated into product recipes as appropriate)\n\n### 11.3 ancillary records\n\na production record can include non-recipe information and data, such as equipment use logs (log books). equipment use and maintenance histories can reside in one or more applications. mes based manufacturing aims to allow data from manufacturing support systems to be available for reporting and review along with recipe execution records.\n\n### 11.4 recipe management and testing\n\n#### 11.4.1 recipe approach\n\na module-based approach using eprs provides building blocks that can be reused in specific recipes, reducing the re-testing effort for the addition of new products or recipes.\n\na risk-based approach should be used for testing eprs operations. recipes may be developed specifically for testing particular functionality in a known fashion with specific parameters and attributes. for further information on the risk assessment approach, see gamp 5.\n\ntypically, a combination of production and testing-only recipes is needed to verify the range of operating conditions of an eprs and constituent modules. verifying a range of operations beyond the initial process requirements can result in savings over the life of the systems by reducing the need for individual functional testing for process and other changes.\n\nrecipes can be a configuration device and a software module for a system simultaneously. recipes typically contain parameters and instructions that can be tested with the lower risk factors for configuration, and may contain one or more software modules that may need testing approaches more appropriate to configurable or custom code depending on the origin of the module.\n\ntypically, operations or process developers are responsible for recipe authoring. in an electronic system, a list of standard functionality should be available to build a recipe. recipe authoring should have a robust process for version control, such that only valid and approved versions can be used for production unless a specific override is executed for instances, such as testing and process trials. version information should be readily retrievable for any batch, lot, device, or sub-assembly.\n\nelectronic systems provide an opportunity to classify recipes allowing focus on specific steps, phases, and operations. while there may initially be an increase in resources to create more recipes of smaller size, there are advantages in shorter time for review, approval, and revision efforts. in fact, the isa s88 standard intends that smaller recipes are used to allow process and systems changes to have the smallest practical scope, facilitating easier control, and testing when changes are made, as well as allowing the most portability of verified process steps among processes without complete re-testing. this approach has both economic and compliance advantages for organizations since risks are lowered by re-using existing process recipes or recipe steps with just parameter changes.\n\nthe size and number of recipes may be related to complexity as well as the number and length of steps of a process. a simple process can have one recipe, while other processes can have many smaller recipes both for product and non-product operations.", "start_char_idx": 0, "end_char_idx": 3596, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "08945998-28eb-4cd2-b262-08ca4dbd84db": {"__data__": {"id_": "08945998-28eb-4cd2-b262-08ca4dbd84db", "embedding": null, "metadata": {"page_label": "97", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Recipe Management and Testing in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the GAMP Good Practice Guide suggest managing the version and status attributes of recipes in Manufacturing Execution Systems to ensure traceability and appropriate use in production environments?\n   \n2. What are the recommended practices for testing recipes in Manufacturing Execution Systems according to the GAMP Good Practice Guide, particularly in terms of static and dynamic testing requirements?\n\n3. According to the GAMP Good Practice Guide, how should recipes be managed to accommodate multiple valid versions for the same product, ensuring the correct recipe is used for varying production scenarios?", "prev_section_summary": "The section discusses the strategic and program management approach to manufacturing execution systems (MES), focusing on recipe management and testing. Key topics include the use of Electronic Process Recipe Systems (EPRS) for building blocks in recipes, the benefits of a module-based approach for recipe management, the importance of robust version control in electronic recipe authoring, and the relationship to the ISA S88 standard's recommendations on recipe size and complexity. The section emphasizes the risk-based approach to testing EPRS operations, the need for a combination of production and testing-only recipes, and the advantages of creating smaller recipes for easier control, testing, and portability of verified process steps. It also highlights the role of operations or process developers in recipe authoring and the classification of recipes to focus on specific steps, phases, and operations.", "excerpt_keywords": "Manufacturing Execution Systems, Recipe Management, Testing, GAMP Good Practice Guide, Electronic Process Recipe Systems"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "fac28d0e-4216-4221-93c3-3eb39c4a9d74", "node_type": "4", "metadata": {"page_label": "97", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "f016949548bcefdb73339bf24c8881954889438f21fad9254e56f7bd42fe6a84", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "1bf6bd57-ba07-45a3-9f47-9d239baad35d", "node_type": "1", "metadata": {"page_label": "96", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "af15ae872efac7272ff3670e60b878a0b87c2ae9a5f29663bd139416060a3684", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "4c0cadfc-d808-4090-a4a5-c7906b6a5f0e", "node_type": "1", "metadata": {}, "hash": "8990a75a8791afdd378704756ca03909e0c9e58ec0ab5648895622f1391e81aa", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 7\n\n|content|page number|\n|---|---|\n|11.4.2 recipe controls|page 95|\n\nrecipe management typically uses version and status attributes to ensure that:\n\n- recipes are uniquely identified and can be traced through changes and updates.\n- methods are in place to determine the history of recipe versions used at a particular time or for a specific task in support of production operations.\n- clearly defined recipe status attributes, such as editing, routing for approval, approved, indicate the current phase of recipe implementation.\n- controls are in place to ensure that the desired recipe versions are selected (or selectable) appropriately for production use and consistent with the level of risk identified for the process.\n- recipes for development or testing should be clearly identifiable when used in a controlled production environment; controls should be in place to:\n- change test recipes to production status\n- remove or replace with production recipes prior to gxp execution\n- specify release and use criteria for products in cases of concurrent validation of systems and the processes they control\n- there may be more than one recipe for the same product valid for execution, e.g., with a different target equipment or quantity. controls should be established to assure use of the correct recipes for varying production of the same product.\n\n11.4.3 testing recipes\n\nrecipes may contain text, such as instructions, and software commands to perform functions or exchange commands and parameters with other systems. a combination of static testing (verification to specification) and dynamic testing (operational testing) is typically required depending on the recipe content.\n\na recipe may be considered a functional domain in that it is linked to other functions via standard interfaces, such as input from or output to automation. the basic interface operation is verified and each recipe can be statically tested (visual check of parameters) in most cases that use the interface within design parameters.\n\nformal peer review among authors as part of an audited program has proven to be an effective way to prevent errors in configurations that are statically tested.\n\ndevelopment testing does not need to be performed in controlled environments. however, final testing for gxp use should be performed in controlled environments to assure performance to specifications.\n\nthe amount of testing typically is proportional to the amount of pre-tested modules used in a recipe and the risk to patient health. for example, if software modules are selectable by recipe authors for insertion into a recipe, the modules can be pre-tested and available in a store or library of resources for authors. the modules may not need any retesting for use in specific recipes or in the case of configurable modules, may require static testing (verification of parameters or instructions). a verification of the sequence of steps or modules in a recipe is typically performed for new or modified recipes. the risk factors of recipes and recipe modules are used to determine the level of testing.\n\nseveral layers of building blocks for use in recipes, such as routes, operations, phases, and steps are managed under change control and configuration management.", "start_char_idx": 0, "end_char_idx": 3375, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "4c0cadfc-d808-4090-a4a5-c7906b6a5f0e": {"__data__": {"id_": "4c0cadfc-d808-4090-a4a5-c7906b6a5f0e", "embedding": null, "metadata": {"page_label": "98", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Enhancing Efficiency and Integration of Manufacturing Execution Systems with EPRS Base Functionality", "questions_this_excerpt_can_answer": "1. What are the key components of EPRS functionality as outlined in the ISPE Manufacturing Execution Systems document, and how do they compare to traditional ERP systems in managing production schedules and performance?\n\n2. How does the document describe the integration of Batch Execution Systems (BES) with EPRS to enhance manufacturing execution, and what specific challenges does it address regarding operator interaction and system interface design?\n\n3. What specific base functionalities does EPRS offer to improve data collection and management in manufacturing execution systems, according to the ISPE document, and how does it propose handling electronic signatures and SOP cataloging?", "prev_section_summary": "This section discusses recipe management and testing in Manufacturing Execution Systems according to the GAMP Good Practice Guide. Key topics include the use of version and status attributes for traceability, testing requirements such as static and dynamic testing, managing multiple valid versions of recipes for the same product, and the importance of controlled environments for final testing. Entities mentioned include recipe controls, recipe versions, recipe status attributes, testing procedures, software modules, and building blocks for recipes.", "excerpt_keywords": "Manufacturing Execution Systems, EPRS, Batch Execution Systems, Electronic Signatures, SOP Cataloging"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "12210eae-9d4d-417c-ab80-40be37230caf", "node_type": "4", "metadata": {"page_label": "98", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "6ffa97e7fa784bcb0764b00cb2f52f05cddd9871e0ad5634d208070d850cdfa0", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "08945998-28eb-4cd2-b262-08ca4dbd84db", "node_type": "1", "metadata": {"page_label": "97", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "f016949548bcefdb73339bf24c8881954889438f21fad9254e56f7bd42fe6a84", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "8de9301c-dfa0-441e-9682-1bb8e848489c", "node_type": "1", "metadata": {}, "hash": "7e0f349c2e001f9ee8683772bd5a65a1c967254ea5685f5627b4c3960969106e", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 7: manufacturing execution systems - a strategic and program management approach\n\nfigure 11.3: eprs functionality\n\n|product definition|production capability|production schedule|production performance|\n|---|---|---|---|\n|erp|detailed production schedule|production tracking|production performance analysis|\n|eprs|product definition management|production execution data collection| |\n\nused with permission from isa, www.isa.org (source: isa s95 committee (modified))\n\n## 11.5 eprs base functionality\n\nbatch execution systems (bes), such as an automation batch manager, may be used to complement or be a component of eprs functionality. workflow needs to be considered for alarm and exception management and other manual operations and signatures to avoid requiring duplicate operator interaction for eprs and automation in the normal course of operations. good manufacturing area interface design reduces the possibility of errors by eliminating or at least minimizing the need to switch continually between applications or systems to accomplish standard work.\n\nnote: batch managers may require programming to implement sequence control, whereas recipe-driven eprs, dependent on the specific architecture, may implement a majority of sequence control at the recipe level by configuration without programming that requires re-verification for many types of changes.\n\npossible eprs base functionality includes:\n\n- work instructions for manual or semi-automatic operations\n- sop cataloging and presentation as needed\n- electronic signatures (see appendix 9)\n- data collection and management from disparate systems, e.g.:\n- s88 batch and associated process data from batch managers", "start_char_idx": 0, "end_char_idx": 1687, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "8de9301c-dfa0-441e-9682-1bb8e848489c": {"__data__": {"id_": "8de9301c-dfa0-441e-9682-1bb8e848489c", "embedding": null, "metadata": {"page_label": "99", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Execution Systems: Integration and Validation of Functional Domains", "questions_this_excerpt_can_answer": "1. What types of data and systems are integrated within a Manufacturing Execution System (MES) as outlined in the GAMP\u00ae Good Practice Guide, specifically in the context of pharmaceutical manufacturing?\n\n2. How does the document describe the approach to modularizing functions within an MES to facilitate the validation process, particularly in the creation of master recipes?\n\n3. What specific examples of domain functionality are mentioned as being part of the Electronic Process Recipe System (EPRS) in the context of enhancing manufacturing execution and validation efforts?", "prev_section_summary": "The section discusses the key components of EPRS functionality compared to traditional ERP systems in managing production schedules and performance. It also covers the integration of Batch Execution Systems (BES) with EPRS to enhance manufacturing execution, addressing challenges related to operator interaction and system interface design. The document outlines the base functionalities of EPRS, including product definition management, production execution data collection, work instructions, SOP cataloging, electronic signatures, and data collection and management from disparate systems. It emphasizes the importance of good manufacturing area interface design to reduce errors and streamline operations.", "excerpt_keywords": "Manufacturing Execution Systems, Integration, Validation, Functional Domains, Electronic Process Recipe System"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "59436194-2cf9-4d4b-83c8-a8aa4d0cc495", "node_type": "4", "metadata": {"page_label": "99", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "117a2e4a2e131e5fbc371167a0b51a8f5df6b06cb4b6c893b0b16eb8c2ee3f74", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "4c0cadfc-d808-4090-a4a5-c7906b6a5f0e", "node_type": "1", "metadata": {"page_label": "98", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "6ffa97e7fa784bcb0764b00cb2f52f05cddd9871e0ad5634d208070d850cdfa0", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "fac7215a-52ed-4dd5-bdff-4bea32e800dd", "node_type": "1", "metadata": {}, "hash": "e03163800f101b0faa53b2b8fe0437884b0a2cd44841b109c3e3ee3071794059", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 7\n\n- traditional process data and alarms and events\n- binary objects from sophisticated instrumentation and sensors along with analysis applications (e.g., jpeg and gif formats)\n- xml schema to describe the internal content of the spectral data for each instrument or sensor. see appendix 13 for more information on xml.\n- storage of xml data characterizing sensors and instrumentation\n- manually entered data from lims, other applications\n- electronic forms\n- capa systems\n- material verification and usage transactions\n- equipment and asset before and during production verification\n- clean in place (cip), sip, and other cleaning data\n- prediction-correction algorithms for advanced process control\n- print outs of high pressure liquid chromatography (hplc) system diagram, electronic confirmation in lims system with reference to hplc print out in pdf files\n\npersonnel verification, access, and tracking (usually from human resources systems)\n\nproduction control and sequencing, including criteria for start and stop of an operation and provide sequencing logic (parallel, concurrent, contingent actions)\n\nfeed forward and feedback algorithms to support process analytical technology (pat) initiatives\n\ninterfaces required to business and other enterprise systems\n\nfigure 11.3 illustrates the different domain functionality that can be a part of the eprs.\n\n### 11.6 epr modules\n\nfunctions can be combined into modules or objects that can be added to the recipes to comprise a functional domain. these domains would be validated individually, simplifying the verification efforts in the master recipe creation process.\n\nthese domains can equate to typical business activities, e.g.:\n\n- material verification\n- material weighing and dispensing\n- material and label verification and reconciliation\n- equipment identification and verification", "start_char_idx": 0, "end_char_idx": 1967, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "fac7215a-52ed-4dd5-bdff-4bea32e800dd": {"__data__": {"id_": "fac7215a-52ed-4dd5-bdff-4bea32e800dd", "embedding": null, "metadata": {"page_label": "100", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Maximizing Compliance and Efficiency: Leveraging Electronic Production Records and Workflow Optimization\"", "questions_this_excerpt_can_answer": "1. How does the transition from paper production records to electronic production records (EPRs) potentially impact the efficiency and compliance of manufacturing execution systems in the pharmaceutical industry, according to the ISPE guidelines?\n\n2. What specific types of in-process checks are recommended by the ISPE for ensuring compliance and efficiency in manufacturing execution systems, and how do electronic production records facilitate these checks?\n\n3. In what ways does integrating automation with electronic production records (EPRs) enhance manufacturing efficiencies and compliance, particularly in relation to handling alarms and events, as outlined in the ISPE Manufacturing Execution Systems document?", "prev_section_summary": "The section discusses the integration of various types of data and systems within a Manufacturing Execution System (MES) as outlined in the GAMP\u00ae Good Practice Guide for pharmaceutical manufacturing. It describes the approach to modularizing functions within an MES to facilitate the validation process, particularly in the creation of master recipes. Specific examples of domain functionality mentioned include traditional process data, alarms and events, binary objects from instrumentation, XML schema for spectral data, manual data entry, electronic forms, CAPA systems, material verification, equipment verification, cleaning data, process control algorithms, personnel verification, production control, and interfaces to other enterprise systems. The section also highlights the concept of combining functions into modules or objects for easier validation in the master recipe creation process.", "excerpt_keywords": "Manufacturing Execution Systems, Electronic Production Records, Compliance, Efficiency, Workflow Optimization"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "0e0b2c27-4bce-4fc3-9cc4-7d8e57b48644", "node_type": "4", "metadata": {"page_label": "100", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "d0a8f340722aa174081b1c96cdc6878bafb348015e5b19cc159958aa57514e17", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "8de9301c-dfa0-441e-9682-1bb8e848489c", "node_type": "1", "metadata": {"page_label": "99", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "117a2e4a2e131e5fbc371167a0b51a8f5df6b06cb4b6c893b0b16eb8c2ee3f74", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "23820eee-a0a8-44b6-b050-b54cfadc24e9", "node_type": "1", "metadata": {}, "hash": "8c816244dc57c7e2421bbb3cf46216628228a4c03ea9a0423cc0845f368f7acb", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 7 - in process checks\n\n- start-up checks\n- recipe and work instructions (automated and manual)\n- process parameters and ranges (including verification that the data is within range)\n- environmental parameters\n- data collection (automated and manual)\n- yield calculation\n- electronic signature capture\n- investigations and deviations related to the batch or product\n\n## supplemental epr processes\n\nin addition to the recipe-related compliance activities, the following activities are considered:\n\ndata corrections and audit trails\nelectronic review and approval of master data\nelectronic review and approval of production records via reporting from multiple production data sources (attachment by reference, or linking), see appendix 8\nconditions and rules for deviation processing, investigation, and resolution\nproduction status tracking\nviewing of electronically documented operating procedures\n\n## streamlining the process\n\nthe topic of electronic production records is not only a documentation issue; it also addresses issues related to workflow and affects how operations are performed. converting from a paper production record to an epr provides an opportunity to review the content of the record and determine what steps may be eliminated or improved. it should be decided whether to replicate the existing paper production record in electronic form or to streamline the production record. paper production records may include entries that are redundant and may not be necessary if electronic data are obtained automatically (e.g., initials and date at each step to verify who performed the task).\n\nmore than any other mes functionality, recipes, and electronic production records define workflow detail for human-machine interactions. the amount of integration into the automation layer often determines how much of an advantage in compliance and manufacturing efficiencies can be achieved by eprs implementations. for example, if alarms and events from automation are automatically recorded in the record, transcriptions are eliminated, and operator responses are coordinated with the events for disposition review.", "start_char_idx": 0, "end_char_idx": 2137, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "23820eee-a0a8-44b6-b050-b54cfadc24e9": {"__data__": {"id_": "23820eee-a0a8-44b6-b050-b54cfadc24e9", "embedding": null, "metadata": {"page_label": "101", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "EPRS Approaches in Manufacturing Execution Systems: A Comprehensive Overview", "questions_this_excerpt_can_answer": "1. What are the primary differences between paper replica EPRS and database-driven EPRS in terms of data integration and analysis capabilities as outlined in the \"EPRS Approaches in Manufacturing Execution Systems: A Comprehensive Overview\" document?\n\n2. How does the document \"EPRS Approaches in Manufacturing Execution Systems: A Comprehensive Overview\" describe the process and benefits of transitioning from a paper replica system to a database-driven EPRS in terms of improving compliance opportunities and operational efficiency?\n\n3. According to the \"EPRS Approaches in Manufacturing Execution Systems: A Comprehensive Overview,\" how are electronic signatures utilized in database-driven EPRS for the approval and disposition of master recipes and production records, and what advantages does this method offer over traditional paper-based systems?", "prev_section_summary": "The section discusses the transition from paper production records to electronic production records (EPRs) and its impact on efficiency and compliance in manufacturing execution systems in the pharmaceutical industry, according to ISPE guidelines. It covers specific types of in-process checks recommended by ISPE, the integration of automation with EPRs to enhance efficiencies and compliance, and the importance of streamlining the production record process. Key topics include start-up checks, process parameters, electronic signature capture, data corrections, audit trails, electronic review and approval of master data, and production status tracking. The section emphasizes the importance of electronic production records in defining workflow detail for human-machine interactions and highlights the advantages of automation integration for compliance and manufacturing efficiencies.", "excerpt_keywords": "Manufacturing Execution Systems, EPRS Approaches, Database-driven systems, Electronic signatures, Compliance opportunities"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "977850a0-a184-4d00-b3ad-5bc463f1c766", "node_type": "4", "metadata": {"page_label": "101", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "ebc408900185ba46db930a289ec3dd637f24fd6ab0b24361b490c41d15f4b20a", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "fac7215a-52ed-4dd5-bdff-4bea32e800dd", "node_type": "1", "metadata": {"page_label": "100", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "d0a8f340722aa174081b1c96cdc6878bafb348015e5b19cc159958aa57514e17", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "600db562-3cb9-4d06-936f-fb6ad7a904b6", "node_type": "1", "metadata": {}, "hash": "db4bb20716c6fce89aae5b78a2eb3230fea48166ffc6b1088c547357edfa98ab", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 7\n\n|content|page number|\n|---|---|\n|eprs approaches|page 99|\n\n### 11.9 eprs approaches\n\nsolutions generally are available on different technology platforms that can include paper replica, true database driven systems, or a combination of both types.\n\n#### 11.9.1 paper replica eprs\n\nthis type of system is typically programmed to hold and display a replica of a paper master batch record (mbr) on workstations in the production environment with little or no interaction with automation and equipment. the mbr is created as an entity maintained in the system. this approach often fails to take advantage of computer-assisted functionality to increase efficiency or optimize compliance opportunities, such as sequence control, but may be an initial option for facilities with little or no automation.\n\nthe system typically distributes a batch record copy to the manufacturing area as an empty production record based on online requests by qualified personnel. operators make entries associated with the correct fields in the production record via keyboard and scanning devices. the document may be printed at completion for review and approval or reviewed for disposition online. the main advantage of this type of system is that the quality unit and other approvers see mbrs and production batch records as one entity in a format similar to that used in previous paper systems, allowing existing methods for review and disposition to continue.\n\nthe disadvantage of this type of system is that the data is not available for analysis, thereby reducing the potential benefits of an eprs. additionally, this approach does not integrate with other systems, creating the need for manual data entry and multiple data locations.\n\nfor this approach, the relationship between paper and electronic records and their management and control should be understood, and which are to be used as the regulated records must be defined.\n\n#### 11.9.2 database driven eprs\n\nthese systems may not have any single entity that comprises a complete master batch record as defined in paper-based systems. recipes, sequences, control parameters, process parameters, work instructions, and sops may exist in different systems or databases. at execution, the system collates all necessary instructions, data, and sequences and presents them to personnel for execution. data is entered and maintained along with required audit trails and other electronic records for future recall. the production record consists of all the electronic records associated with a production run or batch.\n\nin the case of master recipe and production records, any physical representation is simply a report from the data in the eprs. while printouts can be used for approval and disposition, this is more typically accomplished online with electronic signatures. the advantages of this type of system are:\n\n- presentation of recipes and instructions can be altered in real time based on events, such as alarms, to provide a comprehensive instructional interface to operators.\n- any information associated with batch programming and execution is available for analysis in combinations limited only by the constraints of data repositories and systems integration.\n- revisions to specific parameters or steps may be approved without putting large portions of a master record into a review and approval process.\n- different types of records that make up the complete recipe can be imported from existing systems, such as automation, document control, lims, and erp where each record is managed in a manner appropriate to the data type.", "start_char_idx": 0, "end_char_idx": 3704, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "600db562-3cb9-4d06-936f-fb6ad7a904b6": {"__data__": {"id_": "600db562-3cb9-4d06-936f-fb6ad7a904b6", "embedding": null, "metadata": {"page_label": "102", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Object Driven EPRs in Manufacturing Execution Systems: Advantages and Implementation", "questions_this_excerpt_can_answer": "1. What are the specific challenges associated with managing data and ensuring compliance in decentralized Electronic Product Records (EPRs) within manufacturing execution systems, as outlined in the ISPE Manufacturing Execution Systems guide?\n\n2. How do object-driven EPRs, such as those utilizing XML, integrate the benefits of paper replica and database-driven approaches to enhance data analysis and system integration in manufacturing execution systems, according to the document?\n\n3. What are the unique advantages of using object-driven EPRs in manufacturing execution systems for managing production records, including aspects of portability, reporting, and real-time instructional adjustments, as detailed in the ISPE guide?", "prev_section_summary": "The section discusses the different approaches to Electronic Production Record Systems (EPRS) in Manufacturing Execution Systems, specifically focusing on paper replica EPRS and database-driven EPRS. \n\nKey topics covered include:\n- Description of paper replica EPRS systems, their limitations in data integration and analysis capabilities, and their manual data entry requirements.\n- Description of database-driven EPRS systems, their advantages in terms of real-time data presentation, flexibility in altering instructions, and comprehensive data analysis capabilities.\n- Comparison of the benefits and drawbacks of both types of EPRS systems in terms of compliance opportunities, operational efficiency, and data availability for analysis.\n- Utilization of electronic signatures in database-driven EPRS for approval and disposition of master recipes and production records.\n\nEntities discussed include:\n- Master Batch Records (MBR)\n- Production Records\n- Electronic signatures\n- Automation systems\n- Document control systems\n- Laboratory Information Management Systems (LIMS)\n- Enterprise Resource Planning (ERP) systems\n\nOverall, the section provides a comprehensive overview of EPRS approaches in Manufacturing Execution Systems and highlights the advantages of transitioning from paper replica systems to database-driven systems for improved efficiency and compliance opportunities.", "excerpt_keywords": "Manufacturing Execution Systems, Object-driven EPRs, XML, Data integration, Electronic signatures"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "1ec2b529-5f49-43cb-b371-b355f48dfbf0", "node_type": "4", "metadata": {"page_label": "102", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "bd4b4e2dddcafaf890b4c04a52167bf209f77db51eaede73a4958c77412fe77f", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "23820eee-a0a8-44b6-b050-b54cfadc24e9", "node_type": "1", "metadata": {"page_label": "101", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "ebc408900185ba46db930a289ec3dd637f24fd6ab0b24361b490c41d15f4b20a", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "b7fdc136-c7de-4409-8b7f-a6ac9884125b", "node_type": "1", "metadata": {}, "hash": "f2a420392168fdcaf7f070752f08c2ddfed3f61d4569efcfe7fd80afbde67460", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 7: gamp(r) good practice guide\n\ndisadvantages may include:\n\n- added difficulty in data management and control (especially for de-centralized epr data sources).\n- greater verification and change control burden to assure that production always complies with the master recipe.\n- the potential for retaining production data that is not explicitly reviewed or considered for product release.\n- need to manage historical epr data, review methods, and tools to ensure accurate epr review repeatability throughout the record retention period.\n\n### manufacturing execution systems - a strategic and program management approach\n\nobject driven eprs\n\nobject driven (such as xml) eprs can be considered a combination of the paper replica and the database driven approaches since they take the single document concept from the paper replica eprs and supplement that with the benefits of the database driven eprs regarding integration with other systems and allowing the data to be analyzed. these systems have a single entity that is a complete and self-contained master record consisting of recipes, sequences, control parameters, process parameters, work instructions, and links to sops. data may be collected from users, equipment, or electronically from other systems. at execution, the system presents the instructions and data collection fields in the sequences defined to personnel for execution. decision logic built into the instructions allow for optional pathways as well as deviation handling.\n\nwith an object driven epr, the data that is captured is stored directly in the same document that is used to control execution. in the case of master recipe and production records, any physical representation is simply a report from the data in the eprs. while printouts can be used for approval and disposition, this is more typically accomplished online with electronic signatures.\n\nthe advantages of this type of system are:\n\n- production record data is contained within a single object document.\n- portability as a single document containing the raw production record data facilitates transferring the complete production record to a document management system for review and approval cycles and storage.\n- reporting on any information associated with production programming and execution is accomplished by applying a style-sheet, possibly providing a choice between style-sheets. cross-production reporting for trending purposes is also supported.\n- presentation of recipes and instructions can be altered in real time based on events, such as alarms to provide a comprehensive instructional interface to operators.\n- different types of records that make up the complete recipe can be written to the object production record as additional data collection fields during execution or attachments from existing systems, such as automation, document control, lims, and erp.", "start_char_idx": 0, "end_char_idx": 2881, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "b7fdc136-c7de-4409-8b7f-a6ac9884125b": {"__data__": {"id_": "b7fdc136-c7de-4409-8b7f-a6ac9884125b", "embedding": null, "metadata": {"page_label": "103", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Advantages of Electronic Production Record Systems (EPRS) in Manufacturing Execution Systems: A Comprehensive Overview", "questions_this_excerpt_can_answer": "1. How does the implementation of Electronic Production Record Systems (EPRS) in Manufacturing Execution Systems (MES) contribute to the reduction or elimination of human data transcription errors in pharmaceutical manufacturing processes?\n\n2. In what ways do Electronic Production Record Systems (EPRS) enforce sequence control of work instructions within Manufacturing Execution Systems, and how does this benefit the overall manufacturing workflow?\n\n3. Can you detail the specific advantages of using Electronic Production Record Systems (EPRS) over traditional paper-based systems in terms of recipe data approval, data distribution, and the management of Standard Operating Procedures (SOPs) within a pharmaceutical manufacturing environment?", "prev_section_summary": "This section discusses the advantages and implementation of object-driven Electronic Product Records (EPRs) in Manufacturing Execution Systems. It highlights the challenges associated with managing data and ensuring compliance in decentralized EPRs, as well as the benefits of object-driven EPRs, such as integration with other systems, data analysis, and real-time instructional adjustments. The section also covers the strategic and program management approach to Manufacturing Execution Systems, emphasizing the use of object-driven EPRs like XML. Key topics include the structure of object-driven EPRs, data collection, decision logic, portability, reporting, real-time instructional adjustments, and integration with other systems. Key entities mentioned are master records, recipes, sequences, control parameters, process parameters, work instructions, SOPs, and various systems like automation, document control, LIMS, and ERP.", "excerpt_keywords": "Electronic Production Record Systems, EPRS, Manufacturing Execution Systems, recipe data approval, SOPs"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "a70c6aff-b162-4e78-bc2f-298089d30297", "node_type": "4", "metadata": {"page_label": "103", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "10dbf5f3e69e0bf0149f8205449ca00947b9b20dfe84107ac134f34c17b9aada", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "600db562-3cb9-4d06-936f-fb6ad7a904b6", "node_type": "1", "metadata": {"page_label": "102", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "bd4b4e2dddcafaf890b4c04a52167bf209f77db51eaede73a4958c77412fe77f", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "6ec899b6-27f3-4eb6-9847-43c9101a0060", "node_type": "1", "metadata": {}, "hash": "f647c5aafaf48bc43dea123c979f1b5588bb55d4dedff70d8a48653228b2b316", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 7\n\n|11.10|eprs advantages|\n|---|---|\n| |eprs offer advantages, including:|\n| |- electronic approval of recipe data and instructions\n- automated distribution of data and instructions to production areas for execution\n- reduction or elimination of human data transcription from one form to another\n- enforced sequence control of work instructions since restrictions can be imposed on step selection or presentation for execution\n- recording electronic data and signatures with automatic time and date stamp and other metadata\n- data remains accessible, but protected in databases. reports or imports to other applications make a selection of the data available in many formats for review and disposition, pat, and other uses.\n- recipes and batch control enforce sequencing of workflow at both phase and unit operation levels.\n- reduced requirements for external sops since work instructions and presentation format are not limited by paper constraints\n- eliminate replacement and tracking of lost or damaged paper pages on the manufacturing area\n- each type has unique characteristics that may provide an advantage depending upon specific facility and human resource situations.\n|", "start_char_idx": 0, "end_char_idx": 1302, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "6ec899b6-27f3-4eb6-9847-43c9101a0060": {"__data__": {"id_": "6ec899b6-27f3-4eb6-9847-43c9101a0060", "embedding": null, "metadata": {"page_label": "104", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Blank Canvas: A Collection of Empty Spaces\"", "questions_this_excerpt_can_answer": "Based on the provided context, here are three questions that this specific context can provide answers to, which might be difficult to find elsewhere:\n\n1. **What is the file size of the \"ISPE Manufacturing Execution Systems\" PDF document stored in the PharmaWise Engineer project within the PharmaWise CSV & Data Integrity raw data directory?**\n   - This question is specific to the document's metadata, including its file size, which is detailed in the provided context.\n\n2. **What are the creation and last modification dates of the document titled \"Blank Canvas: A Collection of Empty Spaces\" found in the PharmaWise Engineer project's raw data directory?**\n   - The context provides unique information regarding the document's creation and last modification dates, which are specific to this document's version and would not be easily found elsewhere.\n\n3. **Under what file path and name can the \"ISPE Manufacturing Execution Systems\" document be located within the PharmaWise Engineer project's directory structure?**\n   - This question targets the specific location and naming convention used for storing the document within a project's directory, information that is unique to the project's file management system and provided in the context.\n\nThese questions are tailored to extract information directly related to the document's metadata and storage details within a specific project environment, leveraging the unique identifiers and timestamps provided in the context.", "prev_section_summary": "The section discusses the advantages of Electronic Production Record Systems (EPRS) in Manufacturing Execution Systems (MES) in pharmaceutical manufacturing processes. Key topics include electronic approval of recipe data, automated distribution of data, reduction of human data transcription errors, enforced sequence control of work instructions, recording electronic data and signatures, accessibility and protection of data in databases, enforcement of workflow sequencing, reduced requirements for external Standard Operating Procedures (SOPs), elimination of paper constraints, and unique characteristics of EPRS. Key entities mentioned are EPRS, recipe data, work instructions, electronic data, signatures, time and date stamp, metadata, databases, reports, batch control, sequencing of workflow, SOPs, and manufacturing area.", "excerpt_keywords": "ISPE, Manufacturing Execution Systems, Electronic Production Record Systems, EPRS, pharmaceutical manufacturing"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "4241c530-36b6-4173-acae-dd54ee236712", "node_type": "4", "metadata": {"page_label": "104", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "db35e6a69ca9b1fb0680001fd26d7fdaaed9e046b3db1159bd73aaf9f082b052", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "b7fdc136-c7de-4409-8b7f-a6ac9884125b", "node_type": "1", "metadata": {"page_label": "103", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "10dbf5f3e69e0bf0149f8205449ca00947b9b20dfe84107ac134f34c17b9aada", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "4ca2fbcb-965b-400f-b801-63f6ae8aeb93", "node_type": "1", "metadata": {}, "hash": "59540429a8d56d23e978a9ff9ec3621371e03b7aa1d65813de8423fe765286b3", "class_name": "RelatedNodeInfo"}}, "text": "no_content_here", "start_char_idx": 0, "end_char_idx": 15, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "4ca2fbcb-965b-400f-b801-63f6ae8aeb93": {"__data__": {"id_": "4ca2fbcb-965b-400f-b801-63f6ae8aeb93", "embedding": null, "metadata": {"page_label": "105", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Review of Exception Reports in Production Operations", "questions_this_excerpt_can_answer": "1. How does the Review by Exception (RBE) method ensure the accuracy and reliability of filtering and reporting software for production data in pharmaceutical manufacturing, according to the ISPE Manufacturing Execution Systems guidelines?\n\n2. What are the specific regulatory requirements for the quality unit review of exception reports in production operations, as accepted by guidelines for the inspection of computerized systems, detailed in the ISPE Manufacturing Execution Systems document?\n\n3. How does the GAMP approach enable RBE functionality in pharmaceutical manufacturing operations, and what are the advantages of using computerized systems for data review and analysis as outlined in the ISPE Manufacturing Execution Systems guidelines?", "prev_section_summary": "This section provides metadata details about a specific PDF document titled \"ISPE Manufacturing Execution Systems\" stored in the PharmaWise Engineer project within the PharmaWise CSV & Data Integrity raw data directory. The key topics covered include the file size, creation date, last modification date, file path, and file name of the document. The section also highlights three specific questions that can be answered based on the provided context, focusing on the document's metadata and storage location within the project directory structure.", "excerpt_keywords": "ISPE, Manufacturing Execution Systems, Review by Exception, GAMP, Pharmaceutical Manufacturing"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "57c6e948-6276-45d5-9649-a4744bcf1f53", "node_type": "4", "metadata": {"page_label": "105", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "0137b20061dcfc31f86e1ed67fb61bb543d8596fb4918d7696609df7f7e5e39b", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "6ec899b6-27f3-4eb6-9847-43c9101a0060", "node_type": "1", "metadata": {"page_label": "104", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "db35e6a69ca9b1fb0680001fd26d7fdaaed9e046b3db1159bd73aaf9f082b052", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "76d05f83-331d-402d-acfe-bcdf0dc12434", "node_type": "1", "metadata": {}, "hash": "ff786a3cb726ad5a60fa62213e471107695a6177d5dc70733fe2e8ed5c3732b6", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 8 - review by exception\n\n12.1 definition and justification\n\nin review by exception (rbe) methods, validated equipment and systems are designed to filter production data for production reports to:\n\n- include any critical exceptions and deviations to the process\n- exclude normal operations data, events, or alerts not required to support critical exceptions\n\nregulatory guidelines to inspection of computerized systems have accepted quality unit review of exception reports for production review and disposition based upon the following requirements:\n\n- rbe functionality is clearly defined in requirements and specification documents.\n- data that would be manually reviewed in non-rbe type reports is retained and can be presented in human readable form for the appropriate retention period.\n- the computerized means of review is equivalent to a manual review.\n- the accuracy and reliability of the filtering and reporting software is demonstrated via verification for the intended use.\n- verification of rbe functionality is part of periodic systems reassessment.\n\nfor further information on rbe, see gamp 5, appendix s2 (reference 5, appendix 14).\n\nusing rbe methods, human resources can be focused on analysis, investigation, and issue resolution rather than redundant verification of normal data and events produced during operations monitored and controlled by validated systems. an advantage of computerized systems is their ability to process huge quantities of data without the subjectivity inherent in human data review or interpretation of graphics created to condense data to a manageable format. personnel can introduce other errors common to human fatigue or distraction during repetitive activities.\n\nwhere automation or other systems and equipment are present in process control, operations and quality unit personnel routinely rely on accurate output from systems in the review and disposition process. rbe applies filtering functionality to focus information and data into a presentation format conducive to review that takes advantage of the comparative strengths of systems and personnel.\n\nrbe is enabled by the gamp approach, where systems are verified to ensure critical process parameters and overall systems operations function correctly and are appropriate to each process or system function.\n\n12.2 production report content considerations\n\ntextual information should be included when entered into a system by operating personnel specifically for the production review process, such as descriptions of actions taken to address process exceptions or manual operations. alternatively, this information can be made available for concurrent review with related exception reports. production reports, hybrid production records, and sop design efforts should clearly define what types of textual information are required and appropriate for entry into production data.", "start_char_idx": 0, "end_char_idx": 2898, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "76d05f83-331d-402d-acfe-bcdf0dc12434": {"__data__": {"id_": "76d05f83-331d-402d-acfe-bcdf0dc12434", "embedding": null, "metadata": {"page_label": "106", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Execution Systems: Critical Operating Data and Alarm Limits Analysis", "questions_this_excerpt_can_answer": "1. What are the two levels of test points around targets or set points identified for critical process parameters (CPPs) in the context of manufacturing execution systems, and how do they differ in terms of their inclusion in production reports for review by exception (RBE)?\n\n2. How does the document describe the process and requirements for recording and analyzing exceptions to critical process parameter (CPP) action limits, including the specific types of information that must be included in production records and reports for each exception?\n\n3. According to the excerpt from the ISPE Manufacturing Execution Systems guide, what specific roles do validated systems play in the context of alert limit alarms and action limit alarms, and how are these alarms utilized in investigations, Corrective and Preventive Actions (CAPA) support, audits, and Process Analytical Technology (PAT)?", "prev_section_summary": "The section discusses the concept of Review by Exception (RBE) in pharmaceutical manufacturing operations, as outlined in the ISPE Manufacturing Execution Systems guidelines. It explains how RBE methods ensure the accuracy and reliability of filtering and reporting software for production data. The section also covers regulatory requirements for quality unit review of exception reports, the advantages of using computerized systems for data review and analysis, and the role of the GAMP approach in enabling RBE functionality. Additionally, it highlights the importance of including textual information in production reports for effective review and decision-making processes.", "excerpt_keywords": "Manufacturing Execution Systems, Critical Operating Data, Alarm Limits, Review by Exception, Process Analytical Technology"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "25a3c965-76d8-4e3a-9a03-b6809f845c7b", "node_type": "4", "metadata": {"page_label": "106", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "42646880dec183fcc1adc540d9bad5fb7c9cdd8e4d1a86a5fb2625de06affd5d", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "4ca2fbcb-965b-400f-b801-63f6ae8aeb93", "node_type": "1", "metadata": {"page_label": "105", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "0137b20061dcfc31f86e1ed67fb61bb543d8596fb4918d7696609df7f7e5e39b", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "bf552138-df23-4270-b024-2179f2289759", "node_type": "1", "metadata": {}, "hash": "315b18b1d36fd7d1abb77d71b73c9a182ab575ff25cd113463c6b91dc74a749f", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: appendix 8 manufacturing execution systems - a strategic and program management approach\n\nappropriate rbe tools can retrieve, organize, and present data and information in more than one report or format to one or more workstations from multiple sources. operations and quality unit personnel should define requirements based on process complexity, organizational structure, and systems design appropriate to the particular manufacturing model. system or procedural controls should ensure that all required activities for review and disposition are completed.\n\n## 12.2.1 critical operating data\n\ncritical process parameters (cpps) that may have an impact on patient safety or product quality can be identified for each system or equipment unit. these parameters typically have two levels of test points around targets or set points:\n\n|alert limit alarms typically are informational data that:| |\n|---|---|\n|- are used to notify personnel for possible correction of issues in a timely fashion to prevent process limit excursions| |\n|- are usually set closer to target values than process tolerances| |\n|- are not usually included in production reports for rbe| |\n|- are recorded by validated systems and available for critical analysis purposes, such as investigations, capa support, audits, and pat| |\n\n|action limit alarms include process tolerances which are defined in regulatory filings or have a direct impact on intermediate or product quality:| |\n|---|---|\n|- are reported for rbe| |\n|- require investigation| |\n|- are recorded by validated systems and available for critical analysis purposes, such as investigations, capa support, audits, and pat| |\n|- are used where alert limits do not exist for critical operating data, causing all exceptions to be action limit type| |\n\nfor further information on alert limits and action limits, see ispe baseline(r) guides (reference 7, appendix 14).\n\nproduction records and reports typically should include the following for each exception to a cpp action limit:\n\n- date and time for alarm trigger and restoration to in-tolerance conditions\n- magnitude of actual process limit excursions (maximum out of tolerance excursion) and date and time achieved\n- accumulated time a process tolerance was exceeded before restoration to acceptable values. this is accumulated from the first detection time point in cases where triggering a process alarm is delayed by a programmed acceptable out of tolerance time period.\n\ntextual information entered into a system by operating personnel specifically for the product review and disposition process, such as descriptions of actions taken to address process exceptions. alternatively, this information can be made available for concurrent review with related exception reports. production record, production report, and sop design efforts should clearly define which types of information are required and appropriate for entry into production data and are presented in production reports.", "start_char_idx": 0, "end_char_idx": 3004, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "bf552138-df23-4270-b024-2179f2289759": {"__data__": {"id_": "bf552138-df23-4270-b024-2179f2289759", "embedding": null, "metadata": {"page_label": "107", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Execution Systems: Event Reporting, Report Signing, and Considerations for New Systems", "questions_this_excerpt_can_answer": "1. What criteria differentiate critical events from non-critical events in the context of RBE reports within manufacturing execution systems, according to the GAMP\u00ae Good Practice Guide?\n   \n2. How should manufacturing execution systems handle the reporting and retention of RBE reports to meet regulatory submission or rule compliance requirements, as outlined in the GAMP\u00ae Good Practice Guide?\n\n3. What specific considerations are recommended for the validation documentation of new or upgraded systems affecting critical data or RBE functionality, based on the strategic and program management approach provided in the GAMP\u00ae Good Practice Guide?", "prev_section_summary": "This section discusses the critical operating data and alarm limits analysis in the context of Manufacturing Execution Systems (MES). It covers the identification of critical process parameters (CPPs) and the two levels of test points around targets or set points, namely alert limit alarms and action limit alarms. The document describes the process and requirements for recording and analyzing exceptions to CPP action limits, including the information that must be included in production records and reports for each exception. It also highlights the roles of validated systems in alert limit alarms and action limit alarms, and how these alarms are utilized in investigations, Corrective and Preventive Actions (CAPA) support, audits, and Process Analytical Technology (PAT). The section emphasizes the importance of appropriate tools for data retrieval, organization, and presentation, as well as the need for system or procedural controls to ensure all required activities for review and disposition are completed.", "excerpt_keywords": "Manufacturing Execution Systems, Event Reporting, Report Signing, GAMP Good Practice Guide, Validation Documentation"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "8e5c525f-3175-461f-81ef-6c52955d05fc", "node_type": "4", "metadata": {"page_label": "107", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "da1d57ad25644ce41030c5e3476d0eaedc286097b7a8eb7091547e06746c3be3", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "76d05f83-331d-402d-acfe-bcdf0dc12434", "node_type": "1", "metadata": {"page_label": "106", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "42646880dec183fcc1adc540d9bad5fb7c9cdd8e4d1a86a5fb2625de06affd5d", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "88dfee9e-6b50-4483-83fb-5f287b240d6a", "node_type": "1", "metadata": {}, "hash": "ab30f1e1d7e05a5447ea5e4fad51c701b6d9ada6fd42bd699f8e024770474a30", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 8\n\nnon-critical process parameters are those that support or are otherwise secondary to cpps. while not typically reported in rbe, there may be time limits, other continual test criteria, or manual intervention activities that cause additional data for the related cpps to be included in rbe reports.\n\n12.2.2 event reporting\n\nevents other than process exceptions can be included in rbe reports as appropriate. there are typically two types of events considered for rbe: critical and non-critical:\n\n1. critical events that can affect process sequence and timing or data integrity related to patient safety or product quality:\n\n- are typically unplanned events\n- are always included in rbe type reports\n- may be unrelated to critical process parameters, such as disruptive system faults\n- could be a planned event if there is no possible validated system check on the result or if the information is needed to establish context for critical information in an rbe report\n2. non-critical events are system-level or process-related activities or functions which execute as designed and validated:\n\n- are typically planned events\n- are typically not included in rbe reports\n- could be an unplanned event if there is no effect on product quality or product data integrity\n\nan rbe report should not be empty if there are no exceptions. the production report or other disposition vehicle should indicate explicitly that there were no exceptions detected for the production run. systems design also should ensure that exceptions are not lost in communications schemes among systems and equipment. communication failures should be detectable, and exceptions generated for rbe to trigger appropriate action, such as investigation for the possibility of missing data.\n\nsystems may produce specific data or process results that are not testable by the current functionality to the desired accuracy or other criteria. in these cases, data or trends should be included in rbe reports for review.\n\n12.2.3 report signing and retention\n\nif the rbe is used to identify quality attributes about the product, make decisions about the process, release product or support predicate rule reporting requirements, a paper record may be generated and approved for use in regulatory submissions or retained for rule compliance. alternatively, if the rbe record generated is to be kept in an electronic form, the report should be signed electronically.\n\n12.3 considerations for new or upgraded systems\n\ninitial systems implementations or major upgrades affecting critical data or rbe functionality should have performance monitoring defined in validation documentation. the number and content of reports and data samples for review should be defined using a risk-based approach.", "start_char_idx": 0, "end_char_idx": 2872, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "88dfee9e-6b50-4483-83fb-5f287b240d6a": {"__data__": {"id_": "88dfee9e-6b50-4483-83fb-5f287b240d6a", "embedding": null, "metadata": {"page_label": "108", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Optimizing Manufacturing Operations: An Integrated Approach to MES Deployment and Reassessment\"", "questions_this_excerpt_can_answer": "1. What is the recommended approach for integrating various data sources, such as paper, LIMS, ERP, MES, and SCADA, to maximize the benefits of RBE (Risk-Based Execution) in the initial deployment of MES (Manufacturing Execution Systems)?\n\n2. How should companies manage the integration of paper exception reports into the MES environment, especially when dealing with existing or legacy systems that cannot be directly configured to provide electronic outputs?\n\n3. What are the key components of a periodic systems reassessment for MES deployments, particularly in terms of evaluating the impact of changes and verifying the accuracy of RBE functionality through the review of production reports and data samples?", "prev_section_summary": "This section discusses the criteria for differentiating critical events from non-critical events in the context of RBE reports within manufacturing execution systems, as outlined in the GAMP\u00ae Good Practice Guide. It also covers how manufacturing execution systems should handle the reporting and retention of RBE reports to meet regulatory submission or rule compliance requirements. Additionally, specific considerations for the validation documentation of new or upgraded systems affecting critical data or RBE functionality are provided based on a strategic and program management approach. Key topics include event reporting, report signing and retention, and considerations for new or upgraded systems. Key entities mentioned include critical events, non-critical events, RBE reports, process exceptions, system faults, data integrity, product quality, report signing, retention, regulatory submissions, and validation documentation.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Integration, RBE, Data Sources"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "b52ef2c3-351e-44a1-a152-bc1e744431de", "node_type": "4", "metadata": {"page_label": "108", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "30aee95523f1a2a52b22cab951f14b0861b63b7aea3df511b5a187f53c3d1d9f", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "bf552138-df23-4270-b024-2179f2289759", "node_type": "1", "metadata": {"page_label": "107", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "da1d57ad25644ce41030c5e3476d0eaedc286097b7a8eb7091547e06746c3be3", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "35aa6f10-4428-44a6-83e9-81cfbf75d9e0", "node_type": "1", "metadata": {}, "hash": "c7716ebcb29912b47f76996adfc134dfdcfe539354920a0814f70ad90ba65f66", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 8 manufacturing execution systems - a strategic and program management approach\n\n12.4 phased deployment\n\ncoordination of information from various sources, e.g., paper, lims, erp, mes, and scada, will be required to obtain the full benefit of rbe. as initial deployment of mes type manufacturing does not always include integration with all data sources, the review process can include electronic and paper hybrid reports. individual systems and equipment can be designed or configured to provide paper exception reports. where this is not possible due to existing or legacy system capabilities, procedures should define methods to review each report as part of the overall rbe process. paper and electronic systems should provide a governing sequence of activities, as well as references enabling retrieval of the correct data and information from each system for review.\n\n12.5 periodic systems reassessment\n\nperiodic reassessment of systems and processes as a standard life cycle activity should include impact assessment of changes, as well as review of production reports and data samples to verify continuing accuracy of rbe functionality. the number and content of reports and samples should be defined using a risk-based approach.", "start_char_idx": 0, "end_char_idx": 1248, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "35aa6f10-4428-44a6-83e9-81cfbf75d9e0": {"__data__": {"id_": "35aa6f10-4428-44a6-83e9-81cfbf75d9e0", "embedding": null, "metadata": {"page_label": "109", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Electronic Signatures and User Identification in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the GAMP Good Practice Guide differentiate between the requirements for electronic signatures and the identification of individuals in the context of Manufacturing Execution Systems (MES), particularly in relation to GxP electronic signatures and regulatory compliance?\n\n2. What specific guidance does the FDA provide regarding the application of 21 CFR Part 11 to electronic signatures in MES, and how should organizations determine whether specific records and signature events fall under this regulation according to the document?\n\n3. What are the recommended practices for managing user identification and authentication in MES environments, including the use of biometric devices and character-based identification systems, as outlined in the document?", "prev_section_summary": "The section discusses the strategic and program management approach to deploying Manufacturing Execution Systems (MES) in a phased manner. It emphasizes the coordination of information from various sources such as paper, LIMS, ERP, MES, and SCADA to maximize the benefits of Risk-Based Execution (RBE). The excerpt highlights the importance of integrating paper exception reports into the MES environment, especially when dealing with existing or legacy systems. It also mentions the need for periodic systems reassessment to evaluate the impact of changes and verify the accuracy of RBE functionality through the review of production reports and data samples. Key topics include phased deployment, integration of data sources, managing paper exception reports, and periodic systems reassessment. Key entities mentioned are MES, RBE, paper reports, electronic systems, and data samples.", "excerpt_keywords": "Manufacturing Execution Systems, Electronic Signatures, User Identification, GAMP Good Practice Guide, FDA Guidance"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "c67f674d-9203-455b-8dba-0438ffa9caaf", "node_type": "4", "metadata": {"page_label": "109", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "a474863b16e2cbc685616112adbdda4dd02eec014ddbeeecaa962113f6950131", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "88dfee9e-6b50-4483-83fb-5f287b240d6a", "node_type": "1", "metadata": {"page_label": "108", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "30aee95523f1a2a52b22cab951f14b0861b63b7aea3df511b5a187f53c3d1d9f", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "189d546e-b13c-4dd1-ad3c-eff1b111c64a", "node_type": "1", "metadata": {}, "hash": "5c60eb5f2578d97b4e02a83adcea9956197f86a47d12c86ff9b0c92d0641de0f", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 9\n\n### appendix 9 - logon, identification, and signature methods\n\n### 13.1 introduction\n\nsince the majority of mes functions are related to production areas and tasks are often performed by multiple people working together, the methods used for logon, identification, and applying signatures need to be addressed, and are considered in this appendix.\n\nthere is an important distinction between signature events (such as the approval, review, or verification of gxp records) and the identification of individuals who performed an activity. gxp electronic signatures will fall under specific regulations (e.g., 21 cfr part 11), but identification of individuals, although still potentially important from a gxp perspective, will not. for further information, see the ispe gamp good practice guide: a risk-based approach to compliant electronic records and signatures (reference 6, appendix 14).\n\n### 13.1.1 defining electronic signatures\n\nusing us regulation as an example, 21 cfr part 11 applies only to electronic signatures that are intended to be the equivalent of handwritten signatures, initials, and other general signings required by predicate rules. part 11 signatures include electronic signatures that are used, e.g., to document the fact that specific events or actions occurred in accordance with the predicate rule (e.g., approved, reviewed, and verified). for further information, see the fda guidance for industry: part 11, electronic records; electronic signatures - scope and application.\n\nthe guidance recommends that organizations determine, based on the predicate rules, whether specific records are part 11 records and that such decisions are documented. the same logic applies to specific signature events. if electronic signatures are used, the system requirements should define which activities require an electronic signature and how these will meet applicable international regulatory requirements.\n\n### 13.2 physical aspects\n\ntypically, similar mechanisms should be applied both for signature events and identification, often involving two components: one public and one private.\n\nidentification of users can be based on a biometric identifier, a unique combination of user identification (id) and password, or another computer-based technology. regardless of the method used, the system or application should record the associated user information as prescribed in the regulations.\n\nbiometric devices compare some physical feature of a person, such as finger or palm prints or eye scan, to previous entries in verifying or rejecting access to a system. unlike language character-based entries, biometric identification records do not need to be updated on a regular basis, unless there is a physical change in a person that makes them unrecognizable by the system. updates to identification records generally are made when access is to be added or removed for personnel or when changes are made to access levels for personnel who have changed job functions or responsibilities.\n\nsecurity systems require administrative support. this support should be included in the implementation plan and have specific requirements. typically, character-based identification systems have publicly known user identifications and private passwords. this type of system requires security and administrative support to maintain system security or regulatory compliance. automatic expiration (password aging) and password definition (number of characters, password uniqueness) are a part of the system administration. an organization should have procedures in place to specify the mechanics of security maintenance that may become system requirements.", "start_char_idx": 0, "end_char_idx": 3784, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "189d546e-b13c-4dd1-ad3c-eff1b111c64a": {"__data__": {"id_": "189d546e-b13c-4dd1-ad3c-eff1b111c64a", "embedding": null, "metadata": {"page_label": "110", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Ensuring Security and User Identification in Manufacturing Execution Systems: Strategies and Best Practices\"", "questions_this_excerpt_can_answer": "1. What are the specific advantages and disadvantages of using an identification-only strategy for user authentication in Manufacturing Execution Systems (MES) as outlined in the ISPE Good Practice Guide?\n\n2. How does the combined logon/identification strategy for user authentication in MES differ from the identification-only strategy in terms of user responsibility and system navigation privileges, according to the ISPE Manufacturing Execution Systems document?\n\n3. According to the GAMP(r) Good Practice Guide's appendix on Manufacturing Execution Systems, what are the recommended controls for using tokens such as barcodes or RFID tags for user identification and password management in environments where touch screens or other highly visible entry methods are employed?", "prev_section_summary": "The section discusses the importance of logon, identification, and signature methods in Manufacturing Execution Systems (MES). It highlights the distinction between signature events and the identification of individuals, particularly in relation to GxP electronic signatures and regulatory compliance. The section also covers the definition of electronic signatures according to 21 CFR Part 11, recommendations for managing user identification and authentication in MES environments, including the use of biometric devices and character-based identification systems. It emphasizes the need for system requirements to define which activities require an electronic signature and how to meet applicable international regulatory requirements. Additionally, it mentions the administrative support required for security systems and the procedures needed for security maintenance in MES environments.", "excerpt_keywords": "Manufacturing Execution Systems, User Identification, Security, GAMP, Authentication"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "5d26e628-8193-4687-9db1-a2166bcd994d", "node_type": "4", "metadata": {"page_label": "110", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "50311e6f3919388c844bd7e9092974e07b1c9363bb62798f4db31b8d1933320b", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "35aa6f10-4428-44a6-83e9-81cfbf75d9e0", "node_type": "1", "metadata": {"page_label": "109", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "a474863b16e2cbc685616112adbdda4dd02eec014ddbeeecaa962113f6950131", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "6f098676-bef1-450c-a5b5-667f648a8bf4", "node_type": "1", "metadata": {}, "hash": "86ba21645cdadd7551f6179eb2ae4ae5780c277da5bd636a5fa1d1979dbeec09", "class_name": "RelatedNodeInfo"}}, "text": "## page 108\n\n### gamp(r) good practice guide: appendix 9\n\n### manufacturing execution systems - a strategic and program management approach\n\nwhere several people work closely together and touch screen or other highly visible entry methods are used, tokens, such as bar codes or radio frequency identification (rfid) tags, may be used as user identification and passwords may be discerned easily by co-workers. stringent controls should be in place for tokens at all stages of creation, modification, distribution, and collection to prevent inappropriate use. tokens used for user identification and passwords should be physically separate entities. a single token with both components of user identification and password usually is not an acceptable security method. when hardware devices, such as bar code scanners, are used for system access and to capture user identification, acceptable controls should be employed to ensure that passwords are secure.\n\n### 13.3 logical aspects\n\nboth user id and password typically are used for each signature, while only one component may be sufficient for identification, depending on organizational policy. there is no regulatory requirement to create an audit trail for screen navigation activities. there is no requirement to log an audit trail entry for on-screen corrections or changes prior to committing the entry into the system record. when those records are considered to be maintained by the system, any subsequent change may require an audit trail entry, depending on whether those records are within scope and whether there are specific predicate rule requirements. audit trail entries should be considered for human activities that are pertinent to gxp-relevant operational sequence control, even if not required by regulations.\n\n### 13.3.1 identification-only strategy\n\nthis strategy is considered best used for portable devices and scanners where short, non-complex functions are executed. this method does not incorporate a user logon. a user arrives at and accesses a system, and is prompted at appropriate points to enter two components to identify themselves where data will be committed to the system record. the user takes responsibility for all entries performed as the last valid user identification in the system. both user identification and password are required at each entry.\n\nadvantages:\n\n- many users in a work area can utilize a station or device in rapid succession to perform tasks, as data cannot be committed to the system record by anyone without a valid two component identification.\n\ndisadvantages:\n\n- this method usually is not appropriate for operations where the same user needs to sign for many steps in quick succession. this method does not restrict navigation by individual user privileges.\n\n### 13.3.2 combined logon/identification strategy\n\nthis method requires that a user log on to access a system and then enter two components to commit data to the system. this strategy also includes having a computer entry logon requirement.\n\nadvantages:\n\n- user actions performed between identifications are associated with the user noted in system records. the user identification entered at logon may be carried forward and utilized automatically in subsequent activities, thus requiring entry of only the matching password. this method enables the use of authority checks to navigate through the system so users may be restricted from specific screens or functionality.", "start_char_idx": 0, "end_char_idx": 3449, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "6f098676-bef1-450c-a5b5-667f648a8bf4": {"__data__": {"id_": "6f098676-bef1-450c-a5b5-667f648a8bf4", "embedding": null, "metadata": {"page_label": "111", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Identification Strategies in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the specific disadvantages of using manufacturing execution systems (MES) when multiple users need to access short system functions in succession, according to the GAMP Good Practice Guide?\n\n2. How does the document suggest handling identification requirements for personnel completing a small table of entries on a screen within a manufacturing execution system?\n\n3. What criteria does the document recommend for determining when operator identification is necessary versus when it is not required in the context of manufacturing execution systems?", "prev_section_summary": "The section discusses strategies and best practices for ensuring security and user identification in Manufacturing Execution Systems (MES). It covers the use of tokens such as barcodes or RFID tags for user identification, the importance of stringent controls for tokens, and the need for physical separation of user identification and passwords. It also compares the identification-only strategy with the combined logon/identification strategy in terms of user responsibility and system navigation privileges. Additionally, it mentions the advantages and disadvantages of each strategy, highlighting the importance of user authentication and security measures in MES.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Identification Strategies, User Authentication, Security Measures"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "53bf709b-2c17-42e5-b1be-5adb3da5d2bc", "node_type": "4", "metadata": {"page_label": "111", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "1d5e11786723958570b48dd5668ef91bb39e3ccef9e254ae85ed4052e1bfbfdd", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "189d546e-b13c-4dd1-ad3c-eff1b111c64a", "node_type": "1", "metadata": {"page_label": "110", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "50311e6f3919388c844bd7e9092974e07b1c9363bb62798f4db31b8d1933320b", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "42acd762-54f1-49b2-8333-c6398979fde9", "node_type": "1", "metadata": {}, "hash": "8b8272079a7497c464eb008f8b1a5b9c2aa826b51b7abd11b5140b12e87e61b2", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 9\n\ndisadvantages:\n- not efficient when a number of users must access short system functions in succession. designers should take care to describe navigation logs as assumed based on procedural controls, as pe system cannot enforce navigation, unless pere is enforced identification of pe individual between every move or field entry or manipulation.\n\n### 13.3.3 frequency of entries\n\nthe number of identifications required during execution of a system operation or function should consider the criticality of data, as well as the physical and logical aspects of the operation. for example, if personnel need to complete a small table of entries on a screen, system requirements may allow the use of a single identification entry to take responsibility for all data entered into the table. if the person needs to leave a data entry screen, an identification should be required prior to completing or exiting the function. for signature events, a method utilizing multiple entries linked to one signature should be considered by the requirements team with input from appropriate quality unit and operations supervision or management.\n\n### 13.3.4 applying identification strategies\n\nthe distinction between user identification events and signatures should be defined by organizational procedures and predicate rule requirements. the requirements should be defined by the regulated organization. a redesign of the data entry forms may be required to determine the resulting requirements. the appropriate strategy should be selected using an organizations interpretation of different risk-based approaches as a guide. typical examples of when operator identification may be required include:\n\n- an operator has performed functions or entered data to be recorded in a local system record or database(s).\n- an operator has performed functions or entered data to be sent via a transaction or interface to another compliant system.\n- an operator has created output, such as labels, that will be used or referenced in other regulated operations.\n- document approvals\n- mes documents or reports for batch, intermediate, assembly, or material release\n\ntypical examples of where operator identification may not be required include:\n\n- an operator has navigated screens or performed functions for read-only operations (e.g., on-screen reports) and no data or operations are to be recorded for regulatory purposes in local or remote system records or databases.\n- an operator has navigated screens or performed functions to produce printed reports or other output for information-only purposes that will not be used for further regulated operations.\n\ntypical examples of when logons may be required include:\n\n- a workstation or other system device with access to confidential information is physically located in a public or common area.\n- an application is on a workstation shared with another application system.", "start_char_idx": 0, "end_char_idx": 3024, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "42acd762-54f1-49b2-8333-c6398979fde9": {"__data__": {"id_": "42acd762-54f1-49b2-8333-c6398979fde9", "embedding": null, "metadata": {"page_label": "112", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Access Control in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the conditions under which logons may not be required for accessing certain functions within a Manufacturing Execution System (MES) as outlined in the GAMP (r) Good Practice Guide's appendix on MES?\n\n2. How does the GAMP (r) Good Practice Guide suggest handling access to read-only functions in MES for operators in physically or electronically controlled areas?\n\n3. What specific measures are recommended by the GAMP (r) Good Practice Guide for ensuring secure access to MES functions when a signature mechanism is in place and the workstation or device is located in a controlled area?", "prev_section_summary": "This section discusses identification strategies in Manufacturing Execution Systems (MES) and provides guidelines for handling identification requirements for personnel using the system. Key topics include disadvantages of using MES when multiple users need to access short system functions, frequency of identification entries during system operations, and applying identification strategies based on organizational procedures and regulatory requirements. The section also outlines criteria for determining when operator identification is necessary versus when it is not required in the context of MES. Key entities mentioned include system designers, personnel completing data entries, quality unit, operations supervision, and regulated organizations.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP, Access Control, Identification Strategies"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "0109e567-027c-44ed-a9c8-7e6414c64141", "node_type": "4", "metadata": {"page_label": "112", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "97d5c80af7df3f691a1c4588e8259a4533169089632c864e76fb2502bbfd9bcf", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "6f098676-bef1-450c-a5b5-667f648a8bf4", "node_type": "1", "metadata": {"page_label": "111", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "1d5e11786723958570b48dd5668ef91bb39e3ccef9e254ae85ed4052e1bfbfdd", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "4e7253d0-ea29-49b3-9cca-883cb19a1258", "node_type": "1", "metadata": {}, "hash": "49c9681d7021b8dc7875bdd852f44f8bf7bd7932fe3c8bdf0afde60b809ed0c5", "class_name": "RelatedNodeInfo"}}, "text": "## page 110\n\ngamp (r) good practice guide: appendix 9\nmanufacturing execution systems - a strategic and program management approach\nan application screen has selectable functions that are restricted to different user groups in the same system, either within the screen, or when the screen calls a subsequent function in the system.\n\ntypical examples of when logons may not be required:\n\n- an operator only has access to application read-only functions in a physically or electronically controlled area. read-only functions may be accessed for workstations in common or public areas if it is judged that the information is not restricted.\n- some form of signature is in place in the application and the workstation or device is in a physically or electronically controlled area.", "start_char_idx": 0, "end_char_idx": 777, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "4e7253d0-ea29-49b3-9cca-883cb19a1258": {"__data__": {"id_": "4e7253d0-ea29-49b3-9cca-883cb19a1258", "embedding": null, "metadata": {"page_label": "113", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Optimizing Workflow Efficiency and Compliance with MES Technology and Enforced Operational Sequences\"", "questions_this_excerpt_can_answer": "1. How does the implementation of MES technology specifically aim to optimize the workflow within the manufacturing process, according to the GAMP Good Practice Guide: Manufacturing Execution Systems?\n   \n2. What are the two major cost-saving approaches highlighted in the GAMP Good Practice Guide for employing MES technology, and how do they contribute to reducing training time and ensuring compliance?\n\n3. In what ways does the enforced operational sequences feature of MES technology facilitate a more flexible workforce, and how does it prevent job monotony and potential errors as described in the document?", "prev_section_summary": "The section discusses access control in Manufacturing Execution Systems (MES) as outlined in the GAMP (r) Good Practice Guide's appendix on MES. It covers conditions under which logons may not be required for accessing certain functions, handling access to read-only functions for operators in controlled areas, and measures for ensuring secure access to MES functions with a signature mechanism in place. Key topics include user group restrictions, access to read-only functions, and secure access in controlled areas. Key entities mentioned are operators, workstations, devices, and signature mechanisms.", "excerpt_keywords": "MES technology, workflow optimization, compliance, enforced operational sequences, cost-saving approaches"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "4e5919a2-0aa8-4d75-8164-953f384aee5c", "node_type": "4", "metadata": {"page_label": "113", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "c6835c98a8fc1612321bb9d1fab043aea39f01de739d00ed486b050181f97948", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "42acd762-54f1-49b2-8333-c6398979fde9", "node_type": "1", "metadata": {"page_label": "112", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "97d5c80af7df3f691a1c4588e8259a4533169089632c864e76fb2502bbfd9bcf", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "a95f4470-63c8-4cd1-9e87-68185dedd7c2", "node_type": "1", "metadata": {}, "hash": "a23f406d4be066677099272f1db09e41e20924e2e2b0f5dec0ba327c18d5ea01", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\nappendix 10 - human and workflow considerations\npage 111\n\n### appendix 10\n\n### 14.1 introduction\n\nemploying mes technology affords an opportunity to proactively control the movement of materials and personnel throughout the manufacturing process. consideration should be given to modifying current workflow to take advantage of the strengths of the systems functionality in this area. for example, specific process steps may be eliminated by automation of information gathering or control. programming a system to mimic current manual operations usually does not result in optimizing workflow, and may reduce efficiency at the physical level, as additional restrictions may be imposed by mes designs to achieve an overall increase in process compliance and consistency. a current manufacturing-related process typically is the result of cumulative changes over time that may no longer be relevant to a more automated process approach.\n\n### 14.2 standard interface and enforced operational sequences\n\ntwo major cost saving mes approaches are:\n\n1. standardized, widely used interfaces and functions\n2. enforced human action sequence control, such as electronic production record/electronic work instructions (epr/ewis)\n\nthese technologies can provide almost immediate results in:\n\n- reduced training time for physical activities and interaction with systems, due to common approach - keystroke, mouse, and touch screen actions are consistent\n- less required memorization of steps since detailed instructions can be presented by the system at the point of action\n- reduction or elimination of separate sops, paper or electronic, which do not enforce sequences\n- portability of functions across products and processes\n- prevention of out-of-sequence actions\n- automatic, accurate documentation of actions at the desired level of action detail, including personnel signatures and timestamps\n- increased compliance to the defined process\n- restriction of human actions to properly trained personnel by links to appropriate systems, such as training and human resources\n\nthese technologies enable opportunities to share personnel among groups, functions, or processes. enforced sequencing can allow personnel to perform more disparate actions without error and execute multiple functions in different parts of a process. this expanded activity can prevent having job descriptions that mandate simply repeating a small set of functions continuously, which can result in loss of focus or boredom leading to lost productivity or errors, etc. an organization can consider reorganizing groups or departments to take advantage of a more flexible workforce.", "start_char_idx": 0, "end_char_idx": 2755, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "a95f4470-63c8-4cd1-9e87-68185dedd7c2": {"__data__": {"id_": "a95f4470-63c8-4cd1-9e87-68185dedd7c2", "embedding": null, "metadata": {"page_label": "114", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Implementing Manufacturing Execution Systems: Addressing Psychological and Cultural Aspects, User Interface Design, and Portable Devices", "questions_this_excerpt_can_answer": "1. How does the GAMP Good Practice Guide suggest addressing the psychological and cultural aspects when implementing Manufacturing Execution Systems (MES) in a workplace?\n   \n2. What specific user interface considerations does the GAMP Good Practice Guide recommend for integrating technology into manual operations within the context of Manufacturing Execution Systems?\n\n3. According to the GAMP Good Practice Guide, what are the recommended practices for the use of portable devices in Manufacturing Execution Systems, particularly in relation to their size, weight, power consumption, and functionality?", "prev_section_summary": "This section discusses the benefits of implementing Manufacturing Execution Systems (MES) technology in optimizing workflow efficiency and compliance within the manufacturing process. It highlights the importance of modifying current workflows to leverage the functionality of MES systems, rather than simply automating existing manual operations. The section also emphasizes the two major cost-saving approaches of standardized interfaces and enforced operational sequences, such as electronic production records and work instructions. These approaches contribute to reducing training time, ensuring compliance, preventing errors, and facilitating a more flexible workforce. MES technology enables consistent actions, detailed instructions at the point of action, automatic documentation, and increased process compliance. It also allows for the sharing of personnel among different functions or processes and prevents job monotony by enabling personnel to perform diverse actions within a process.", "excerpt_keywords": "Manufacturing Execution Systems, GAMP Good Practice Guide, User Interface Design, Portable Devices, Workforce Flexibility"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "5def2501-4ba2-4508-86b9-e9f44bbcd18c", "node_type": "4", "metadata": {"page_label": "114", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "378f008d25d076075dd5de1592288dca78e9f6eb246c3b9e3f1d2f6fc4a23bd8", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "4e7253d0-ea29-49b3-9cca-883cb19a1258", "node_type": "1", "metadata": {"page_label": "113", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "c6835c98a8fc1612321bb9d1fab043aea39f01de739d00ed486b050181f97948", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "fd0a37ac-6844-45fa-8c8f-d9a84a9e931a", "node_type": "1", "metadata": {}, "hash": "bea9195e765563d41d0041803a77dde96dc2319166eb71519593262c4a25e009", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: appendix 10\n\n### manufacturing execution systems - a strategic and program management approach\n\n### 14.3 psychological and cultural aspects\n\nthe impact of introducing technology to human-interactive processes often creates anxiety and needs to be addressed during the design phases. manufacturing personnel should be involved in the design process whenever practical to build confidence in the outcome. personnel should be provided opportunity to become familiar with safety aspects of technologies. false perceptions of risk for technologies, such as scanners, should be dispelled prior to implementation.\n\nin addition to being cautious about new technology, personnel often are apprehensive about work redesigns that may impact job functions. human resources departments should consider involvement in assisting facilities in managing acceptance of changes.\n\nconstraints imposed by established corporate governance, work rules, local laws, languages, and cultures need to be taken into account in designing an mes based work environment, especially for regional or international deployments.\n\n### 14.4 user interface considerations\n\n#### 14.4.1 physical constraints\n\nwhen applying technology to manual operations, considerations include the physical limitations of personnel, and reduced dexterity imposed by required safety and cleanliness apparel. the following should be considered:\n\n- height and reach of employees when locating devices\n- workstation location\n- screen brightness\n- input devices, such as keyboard, mouse, touch screen, and bar code and rfid scanners, should be chosen and configured for access with minimal physical stress.\n- room lighting and screen backlighting should be appropriate for each location to maximize legibility from all required viewing angles. emergency lighting designed and tested to ensure that it does not obscure displays required for safe operation when required.\n\nworkstations and devices must meet all applicable safety, environmental, and electrical standards.\n\n#### 14.4.2 portable devices\n\nsmall portable devices should be considered for functions that may include bar code or rfid scanning, or where instructions are needed for manual operations in remote or large areas. one portable device can serve many locations, reducing the number of expensive hardened workstations, associated wiring, and any required heating, cooling, or other environmental conditioning components.\n\nportable devices are available in many sizes and capabilities, from simple scanning units with small screens to full-function, full screen portable workstations. size, weight, and power consumption (running time) should be balanced against required functionality. facilities should be designed for and have implementation of safe areas for changing and recharging batteries in continuous use devices.", "start_char_idx": 0, "end_char_idx": 2862, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "fd0a37ac-6844-45fa-8c8f-d9a84a9e931a": {"__data__": {"id_": "fd0a37ac-6844-45fa-8c8f-d9a84a9e931a", "embedding": null, "metadata": {"page_label": "115", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Revolutionizing Manufacturing Execution Systems: Integrating Portable Devices and Wireless Technology for Enhanced Efficiency\"", "questions_this_excerpt_can_answer": "1. What are the limitations of using data-storing portable devices that are docked to a workstation within manufacturing execution systems, especially in terms of real-time data checking and updating data acceptance criteria?\n\n2. How does wireless technology enhance the functionality of portable devices in manufacturing execution systems, particularly in relation to security functions and real-time data verification?\n\n3. What considerations should be taken into account to ensure interface consistency when integrating portable devices with manufacturing execution systems, and how can these considerations help minimize operational errors and improve efficiency in manufacturing operations?", "prev_section_summary": "This section discusses the psychological and cultural aspects that need to be addressed when implementing Manufacturing Execution Systems (MES) in a workplace. It emphasizes the importance of involving manufacturing personnel in the design process to build confidence in the outcome and dispel false perceptions of risk for new technologies. The section also highlights the user interface considerations, such as physical constraints and the use of portable devices, in integrating technology into manual operations within the context of MES. Key topics include addressing anxiety related to technology introduction, involving human resources in managing acceptance of changes, considering physical limitations of personnel, and balancing size, weight, power consumption, and functionality of portable devices.", "excerpt_keywords": "Manufacturing Execution Systems, Portable Devices, Wireless Technology, Data Integrity, Interface Consistency"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "8154f83d-5749-4b5a-9d12-86644f8c8c8c", "node_type": "4", "metadata": {"page_label": "115", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "0990700f1a0cb3c396376f817e7f8652548332eb558be8496839cd447377c308", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "a95f4470-63c8-4cd1-9e87-68185dedd7c2", "node_type": "1", "metadata": {"page_label": "114", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "378f008d25d076075dd5de1592288dca78e9f6eb246c3b9e3f1d2f6fc4a23bd8", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "63fea5dc-bc29-4aa9-9daf-c7acce773b44", "node_type": "1", "metadata": {}, "hash": "f647c5aafaf48bc43dea123c979f1b5588bb55d4dedff70d8a48653228b2b316", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\nappendix 10\n\ndata-storing portable devices that are docked to a workstation to synchronize or upload data can be used for low volume operations, hazardous, or explosive locations and for cost considerations. these devices typically lack real-time, point-of-use checking of most input; however, negating some key advantages of mes technology. these devices can have some data acceptance criteria downloaded to them prior to use, but the criteria cannot be updated as processes continue, until they are docked again.\n\nwireless technology can provide true real-time interaction of portable devices for security functions, point-of-use data checking, and electronic production record/electronic work instructions (epr/ewis) for manual or human confirmation operations. considerations for wireless networks include:\n\n- infrastructure - cost and support\n- number of devices - larger numbers offset infrastructure costs\n- security\n- verification\n- data/signal integrity\n\n### interface consistency\n\nthe following should be considered:\n\n- using common display functions with the same or similar look and feel within job function groups to eliminate confusion and prevent operational errors\n- minimizing the need to toggle between applications in the course of performing routine job functions, especially in manufacturing operations\n- avoiding interface designs that require many mouse clicks, key-driven page or window changes, and other complex hand manipulations that can be inappropriate for touch screen or repetitive/sequential operations in manufacturing", "start_char_idx": 0, "end_char_idx": 1664, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "63fea5dc-bc29-4aa9-9daf-c7acce773b44": {"__data__": {"id_": "63fea5dc-bc29-4aa9-9daf-c7acce773b44", "embedding": null, "metadata": {"page_label": "116", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Blank Canvas: A Collection of Unique Entities and Themes\"", "questions_this_excerpt_can_answer": "Based on the provided context, here are three questions that this specific context can provide specific answers to, which are unlikely to be found elsewhere:\n\n1. **What is the file size of the \"ISPE Manufacturing Execution Systems\" PDF document stored in the PharmaWise Engineer project within the PharmaWise CSV & Data Integrity directory?**\n   - This question is directly answered by the provided context, which specifies the file size as 7322258 bytes.\n\n2. **What are the creation and last modification dates of the document titled \"Blank Canvas: A Collection of Unique Entities and Themes\" found in the PharmaWise Engineer project's raw data directory?**\n   - The context provides specific dates for both the creation (2024-04-07) and last modification (2024-04-04) of the document, which is a detail unique to this document and unlikely to be found elsewhere.\n\n3. **Under what file path and name can the \"ISPE Manufacturing Execution Systems\" document be located within the PharmaWise CSV & Data Integrity project's raw data directory?**\n   - The context gives a precise file path (/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf) and file name ([10] ISPE Manufacturing Execution Systems.pdf), which is specific information not likely to be replicated in other sources.\n\nThese questions are tailored to extract unique information provided by the context, focusing on details such as file specifics and document metadata that are unlikely to be found in other sources or documents.", "prev_section_summary": "The section discusses the limitations of using data-storing portable devices docked to workstations in manufacturing execution systems, the benefits of wireless technology in enhancing functionality and security, and considerations for interface consistency when integrating portable devices. Key topics include real-time data checking, updating data acceptance criteria, wireless technology for security and verification, and interface design considerations for minimizing operational errors and improving efficiency in manufacturing operations. Key entities mentioned are data-storing portable devices, wireless technology, infrastructure, security, verification, data/signal integrity, interface consistency, common display functions, and minimizing the need to toggle between applications.", "excerpt_keywords": "ISPE, Manufacturing Execution Systems, Portable Devices, Wireless Technology, Interface Design"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "71a77891-e647-4597-8e01-a00cc16c627d", "node_type": "4", "metadata": {"page_label": "116", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "ba874aa3b7766ea23b75a32a4cd294d83501e60c287a3ce4c87ba7ba1624b3fe", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "fd0a37ac-6844-45fa-8c8f-d9a84a9e931a", "node_type": "1", "metadata": {"page_label": "115", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "0990700f1a0cb3c396376f817e7f8652548332eb558be8496839cd447377c308", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "6d5a0f9c-3842-4467-ab0a-7eef13175a49", "node_type": "1", "metadata": {}, "hash": "ec585a3d6fa3debd4da5121ff1765f0b70baa93b20c2b4a3d7e9e684cfe8fbe3", "class_name": "RelatedNodeInfo"}}, "text": "no_content_here", "start_char_idx": 0, "end_char_idx": 15, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "6d5a0f9c-3842-4467-ab0a-7eef13175a49": {"__data__": {"id_": "6d5a0f9c-3842-4467-ab0a-7eef13175a49", "embedding": null, "metadata": {"page_label": "117", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Comprehensive Guide to Compliant WIP Materials Management and Inventory Control in Manufacturing Operations", "questions_this_excerpt_can_answer": "1. How do resource management systems like ERP differ from GxP-compliant systems in handling materials in the context of manufacturing execution systems, specifically regarding the timing and conditions under which materials are considered consumed?\n\n2. What are the specific considerations and benefits of using container tracking in WIP materials management within complex manufacturing operations, as outlined in the ISPE Manufacturing Execution Systems guide?\n\n3. What are the key status attributes that should be checked during consumption activities for materials in dispensing or manufacturing processes to ensure compliance with GxP regulations, according to the comprehensive guide on WIP materials management and inventory control in manufacturing operations?", "prev_section_summary": "The key topics and entities of this section include the file size, creation date, last modification date, document title, file path, and file name of the \"ISPE Manufacturing Execution Systems\" PDF document stored in the PharmaWise Engineer project within the PharmaWise CSV & Data Integrity directory. The section provides specific details about the document, such as its unique identifiers and metadata, which are unlikely to be found elsewhere.", "excerpt_keywords": "Compliant WIP Materials Management, Inventory Control, Manufacturing Execution Systems, Container Tracking, GxP Regulations"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "6bcee7f3-99c7-4167-9899-6c6251925cac", "node_type": "4", "metadata": {"page_label": "117", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "60e1dafbe44f258bf22a992e908ee6a7411f5d0f742fadbcab2b2878fca813fd", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "63fea5dc-bc29-4aa9-9daf-c7acce773b44", "node_type": "1", "metadata": {"page_label": "116", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "ba874aa3b7766ea23b75a32a4cd294d83501e60c287a3ce4c87ba7ba1624b3fe", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "faf396e4-6464-4233-92f8-eebd06bade83", "node_type": "1", "metadata": {}, "hash": "c4239f0f5680797ca10ae92eb895629117ad60ab12808ebf373c94c10a1b37f3", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 11 - compliant wip materials management\n\n15.1 accounting versus gxp methods\n\nresource management systems, such as erp, handle materials in a manner convenient for material and business accounting, but not necessarily in compliance with industry standards, such as ansi/isa s88 (reference 2, appendix 14) and applicable gxp regulations. mrp/erp systems usually are configured to consume or otherwise remove materials from inventory when assigned to shop orders or dispensed. systems subject to gxp and associated electronic record and signature regulations must be designed and configured to execute material transactions contemporaneously with the physical activities associated with the materials.\n\na dispensing operation divides materials into portions to meet the requirements of the approved master production and control records. dispensed materials typically are assigned an expiration date and time based on material specifications, such as volatility, cleanliness, and storage requirements. the materials typically are not consumed until they are used in a specific production batch, such that they cannot be recovered as a distinct material.\n\n15.2 managing material inventory and status\n\nwip inventory may be managed by the same system used for warehousing or may be handled by applications that can be better suited for managing smaller units than warehouse quantities. if using more than one system, transfer points and methods should be clearly defined for materials coming into wip and products and intermediates reported back to the mrp/erp.\n\nchoosing one method over another is dependent on the type of manufacturing-related processes and the demands on controlling large, moderate, or small quantities. complex manufacturing operations can benefit from individually identifying smaller containers of materials, allowing closer control of quantities (including overage and underage adjustments), facilitating tracking of containers that move through complex routes or enforcing critical storage requirements at various points in the process for designated containers.\n\ncontainer tracking can provide more direct genealogy for specific quantities and can clearly scope investigation of product manufacturing if a container or the comprised material is found to be compromised.\n\nconsumption activities for materials, whether in dispensing or manufacturing processes, should check material status as close to the point of use as practical before allowing the activity to continue. status attributes examples include:\n\n- correct material (identification)\n- correct disposition, e.g., released or in-process\n- temperature profile maintained throughout handling\n- moisture exposure\n- supplier expiration date and time\n- internal expiration date and time\n- time since dispensing\n- time since becoming wip material", "start_char_idx": 0, "end_char_idx": 2833, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "faf396e4-6464-4233-92f8-eebd06bade83": {"__data__": {"id_": "faf396e4-6464-4233-92f8-eebd06bade83", "embedding": null, "metadata": {"page_label": "118", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Best Practices for Material Tracking and Dispensing in Manufacturing Operations", "questions_this_excerpt_can_answer": "1. What specific strategies does the GAMP (r) Good Practice Guide suggest for ensuring the correct material is dispensed in manufacturing operations where multiple weigh stations are present in a dispense room?\n\n2. How does the document recommend handling the genealogy of lots and sub-lots in manufacturing execution systems, particularly in relation to the system of record and the system of genealogy between WIP management systems and MRP/ERP systems?\n\n3. What are the best practices for material tracking and dispensing in manufacturing operations to prevent cross-contamination or the physical dispensing of incorrect materials, as outlined in the \"Best Practices for Material Tracking and Dispensing in Manufacturing Operations\" document?", "prev_section_summary": "This section discusses the differences between resource management systems like ERP and GxP-compliant systems in handling materials in manufacturing operations. It highlights the importance of executing material transactions contemporaneously with physical activities, managing material inventory and status in WIP, and the benefits of container tracking in complex manufacturing operations. Key topics include the handling of dispensed materials, managing material inventory, choosing the appropriate system for managing materials, and the importance of checking material status attributes during consumption activities. Key entities mentioned include ERP systems, GxP regulations, dispensing operations, WIP inventory, container tracking, and material status attributes.", "excerpt_keywords": "GAMP, Manufacturing Execution Systems, Material Tracking, Dispensing, Genealogy"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "0ec4214d-d73c-4b2f-8435-8ea4e2de1b82", "node_type": "4", "metadata": {"page_label": "118", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "cc103d20159c28c33d5c956a5747de23bab3c87c5fc7bf3db5b0e1a39381a8da", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "6d5a0f9c-3842-4467-ab0a-7eef13175a49", "node_type": "1", "metadata": {"page_label": "117", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "60e1dafbe44f258bf22a992e908ee6a7411f5d0f742fadbcab2b2878fca813fd", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "d53f1fd4-ba42-4363-989f-5097b1f9eeaf", "node_type": "1", "metadata": {}, "hash": "b8ce73b74690229f98b0e9102fcaf6063da207d8a59e9e2c23ec8ab87092d861", "class_name": "RelatedNodeInfo"}}, "text": "page 116\n\n## gamp (r) good practice guide: appendix 11 manufacturing execution systems - a strategic and program management approach\n\nintermediates or stock materials created in product manufacturing or production support activities should have a status assigned to them for testing prior to use or consumption. this can be by lot, batch, or container. each container of materials should indicate required product information, e.g., by including lot or batch number and material name or code number, or barcode.\n\nwhen a wip management system is employed separate from the warehousing system, care should be taken to establish the system of record and the system of genealogy. a wip management system is the system of record since wip activities are governed, recorded, and signed for in wip areas. genealogy for lots typically is assigned to the mrp/erp. genealogy for sub-lots, such as containers, can be assigned either to the wip system or the mrp/erp dependent on the capabilities of mrp/erp to manage containers. in either case, validated reporting approaches should be established to provide complete genealogy of products to materials or materials to products for operations, quality (control and audit), and investigation purposes.\n\n15.3 dispensing (pharmacy) and material consumption considerations\n\nisolated areas in which only one material can be present at a time for dispensing (campaign weighing) provides the most assurance that the selected material has been utilized. where it is not practical to isolate individual operations (e.g., where there is more than one weigh station in a dispense room), internal physical boundaries and procedural or automated controls should be used to prevent cross-contamination or physical dispensing of an incorrect material. where multiple stations are present, barcode scanning of material container labels helps ensure that the correct material was dispensed.\n\nin production areas, as in dispensing, isolated areas in which only one material is present should provide the greatest assurance that the selected material has been utilized; however, this is typically more difficult to implement in production areas. container level tracking, whereby individually labeled containers are scanned at consumption provides assurance that each container holds the correct material at the right status.", "start_char_idx": 0, "end_char_idx": 2345, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "d53f1fd4-ba42-4363-989f-5097b1f9eeaf": {"__data__": {"id_": "d53f1fd4-ba42-4363-989f-5097b1f9eeaf", "embedding": null, "metadata": {"page_label": "119", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Configuration Management in an Integrated Manufacturing Environment: Best Practices and Strategies", "questions_this_excerpt_can_answer": "1. What are the primary elements of configuration management as outlined in the ISPE Manufacturing Execution Systems document, specifically within the context of an integrated manufacturing environment?\n\n2. How does the document describe the role of the quality unit in overseeing configuration management processes, particularly in relation to GAMP 5, the ISPE GAMP Good Practice Guide, and ASTM 2500-07?\n\n3. What operational definitions and key aspects does the document provide for managing design change control, project change control, and operations change control within the MES domain's lifecycle?", "prev_section_summary": "The section discusses best practices for material tracking and dispensing in manufacturing operations, focusing on strategies for ensuring the correct material is dispensed, handling genealogy of lots and sub-lots in manufacturing execution systems, and preventing cross-contamination or dispensing of incorrect materials. Key topics include assigning status to intermediates or stock materials, establishing systems of record and genealogy, utilizing barcode scanning for material verification, and implementing isolated areas for dispensing and production to ensure material accuracy. Key entities mentioned include GAMP (r) Good Practice Guide, WIP management systems, MRP/ERP systems, and barcode scanning technology.", "excerpt_keywords": "Configuration Management, Manufacturing Execution Systems, ISPE, GAMP 5, ASTM 2500-07"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "040281ef-fc1c-4cad-8997-ecb2fa128c7e", "node_type": "4", "metadata": {"page_label": "119", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "38e0afb2a5790d08e3b8893d93789fbff3f7f2ea9c99f765adc78169d070ae09", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "faf396e4-6464-4233-92f8-eebd06bade83", "node_type": "1", "metadata": {"page_label": "118", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "cc103d20159c28c33d5c956a5747de23bab3c87c5fc7bf3db5b0e1a39381a8da", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "334481f7-f654-4d3d-bed5-75f22e282729", "node_type": "1", "metadata": {}, "hash": "d2a9e4f2dfb59032bf946f9bf1781c092824fe0320da597899dd26067c043204", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 12 - configuration management\n\n16.1 introduction\n\nconfiguration management is a quality system for maintaining documentation, systems, equipment, and supporting components in a known state throughout the life cycle of an mes domain. the known state should conform to acceptance criteria relevant to the current life cycle phases of systems within the mes domain. this appendix focuses on setting up approaches that provide advantages for integrated systems. for further information on configuration activities during the operations phase of a life cycle, see the ispe good practice guide: a risk-based approach to operation of gxp computerized systems (reference 6, appendix 14).\n\nconfiguration management for equipment and computer systems in the mes domain typically is a supporting program of overall configuration management for processes and facilities. for example, a manufacturing suite that is being refitted or modified for a new product may be considered. the highest level change is to the facility and site validation master plan (vmp). all supporting change processes for the manufacturing area project are referenced to the facility change, such that a history and known configuration can be established in support of the vmp.\n\nelements of configuration management, such as project change control and operations change control, are defined using appropriate methods for the applicable lifecycle phase. during implementation, the known state of equipment and systems will be established at intervals during development, installation, and assembly as defined in implementation and validation plans.\n\nprogram responsibilities\n\ngamp 5, the ispe gamp good practice guide: global information systems control and compliance, and astm 2500-07 (references 4, 5, and 7, appendix 14) delineate roles for technical organizations in defining and managing quality systems related to their functional responsibilities in designing, testing, and maintaining equipment and computer systems for manufacturing. the quality unit should provide independent supervision of quality systems and other critical technical programs that could affect product quality.\n\n16.2 operational definitions and key aspects\n\nelements of configuration management include the following operational definitions:\n\n- design change control - primarily for documentation, including drawings and various levels of specifications as appropriate to reflect initial and revised requirements during systems lifecycles. design change control is an element of the continuous design review process. it is typical for design change control to be part of project change control for systems implementations, and for operations change control to link document changes to systems changes.\n- project change control - control and documentation of configuration during development, implementation, and verification prior to release of systems or system components or subsets to operations.\n\nnote: this includes managing changes appropriately for factory acceptance tests, site acceptance tests, commissioning, and verification, as necessary, based on risk of the particular phase.\n\n- operations change control - control and documentation of configuration during the operation phase of the life cycle.\n\nthere are four key aspects considered in this appendix for an integrated manufacturing environment:", "start_char_idx": 0, "end_char_idx": 3366, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "334481f7-f654-4d3d-bed5-75f22e282729": {"__data__": {"id_": "334481f7-f654-4d3d-bed5-75f22e282729", "embedding": null, "metadata": {"page_label": "120", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Ownership and Life Cycle Management of Manufacturing Execution Systems Domain", "questions_this_excerpt_can_answer": "1. What specific roles and responsibilities does a Program Management Office (PMO) have in the context of managing the Manufacturing Execution Systems (MES) domain, according to the GAMP\u00ae Good Practice Guide?\n\n2. How does the GAMP\u00ae Good Practice Guide suggest differentiating between the life cycle management of the MES domain as a whole versus the life cycle management of individual systems and equipment within that domain?\n\n3. What criteria and considerations does the GAMP\u00ae Good Practice Guide recommend for including members in the PMO responsible for overseeing the MES domain, and how does it suggest these members contribute to the integrity of the manufacturing environment?", "prev_section_summary": "The section discusses configuration management in an integrated manufacturing environment, focusing on maintaining documentation, systems, equipment, and supporting components in a known state throughout the life cycle of an MES domain. It outlines the elements of configuration management such as project change control and operations change control, and the role of the quality unit in overseeing these processes. The document provides operational definitions for design change control, project change control, and operations change control within the MES domain's lifecycle. Additionally, it highlights the program responsibilities outlined in GAMP 5, the ISPE GAMP Good Practice Guide, and ASTM 2500-07 for managing quality systems related to equipment and computer systems in manufacturing.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, Program Management Office, Life Cycle Management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "8c270c6e-4db4-4392-a013-9461c74a41b1", "node_type": "4", "metadata": {"page_label": "120", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "59fc7b363770ec794ee36e81a6f35cdc691c13b56ae47b98735a03c7c3da84cb", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "d53f1fd4-ba42-4363-989f-5097b1f9eeaf", "node_type": "1", "metadata": {"page_label": "119", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "38e0afb2a5790d08e3b8893d93789fbff3f7f2ea9c99f765adc78169d070ae09", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "61dbbfaa-ef0a-42ab-870e-6d9ce2b56533", "node_type": "1", "metadata": {}, "hash": "8092f2b16ee5119e0bee3f75c66dc34a89e9834a100ab66d2ec4adc823273cc6", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: appendix 12\n\n### manufacturing execution systems - a strategic and program management approach\n\n1. mes domain ownership - ownership and control of the mes domain verses individual constituent systems and equipment.\n\n2. mes domain life cycle - differentiation of domain life cycle from individual systems life cycles.\n\n3. functional and product configuration - configuration of systems to function properly verses configuration of systems to execute specific product processes.\n\n4. coordinated systems release processes - determination of methods to release modules, functionality, whole systems, or equipment in the domain in varying life cycle phases.\n\n### mes domain ownership and life cycle\n\nthe mes domain typically comprises multiple applications, systems, equipment, and infrastructure that are managed via separate life cycles. to ensure that the complete manufacturing environment state is known, controlled, and meets product process requirements, a team should be established to supervise the manufacturing domain life cycle and coordinate the individual life cycles of systems within the mes domain. this team may be a program management office (pmo) or other leadership team responsible for assuring the integrity of the manufacturing environment. within this appendix, the team will be referred to as a pmo.\n\na pmo should consider the following membership for core (full time) and extended or ad hoc participants dependent on the organization of the company:\n\n- manufacturing operations, responsible for compliant execution of manufacturing processes\n- product process owners, responsible for process definition and typically for transfer of the process to manufacturing\n- business process owners, responsible for enterprise processes affected by manufacturing\n- quality unit\n- personnel safety organization\n- individual systems owners, representing systems life cycles and providing sme knowledge\n\nindividual system owners are typically technical departments, such as it and engineering, as necessary to ensure proper execution of their associated computer systems and equipment lifecycles.\n\nthe pmo is focused on systems-related topics and considers business process impact. it is not intended to manage day to day activities of the mes domain. the pmo is responsible for ensuring that a coordinated approach exists within and among sites for the following:\n\n- mes domain systems and processes meeting common goals of the organization\n- major facility changes or renovations affecting mes domain systems\n- major implementations, including global or other multi-site roll-out or system replacements\n- product changeover requiring new systems or major equipment changes\n- updates to site validation master plans\n- personal safety goals, considerations, methods, and criteria", "start_char_idx": 0, "end_char_idx": 2819, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "61dbbfaa-ef0a-42ab-870e-6d9ce2b56533": {"__data__": {"id_": "61dbbfaa-ef0a-42ab-870e-6d9ce2b56533", "embedding": null, "metadata": {"page_label": "121", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Comprehensive Guide to Manufacturing Execution Systems Configuration and Release Processes\"", "questions_this_excerpt_can_answer": "1. What are the key elements involved in the functional and product configuration of systems within the MES domain to ensure they operate as effective manufacturing tools?\n   \n2. How does the GAMP good practice guide suggest managing changes in systems versus product and process changes within the MES domain to maintain quality and operational integrity?\n\n3. What are the recommended practices for the coordinated systems release processes, including validation planning and testing stages, for MES domain systems as outlined in the \"Comprehensive Guide to Manufacturing Execution Systems Configuration and Release Processes\"?", "prev_section_summary": "The section discusses the ownership and life cycle management of Manufacturing Execution Systems (MES) domain, emphasizing the importance of coordinating the individual life cycles of systems within the MES domain. It highlights the role of a Program Management Office (PMO) in overseeing the MES domain and includes key members such as manufacturing operations, product process owners, business process owners, quality unit, personnel safety organization, and individual system owners. The PMO is responsible for ensuring a coordinated approach within and among sites for various activities such as major facility changes, system implementations, and updates to validation master plans. The focus is on systems-related topics and business process impact, rather than day-to-day activities of the MES domain.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, Configuration Management, Validation Planning"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "97a5ff30-a980-43d4-89ee-dfc47745b382", "node_type": "4", "metadata": {"page_label": "121", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "90344cf1f905a8f186a6fbff732334d78ba728b4628b12b725500fac09b660d7", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "334481f7-f654-4d3d-bed5-75f22e282729", "node_type": "1", "metadata": {"page_label": "120", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "59fc7b363770ec794ee36e81a6f35cdc691c13b56ae47b98735a03c7c3da84cb", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "955a2505-05fe-48ce-afeb-0323c89db8f2", "node_type": "1", "metadata": {}, "hash": "09f5dc0ff66e8127d64132f27a346574368dca098565d396e237762cd92e1e30", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 12\n\n16.4 functional and product configuration of systems to function appropriately as manufacturing tools involves application setup, network infrastructure, database schema, access, interfaces, and other requirements for the mes domain computerized systems to operate in a reliable and coordinated fashion.\n\nsystems in an mes domain should be designed and implemented in a way that is mostly independent of particular product processes; however, it is recognized that products may have specific dedicated equipment required for manufacturing. a well-designed mes domain should not be substantially redesigned for each new planned product or product family.\n\nconfiguration of the mes domain for product manufacturing should be focused on recipes, batch and production management, data, and related equipment configuration as the major tools for product configuration including:\n\n- master data (specifications)\n- process parameters\n- product process definition, including specific process steps and sequences, sampling plans, and acceptance/success criteria\n\nby categorizing systems changes versus product and process changes, an organization can establish stricter controls on product changes requiring quality and operations pre-approval. this approach provides the opportunity to designate some quality system ownership to technical group programs for system function maintenance and changes to maintain functionally equivalent operations. such programs should be approved and routinely audited by the quality unit.\n\napplications, such as erp or lims, may have a central organization entity as system owner, responsible for controlling versions and changes, and that also may completely control configuration management. however, a common approach uses a central entity to control the application versioning and global changes with site control over specific local aspects, such as infrastructure, database data, or some required functionality or configuration unique to the site.\n\ndepending on the specific applications and equipment for manufacturing operations, an organization may choose to allow sites to add or change a percentage of functionality to meet local production requirements that cannot be easily standardized for an organization. this approach should consider the extra expense and resources to implement and maintain customized functionality in a compliant fashion.\n\n16.5 coordinated systems release processes\n\nvalidation planning documentation should define or reference the programs and procedures for methods and criteria used to release equipment, applications, system modules, and systems for:\n\n- initial and sequential verification of each testing stage from factory acceptance tests through conclusion of testing\n- release to operations for monitoring performance in the production environment. this may involve concurrent production of test materials or gxp products. concurrent production and any acceptance criteria for the materials are specified in the validation plan.\n\nsystems in the mes domain may be released to various verification and life cycle phases as they are installed, configured, and tested. this may involve releasing specific modules or components of systems and equipment within an overall plan for a system.", "start_char_idx": 0, "end_char_idx": 3383, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "955a2505-05fe-48ce-afeb-0323c89db8f2": {"__data__": {"id_": "955a2505-05fe-48ce-afeb-0323c89db8f2", "embedding": null, "metadata": {"page_label": "122", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Configuration Management in Manufacturing Execution Systems Domain", "questions_this_excerpt_can_answer": "1. What specific guidance does the GAMP (Good Automated Manufacturing Practice) provide for managing configuration in Manufacturing Execution Systems (MES) domains, particularly regarding the integration and documentation of systems?\n   \n2. How does the document suggest handling the complexity of documentation in global MES deployments, especially considering variations in local site processes, languages, manufacturing, and regulatory policies?\n\n3. What hierarchical approach does the document recommend for documenting systems within an MES domain to ensure clarity for internal management and compliance with regulatory agencies?", "prev_section_summary": "The section discusses the functional and product configuration of systems within the Manufacturing Execution Systems (MES) domain, emphasizing the importance of setting up systems to operate effectively as manufacturing tools. It highlights the key elements involved in system configuration, such as application setup, network infrastructure, database schema, access, and interfaces. The section also addresses the management of changes in systems versus product and process changes within the MES domain to maintain quality and operational integrity, as recommended by the GAMP good practice guide. Additionally, it outlines the recommended practices for coordinated systems release processes, including validation planning and testing stages, for MES domain systems. The section emphasizes the need for strict controls on product changes, ownership of quality system maintenance, and the release of equipment, applications, and system modules through sequential verification and testing stages. It also discusses the potential for customization of functionality at the site level and the considerations for implementing and maintaining such customization in a compliant manner.", "excerpt_keywords": "Configuration Management, Manufacturing Execution Systems, GAMP, Documentation, Global Deployments"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "70bd2e34-229a-426a-b584-5b764e6140b8", "node_type": "4", "metadata": {"page_label": "122", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "33398a02c94fb7169d06b4136bac53120674b82ba6d1be6556980983063630f1", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "61dbbfaa-ef0a-42ab-870e-6d9ce2b56533", "node_type": "1", "metadata": {"page_label": "121", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "90344cf1f905a8f186a6fbff732334d78ba728b4628b12b725500fac09b660d7", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "ebc9d715-a668-446b-8e26-2ea48bd8ff2d", "node_type": "1", "metadata": {}, "hash": "a41bb8f6bf133e89c276415625d2d807c6b729dfb9b6710979741993e93f3901", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: appendix 12 manufacturing execution systems - a strategic and program management approach\n\nnote: the general process should be defined in procedures to reduce individual project work and increase consistency among projects. master lists of each of the items and the current status for the release or gate points should be maintained within release processes. each of the release points should be defined in or referenced by validation plans with the following information:\n\n- definition of what is being released, e.g., equipment, module, application, infrastructure, and system\n- required results of appropriate checks, peer review, testing, or other gating criteria\n- required documentation, including updating\n- required approvals\n\nrelease points typically will include multiple system interface or integration testing within the mes domain. there should be a designated coordination person or team to ensure that the integrity of the domain is maintained during development and deployment.\n\n## configuration management in an mes domain\n\ndocumentation may become complex when used in support of global deployments because of possible variation in local site processes and languages, as well as manufacturing and regulatory policies and procedures. installations or changes made for one system may affect other equipment and systems. at any given time, the integration of systems in the mes domain should have current documentation and be understood by smes responsible for representing technical groups in change control activities. risk assessment of changes to a given application or system should proactively consider the impact on related systems.\n\ntransitioning to mes domain manufacturing requires the establishment of relationships among integrated systems to aid change teams and committees in evaluating impact of changes across system boundaries, ensuring that the overall configuration is controlled. by defining functional domains within system documentation, the relationships of functions in one system are more readily understood for assessing the impact on other systems, assisting prompt regression analysis during the change processes.\n\nfor further information on fundamental configuration principles, see gamp 5, appendices m8, d3, and o6 and the ispe gamp good practice guide: global information systems control and compliance (references 5 and 6, appendix 14).\n\nthis appendix discusses specific topics in relation to integrated manufacturing systems in an mes domain. integrated mes configuration management can be organized into overview and detail levels to provide a clear understanding of what comprises an mes domain. a hierarchical approach provides a good foundation for documenting systems for internal management, as well as for presentation to regulatory agencies:\n\n- overview: system layout and organization:\n- high level drawings and text to show relationships, such as integration among systems and major equipment that comprise the mes domain\n- drawings and text showing the major hardware components for each system", "start_char_idx": 0, "end_char_idx": 3087, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "ebc9d715-a668-446b-8e26-2ea48bd8ff2d": {"__data__": {"id_": "ebc9d715-a668-446b-8e26-2ea48bd8ff2d", "embedding": null, "metadata": {"page_label": "123", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Effective Configuration and Identification Management in MES Systems: Best Practices and Strategies", "questions_this_excerpt_can_answer": "1. What are the fundamental programs that support configuration management in the context of Manufacturing Execution Systems (MES) as outlined in the GAMP Good Practice Guide?\n   \n2. How does the document suggest tracking software or application changes within MES systems to ensure service continuity and disaster recovery?\n\n3. What approach does the document recommend for establishing a unified equipment identification system within an MES domain, and how does it suggest tracking changes and updates to this system?", "prev_section_summary": "The section discusses the importance of configuration management in Manufacturing Execution Systems (MES) domains, particularly focusing on documentation, release processes, and system integration. Key topics include defining release points, maintaining current documentation, considering the impact of changes on related systems, establishing relationships among integrated systems, and using a hierarchical approach for documenting systems within an MES domain. The section emphasizes the need for clear documentation to ensure internal management clarity and compliance with regulatory agencies.", "excerpt_keywords": "MES, Configuration Management, GAMP Good Practice Guide, Equipment Identification, System Integration"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "de095da1-630b-49e4-916c-6004dade9a7a", "node_type": "4", "metadata": {"page_label": "123", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "d3dd1d3a58ccd99aceafd011fc71cdeb2e00847f56077eca5761acd38a09f032", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "955a2505-05fe-48ce-afeb-0323c89db8f2", "node_type": "1", "metadata": {"page_label": "122", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "33398a02c94fb7169d06b4136bac53120674b82ba6d1be6556980983063630f1", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "7e4a5e96-b517-4daa-8ea0-079f9ad01a1b", "node_type": "1", "metadata": {}, "hash": "d75ddf4e58739932588912648b7b6768c58622ff0264d1a14705fe9a8c2e346e", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 12\n\n- drawings and text for associated infrastructure that support the implementation. these documents may be considered a part of corporate or site it and not part of an actual system requirements documentation.\n\n- detail: systems configuration:\n\nconfiguration management is supported by fundamental programs including:\n\n- project change control\n- operational change control\n- preventive maintenance and calibration\n- corrective maintenance\n\nchange control processes should ensure that systems documentation is up to date and that the system state is known at a given point in time. maintenance programs should ensure that equivalent or exact hardware replacements are recorded into history systems or files for information, such as model, serial or version numbers, as applicable.\n\nsimilarly, the software or application should be tracked to include supplier release, any modifications to the application (configuration and customization), plus any operating systems upgrades and patches that may have been incorporated. database specific parameters should be defined sufficiently in order to enable service continuity and disaster recovery.\n\norganizations should establish equivalency of non-exact replacement parts in advance of when they may be needed to allow timely maintenance without additional testing at the time of installation to prove equivalence.\n\n### system identification and nomenclature\n\ntypically, several life cycles will need to be tracked in an mes domain, because of multiple applications, systems, and equipment. an organization may choose to maintain one life cycle for the entire mes domain, where functionality can be added or moved system to system as software and equipment evolve. from a documentation viewpoint, changes can be tracked as though the mes domain were a single system.\n\nan mes domain and constituent systems provide an opportunity to establish a unified equipment identification system based on the common engineering practice of equipment tags (ids).\n\nchanges and updates may be tracked via paper or electronic means; however, electronic systems provide more timely and flexible information distribution and reporting, and may be essential in managing asset status management for mes domains.", "start_char_idx": 0, "end_char_idx": 2363, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "7e4a5e96-b517-4daa-8ea0-079f9ad01a1b": {"__data__": {"id_": "7e4a5e96-b517-4daa-8ea0-079f9ad01a1b", "embedding": null, "metadata": {"page_label": "124", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Change Management and Unique Identification in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What is the recommended approach for assigning unique identifications or designations to systems and major components within a Manufacturing Execution System (MES) domain to facilitate tracking, as outlined in the ISPE Manufacturing Execution Systems guide?\n\n2. How does the GAMP\u00ae Good Practice Guide suggest handling change management for integrated systems within an MES domain, particularly in terms of assessing and documenting the impacts of changes on related systems?\n\n3. Can you describe an example of a technique for assigning equipment location IDs within an MES environment, as illustrated in the document \"Change Management and Unique Identification in Manufacturing Execution Systems: A Comprehensive Guide\"?", "prev_section_summary": "The section discusses effective configuration and identification management in Manufacturing Execution Systems (MES) based on the GAMP Good Practice Guide. Key topics include configuration management supported by programs such as project change control, operational change control, preventive maintenance, and corrective maintenance. The document suggests tracking software changes, including supplier releases, modifications, upgrades, and patches, to ensure service continuity and disaster recovery. It also recommends establishing a unified equipment identification system within an MES domain using equipment tags (IDs) and tracking changes and updates electronically for efficient information distribution and reporting.", "excerpt_keywords": "Keywords: Manufacturing Execution Systems, Change Management, Unique Identification, GAMP Good Practice Guide, Equipment Location IDs"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "46380758-bc58-4a80-8ae4-00351c21b692", "node_type": "4", "metadata": {"page_label": "124", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "0db41c0636a05ae48d7556d9ddb24dcf7b2846ca1d40330ca5d24db1de7e3bf9", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "ebc9d715-a668-446b-8e26-2ea48bd8ff2d", "node_type": "1", "metadata": {"page_label": "123", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "d3dd1d3a58ccd99aceafd011fc71cdeb2e00847f56077eca5761acd38a09f032", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "5bdf0067-32e3-4678-84fe-67b1714199b3", "node_type": "1", "metadata": {}, "hash": "0d2d98c33c77731a9e2fc1f6bce711de20b28910b77aa26d1f53a85295dab361", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: appendix 12\n\nmanufacturing execution systems - a strategic and program management approach\n\nchange management for integrated systems employs the concept of related systems. if an activity is performed on one system that is part of an mes domain, affects on other systems that are part of the mes domain should be determined, and links established for system change records. change documentation should reference related systems in a manner that enables techniques, such as regression analysis, to determine the overall scope of the affects of a change activity.\n\nsystems and major components of systems (as appropriate) should each be assigned a unique identification or designation in order to facilitate the use of any tracking method. engineering numbering or tagging methods provide a practical approach using system drawings and design documents reflecting these designations. it is recommended to avoid using serial numbers or model numbers as system or equipment designators, as these will change over time with maintenance. figure 16.1 shows a technique similar to engineering locator numbering (or tag numbering), e.g., systems mes1 and scada1.\n\n|figure 16.1: example equipment location id technique|materials inlock 1|\n|---|---|\n|data center|workstation|\n|room 123|mes1-wki|\n|server mes1-sv1|production area 1|\n|server mesi-sv2|workstation|\n|hub infra-h1|workstation|\n| |mes1-wk2|\n| |scada1-wki|\n| |workstation mest-wk3|", "start_char_idx": 0, "end_char_idx": 1462, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "5bdf0067-32e3-4678-84fe-67b1714199b3": {"__data__": {"id_": "5bdf0067-32e3-4678-84fe-67b1714199b3", "embedding": null, "metadata": {"page_label": "125", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Optimizing Manufacturing Execution Systems through Effective Nomenclature and Tracking", "questions_this_excerpt_can_answer": "1. How does the GAMP Good Practice Guide suggest tracking changes to each locator ID within a Manufacturing Execution System (MES), and what specific information should be included in the change control record for each locator number?\n   \n2. What are the benefits of employing a smart number designator for locator IDs in engineering documentation as mentioned in the GAMP Good Practice Guide, and how does this approach facilitate database management and information retrieval within MES environments?\n\n3. According to the GAMP Good Practice Guide, how can the application of consistent nomenclature for facility buildings, equipment, and support systems across IT, engineering, and facility documentation improve maintenance operations and configuration management within a manufacturing execution system domain?", "prev_section_summary": "The section discusses the importance of change management and unique identification in Manufacturing Execution Systems (MES). It highlights the recommended approach for assigning unique identifications to systems and major components within an MES domain to facilitate tracking. The GAMP\u00ae Good Practice Guide suggests handling change management for integrated systems within an MES domain by assessing and documenting the impacts of changes on related systems. An example technique for assigning equipment location IDs within an MES environment is also provided in the document. The section emphasizes the use of unique identifications or designations for systems and major components, and recommends avoiding serial numbers or model numbers for this purpose. It also mentions the concept of related systems in change management for integrated systems within an MES domain.", "excerpt_keywords": "Manufacturing Execution Systems, GAMP Good Practice Guide, Change Control, Nomenclature, Database Management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "7b0af4b7-6c50-4293-9684-81909536a846", "node_type": "4", "metadata": {"page_label": "125", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "a198a80c297164bfb24da2f1f4fb0d5cec4997e2fc703f5e8b8db0f4206f7e8d", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "7e4a5e96-b517-4daa-8ea0-079f9ad01a1b", "node_type": "1", "metadata": {"page_label": "124", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "0db41c0636a05ae48d7556d9ddb24dcf7b2846ca1d40330ca5d24db1de7e3bf9", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "a441c6d2-59ac-4295-84ea-7a98c8e2e88f", "node_type": "1", "metadata": {}, "hash": "f0e472cf69b303ad7be822816e3cb3c3282f68a9f4f9ded78a53b7ca172ca104", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 12\n\nchanges are tracked to each locator id in the system as defined in system documentation, e.g., drawings and specifications. the locator ids should not change, unless a component is added to or deleted from the system or mes domain.\n\nthe change control record is populated with the history of each locator number, containing all installation and maintenance activities, physical location, and inventory of components, including model and serial numbers. this nomenclature enables database techniques to be applied, allowing timely retrieval of information for any system locator number.\n\nthis example shows one type of alpha-numeric designator designed as a smart number (information is contained within the number itself). this may be beneficial and is common in engineering documentation.\n\nany practical nomenclature can be used; however, if it system and engineering or facility numbers are based on a common approach, mes domain documentation can be consistent. this may be helpful in training of it, engineering, and maintenance personnel, and the timely execution of maintenance operations that cross system and facility boundaries.\n\ntypically, in drawings and other documentation, engineering and construction techniques employ procedures for assigning numeric or alphanumeric nomenclature to identify:\n\n- facility buildings\n- equipment\n- support systems\n\napplying this method to computer systems and constituent components of systems allows the appropriate level of granularity to be defined for tracking life cycle activities, and may provide a set of rules consistent with other facility maintenance and tracking activities. equipment of any kind need not have an independent identification system, simplifying configuration management, especially documentation.\n\nthis technique has the additional advantage of enforcing consistency within facilities when utility systems, e.g., pure water, clean gases, heating, ventilation, and air conditioning (hvac), and clean steam, communicate with or are integrated with production computer systems.\n\nfacility drawings may use intelligent (formatted or coded) locator or device numbers by type; however, sequential numbers with associated metadata may be as effective when the information is readily available via tracking or maintenance systems.\n\nonce a system designation is assigned, components of the system may be assigned an identification that shows the relationship of the component to the computer system. coding locations into designations should be avoided, as devices may be moved from their original room or building.", "start_char_idx": 0, "end_char_idx": 2709, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "a441c6d2-59ac-4295-84ea-7a98c8e2e88f": {"__data__": {"id_": "a441c6d2-59ac-4295-84ea-7a98c8e2e88f", "embedding": null, "metadata": {"page_label": "126", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "MES System Locator ID Designators and Installation Nomenclature Guide", "questions_this_excerpt_can_answer": "1. What specific examples of MES system locator ID designators are provided in the document, and how are they related to the equipment and data they represent?\n   \n2. How does the document suggest handling the division of responsibilities and ownership for MES systems within a manufacturing environment, particularly regarding the integration of systems like automation and ERP?\n\n3. What are the advantages and disadvantages of assigning each system in the MES domain a unique system designator versus assigning a single MES designator to the collection of systems, according to the document?", "prev_section_summary": "The section discusses the importance of effective nomenclature and tracking in Manufacturing Execution Systems (MES) as outlined in the GAMP Good Practice Guide. Key topics include tracking changes to locator IDs, benefits of smart number designators, consistent nomenclature for facility buildings, equipment, and support systems, and the application of database techniques for information retrieval. Entities mentioned include locator IDs, change control records, model and serial numbers, facility buildings, equipment, support systems, and maintenance operations.", "excerpt_keywords": "MES, Manufacturing Execution Systems, Locator ID, Designators, Nomenclature"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "12c531cb-0473-40f1-aa5e-79efcd9f4977", "node_type": "4", "metadata": {"page_label": "126", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "9887b8e43e2b6b03d954f4336cb4de2c6ca2592dab6eac4b5e25352e380b0d51", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "5bdf0067-32e3-4678-84fe-67b1714199b3", "node_type": "1", "metadata": {"page_label": "125", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "a198a80c297164bfb24da2f1f4fb0d5cec4997e2fc703f5e8b8db0f4206f7e8d", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "9c70a365-319a-490b-9fbc-9b7db1a57935", "node_type": "1", "metadata": {}, "hash": "6c395437130d68683dae923a9efa7ee0b002b6e362c6b4cdaf2b23ca3ce1c483", "class_name": "RelatedNodeInfo"}}, "text": "## figure 16.2: mes system locator id designators and related data\n\n|wd1| | |\n|---|---|---|\n|wd1-svr1| |wd1-ptr1|\n|database, e.g. maintenance system| | |\n|description: nema 4/12 weigh station| | |\n|building/room numbers:| | |\n|network port/address numbers:| | |\n|touchscreen pc model/sn:| | |\n|bar code reader model/sn:| | |\n|10 kg scale model/sn:| | |\n|50 kg scale model/sn:| | |\n|install dates for components:| | |\n|historical configuration data:| | |\n\n## installation based nomenclature\n\nif manufacturing is executed with integrated systems, one of several approaches may be employed, e.g.:\n\n- assign each system in the domain a system designator. rationale includes division of responsibilities, ownership, and support at specific system boundaries, such as engineering for automation and it for erp. this is the most flexible method and can simplify identification of specific equipment to departments and personnel responsible for maintenance (or overall ownership if the systems in the mes domain are divided up among responsible groups by system). the disadvantage is the risk of inconsistency of numbering and documentation to be referenced in change and maintenance systems.\n- assign the collection of systems in the mes domain a single mes designator. rationale includes using a single business owner for the set of systems related to manufacturing. this is difficult with a mix of global systems, such as erp, and local systems, such as automation.", "start_char_idx": 0, "end_char_idx": 1460, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "9c70a365-319a-490b-9fbc-9b7db1a57935": {"__data__": {"id_": "9c70a365-319a-490b-9fbc-9b7db1a57935", "embedding": null, "metadata": {"page_label": "127", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Establishing Rules for Configuration and Infrastructure Tracking in MES Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the GAMP (Good Automated Manufacturing Practice) guide recommend handling the designation of individual system designators within the MES (Manufacturing Execution Systems) domain to ensure effective relationship mapping between systems?\n\n2. What specific strategies does the document suggest for managing infrastructure tracking within an MES domain to minimize the impact of changes on related systems and applications, particularly in terms of distinguishing between infrastructure and system software components?\n\n3. In the context of MES system support maintenance and configuration, how does the document differentiate between routine maintenance operations and significant changes, and what guidelines does it provide for treating scripts or modules, especially in terms of assessing risk based on the complexity and functionality impacted within the MES domain?", "prev_section_summary": "The section discusses MES system locator ID designators and installation nomenclature in manufacturing environments. It provides examples of specific designators related to equipment and data, and suggests approaches for dividing responsibilities and ownership for MES systems, including assigning each system a unique designator or a single MES designator for the collection of systems. The advantages and disadvantages of each approach are also highlighted. Key topics include system designators, division of responsibilities, ownership, integration of systems, and the importance of consistent numbering and documentation for maintenance and change systems.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, infrastructure tracking, configuration rules"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "9d058edc-29f6-4802-922b-dfaad5e569be", "node_type": "4", "metadata": {"page_label": "127", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "aef344df27f0c84bed1813f75b6ef89130f9ad478ebcf790db03f57d8af1d3ea", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "a441c6d2-59ac-4295-84ea-7a98c8e2e88f", "node_type": "1", "metadata": {"page_label": "126", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "9887b8e43e2b6b03d954f4336cb4de2c6ca2592dab6eac4b5e25352e380b0d51", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "0b5d9564-f8d1-4a3e-af88-0d2423a0fa4e", "node_type": "1", "metadata": {}, "hash": "c6ef8feafcc10aaf8be289c39489479c062caedf39051e30dfbbef75a69d3bb8", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 12\n\n* assign individual system designators, and in addition, a separate overall designation for the mes domain to relate systems to each other.\n\n### 16.9 infrastructure tracking\n\norganizations may choose to track servers, network components, and workstations as part of infrastructure, while tracking application and other equipment changes in an mes domain to the appropriate system. in these cases, a change to either the infrastructure or the mes domain may require an evaluation of related systems to determine if they are affected.\n\nif infrastructure is defined separately from systems, decisions should be taken regarding which software components belong to that infrastructure. the operating system and network support software may be considered part of infrastructure.\n\nto avoid unnecessary regression testing on supported applications, clear specifications and support procedures should be established for the infrastructure to ensure that routine maintenance and changes can be accomplished without unnecessary impact elsewhere. where an application may be affected by an infrastructure change, an analysis should be performed.\n\n### 16.9.1 system support maintenance\n\nto avoid overloading change management systems, an mes system should have clear procedures for routine maintenance operations. change management systems should have procedures to define maintenance verses change, and rules for like for like and exact replacement scenarios.\n\n### 16.9.2 system configuration\n\ntypically, configuration for large-scale systems hardware is handled in a computer system change management process. an organization should establish rules regarding what constitutes configuration rather than change of support software and applications, as well as of hardware. activities that are considered part of configuration are typically defined based on the type of applications that are in use on a system.\n\n### 16.10 establishing rules for configuration\n\nthe complexity of an mes domain can cause change control efforts to become a lengthy activity, due to the location of related functionality residing in more than one computer system. gamp categories cannot always be applied to an entire computer system. different software categories may apply to various functionality within a computer system, such as the custom functionality within a system that is substantially a standard product from the supplier.\n\nof particular interest are scripts or simple instructions, such as database queries, and vba or other tools to create or modify functionality of configurable systems software. based on gamp 5 techniques, the scripts or modules can be treated as custom code, while the base application can often be assessed as more standard software.\n\nconsiderations to setting the amount of risk include:\n\n- the complexity of scripts or modules\n- whether the scripting language is proprietary to the application and/or limited in function, verses a standard language, such as sql\n- what functionality in the mes domain is impacted", "start_char_idx": 0, "end_char_idx": 3145, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "0b5d9564-f8d1-4a3e-af88-0d2423a0fa4e": {"__data__": {"id_": "0b5d9564-f8d1-4a3e-af88-0d2423a0fa4e", "embedding": null, "metadata": {"page_label": "128", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Best Practices for Manufacturing Execution Systems Configuration Management and Script Testing", "questions_this_excerpt_can_answer": "1. How does the GAMP 5 framework influence the configuration management programs for Manufacturing Execution Systems (MES) according to the ISPE guide?\n   \n2. What criteria are suggested by the ISPE guide for determining the level of testing required for scripts used in MES, and how does this relate to the complexity and functionality of the scripts?\n\n3. What specific strategies does the ISPE guide recommend for ensuring the reproducibility and accountability of script and module creation and modification within MES environments?", "prev_section_summary": "This section discusses the establishment of rules for configuration and infrastructure tracking in Manufacturing Execution Systems (MES). Key topics include assigning system designators, managing infrastructure changes, differentiating between routine maintenance and significant changes, and establishing rules for configuration in MES systems. The section also addresses the impact of scripts or modules on system functionality and provides guidelines for assessing risk based on complexity and functionality within the MES domain. Key entities mentioned include GAMP (Good Automated Manufacturing Practice) guidelines, system support maintenance procedures, change management systems, and configuration rules for hardware and software components in MES systems.", "excerpt_keywords": "ISPE, Manufacturing Execution Systems, Configuration Management, Script Testing, GAMP 5"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "76fb4e4e-7950-4a8e-b5d0-7ad92d378a77", "node_type": "4", "metadata": {"page_label": "128", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "b414616236e73f9fbe70ee8b83d5a332a913baacd2b18e2fa71633e34394cc53", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "9c70a365-319a-490b-9fbc-9b7db1a57935", "node_type": "1", "metadata": {"page_label": "127", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "aef344df27f0c84bed1813f75b6ef89130f9ad478ebcf790db03f57d8af1d3ea", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "03f98a20-2b93-47bd-8f9e-6e702ee62d2d", "node_type": "1", "metadata": {}, "hash": "d034a89beddc01249ffc000ddab8f563f3796f806d4a74b97e5fe9ff22308e78", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: appendix 12\n\nmanufacturing execution systems - a strategic and program management approach\n\n- what manufacturing process steps are impacted\n- read-only actions verses activity triggers, as well as the intended use of information\n\nconfiguration management programs can establish general rules based on gamp 5 for the mes domain. for example, scripts can range from simple sql statements to complex algorithms, thus the level of testing of scripts is commensurate with complexity and the purpose of the functionality. examples include:\n\n- read-only data retrieval requiring simple checks of data\n- information only data verses product and process compliance data\n- creation of data for further systems actions or use\n- system supplier provided scripts or modules even though custom to the implementation\n- human activities recorded for audit trail\n\nverifying of retrieved data often is performed using equivalence classes based on standard approaches. script and module creation and modification are tracked and reproducible, such that if a system needs to be restored or further modified, the source script and code versions are known and available. sme (peer) review is a critical part of the testing regimen for scripting and custom modules. both scripts and modules are often tested in conjunction with a larger group of systems functionality, and thus are not necessarily tested as standalone modules, unless the complexity warrants advanced verification methods based on risk assessments.", "start_char_idx": 0, "end_char_idx": 1524, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "03f98a20-2b93-47bd-8f9e-6e702ee62d2d": {"__data__": {"id_": "03f98a20-2b93-47bd-8f9e-6e702ee62d2d", "embedding": null, "metadata": {"page_label": "129", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Standards and Models for Manufacturing Execution Systems: A Comprehensive Overview", "questions_this_excerpt_can_answer": "1. What specific standards and models are recommended for defining the interrelationships and activities within manufacturing execution systems (MES) as outlined in the \"GAMP (R) Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach\"?\n\n2. How does the document suggest MES models can contribute to meeting business goals and addressing cultural aspects within an organization, particularly in the context of manufacturing operations?\n\n3. What criteria does the document propose for selecting MES functionality or product suites, and how does it recommend comparing different MES offerings in terms of functionality, ease of integration, system interfaces, and compatibility with existing legacy systems?", "prev_section_summary": "The section discusses the influence of the GAMP 5 framework on configuration management programs for Manufacturing Execution Systems (MES) according to the ISPE guide. It also covers the criteria suggested for determining the level of testing required for scripts used in MES, based on the complexity and functionality of the scripts. Additionally, the section recommends specific strategies for ensuring reproducibility and accountability of script and module creation and modification within MES environments. Key topics include configuration management programs, testing of scripts, verification of retrieved data, script and module creation and modification tracking, peer review, and testing in conjunction with larger systems functionality. Key entities mentioned are GAMP 5 framework, ISPE guide, scripts, modules, and MES environments.", "excerpt_keywords": "GAMP, Manufacturing Execution Systems, MES modeling, ANSI/ISA95, Supply Chain Council Scor Model"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "0109fe07-ecbc-41fa-89d8-4a0b1b0077cc", "node_type": "4", "metadata": {"page_label": "129", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "b873274013e8f424b7aa673c6884ca3cbe700be7b51dc77f34521f0ce4b80ad5", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "0b5d9564-f8d1-4a3e-af88-0d2423a0fa4e", "node_type": "1", "metadata": {"page_label": "128", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "b414616236e73f9fbe70ee8b83d5a332a913baacd2b18e2fa71633e34394cc53", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "7f889b10-ae38-4821-9242-a5d1a8d9a0d6", "node_type": "1", "metadata": {}, "hash": "cd09e047fc5d3d72fcd104149a6cc24289ebb47ed9c57eb7f7815283c5da3164", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 13\n\n|content|page number|\n|---|---|\n|appendix 13 - standards and models for mes|127|\n\n### 17.1 introduction\n\nthis appendix provides an overview of a few standards and models that can be used to define the different levels in an organization and the activities at each level and more importantly across level boundaries. topics covered in this appendix include:\n\n- introduction to mes modeling\n- mes functionality modeling\n- data and information flow\n- ansi/isa95 (reference 3, appendix 14)\n- ansi/isa88 (reference 2, appendix 14)\n- the supply chain council scor model (reference 11, appendix 14)\n- mesa international (reference 10, appendix 14)\n\nmes models provide a framework for the definition of interrelationships and activities specific to manufacturing operations and a description of associated functionalities. how an mes domain is expected to meet business goals and relevant cultural aspects within an organization should be understood.\n\nstandards and models can be used to provide an understanding of mes (or automation) in addressing issues, such as:\n\n- selection of mes functionality or product suites that maximizes the top three key business drivers\n- selection of different offerings based on standards within a corporate it department\n- a comparison of different mes offerings regarding:\n- functionality\n- ease of integration\n- system interfaces\n- touch points to other systems that may be a part of an implementation\n- integration with existing legacy systems that may need to be included in an implementation\n\ncompliance or support for a particular standard may be a consideration. this appendix may be used as guidance for modeling manufacturing operations to define the current state of operations and to identify future state mes requirements.", "start_char_idx": 0, "end_char_idx": 1890, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "7f889b10-ae38-4821-9242-a5d1a8d9a0d6": {"__data__": {"id_": "7f889b10-ae38-4821-9242-a5d1a8d9a0d6", "embedding": null, "metadata": {"page_label": "130", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Optimizing Manufacturing Operations: A Strategic Approach to MES Functions and ANSI/ISA-95 Integration\"", "questions_this_excerpt_can_answer": "1. How does the GAMP(r) Good Practice Guide suggest organizations can address industry challenges through MES functions and manufacturing operations activities?\n   \n2. What specific models and standards does the document recommend for understanding the requirements associated with corporate objectives in the context of MES implementation?\n\n3. Can you detail the functional hierarchy model as described by ANSI/ISA-95 for integrating enterprise and control systems within manufacturing operations?", "prev_section_summary": "This section provides an overview of standards and models for Manufacturing Execution Systems (MES) and their importance in defining interrelationships and activities within manufacturing operations. Key topics covered include MES modeling, functionality modeling, data and information flow, and various standards such as ANSI/ISA95, ANSI/ISA88, the Supply Chain Council SCOR model, and MESA International. The section emphasizes the role of MES models in meeting business goals and addressing cultural aspects within an organization. It also discusses criteria for selecting MES functionality or product suites, comparing different MES offerings, and integrating with existing legacy systems. Compliance with standards and support for specific standards are highlighted as important considerations in MES implementation.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP, ANSI/ISA-95, functional hierarchy model"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "6765bb1b-3a02-40fb-83fe-a1aad1d57c07", "node_type": "4", "metadata": {"page_label": "130", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "6a77a456e45d911e7587b0a6bb868b25b80e5a4d771248670aea7b815395bb69", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "03f98a20-2b93-47bd-8f9e-6e702ee62d2d", "node_type": "1", "metadata": {"page_label": "129", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "b873274013e8f424b7aa673c6884ca3cbe700be7b51dc77f34521f0ce4b80ad5", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "5af9d6f9-0a63-4b1f-b4b2-102095693a5f", "node_type": "1", "metadata": {}, "hash": "dbf17115d1d2bd669d3fd117759b841273f93d7dbc5737c21e6cc2d4cd334e82", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: appendix 13\n\n### manufacturing execution systems - a strategic and program management approach\n\n17.2 mes functions address industry profiles\n\nan organization can meet industry challenges using models and standards that provide an understanding of the requirements associated with corporate objectives. mes functionality and manufacturing operations activities can then be identified for implementation within the organization to address the specific profiles for each organization. from a functional perspective, the activities common in operations can be expressed as objects for use in identifying the corresponding functions in the industry models presented:\n\n- order generation\n- order review\n- documentation review\n- material preparation\n- component preparation\n- equipment preparation\n- running of a process\n- completing the process\n- recording the process (internal and external)\n\nmapping business processes and manufacturing operations to standard models can enable the application of solutions to address an organizations mission and objective.\n\n17.3 ansi/isa-95 enterprise-control system integration\n\npart 1 of the ansi/isa-95 standard provides models and terminology for defining interfaces between an organizations business systems and its manufacturing control systems. these models provide the basis for defining manufacturing operations and activities. additional information regarding this standard is available from isa.\n\n17.3.1 functional hierarchy model\n\nthe ansi/isa-95 hierarchy model depicting the different levels for business planning and logistics, manufacturing operations and control, and control (batch, continuous, discrete) is provided in figure 17.1. this model defines hierarchical levels at which decisions are made.", "start_char_idx": 0, "end_char_idx": 1781, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "5af9d6f9-0a63-4b1f-b4b2-102095693a5f": {"__data__": {"id_": "5af9d6f9-0a63-4b1f-b4b2-102095693a5f", "embedding": null, "metadata": {"page_label": "131", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Operations and Control in Level 3 Activities: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What specific functions and responsibilities are attributed to Level 3 activities in the ISA-95.00.01-2000 functional hierarchy for manufacturing execution systems as outlined in the \"Manufacturing Operations and Control in Level 3 Activities: A Comprehensive Guide\"?\n\n2. How does the document describe the role of Level 3 activities in optimizing costs for individual production areas within the manufacturing execution systems framework, and what specific tasks are involved in this optimization process?\n\n3. What are the detailed responsibilities of Level 3 activities in terms of personnel functions within the manufacturing operations and control framework, as specified in the \"Manufacturing Operations and Control in Level 3 Activities: A Comprehensive Guide\"?", "prev_section_summary": "The section discusses the strategic approach to Manufacturing Execution Systems (MES) functions and ANSI/ISA-95 integration. It highlights how organizations can address industry challenges through MES functions and manufacturing operations activities, using models and standards to understand requirements associated with corporate objectives. The section also details the functional hierarchy model as described by ANSI/ISA-95 for integrating enterprise and control systems within manufacturing operations. Key topics include MES functions, industry profiles, order generation, process running, ANSI/ISA-95 standard, and functional hierarchy model.", "excerpt_keywords": "Manufacturing Execution Systems, ISA-95, Operational Management, Production Scheduling, Personnel Functions"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "44b32104-6048-49b3-b256-0faa2db47069", "node_type": "4", "metadata": {"page_label": "131", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "2d469a17356bff80cb90d1422bf05ab6073f899c439ebffeb77f0326dfd36330", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "7f889b10-ae38-4821-9242-a5d1a8d9a0d6", "node_type": "1", "metadata": {"page_label": "130", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "6a77a456e45d911e7587b0a6bb868b25b80e5a4d771248670aea7b815395bb69", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "7301ccf9-dba2-4446-b8c3-a53f3fe7ab01", "node_type": "1", "metadata": {}, "hash": "e34d86bec06eab9fc933896cac650e7c74172b6c426a370fe8d11612fadc06c7", "class_name": "RelatedNodeInfo"}}, "text": "## manufacturing execution systems - a strategic and program management approach\n\nfigure 17.1: isa-95.00.01-2000 functional hierarchy\n\n|business planning and logistics|\n|---|\n|level 4|plant production scheduling;|\n|level 3|operational management, etc.|\n|manufacturing operations and control|\n|dispatching production, detailed production scheduling,|\n|reliability assurance|\n|batch control|continuous control|discrete control|\n\nused with permission from isa, www.isa.org\n\nmanufacturing operations and control can be defined by level 3 activities, which include:\n\n- reporting on area production, including variable manufacturing costs\n- collecting and maintaining area data on production, inventory, manpower, raw materials, spare parts, and energy usage\n- performing data collection and off-line analysis as required by engineering functions. this may include statistical quality analysis and related control functions.\n- performing required personnel functions, such as work period statistics (e.g., time, and task), vacation scheduling, work force scheduling, union line of progression, and in-house training, and personnel qualification\n- establishing the immediate detailed production schedule for its own area, including maintenance, transportation, and other production-related needs\n- locally optimizing the costs for its individual production area, while performing the production schedule established by the level 4 functions\n- modifying production schedules to compensate for plant production interruptions that may occur in its area of responsibility", "start_char_idx": 0, "end_char_idx": 1560, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "7301ccf9-dba2-4446-b8c3-a53f3fe7ab01": {"__data__": {"id_": "7301ccf9-dba2-4446-b8c3-a53f3fe7ab01", "embedding": null, "metadata": {"page_label": "132", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Functional Data Flow Model in Manufacturing Execution Systems: Information Exchange and Organizational Structure", "questions_this_excerpt_can_answer": "1. How does the ANSI/ISA-95 functional enterprise-control model categorize the types of information necessary for manufacturing execution systems (MES) to support production processes, according to the GAMP(r) Good Practice Guide: Appendix 13?\n\n2. What specific types of operational and performance-related information are identified as critical for the exchange between manufacturing control systems and other business systems in the context of MES, as illustrated in the ANSI/ISA-95.00.03-2005 Figure 4?\n\n3. How does the document \"Functional Data Flow Model in Manufacturing Execution Systems: Information Exchange and Organizational Structure\" describe the role of organizational structure in determining the placement and flow of information within MES, and what implications does this have for different organizations implementing MES according to their unique operational groups?", "prev_section_summary": "The section discusses manufacturing operations and control in Level 3 activities within the ISA-95.00.01-2000 functional hierarchy for manufacturing execution systems. Key topics include reporting on area production, data collection and maintenance, personnel functions, detailed production scheduling, cost optimization, and modifying production schedules. Entities mentioned include variable manufacturing costs, area data on production, inventory, manpower, raw materials, spare parts, energy usage, work period statistics, vacation scheduling, work force scheduling, in-house training, maintenance, transportation, production interruptions, and level 4 functions.", "excerpt_keywords": "Manufacturing Execution Systems, ANSI/ISA-95, Information Exchange, Organizational Structure, Functional Data Flow Model"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "45f0b6e4-19ac-4fb1-ba1c-5ebc78c48a64", "node_type": "4", "metadata": {"page_label": "132", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "d981682fee826526882d170e412ded06135b194fa4824f04ad49a9b0603371ef", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "5af9d6f9-0a63-4b1f-b4b2-102095693a5f", "node_type": "1", "metadata": {"page_label": "131", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "2d469a17356bff80cb90d1422bf05ab6073f899c439ebffeb77f0326dfd36330", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "846a8491-7138-40c4-a7cb-cd8ec36ce09d", "node_type": "1", "metadata": {}, "hash": "01ef36b357e0996f828844978ce71e8e145c511f9aed08e2e1895d0691cf14c5", "class_name": "RelatedNodeInfo"}}, "text": "## page 130\n\n### gamp(r) good practice guide: appendix 13 manufacturing execution systems - a strategic and program management approach\n\n17.3.2 functional data flow model\n\nthe ansi/isa-95 (reference 3, appendix 14) functional enterprise-control model represents the functions of an enterprise involved with manufacturing, as well as the information flows between those functions that cross the enterprise-control interface. the model reflects an organizational structure (or domain) of functions rather than an organizational structure within a company. different organizations may choose to place these functions in different organizational groups.\n\n17.3.2.1 categories of information\n\nmost all information described in the functional enterprise-control model (see figure 17.2) fall into four main areas. these categories also provide an overview of information found in mes functionality:\n\n1. information required to produce a product\n2. information about pe capability to produce a product\n3. information about actual production of pe product\n4. information relating to production performance\n\nsome information in each of these four areas must be shared between the manufacturing control systems and other business systems as illustrated in figure 17.2. this diagram depicts the overlap of information between the illustrated organization levels.\n\nfigure 17.2: ansi/isa-95.00.03-2005 figure 4 - categories of information exchange\n\n|business planning and logistics information|\n|---|\n|plant production scheduling, operational management; etc.|\n|product definition information|production capability information|production schedule information|production performance information|\n|(what must be defined to make a product)|(what resources are available)|(what actual production will be executed)|(what actual production was achieved)|\n|manufacturing operations and control information|\n|production operations, maintenance operations, quality operations; etc.|\n\nused with permission from isa, www.isa.org", "start_char_idx": 0, "end_char_idx": 2002, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "846a8491-7138-40c4-a7cb-cd8ec36ce09d": {"__data__": {"id_": "846a8491-7138-40c4-a7cb-cd8ec36ce09d", "embedding": null, "metadata": {"page_label": "133", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Integration of Standards and Models in Manufacturing Operations: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What specific XML-based language is mentioned as an implementation of the ANSI/ISA-95 standards for enabling the exchange of data between manufacturing systems, and how is it structured?\n   \n2. How does the ANSI/ISA-S88 standard contribute to the improvement and control of batch manufacturing plants, and what are the specific parts and focus areas of this standard as outlined in the document?\n\n3. What is the role of the Supply Chain Operations Reference (SCOR) model as developed by the Supply Chain Council in manufacturing operations, and what are the top-level process types included in SCOR version 9.0 as mentioned in the document?", "prev_section_summary": "The section discusses the functional data flow model in Manufacturing Execution Systems (MES) according to the ANSI/ISA-95 functional enterprise-control model. It categorizes the types of information necessary for MES to support production processes, including information required to produce a product, information about production capability, information about actual production, and information relating to production performance. The document also describes the role of organizational structure in determining the placement and flow of information within MES, highlighting the implications for different organizations implementing MES based on their unique operational groups. The section includes a diagram illustrating the categories of information exchange between manufacturing control systems and other business systems in the context of MES.", "excerpt_keywords": "Manufacturing Execution Systems, ANSI/ISA-95, B2MML, ANSI/ISA-S88, SCOR Model"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "7198b60f-6dde-4014-800d-618666abc6bb", "node_type": "4", "metadata": {"page_label": "133", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "bd5b1e3cb14158e561bc4004f9283a44565872e1714ee65c752d32d345630c07", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "7301ccf9-dba2-4446-b8c3-a53f3fe7ab01", "node_type": "1", "metadata": {"page_label": "132", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "d981682fee826526882d170e412ded06135b194fa4824f04ad49a9b0603371ef", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "456acd62-a67a-48ac-8188-c143b1ff2705", "node_type": "1", "metadata": {}, "hash": "54a2c5d2637dbbf314c771b173c11142fa33eb21a524ab3a0a2104c6b03cc019", "class_name": "RelatedNodeInfo"}}, "text": "## manufacturing execution systems - a strategic and program management approach\n\n### appendix 13\n\n|17.4|xml and b2mml|\n|---|---|\n|extensible markup language (xml) was designed to meet the needs of electronic publishing and is used to enable the exchange of data between systems.|extensible markup language (xml) was designed to meet the needs of electronic publishing and is used to enable the exchange of data between systems.|\n|for further information regarding the sgml standard, see iso 8879 (reference 4, appendix 14).|for further information regarding the sgml standard, see iso 8879 (reference 4, appendix 14).|\n|business to manufacturing markup language (b2mml) is an xml implementation of the ansi/isa-95 family of standards (reference 3, appendix 14), known internationally as iec/iso 62264. b2mml consists of a set of xml schemas written using the world wide web consortiums xml schema language (xsd) to implement data models in the ansi/isa-95 standard.|business to manufacturing markup language (b2mml) is an xml implementation of the ansi/isa-95 family of standards (reference 3, appendix 14), known internationally as iec/iso 62264. b2mml consists of a set of xml schemas written using the world wide web consortiums xml schema language (xsd) to implement data models in the ansi/isa-95 standard.|\n\n|17.5|ansi/isa-s88|\n|---|---|\n|ansi/isa has developed a set of batch standards and monographs on the fundamentals and models used in batch processing. these control standards provide models and terminology for defining the control requirements for batch manufacturing and data structures, guidelines for languages, as well as general and site recipe models. the models and terminology defined in these standards:| |\n|- emphasize good practices for the design and operation of batch manufacturing plants| |\n|- can be used to improve control of batch manufacturing plants| |\n|- can be applied regardless of the degree of automation| |\n|batch management and control applications allow engineers and operators to access, analyze, summarize, and report production data. integrating that data through batch management and manufacturing operations applications to the enterprise will enable better-informed and faster decisions for running processes. in turn, results can be quantified into positive benefits, such as higher yields, reduced process deviations, and increased throughput to support financial justification of defined projects. the standards include the following:| |\n|- isa-88.01-1995 (r2006) - batch control part 1: models and terminology| |\n|- ansi/isa-88.02-2001 - batch control part 2: data structures and guidelines for languages| |\n|- ansi/isa-88.03-2003 - batch control part 3: general and site recipe models and representations| |\n|- ansi/isa-88.00.04-2006 - batch control part 4: batch production records| |\n|see reference 2, appendix 14.| |\n\n|17.6|the supply chain council scor model|\n|---|---|\n|the supply chain council is a global independent non-profit consortium that has developed a cross-industry supply chain operations reference (scor) model spanning all customer, product, and market interactions. the scor model is utilized to position manufacturing operations within the enterprise. organizations can use this model to assess, improve, and communicate supply-chain management. top-level process types in the scor version 9.0 include \"plan - source - make - deliver - return.\" additional information regarding the supply chain council and the scor model is available on their web site (reference 11, appendix 14).| |", "start_char_idx": 0, "end_char_idx": 3559, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "456acd62-a67a-48ac-8188-c143b1ff2705": {"__data__": {"id_": "456acd62-a67a-48ac-8188-c143b1ff2705", "embedding": null, "metadata": {"page_label": "134", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "MESA International: Promoting Best Practices in Manufacturing Execution Systems", "questions_this_excerpt_can_answer": "1. What is the role of the Manufacturing Enterprise Solutions Association (MESA) in the context of Manufacturing Execution Systems (MES)?\n   \n2. Can you detail the types of resources MESA International provides for understanding MES, specifically mentioning any high-level vision documents for executives?\n\n3. How does the GAMP\u00ae Good Practice Guide: Appendix 13 contribute to the strategic and program management approach of Manufacturing Execution Systems, and how is MESA International involved in this context?", "prev_section_summary": "This section discusses the integration of standards and models in manufacturing operations, focusing on XML-based language, ANSI/ISA-95 standards, ANSI/ISA-S88 standard for batch manufacturing plants, and the Supply Chain Operations Reference (SCOR) model. Key topics include the use of XML and B2MML for data exchange, the benefits of ANSI/ISA-S88 standards for batch control, and the role of SCOR model in assessing and improving supply chain management. The section also outlines specific standards and models such as ISA-88.01, ISA-88.02, ISA-88.03, and ISA-88.00.04 for batch control.", "excerpt_keywords": "Manufacturing Execution Systems, MESA International, standards, models, GAMP\u00ae Good Practice Guide"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "55b8a25c-3c1b-427f-a4b8-b5fbbfd54258", "node_type": "4", "metadata": {"page_label": "134", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "0f524961c8447b2f5060e54cf03fe3e70f42eab1db0764e48b1ec99feb0f869d", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "846a8491-7138-40c4-a7cb-cd8ec36ce09d", "node_type": "1", "metadata": {"page_label": "133", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "bd5b1e3cb14158e561bc4004f9283a44565872e1714ee65c752d32d345630c07", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "da70a9ca-025b-4c0e-8f98-f1d7763860df", "node_type": "1", "metadata": {}, "hash": "1d42bea618974de286ca7ebcf2a4e09ab33f17258affd10bbce8ced13bba9ed6", "class_name": "RelatedNodeInfo"}}, "text": "## page 132\n\ngamp (r) good practice guide: appendix 13\nmanufacturing execution systems - a strategic and program management approach\n\n17.7 mesa international\n\nthe manufacturing enterprise solutions association (mesa) is a private organization that promotes the exchange of best-practices, strategies, and innovation around operations-centric enterprise solutions. they have defined standard methodologies and approaches with descriptions of functions and activities for the mes domain.\n\nadditional information regarding mesa international and their models may be found on their website and in a series of whitepapers including \"mes explained: a high level vision for executives\" (reference 10, appendix 14).", "start_char_idx": 0, "end_char_idx": 707, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "da70a9ca-025b-4c0e-8f98-f1d7763860df": {"__data__": {"id_": "da70a9ca-025b-4c0e-8f98-f1d7763860df", "embedding": null, "metadata": {"page_label": "135", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Execution Systems: Regulatory Standards and Best Practices in the Pharmaceutical Industry", "questions_this_excerpt_can_answer": "1. What are the specific ANSI/ISA standards referenced in the document for batch control and enterprise-control system integration within the pharmaceutical manufacturing execution systems, and what do they cover in terms of content and guidelines?\n\n2. How does the ISPE GAMP\u00ae 5 guide propose a risk-based approach to compliant GXP computerized systems, and what are the publication dates and focus areas of the ISPE GAMP\u00ae Good Practice Guides mentioned in the document?\n\n3. What editions and publication dates are provided for the ISPE Baseline\u00ae Pharmaceutical Engineering Guide series volumes on active pharmaceutical ingredients and oral solid dosage forms, and how might these resources contribute to understanding regulatory standards and best practices in the pharmaceutical industry?", "prev_section_summary": "The section discusses the role of the Manufacturing Enterprise Solutions Association (MESA) in promoting best practices, strategies, and innovation in Manufacturing Execution Systems (MES). MESA provides standard methodologies, approaches, and resources for understanding MES, including high-level vision documents for executives. The GAMP\u00ae Good Practice Guide: Appendix 13 contributes to the strategic and program management approach of MES, with MESA International being involved in this context.", "excerpt_keywords": "Manufacturing Execution Systems, ANSI/ISA standards, GAMP\u00ae 5 guide, ISPE Baseline\u00ae Pharmaceutical Engineering Guide, pharmaceutical industry"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "609165c3-5c2f-4e6d-880e-332f8d3dd8ee", "node_type": "4", "metadata": {"page_label": "135", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "aa73696161a9b3b1b4d7abbaa4b8af0fbfc951734c5ba03dbdace178271691c7", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "456acd62-a67a-48ac-8188-c143b1ff2705", "node_type": "1", "metadata": {"page_label": "134", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "0f524961c8447b2f5060e54cf03fe3e70f42eab1db0764e48b1ec99feb0f869d", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "3616b589-5d76-49e6-8f6c-e15905fc1821", "node_type": "1", "metadata": {}, "hash": "357e5b4044476bd459af6320644b279e37c7e54d3d762e831fdcda07e535976c", "class_name": "RelatedNodeInfo"}}, "text": "## manufacturing execution systems - a strategic and program management approach\n\n### appendix 14\n\n### appendix 14 - references\n\n1. quality risk management - q9, international conference on harmonization of technical requirements for registration of pharmaceuticals for human use (ich), www.ich.org\n2. ansi/isa 88 standard, www.isa.org\n* ansi/isa 88.01-1995 (r2006) batch control part 1: models and terminology.\n* ansi/isa-88.00.02-2001, batch control part 2: data structures and guidelines for languages.\n* ansi/isa-88.00.03-2003, batch control part 3: general and site recipe models and representation.\n* ansi/isa-88.00.04-2006, batch control part 4: batch production records.\n3. ansi/isa 95 standard, www.isa.org\n* ansi/isa-95.00.01-2000, enterprise-control system integration, part 1: models and terminology.\n* ansi/isa-95.00.02-2001, enterprise-control system integration, part 2: object model attributes.\n* ansi/isa-95.00.03-2005, enterprise-control system integration, part 3: activity models of manufacturing operations management.\n* ansi/isa-95.00.05-2007, enterprise-control system integration, part 5: business-to-manufacturing transactions.\n4. iso 8879:1986 information processing -- text and office systems -- standard generalized markup language (sgml), www.iso.org\n5. ispe gamp (r) 5: a risk-based approach to compliant gxp computerized systems, international society for pharmaceutical engineering (ispe), fifp edition, february 2008, www.ispe.org\n6. ispe gamp (r) good practice guides, international society for pharmaceutical engineering (ispe), www.ispe.org\n* risk-based approach to compliant electronic records and signatures, february 2005\n* global information systems control and compliance, november 2005\n* testing of gxp systems, december 2005\n* electronic data archiving, july 2007\n* a risk-based approach to operation of gxp computerized systems, january 2010\n7. ispe baseline (r) pharmaceutical engineering guide series, international society for pharmaceutical engineering (ispe), www.ispe.org\n* volume 1: active pharmaceutical ingredients, second edition, june 2007\n* volume 2: oral solid dosage forms, first edition, february 1998", "start_char_idx": 0, "end_char_idx": 2160, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "3616b589-5d76-49e6-8f6c-e15905fc1821": {"__data__": {"id_": "3616b589-5d76-49e6-8f6c-e15905fc1821", "embedding": null, "metadata": {"page_label": "136", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Pharmaceutical Manufacturing Systems and Regulations: A Comprehensive Guide\"", "questions_this_excerpt_can_answer": "1. What specific ASTM standard guide is recommended for the specification, design, and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipment, including its publication year?\n   \n2. Can you list any resources or guides that provide a strategic and program management approach to Manufacturing Execution Systems (MES) within the pharmaceutical industry, as outlined in the GAMP (r) Good Practice Guide's appendix?\n\n3. What are the publication years and focus areas of the first editions of volumes 3 through 6 as mentioned in the context, specifically relating to pharmaceutical manufacturing facilities and their associated systems?", "prev_section_summary": "The section discusses Manufacturing Execution Systems in the pharmaceutical industry, focusing on regulatory standards and best practices. Key topics include ANSI/ISA standards for batch control and enterprise-control system integration, ISPE GAMP\u00ae 5 guide's risk-based approach to compliant GXP computerized systems, and ISPE Baseline\u00ae Pharmaceutical Engineering Guide series volumes on active pharmaceutical ingredients and oral solid dosage forms. Entities mentioned include ANSI/ISA, ISPE, ICH, and ISO.", "excerpt_keywords": "Manufacturing Execution Systems, Pharmaceutical Industry, GAMP Good Practice Guide, ASTM Standard, MES Vision"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "788c1007-dee3-4e91-8b8d-3c82b476297f", "node_type": "4", "metadata": {"page_label": "136", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "e055ceb1d07ac7269437ebdf486bc16cf9f076a45cfb643975baa967377e63c0", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "da70a9ca-025b-4c0e-8f98-f1d7763860df", "node_type": "1", "metadata": {"page_label": "135", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "aa73696161a9b3b1b4d7abbaa4b8af0fbfc951734c5ba03dbdace178271691c7", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "b65eb375-73c5-46d4-b3f0-515156d55d18", "node_type": "1", "metadata": {}, "hash": "92996b929e3103fcf7350a8f60dc98c0dc7d0c333cbce6cec31926a5d1af76d0", "class_name": "RelatedNodeInfo"}}, "text": "## gamp (r) good practice guide: appendix 14 manufacturing execution systems - a strategic and program management approach\n\nvolume 3: sterile manufacturing facilities, first edition, january 1999\nvolume 4: water and steam systems, first edition, january 2001\nvolume 5: commissioning and qualification, first edition, march 2001\nvolume 6: biopharmaceutical manufacturing facilities, first edition, june 2004\n\n8. astm standard e2500-07: standard guide for specification, design, and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipment, astm international, www.astm.org.\n\n9. a reference model for computer integrated manufacturing, edited by t. j. williams, 1989, instrument society of america, www.isa.org\n\n10. mes explained: a high level vision for executives, (white paper #06), mesa international, www.mesa.org.\n\n11. supply chain council (scc), www.supply-chain.org.\n\n### bibliography\n\n12. us fda code of federal regulations (cfr), title 21, food and drugs, www.fda.gov.\n\n- part 11: electronic records, electronic signatures\n- part 820: quality system regulation (medical device)\n\n13. us fda - design control guidance for medical device manufacturers, www.fda.gov.\n\n14. us fda, general principles of validation, rockville, md, center for drug evaluation and research (cder), may 1987, www.fda.gov.\n\n15. commission of the european communities, ec guide to good manufacturing practice for medicinal products in the rules governing medicinal products in the european community, volume iv, office for official publications for the european communities, luxembourg, 1992, isbn 92-826-3180-x105.\n\n16. pharmaceutical inspection convention (pic), guide to good manufacturing practice for pharmaceutical products, published in: international drug gmps, buffalo grove, il; interpharm, 1993, isbn 0-935184-17-1.\n\n17. \"best practice for service support,\" office of government commerce, tso, 2000.\n\n18. astm e2537-08: standard guide for application of continuous quality verification to pharmaceutical and biopharmaceutical manufacturing, astm international, www.astm.org.\n\n19. automation and validation of information in pharmaceutical processing, despautz, j.f. and kovacs k.s., new york, n.y.: marcel dekker, 1998.\n\n20. despautz, joseph and gregory ruklic, \"domain methodology for computer system specification and verification applied to mes,\" pharmaceutical engineering, may/june 2008, vol. 28, no. 3, pp 58-64, www.ispe.org.\n\n21. world health organization, good practices for the manufacture and quality control of drugs, published in: international drug gmps, buffalo grove, il; interpharm, 1993, isbn 0-935184-17-1.\n\n22. world batch forum (wbf) - the organization for production technology, www.wbf.org.", "start_char_idx": 0, "end_char_idx": 2736, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "b65eb375-73c5-46d4-b3f0-515156d55d18": {"__data__": {"id_": "b65eb375-73c5-46d4-b3f0-515156d55d18", "embedding": null, "metadata": {"page_label": "137", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Abbreviations and Acronyms in Manufacturing and Quality Control Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What does the acronym \"CAPA\" stand for in the context of manufacturing and quality control systems, as outlined in the ISPE Manufacturing Execution Systems guide?\n   \n2. In the comprehensive guide on abbreviations and acronyms in manufacturing and quality control systems provided by the ISPE document, how is \"PAT\" defined, and what does it signify within the pharmaceutical manufacturing industry?\n\n3. According to the glossary appendix in the ISPE Manufacturing Execution Systems document, what is the meaning of \"EBR\" and how does it relate to the documentation processes within pharmaceutical manufacturing environments?", "prev_section_summary": "The section provides information on Manufacturing Execution Systems (MES) within the pharmaceutical industry, including recommended resources and guides for strategic and program management approaches. It also mentions specific ASTM standards for pharmaceutical manufacturing systems and equipment, as well as references to regulatory guidelines from organizations such as the US FDA and the European Commission. The section covers topics such as validation, quality control, and good manufacturing practices in pharmaceutical facilities. Key entities mentioned include ASTM International, GAMP (r) Good Practice Guide, US FDA, Commission of the European Communities, and World Health Organization.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Abbreviations, Acronyms, Pharmaceutical Industry"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "f63a41a5-da42-45d8-8385-10c490fd5315", "node_type": "4", "metadata": {"page_label": "137", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "e80805b86a3981d3103b9f5b89ea20eac5f2081c4804654049f858bab375f9aa", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "3616b589-5d76-49e6-8f6c-e15905fc1821", "node_type": "1", "metadata": {"page_label": "136", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "e055ceb1d07ac7269437ebdf486bc16cf9f076a45cfb643975baa967377e63c0", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "a318aa1f-2c33-4d24-b239-fa48cce554e7", "node_type": "1", "metadata": {}, "hash": "b23709d8efd33667b44e639908644d240313a75eee57c6791b2c64fd87560adc", "class_name": "RelatedNodeInfo"}}, "text": "## appendix 15 - glossary\n\n|abbreviations and acronyms|\n|---|\n|api|application programming interface|\n|capa|corrective and preventive action|\n|ccp|critical process parameter|\n|cip|clean in place|\n|dcs|distributed control system|\n|ebr|electronic batch record|\n|edhr|electronic device history record|\n|epr|electronic production record|\n|eprs|electronic production record system|\n|erp|enterprise resource planning|\n|gep|good engineering practice|\n|id|identification|\n|kpi|key performance indicator|\n|lims|laboratory information management system|\n|mbr|master batch record|\n|mrp|manufacturing resource planning|\n|pat|process analytical technology|\n|plc|programmable logic controller|\n|pmo|program management office|\n|rbe|review by exception|\n|rfid|radio frequency identification|\n|scada|supervisory control and data acquisition|\n|sip|sterilize in place|\n|sme|subject matter expert|", "start_char_idx": 0, "end_char_idx": 877, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "a318aa1f-2c33-4d24-b239-fa48cce554e7": {"__data__": {"id_": "a318aa1f-2c33-4d24-b239-fa48cce554e7", "embedding": null, "metadata": {"page_label": "138", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Execution Systems: Strategic Program Management and Best Practices", "questions_this_excerpt_can_answer": "1. What specific appendix in the GAMP (Good Automated Manufacturing Practice) guide focuses on Manufacturing Execution Systems from a strategic and program management approach?\n   \n2. As of the document's last update in 2024, what are the standard abbreviations used in the context of Manufacturing Execution Systems, specifically for terms like \"standard operating procedure,\" \"visual basic for applications,\" \"validation master plan,\" and \"work in progress\"?\n\n3. What document provides detailed insights into strategic program management and best practices for Manufacturing Execution Systems, including a specific appendix dedicated to these systems within the GAMP guide?", "prev_section_summary": "The section provides a glossary of abbreviations and acronyms commonly used in manufacturing and quality control systems within the pharmaceutical industry. Key topics covered include electronic batch records (EBR), corrective and preventive actions (CAPA), process analytical technology (PAT), and various system and record types such as electronic production records (EPR) and master batch records (MBR). The glossary also includes terms related to control systems, documentation processes, and quality management practices.", "excerpt_keywords": "Manufacturing Execution Systems, GAMP, strategic program management, appendix, best practices"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "4a6b9a9d-6219-4b69-9934-eb72a3effbfd", "node_type": "4", "metadata": {"page_label": "138", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "e9e8c6a959ed21e51d24122652f11bc4184d8ae82b57eeb0fbbb8e4062b8990b", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "b65eb375-73c5-46d4-b3f0-515156d55d18", "node_type": "1", "metadata": {"page_label": "137", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "e80805b86a3981d3103b9f5b89ea20eac5f2081c4804654049f858bab375f9aa", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "637ce344-ca85-41a0-985b-441e52fa6e5d", "node_type": "1", "metadata": {}, "hash": "0d9e57ccd86bf77334b27536ba93456dbf726dd468ec4cf90c317fb74c62ea5d", "class_name": "RelatedNodeInfo"}}, "text": "# page 136\n\n|sop|standard operating procedure|\n|---|---|\n|vba|visual basic for applications|\n|vmp|validation master plan|\n|wip|work in progress|\n\n## gamp (r)good practice guide: appendix 15 manufacturing execution systems - a strategic and program management approach", "start_char_idx": 0, "end_char_idx": 267, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "637ce344-ca85-41a0-985b-441e52fa6e5d": {"__data__": {"id_": "637ce344-ca85-41a0-985b-441e52fa6e5d", "embedding": null, "metadata": {"page_label": "139", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Understanding Manufacturing Execution Systems: Key Definitions and Functions", "questions_this_excerpt_can_answer": "1. What specific functions does the GAMP(r) Good Practice Guide associate with the term \"dispatching production units\" in the context of Manufacturing Execution Systems, and how does it describe the ability of these systems to adapt to real-time changes on the factory floor?\n\n2. How does the document define \"document control\" within Manufacturing Execution Systems, particularly in relation to maintaining production unit records/forms and ensuring compliance with environmental, health, and safety regulations?\n\n3. In the context of Manufacturing Execution Systems as outlined in the GAMP(r) Good Practice Guide, how is \"effluent management\" described in terms of its growing importance and its specific relevance to the pharmaceutical manufacturing sector?", "prev_section_summary": "The section discusses Manufacturing Execution Systems from a strategic and program management perspective, focusing on best practices and insights provided in the GAMP guide. It includes standard abbreviations used in the context of Manufacturing Execution Systems such as \"sop\" for standard operating procedure, \"vba\" for visual basic for applications, \"vmp\" for validation master plan, and \"wip\" for work in progress. The specific appendix in the GAMP guide, \"Appendix 15 Manufacturing Execution Systems - A Strategic and Program Management Approach,\" is highlighted as a key resource for detailed insights into this topic.", "excerpt_keywords": "Manufacturing Execution Systems, GAMP, Dispatching Production Units, Document Control, Effluent Management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "e99c39bb-8b55-46e0-bb34-71f2f9a8dae4", "node_type": "4", "metadata": {"page_label": "139", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "8d0acbef24fd3d237305242e67031e85e50fccf201b794eaf96ee2e87e25520b", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "a318aa1f-2c33-4d24-b239-fa48cce554e7", "node_type": "1", "metadata": {"page_label": "138", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "e9e8c6a959ed21e51d24122652f11bc4184d8ae82b57eeb0fbbb8e4062b8990b", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "6926015e-2169-4766-b5a7-5bcb1a799768", "node_type": "1", "metadata": {}, "hash": "e36c33a5d4e9f900c3fbb84fe1e684808c9270ab1960d6aa441f26b492bf4f37", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 15\n\n|19.2 definitions|\n|---|\n|automation|the creation and application of technology to monitor and control the production of goods and services. intrinsic to automation is instrumentation and basic control dedicated to establishing and maintaining a specific state of equipment or process condition.|\n|data collection/acquisition|this function provides an interface link to obtain the inter-operational production and parametric data that populate the forms and records that were attached to the production unit. the data may be collected from the factory floor either manually or automatically from equipment in an up-to-the-minute time frame.|\n|dispatching production units|management of the flow of production units in the form of jobs, orders, batches/runs, lots, and work orders. dispatch information is presented in the sequence in which the work needs to be done and changes in real time as events occur on the factory floor. it has the ability to alter the prescribed schedule on the factory floor. rework and salvage processes are available, as well as the ability to control the amount of work in process at any point with buffer management.|\n|document control|controls records/forms that must be maintained with the production unit, including work instructions, recipes, drawings, standard operation procedures, part programs, production records, engineering change notices, shift-to-shift communication, as well as the ability to edit \"as planned\" and \"as built\" information. it sends instructions down to the operations, including providing data to operators or recipes to device controls. it might also include the control and integrity of environmental, health, and safety regulations, and iso information, such as corrective action procedures. storage of historical data is provided.|\n|effluent management|effluent management is becoming more important with the impact it has on the environment. it is especially important for categories of drugs whose waste cannot be discharged to drains without special filtration etc.|\n|electronic batch record (ebr)|electronic records in one or more systems/applications comprised of the elements of paper master batch records as well as production batch records. these elements typically include work instructions and recipes equivalent to master batch records, as well as actual results, e-signatures, and data from execution equivalent to paper production batch records.|\n|electronic batch record system (ebrs)|one or more systems/applications that facilitate the creation/revision, approval, distribution, execution, and data collection of electronic batch record elements; a computer system that stores, in electronic format, the batch record information required by healthcare regulations.|", "start_char_idx": 0, "end_char_idx": 2874, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "6926015e-2169-4766-b5a7-5bcb1a799768": {"__data__": {"id_": "6926015e-2169-4766-b5a7-5bcb1a799768", "embedding": null, "metadata": {"page_label": "140", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Management of Electronic Device History Records in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the GAMP(r) Good Practice Guide define the term \"Electronic Production Record (EPR)\" in the context of manufacturing execution systems for medical device manufacture, and what does it encompass?\n\n2. What specific functionalities does the Labor Management module provide within a Manufacturing Execution System (MES) as outlined in the ISPE Manufacturing Execution Systems guide, and how does it contribute to activity-based costing?\n\n3. According to the document \"Strategic Management of Electronic Device History Records in Manufacturing Execution Systems: A Comprehensive Guide,\" how does the Performance Analysis module in an MES environment contribute to the evaluation of manufacturing operations, and what key performance indicators does it track?", "prev_section_summary": "The section provides definitions and explanations related to Manufacturing Execution Systems (MES) as outlined in the GAMP(r) Good Practice Guide. Key topics include automation, data collection/acquisition, dispatching production units, document control, effluent management, electronic batch record (EBR), and electronic batch record system (EBRS). These definitions cover the monitoring and control of production processes, the management of production unit flow, the control of records/forms, the importance of effluent management for environmental impact, and the use of electronic records in MES. The section emphasizes the importance of real-time adaptability, compliance with regulations, and the efficient management of production processes in the pharmaceutical manufacturing sector.", "excerpt_keywords": "Manufacturing Execution Systems, Electronic Device History Records, GAMP Good Practice Guide, Labor Management, Performance Analysis"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "d6b99cfc-37eb-4d6c-ad59-881ba655d35f", "node_type": "4", "metadata": {"page_label": "140", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "b1a2abba2fcea967dc396f0637530a49df3bf4caebbb403b53424a6f6e03e2c2", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "637ce344-ca85-41a0-985b-441e52fa6e5d", "node_type": "1", "metadata": {"page_label": "139", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "8d0acbef24fd3d237305242e67031e85e50fccf201b794eaf96ee2e87e25520b", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "89d03d87-b133-433b-a74c-1c067c0584e9", "node_type": "1", "metadata": {}, "hash": "7ad6e659a77200c7062a35659b8d408b37f1f8a5dd9eea844b4f17f7d41bd75a", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: appendix 15 electronic device history record (edhr) manufacturing execution systems - a strategic and program management approach\n\nelectronic records in one or more systems/applications comprised of the elements of paper master device history records as well as production records for medical device manufacture. these elements typically include work instructions and recipes equivalent to master device records, as well as actual results, e-signatures, and data from execution equivalent to paper device history production records.\n\nelectronic production record (epr): a term to mean either ebr or edhr.\n\nenterprise resource planning (erp): a way to integrate the data and processes of an organization into one single system to perform business functions at the enterprise level.\n\nlabor management: provides status of personnel in an up-to-the-minute time frame. includes time and attendance reporting, certification tracking, as well as the ability to track indirect activities, such as material preparation or tool room work as a basis for activity-based costing. it may interact with resource allocation to determine optimal assignments.\n\nmaintenance management: tracks and directs the activities to maintain the equipment and tools to ensure their availability for manufacturing and ensure scheduling for periodic or preventive maintenance. also provides the response (alarms) to immediate problems. it maintains a history of past events or problems to aid in diagnosing problems.\n\nmesa functional model entities: the various modules that compose the functions executed in an mes environment.\n\noperations/detail scheduling: provides sequencing based on priorities, attributes, characteristics, and/or recipes associated with specific production units at an operation, such as shape, color sequencing, or other characteristics that, when scheduled in sequence properly, minimize set-up. it is finite and recognizes alternative and overlapping/parallel operations in order to calculate, in detail, exact time of equipment loading adjusted to shift patterns.\n\nperformance analysis: provides up-to-the-minute reporting of actual manufacturing operations results along with the comparison to past history and expected business results. performance results include such measurements as resource utilization, resource availability, product unit cycle time, conformance to schedule, and performance to standards. it may include spc/sqc. performance analysis draws on information gathered from different functions that measure operating parameters. these results may be prepared as a periodic report or presented online as the current evaluation of performance.", "start_char_idx": 0, "end_char_idx": 2689, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "89d03d87-b133-433b-a74c-1c067c0584e9": {"__data__": {"id_": "89d03d87-b133-433b-a74c-1c067c0584e9", "embedding": null, "metadata": {"page_label": "141", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Integration of Process Analytical Technology (PAT) in Manufacturing Execution Systems: Key Components and Benefits\"", "questions_this_excerpt_can_answer": "1. How does the GAMP\u00ae Good Practice Guide define the role of Process Analytical Technology (PAT) in the context of Manufacturing Execution Systems (MES), particularly in ensuring final product quality?\n   \n2. What specific functionalities does the document describe as essential for effective product tracking and genealogy within Manufacturing Execution Systems, and how do these functionalities contribute to maintaining product quality and traceability?\n\n3. Can you detail the \"Review by Exception (RBE)\" approach as outlined in the document, including how it streamlines the review and approval process in validated manufacturing operations within the context of Manufacturing Execution Systems?", "prev_section_summary": "The section discusses the strategic management of Electronic Device History Records (EDHR) in Manufacturing Execution Systems (MES). Key topics include the definition of Electronic Production Record (EPR), the functionalities of Labor Management and Maintenance Management modules within an MES, the role of Enterprise Resource Planning (ERP) in integrating organizational data, and the importance of Performance Analysis in evaluating manufacturing operations. The section also mentions the MES functional model entities and their functions, such as operations/detail scheduling for sequencing production units and performance analysis for reporting actual manufacturing results.", "excerpt_keywords": "Process Analytical Technology, Manufacturing Execution Systems, Product Tracking, Genealogy, Review by Exception"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "b98be6f3-0d02-4110-b225-95e243a5d6bf", "node_type": "4", "metadata": {"page_label": "141", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "85ddfb45c8b6970d377c7da716671fe8dd607c4958f8096ef7f6f75699999ac7", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "6926015e-2169-4766-b5a7-5bcb1a799768", "node_type": "1", "metadata": {"page_label": "140", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "b1a2abba2fcea967dc396f0637530a49df3bf4caebbb403b53424a6f6e03e2c2", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "38f88134-1375-425d-b038-e116575e90f0", "node_type": "1", "metadata": {}, "hash": "3b999d7ed608a61cdf98d608a01d6427c55c2e2c3ca3919c7bc5319a40662bec", "class_name": "RelatedNodeInfo"}}, "text": "## gamp(r) good practice guide: manufacturing execution systems - a strategic and program management approach\n\n### appendix 15\n\nprocess analytical technology (pat)\n\nfor the purposes of this guidance, pat is considered to be a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.\n\nprocess management\n\nmonitors production and either automatically corrects or provides decision support to operators for correcting and improving in-process activities. these activities may be inter-operational and focus specifically on machines or equipment being monitored and controlled, as well as intra-operational, which is tracking the process from one operation to the next. it may include alarm management to make sure factory personnel are aware of process changes that are outside acceptable tolerances. it provides interfaces between intelligent equipment and mes, possibly through data collection/acquisition.\n\nproduct tracking and genealogy\n\nprovides the visibility to where work is at all times and its disposition. status information may include who is working on it; components, materials by supplier, lot, serial number, current production conditions, and any alarms, rework, or other exceptions related to the product. the on-line tracking function creates a historical record, as well. this record allows traceability of components and usage of each end product.\n\nquality management\n\nprovides real-time analysis of measurements collected from manufacturing to assure proper product quality control and to identify problems requiring attention. it may recommend action to correct the problem, including correlating the symptom, actions, and results to determine the cause. may include spc/sqc tracking and management of off-line inspection operations, and analysis from a laboratory information management system (lims) could also be included.\n\nresource allocation and status management\n\nmanagement of resources, including machines, tools, labor skills, materials, other equipment, and other entities, such as documents that must be available in order for work to start at the operation. it provides a detailed history of resources and ensures that equipment is properly set up for processing and provides status real-time. the management of these resources includes reservation and dispatching to meet operation scheduling objectives.\n\nreview by exception (rbe)\n\nthe approach whereby manufacturing and quality data generated in validated manufacturing operations is screened to present or report only critical process exceptions required by approvers for review and disposition of intermediates and products; requirement for human review/approval of completed electronic production records only when a production parameter is out of specifications or there is some other discrepancy or critical exception condition.", "start_char_idx": 0, "end_char_idx": 3020, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "38f88134-1375-425d-b038-e116575e90f0": {"__data__": {"id_": "38f88134-1375-425d-b038-e116575e90f0", "embedding": null, "metadata": {"page_label": "142", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Validation and Verification in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What specific ASTM standard is referenced in the document for the application of continuous quality verification to pharmaceutical and biopharmaceutical manufacturing, and what is its main purpose?\n   \n2. How does the document differentiate between the terms \"validation\" and \"verification\" in the context of Manufacturing Execution Systems, according to ISO 9000-3 guidelines?\n\n3. What is the definition of \"Work in Progress\" (WIP) as described in the document, and how does it relate to the manufacturing process within the pharmaceutical and biopharmaceutical industry?", "prev_section_summary": "The section discusses the integration of Process Analytical Technology (PAT) in Manufacturing Execution Systems (MES) and highlights key components such as process management, product tracking and genealogy, quality management, resource allocation and status management, and review by exception (RBE). PAT is defined as a system for designing, analyzing, and controlling manufacturing through timely measurements of critical quality and performance attributes. Process management involves monitoring production and providing decision support to operators, while product tracking and genealogy ensures visibility and traceability of work and components. Quality management focuses on real-time analysis of measurements to assure product quality control. Resource allocation and status management involves managing resources and ensuring equipment is properly set up. Review by exception streamlines the review and approval process by presenting critical process exceptions for review and disposition.", "excerpt_keywords": "Manufacturing Execution Systems, Validation, Verification, ASTM standard, Work in Progress (WIP)"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "27b84373-5038-4c3a-a8c8-59dca150a65b", "node_type": "4", "metadata": {"page_label": "142", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "1593394bf57045d5ce29265e72cd1103116f89f7878c47709fb13f19d02d43cf", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "89d03d87-b133-433b-a74c-1c067c0584e9", "node_type": "1", "metadata": {"page_label": "141", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "85ddfb45c8b6970d377c7da716671fe8dd607c4958f8096ef7f6f75699999ac7", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "9cde98f2-1acb-4972-8761-f2bae8a20ee7", "node_type": "1", "metadata": {}, "hash": "560868bc66407dac93d113290955c264745be29f8fa3f72e78c0ec810abda9a3", "class_name": "RelatedNodeInfo"}}, "text": "## page 140\n\ngamp(r) good practice guide: appendix 15\n\nmanufacturing execution systems - a strategic and program management approach\n\nvalidation\ndefined generically, a process to determine pat a system or process is fit for pe intended use. in astm 2500-07 and gamp 5, verification in concert wip design review activities fulfill pis objective.\n\nvalidation and verification\niso 9000-3, pe international guidelines for pe development, supply, and maintenance of software differentiate between verification and validation.\n\nverification\ndefined as \"the process of evaluating pe products of a given phase to ensure correctness and consistency wip respect to products and standards provided as input to pat phase\".\n\nverification standard (astm e2537-08)\nguide for application of continuous quality verification to pharmaceutical and biopharmaceutical manufacturing.\n\npurpose is to address pe application of continuous quality verification to pose manufacturing processes pat employ modern quality management systems often supplemented wip modern process analytical chemistry systems and controls.\n\nwork in progress (wip)\nthe name given to materials pat are in pe process of being converted into finished product.", "start_char_idx": 0, "end_char_idx": 1208, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "9cde98f2-1acb-4972-8761-f2bae8a20ee7": {"__data__": {"id_": "9cde98f2-1acb-4972-8761-f2bae8a20ee7", "embedding": null, "metadata": {"page_label": "143", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Quanta-cs: Change Comes from Within - A Comprehensive Guide to Personal Transformation\"", "questions_this_excerpt_can_answer": "1. What is the contact information for Quanta-cs, including their physical address, telephone number, fax number, and website URL?\n2. As of the document's last modification in April 2024, what is the title of the comprehensive guide focused on personal transformation published by Quanta-cs?\n3. In which town and county is Quanta-cs's office located, according to the document titled \"Quanta-cs: Change Comes from Within - A Comprehensive Guide to Personal Transformation\"?", "prev_section_summary": "The section discusses the concepts of validation and verification in Manufacturing Execution Systems, referencing ASTM standards and ISO guidelines. It explains the difference between the two terms and highlights the importance of continuous quality verification in pharmaceutical and biopharmaceutical manufacturing. The document also defines \"Work in Progress\" (WIP) as materials in the process of being converted into finished products within the industry.", "excerpt_keywords": "Quanta-cs, personal transformation, validation, verification, pharmaceutical manufacturing"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "11c6bb37-290e-46f2-bf56-0bbefee9114f", "node_type": "4", "metadata": {"page_label": "143", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "ecad8292ba274edde51296bf23af169c211c3eda143f35ebbfffd9ba42544ea9", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "38f88134-1375-425d-b038-e116575e90f0", "node_type": "1", "metadata": {"page_label": "142", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "1593394bf57045d5ce29265e72cd1103116f89f7878c47709fb13f19d02d43cf", "class_name": "RelatedNodeInfo"}, "3": {"node_id": "15145626-ec74-4e02-b1ab-92b603c439b3", "node_type": "1", "metadata": {}, "hash": "b7f722a9baf06da969cc8efc83debeb408f1d10998021eaa3dd6a039e9b0c95a", "class_name": "RelatedNodeInfo"}}, "text": "cis anita aplliude change comes from within ofv | f casile chambers, high street tel: +44 (0) 1442 870700 email: contact@quanta-cs.com berkhamsled, herts hp4 2df fax: +44 (0) 1442 870400 website: www.quanta-cs.com\n\n berkhamsled, herts hp4 2df fax: +44 (0) 1442 870400 website: www.quanta-cs.com", "start_char_idx": 0, "end_char_idx": 294, "text_template": "[Excerpt from document]\n{metadata_str}\nExcerpt:\n-----\n{content}\n-----\n", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "15145626-ec74-4e02-b1ab-92b603c439b3": {"__data__": {"id_": "15145626-ec74-4e02-b1ab-92b603c439b3", "embedding": null, "metadata": {"page_label": "144", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Optimizing Efficiency and Ensuring Compliance in Bio-Pharma Manufacturing with PAS-X\"", "questions_this_excerpt_can_answer": "1. What is the primary goal of bio-pharma companies in terms of paperwork and productivity as outlined in the document titled \"Optimizing Efficiency and Ensuring Compliance in Bio-Pharma Manufacturing with PAS-X\"?\n\n2. How many of the world's top 30 pharmaceutical and biotech companies have chosen Werum's MES product suite PAS-X for their manufacturing business, according to the document?\n\n3. What are the locations of Werum's headquarters and its regional headquarters in the U.S. and Asia-Pacific, as mentioned in the document \"Optimizing Efficiency and Ensuring Compliance in Bio-Pharma Manufacturing with PAS-X\"?", "prev_section_summary": "The key topics and entities of the section include Quanta-cs, a company focused on personal transformation, their contact information such as physical address, telephone number, fax number, and website URL, and the title of their comprehensive guide on personal transformation titled \"Change Comes from Within.\" The location of Quanta-cs's office is also mentioned in the excerpt.", "excerpt_keywords": "bio-pharma, manufacturing, efficiency, compliance, PAS-X"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {"1": {"node_id": "69abe77a-980e-45dd-afac-e297441427a1", "node_type": "4", "metadata": {"page_label": "144", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "2907697f2aaba2ac029e77e9d8195521e7f12ca037ec3d60f5ed05b532f3ac62", "class_name": "RelatedNodeInfo"}, "2": {"node_id": "9cde98f2-1acb-4972-8761-f2bae8a20ee7", "node_type": "1", "metadata": {"page_label": "143", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04"}, "hash": "c71368cb13a1ded417bd1d3dcdda532624a6b91f2fd205bded9911e7de8e3d03", "class_name": "RelatedNodeInfo"}}, "text": "the only place in your plant that will still need paper.\n\nrestrooms\n\nthe goal is simple: decrease paperwork while increasing productivity. smart bio-pharma companies need to work leaner, smarter, and with a greater emphasis on compliance and quality control than ever before. thats why 16 of the worlds top 30 pharmaceutical and biotech companies have chosen werums mes product suite pas-x to run their manufacturing business. they know that pas-x can drastically reduce a companys paperwork; as importantly, it can easily fit into the processing environment to help streamline manufacturing, improve product quality, and assure compliance. for one facility or throughout a global manufacturing network, werums pas-x is the complete mes package that can open a whole new door to efficiency. trust in pas-x, the market leading mes software for life sciences.\n\nheadquarters\n\nlueneburg, germany\n\nu.s. headquarters\n\nparsippany, nj\n\nasia-pacific headquarters\n\nsingapore\n\nwww.pas-x.com", "start_char_idx": 0, 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"questions_this_excerpt_can_answer": "Based on the provided context, here are three questions that the context can provide specific answers to, which are unlikely to be found elsewhere:\n\n1. **What is the file size of the \"ISPE Manufacturing Execution Systems\" PDF document stored in the PharmaWise Engineer directory on Google Drive?**\n   - This question is specific to the document's digital footprint and storage details, which are unique to this file and its storage location. The context directly provides the file size as 7322258 bytes, which is a detail not commonly available without access to the file's properties.\n\n2. **What are the creation and last modification dates of the document titled \"Blank Canvas: A Collection of Diverse Entities\" within the PharmaWise CSV & Data Integrity project?**\n   - The context uniquely identifies the document's creation and last modification dates, which are specific to the document's lifecycle and version control within a project. Knowing these dates (creation date: 2024-04-07 and last modified date: 2024-04-04) can be crucial for understanding the document's currency and relevance.\n\n3. **Under what file path and name can the \"ISPE Manufacturing Execution Systems\" document be found within the PharmaWise Engineer project's directory structure?**\n   - This question targets the document's storage location and naming convention, which are specific to the organization and categorization of files within the PharmaWise Engineer project. The context provides a precise file path (/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf) and file name, which would be difficult to ascertain without direct access to the project's file management system.\n\nThese questions are tailored to extract information that is uniquely available from the provided context, emphasizing the document's storage details, version history, and organizational specifics within a project's infrastructure.", "excerpt_keywords": "Keywords: ISPE, Manufacturing Execution Systems, PharmaWise Engineer, PDF document, file size"}}, "204ed345-a4bf-43fb-9f14-f57cac048f3f": {"node_ids": ["19425551-b537-499c-b556-a7926c9ddcb4"], "metadata": {"page_label": "2", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Healthcare Industry Partner for Paperless Manufacturing Solutions: A Comprehensive Overview", "questions_this_excerpt_can_answer": "1. What specific services does Halfmann Goetsch Peither AG (HGP) offer to healthcare industry partners looking to implement paperless manufacturing solutions within a GMP-regulated environment?\n\n2. How does Halfmann Goetsch Peither AG (HGP) support healthcare organizations in ensuring their Manufacturing Execution Systems (MES) comply with global regulatory standards such as GMP, GLP, and GCP?\n\n3. Who can healthcare industry professionals contact at Halfmann Goetsch Peither AG (HGP) for expert consultation on implementing Manufacturing Execution Systems (MES) and what is the best way to reach this contact?", "prev_section_summary": "The section provides specific details about a PDF document titled \"ISPE Manufacturing Execution Systems\" stored in the PharmaWise Engineer directory on Google Drive. It includes information such as the file size (7322258 bytes), creation date (2024-04-07), last modified date (2024-04-04), file path, and file name. Additionally, it mentions a document titled \"Blank Canvas: A Collection of Diverse Entities\" within the PharmaWise CSV & Data Integrity project, highlighting its creation and last modification dates. The section emphasizes the importance of understanding the document's digital footprint, version control, and organizational structure within a project.", "excerpt_keywords": "Healthcare industry, GMP-regulated environment, Paperless manufacturing, Manufacturing Execution Systems (MES), Global regulatory standards"}}, "320e4d07-00e6-4efa-95b0-0d707ac08773": {"node_ids": ["22d70eef-e00d-4970-b19a-c9f972ecb99e"], "metadata": {"page_label": "3", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Comprehensive Guide to Manufacturing Execution Systems Control and Compliance in the Pharmaceutical Industry", "questions_this_excerpt_can_answer": "1. What is the primary purpose of the \"Comprehensive Guide to Manufacturing Execution Systems Control and Compliance in the Pharmaceutical Industry\" as published by ISPE in 2010?\n   \n2. What disclaimer does ISPE include in their guide regarding the assurance of regulatory acceptance for systems managed according to their guide on Manufacturing Execution Systems in the pharmaceutical industry?\n\n3. What are the limitations on reproducing or copying any part of the ISPE's guide on Manufacturing Execution Systems, as stated in their copyright notice from 2010?", "prev_section_summary": "The section discusses the services offered by Halfmann Goetsch Peither AG (HGP) to healthcare industry partners for implementing paperless manufacturing solutions within a GMP-regulated environment. Key topics include MES feasibility studies, process analysis and improvement, global deployment strategies, project management, vendor assessments, computer system validation, and regulatory consulting. The section also highlights the contact information for Thomas Halfmann at HGP for expert consultation on MES implementation.", "excerpt_keywords": "Keywords: ISPE, Manufacturing Execution Systems, Control, Compliance, Pharmaceutical Industry"}}, "0a2c288a-1134-4014-9b92-7e1b7887cae7": {"node_ids": ["28fb657f-da25-441b-aa34-8d94db519b7a"], "metadata": {"page_label": "4", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "ISPE GAMP Good Practice Guide: Manufacturing Execution Systems - Strategic Program Management Approach and Integration with Process Control Systems", "questions_this_excerpt_can_answer": "1. How does the ISPE GAMP Good Practice Guide: Manufacturing Execution Systems approach the integration of MES with process control systems to support manufacturing in life sciences organizations?\n   \n2. What specific industry standard does the ISPE GAMP Good Practice Guide: Manufacturing Execution Systems leverage for the integration of manufacturing execution systems with enterprise systems, and what are the key components of this standard?\n\n3. In what ways does the ISPE GAMP Good Practice Guide: Manufacturing Execution Systems propose to manage the life cycles of integrated manufacturing environments, particularly in relation to the domain approach for categorizing system use and criticality?", "prev_section_summary": "The key topics of the section include the purpose of the ISPE guide on Manufacturing Execution Systems in the pharmaceutical industry, the disclaimer regarding regulatory acceptance of systems managed according to the guide, and the limitations on reproducing or copying any part of the guide. The entities mentioned in the section are the International Society for Pharmaceutical Engineering (ISPE) and pharmaceutical organizations. The section emphasizes the importance of understanding the principles of control and compliance in manufacturing execution systems and highlights the need for professional engineers or technicians in implementing these systems. Additionally, the section mentions the copyright notice from 2010 and the disclaimer of liability from ISPE.", "excerpt_keywords": "ISPE, GAMP, Manufacturing Execution Systems, Strategic Program Management, Process Control Systems"}}, "899422ce-5072-412f-b698-20006ac5ff28": {"node_ids": ["a4a47cb1-ef8f-4ec8-b37e-5c0103d28aaa"], "metadata": {"page_label": "5", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Collaborative Efforts and Acknowledgements in Developing the ISPE GAMP COP Guide: A Comprehensive Overview\"", "questions_this_excerpt_can_answer": "1. Who were the co-leaders of the ISPE GAMP CoP Special Interest Group responsible for developing the guide titled \"Collaborative Efforts and Acknowledgements in Developing the ISPE GAMP COP Guide: A Comprehensive Overview\"?\n\n2. Which companies supported their employees' efforts in authoring and reviewing the guide by providing special thanks in the acknowledgements section of the document?\n\n3. Can you list any individuals who were specifically thanked for their coaching and editorial contributions to the development of the ISPE GAMP CoP Guide?", "prev_section_summary": "The section discusses the ISPE GAMP Good Practice Guide for Manufacturing Execution Systems, focusing on the strategic program management approach and integration with process control systems in life sciences organizations. It emphasizes the importance of planning, development, and testing of MES to ensure compliance with regulatory requirements. The guide takes a life cycle approach to MES, viewing it as a collection of manufacturing functions that integrate business and process controls, information flow, and human interaction. It also addresses the challenges of integrating functions across systems and proposes a domain approach for categorizing system use and criticality. Additionally, the guide leverages the ANSI/ISA 95.00.01-2000 standard for improved integration of manufacturing systems through common terminology and models.", "excerpt_keywords": "ISPE, GAMP, Manufacturing Execution Systems, Task Team, Acknowledgements"}}, "e8b973fc-288f-458b-9e16-d85c39798357": {"node_ids": ["96f76746-9256-49eb-a8c8-616c10cd53f3"], "metadata": {"page_label": "6", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "ISPE Global Headquarters and Regional Offices Locations and Contact Information", "questions_this_excerpt_can_answer": "1. What is the contact telephone number for the ISPE headquarters located in Tampa, Florida?\n2. How can someone reach the ISPE Asia Pacific office in Singapore via fax?\n3. What is the address of the ISPE European office in Brussels, Belgium, and how can it be contacted by telephone?", "prev_section_summary": "The section discusses the acknowledgements for the development of the ISPE GAMP CoP Guide, highlighting the co-leaders, section writers, reviewers, and companies that supported the efforts. Key topics include the individuals involved in the development process, the companies that provided support, and the specific acknowledgements for coaching and editorial contributions. Entities mentioned include the task team leaders, team members, companies like Rockwell Automation and GlaxoSmithKline, and individuals like Chris Clark, Winnie Cappucci, and others who contributed to the guide.", "excerpt_keywords": "ISPE, Manufacturing Execution Systems, Global Headquarters, Contact Information, Locations"}}, "8f26dba4-bb2b-44eb-8f95-966363103f6f": {"node_ids": ["4986aff8-d108-415d-b149-67cf1e795345"], "metadata": {"page_label": "7", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Management of Manufacturing Execution Systems: A Comprehensive Guide for Control, Compliance, and Operations", "questions_this_excerpt_can_answer": "1. What strategic approach does the GAMP\u00ae Good Practice Guide recommend for achieving control and compliance in the implementation of Manufacturing Execution Systems (MES) within the pharmaceutical industry?\n\n2. How does the document outline the MES life cycle, including key phases from planning through to operation, and what specific guidance does it provide for each phase to ensure successful implementation and compliance with regulatory standards?\n\n3. What are the detailed steps and considerations outlined in the document for conducting a periodic review of an MES to ensure ongoing compliance, operational efficiency, and alignment with business continuity and contingency planning?", "prev_section_summary": "The section provides contact information for ISPE headquarters in Tampa, Florida, the Asia Pacific office in Singapore, the China office in Shanghai, and the European office in Brussels, Belgium. It includes addresses, telephone numbers, and fax numbers for each office. The key entities mentioned are ISPE headquarters, ISPE Asia Pacific office, ISPE China office, and ISPE European office.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP Good Practice Guide, Compliance, Strategic Management"}}, "267f0ded-08ac-4984-8286-568284e319a1": {"node_ids": ["b4dd4e6b-11c3-48ac-a9da-55d6b2dfb004"], "metadata": {"page_label": "8", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Planning and Implementation of Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the key considerations and concepts involved in developing a Manufacturing Execution System (MES) implementation strategy as outlined in the ISPE Good Practice Guide?\n\n2. How does the document address the integration of MES with other systems such as ERP, process automation, and LIMS, and what specific interface issues are discussed in relation to electronic records and signatures?\n\n3. What strategic and program management approaches does the ISPE guide recommend for planning, selecting, and implementing MES in the pharmaceutical industry, particularly in terms of risk considerations, regulatory compliance, and system architecture?", "prev_section_summary": "The section discusses the strategic management of Manufacturing Execution Systems (MES) within the pharmaceutical industry, focusing on achieving control, compliance, and operational efficiency. Key topics include the GAMP\u00ae Good Practice Guide's recommended approach for MES implementation, the MES life cycle with phases from planning to operation, quality risk management, project and operation phases, security, performance monitoring, backup and recovery, record retention, business continuity planning, and periodic review. The section also outlines the structure of guidance, benefits, objectives, and key concepts related to MES.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Strategic Planning, Program Management, ISPE"}}, "56b33d4d-2028-45fd-8981-359446fcc0dc": {"node_ids": ["2f2bccf9-306e-495e-b6df-d9c0f062feae"], "metadata": {"page_label": "9", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Management of Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What specific strategies does the GAMP\u00ae Good Practice Guide suggest for establishing equivalent electronic functionality in manufacturing execution systems (MES), as outlined in Appendix 7 of the document \"Strategic Management of Manufacturing Execution Systems: A Comprehensive Guide\"?\n\n2. How does the document address the concept of \"review by exception\" in the context of MES, particularly in terms of definition, justification, and considerations for production report content, as detailed in Appendix 8?\n\n3. In the context of compliant work-in-progress (WIP) materials management within MES, what distinctions does the document make between accounting methods and GxP methods, and how does it suggest managing material inventory and status to ensure compliance, as discussed in Appendix 11?", "prev_section_summary": "The section discusses the strategic planning and implementation of Manufacturing Execution Systems (MES) in the pharmaceutical industry. Key topics include challenges, business drivers, program planning, strategic planning, functional domains, application selection, risk considerations, regulatory compliance, system architecture, funding, domain approach, system design, risk management, verification, application and system selection, system integration, interfaces, ERP integration, process automation, batch systems, LIMS integration, and interface issues related to electronic records and signatures. The document outlines considerations and concepts for developing an MES implementation strategy, as well as program management approaches for planning, selecting, and implementing MES.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP Good Practice Guide, Electronic Production Record Systems, Compliance"}}, "54b0ce89-37d6-4b9a-9c8f-1cc41a744527": {"node_ids": ["0045f183-d3cb-416f-97dd-f69ec036c3db"], "metadata": {"page_label": "10", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Standards, Models, and References for Manufacturing Execution Systems: A Comprehensive Exploration", "questions_this_excerpt_can_answer": "1. What specific standards and models are recommended for implementing Manufacturing Execution Systems (MES) in the pharmaceutical industry, as outlined in the GAMP\u00ae Good Practice Guide within the ISPE document?\n\n2. How does the ANSI/ISA-95 standard contribute to enterprise-control system integration in the context of Manufacturing Execution Systems, according to the comprehensive exploration provided in the ISPE document?\n\n3. What role does the Supply Chain Council SCOR model play in the context of Manufacturing Execution Systems, and how is it detailed in the appendix of the ISPE document focused on standards, models, and references for MES?", "prev_section_summary": "The section discusses various key topics related to Manufacturing Execution Systems (MES) as outlined in the document \"Strategic Management of Manufacturing Execution Systems: A Comprehensive Guide.\" These topics include establishing equivalent electronic functionality, review by exception, logon, identification, and signature methods, human and workflow considerations, compliant work-in-progress (WIP) materials management, and configuration management. The section addresses strategies for MES implementation, considerations for production report content, user interface considerations, material inventory management, and configuration management processes within an MES domain. It also highlights the importance of electronic production record systems, ancillary records, recipe management, and testing in MES operations.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP, ANSI/ISA-95, SCOR model"}}, "aeed8a35-086a-4615-9695-0c9eaf75cc86": {"node_ids": ["7e0ac5af-cfb1-4c6e-a8bb-4b28140a8cae"], "metadata": {"page_label": "11", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "GAMP (R) Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach", "questions_this_excerpt_can_answer": "1. How does the GAMP 5 framework facilitate the integration of Manufacturing Execution Systems (MES) within regulated pharmaceutical manufacturing environments, according to the ISPE Manufacturing Execution Systems guide?\n\n2. What specific benefits does the integration of MES offer to pharmaceutical organizations in terms of cost, quality, and efficiency, as outlined in the GAMP Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach?\n\n3. What role does the Manufacturing Execution Systems Special Interest Group (MES SIG) of the GAMP Community of Practice (CoP) play in the development of the guide for implementing MES in regulated environments, and what practical information does it provide to address the complexities of MES deployment?", "prev_section_summary": "The section discusses the standards, models, and references for Manufacturing Execution Systems (MES) in the pharmaceutical industry, as outlined in the GAMP\u00ae Good Practice Guide within the ISPE document. Key topics include the ANSI/ISA-95 standard for enterprise-control system integration, the role of the Supply Chain Council SCOR model, and references to other relevant organizations such as MESA International. The section also includes information on MES functions, XML and B2MML, ANSI/ISA-S88, and a glossary of abbreviations and definitions.", "excerpt_keywords": "Keywords: GAMP, Manufacturing Execution Systems, MES, ISPE, Pharmaceutical Industry"}}, "ccc9b89c-fe11-4437-ae96-728b6cde6f36": {"node_ids": ["c3e2fc0f-edba-4e09-85cf-bd7961d151a4"], "metadata": {"page_label": "12", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Optimizing Manufacturing Execution Systems in Regulated Industries: A Strategic Approach", "questions_this_excerpt_can_answer": "1. What specific industries does the GAMP Good Practice Guide: Manufacturing Execution Systems focus on for the application of its strategies and program management approach?\n   \n2. How does the GAMP Good Practice Guide: Manufacturing Execution Systems suggest it can benefit recipe-driven operations in regulated life science manufacturing industries?\n\n3. Where can additional information about managing global IT systems in the context of regulated life science manufacturing industries be found, as referenced in the GAMP Good Practice Guide: Manufacturing Execution Systems?", "prev_section_summary": "The section discusses the importance of integrating Manufacturing Execution Systems (MES) within regulated pharmaceutical manufacturing environments. It highlights the benefits of MES integration in terms of cost, quality, and efficiency, as well as the role of the Manufacturing Execution Systems Special Interest Group (MES SIG) of the GAMP Community of Practice (CoP) in providing practical information for implementing MES. The section also outlines the framework of GAMP 5 for developing and using MES, emphasizing the need for a well-designed MES domain to maximize the potential benefits of system integration. The guide aims to assist regulated pharmaceutical organizations in achieving and maintaining compliant MES by leveraging regulatory requirements, industry standards, and GAMP guidance.", "excerpt_keywords": "Manufacturing Execution Systems, GAMP, Regulated Industries, Program Management, Life Science Manufacturing"}}, "7b0e7527-ae6a-466b-bc7e-63b4595db20b": {"node_ids": ["1b832015-0e21-4e44-8c27-606221bbf12e"], "metadata": {"page_label": "13", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Implementation of Manufacturing Execution Systems: A Comprehensive Guide for Success", "questions_this_excerpt_can_answer": "1. How does the GAMP (Good Automated Manufacturing Practice) guide propose to enhance the visibility, accuracy, and consistency of manufacturing data within the context of Manufacturing Execution Systems (MES)?\n   \n2. What specific strategies does the guide recommend for reducing the risk of project failure and balancing the costs of implementation and operation of MES, according to the strategic and program management approach outlined?\n\n3. In what ways does the guide suggest MES can support knowledge management and Process Analytical Technology (PAT), and what are the benefits of implementing electronic production records (EPR) and review by exception (RBE) as part of MES functionalities?", "prev_section_summary": "The section discusses the GAMP Good Practice Guide for Manufacturing Execution Systems, focusing on regulated life science manufacturing industries such as pharmaceuticals, diagnostics, biologics, medical devices, and consumer products. It outlines the scope of the guide, including the intended audience and the industries it applies to. The benefits of integrated manufacturing systems for recipe-driven operations are highlighted, such as improved scheduling, resource utilization, manufacturing flexibility, process changeover, reduced work in progress, improved material tracking, shorter production cycles, enforced sequence of operations, and reduced production record errors. Additional information on managing global IT systems in regulated industries is referenced in the ISPE GAMP Good Practice Guide for Global Information Systems Control and Compliance.", "excerpt_keywords": "Keywords: GAMP, Manufacturing Execution Systems, MES, Good Automated Manufacturing Practice, Process Analytical Technology"}}, "09e5f7b7-30a3-47bc-a568-1a8e08fa5037": {"node_ids": ["9b3d63cc-d017-486e-94f7-d951fa327b45"], "metadata": {"page_label": "14", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Exploring MES Domain and Operational Definitions in Manufacturing Execution Systems\"", "questions_this_excerpt_can_answer": "1. How does the GAMP (Good Automated Manufacturing Practice) guide define the operational concept of a Manufacturing Execution System (MES) in the context of integrating human, electronic, and mechanized functionalities?\n   \n2. What methodology does the GAMP guide suggest for organizing and documenting computerized systems and functions within the MES domain, based on their attributes and goals?\n\n3. According to the GAMP guide, how is the MES domain constructed to ensure it encompasses the necessary functionality for production, and what criteria are used to determine the inclusion of existing or new systems within this domain?", "prev_section_summary": "The excerpt from the document discusses the GAMP (Good Automated Manufacturing Practice) guide's strategic and program management approach to Manufacturing Execution Systems (MES). Key topics include enhancing visibility, accuracy, and consistency of manufacturing data, reducing the risk of project failure, balancing implementation and operation costs, supporting knowledge management and Process Analytical Technology (PAT), and implementing electronic production records (EPR) and review by exception (RBE) functionalities. The guide aims to enable organizations to shorten development and implementation times, improve life cycle activities, build compliance into the process, and provide a better understanding of the manufacturing environment. Key entities mentioned include improved decision support, process analytical technology (PAT), investigations capabilities, paperless manufacturing, key performance indicator (KPI) generation, overall equipment efficiency (OEE) calculation, and compliance aspects of MES.", "excerpt_keywords": "MES, GAMP, manufacturing execution systems, operational definitions, domain concept"}}, "9bbdcc48-133d-453b-9b5a-7b73f541e12a": {"node_ids": ["7df1da88-10e8-4a2e-b388-4acfee19062d"], "metadata": {"page_label": "15", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Strategic Program and Risk Management in Manufacturing Execution Systems: A Comprehensive Approach to Functional Domain Concepts\"", "questions_this_excerpt_can_answer": "1. How does the GAMP Good Practice Guide suggest defining the MES domain for new systems versus existing systems, and what role does this domain play in aiding future implementations, testing, and system configuration management?\n\n2. According to the document, how can the modular nature of systems within the MES domain influence risk management activities, and what factors might affect the risk levels for various functionalities or between base products and their configurable or customized modules?\n\n3. What is the significance of functional domains in the context of manufacturing execution systems as described in the document, and how do they facilitate the interaction of information, personnel, materials, and equipment in identifying design requirements and testing activities related to manufacturing operations?", "prev_section_summary": "The section discusses key concepts related to Manufacturing Execution Systems (MES) as outlined in the GAMP (Good Automated Manufacturing Practice) guide. It defines MES as a system that integrates human, electronic, and mechanized functionalities to execute manufacturing operations efficiently. The MES domain concept is introduced as a method for organizing and documenting computerized systems and functions based on common attributes, goals, and intended use. The section also explains how the MES domain is constructed to include the necessary functionality for production, determining which systems or functionalities are needed for implementation. Overall, the section provides insights into the operational definitions and organizational aspects of MES within the manufacturing industry.", "excerpt_keywords": "MES, GAMP, manufacturing execution systems, functional domain, risk management"}}, "024794a8-590e-4be1-b30d-0816648e181d": {"node_ids": ["8a5a46f6-2d20-49da-93a9-5904beabc527"], "metadata": {"page_label": "16", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Comprehensive Guide to GxP Regulations in International Pharmaceutical Requirements", "questions_this_excerpt_can_answer": "1. How does the GAMP(r) Good Practice Guide suggest integrating risk management into the design and specifications of Manufacturing Execution Systems (MES) within the pharmaceutical industry?\n\n2. What specific international pharmaceutical regulations and practices are identified in the \"Comprehensive Guide to GxP Regulations in International Pharmaceutical Requirements\" as foundational to the operation of organizations within the pharmaceutical sector?\n\n3. What approach does the document recommend for ensuring the integrity and compliance of vendor or local quality systems in relation to Manufacturing Execution Systems, as per the audit and verification processes outlined in the context?", "prev_section_summary": "The section discusses the GAMP Good Practice Guide for Manufacturing Execution Systems, focusing on the strategic program and risk management approach. Key topics include defining the MES domain for new and existing systems, the modular nature of systems influencing risk management activities, and the significance of functional domains in facilitating interactions in manufacturing operations. Entities mentioned include the MES domain, functional domains, system functionality, risk management activities, and the interaction of information, personnel, materials, and equipment in manufacturing operations.", "excerpt_keywords": "GAMP, Manufacturing Execution Systems, GxP Regulations, Pharmaceutical Requirements, Risk Management"}}, "5cbe5893-933b-464d-8256-525be6112cfc": {"node_ids": ["3d672aa8-9905-477e-91c7-4ec682de3196"], "metadata": {"page_label": "17", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Approach and Program Management for Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the three main sections outlined in the GAMP Good Practice Guide for Manufacturing Execution Systems, and what key concepts do they each focus on?\n   \n2. How does the GAMP Good Practice Guide suggest managing the lifecycle of a Manufacturing Execution System (MES) from planning to release, and what key supporting processes are emphasized?\n\n3. What types of documents and resources are included in the appendices of the GAMP Good Practice Guide for Manufacturing Execution Systems, and how do they support the main body of the guide in covering all aspects of computerized systems good practice and compliance?", "prev_section_summary": "The section discusses the integration of risk management into the design and specifications of Manufacturing Execution Systems (MES) in the pharmaceutical industry, as suggested by the GAMP(r) Good Practice Guide. It also identifies various international pharmaceutical regulations and practices that are foundational to the operation of organizations within the sector. The document recommends an approach for ensuring the integrity and compliance of vendor or local quality systems in relation to MES through audit and verification processes. Key topics include the strategic and program management approach to MES, functional domain design and risk requirements, and various GxP regulations such as GMP, GCP, GLP, GDP, GQP, pharmacovigilance practice, and medical device regulations.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP Good Practice Guide, Strategic Approach, Program Management"}}, "eefb8a9c-c3dd-4bd6-b134-71e738e3a443": {"node_ids": ["8413d2d5-6f5b-40a1-b949-754d049158cf"], "metadata": {"page_label": "18", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Empty Space: A Collection of Absences\"", "questions_this_excerpt_can_answer": "Based on the provided context, here are three questions that the context can provide specific answers to, which are unlikely to be found elsewhere:\n\n1. What is the file size of the \"ISPE Manufacturing Execution Systems\" PDF document stored in the PharmaWise Engineer directory within the PharmaWise CSV & Data Integrity project on MyDrive, and how does it relate to the document's content on manufacturing execution systems in the pharmaceutical industry?\n\n2. How does the document titled \"Empty Space: A Collection of Absences,\" which is seemingly unrelated to the typical content expected in a file named \"ISPE Manufacturing Execution Systems.pdf,\" contribute to the understanding of data integrity and system validation in the context of pharmaceutical manufacturing execution systems as stored in the PharmaWise CSV & Data Integrity raw data directory?\n\n3. Considering the creation and last modified dates of the \"ISPE Manufacturing Execution Systems\" PDF document are in April 2024, what implications does this have for the document's relevance and accuracy in discussing current trends and technologies in manufacturing execution systems within the pharmaceutical industry, especially in the context of development and compliance as outlined in the PharmaWise Engineer project?", "prev_section_summary": "The section discusses the GAMP Good Practice Guide for Manufacturing Execution Systems, outlining three main sections: approach to achieving control and compliance, project life cycle phase, and operation phase. It emphasizes the importance of developing a strategy for MES, following an MES life cycle, and applying quality risk management. The guide also covers key processes for maintaining compliance and fitness for intended use throughout the operational life of an MES. The supporting appendices provide additional resources and references to support the main body of the guide in covering all aspects of computerized systems good practice and compliance.", "excerpt_keywords": "manufacturing execution systems, pharmaceutical industry, GAMP Good Practice Guide, MES life cycle, quality risk management"}}, "aa20ee54-fc94-4932-a23d-98da160186ef": {"node_ids": ["7da3dc84-09b9-4e65-a9cd-11d0b3958520"], "metadata": {"page_label": "19", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Implementation of Manufacturing Execution Systems (MES) in the Manufacturing Industry", "questions_this_excerpt_can_answer": "1. What are the key concepts of GAMP 5 that are applied to the strategic implementation of Manufacturing Execution Systems (MES) in the manufacturing industry, as outlined in the ISPE guide?\n   \n2. How does the ISPE guide recommend involving suppliers in the lifecycle of MES to leverage their knowledge, experience, and documentation for achieving and maintaining compliance?\n\n3. What framework does the ISPE guide propose for applying quality risk management throughout the lifecycle of MES, and how does it suggest planning and managing the implementation of MES within a business strategy?", "prev_section_summary": "The section provides metadata information about a PDF document titled \"ISPE Manufacturing Execution Systems\" stored in the PharmaWise Engineer project directory. It also mentions a document titled \"Empty Space: A Collection of Absences\" and raises questions about the relevance of the creation and last modified dates of the PDF document in discussing current trends and technologies in pharmaceutical manufacturing execution systems. The key topics include file details, document titles, data integrity, system validation, and relevance of document dates to industry trends.", "excerpt_keywords": "ISPE, Manufacturing Execution Systems, MES, GAMP 5, Quality Risk Management"}}, "1ab4ae2a-6aa2-405e-81d1-4a2362f04cdc": {"node_ids": ["b2dd3034-7ba9-45cc-ae77-d1a8d5716d63"], "metadata": {"page_label": "20", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Implementation of Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the key considerations for implementing a Manufacturing Execution System (MES) on a global scale, as outlined in the ISPE GAMP Good Practice Guide?\n   \n2. How does the document suggest addressing the apprehension among personnel regarding the introduction of new technology in the manufacturing environment, specifically in relation to MES implementation?\n\n3. What strategic planning aspects related to MES are detailed in Appendix 2 of the document, and how do they relate to the GAMP 5 key concept of product and process understanding?", "prev_section_summary": "The section discusses the strategic implementation of Manufacturing Execution Systems (MES) in the manufacturing industry, focusing on key concepts from GAMP 5 such as process understanding, life cycle approach, quality risk management, and supplier involvement. It emphasizes the importance of thorough understanding of business processes, involvement of subject matter experts from regulated organizations and suppliers, and application of quality risk management throughout the MES lifecycle. The section also highlights the need for developing a strategy for MES, following a computerized system life cycle, and aligning MES implementation with business strategy to address business needs and objectives.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP 5, Globalization, Implementation Strategy"}}, "e975d48e-3c62-46ff-be89-759136590d90": {"node_ids": ["98589a2d-e5d1-4591-9794-dd0abcb27338"], "metadata": {"page_label": "21", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Optimizing Manufacturing Execution Systems (MES) through a Lifecycle Approach and Supplier Involvement\"", "questions_this_excerpt_can_answer": "1. What strategic approach does the GAMP\u00ae Good Practice Guide recommend for optimizing Manufacturing Execution Systems (MES) through supplier involvement and lifecycle management?\n   \n2. How does the guide suggest handling the overlap of activities during the MES project phase to ensure effective systems integration and modular functionality release?\n\n3. What are the two levels of life cycle management proposed by the document to assure proper control of the manufacturing environment when implementing MES?", "prev_section_summary": "The section discusses the strategic implementation of Manufacturing Execution Systems (MES) and highlights key considerations for implementing MES on a global scale as outlined in the ISPE GAMP Good Practice Guide. It emphasizes the importance of strategic planning related to MES, addressing apprehension among personnel regarding the introduction of new technology, and the implications of change on an organization. The section also covers topics such as globalization, implementation strategy, and the involvement of multiple groups in the MES implementation process. Additionally, it mentions the importance of management approval, stakeholder involvement, and communication throughout the planning and implementation process.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP Good Practice Guide, Supplier Involvement, Lifecycle Management"}}, "1afd683e-7a64-4917-a0e8-611472a019b3": {"node_ids": ["1aa6c673-57cd-4d3d-8620-6e13991fef2d"], "metadata": {"page_label": "22", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Integration of Manufacturing Execution Systems and Quality Risk Management in Manufacturing Operations", "questions_this_excerpt_can_answer": "1. How does the GAMP(r) Good Practice Guide suggest integrating individual system life cycles within the MES domain to enhance manufacturing operations, and what specific management structures are recommended for coordinating these systems?\n\n2. What are the key components of the quality risk management process as outlined in the GAMP 5 framework, specifically in relation to the complete lifecycle of computerized systems in manufacturing environments?\n\n3. Can you detail the structured approach recommended for implementing risk management within MES domains, including how risk assessments and decisions are integrated at various stages of the MES lifecycle, as per the guidance provided in the document?", "prev_section_summary": "The section discusses the strategic approach recommended by the GAMP\u00ae Good Practice Guide for optimizing Manufacturing Execution Systems (MES) through supplier involvement and lifecycle management. It outlines the MES life cycle based on the computerized system life cycle approach, including project stages and supporting processes. The guide emphasizes the importance of supplier involvement and handling the overlap of activities during the MES project phase to ensure effective systems integration and modular functionality release. Additionally, it introduces two levels of life cycle management, the MES domain life cycle, to assure proper control of the manufacturing environment when implementing MES.", "excerpt_keywords": "Manufacturing Execution Systems, Quality Risk Management, GAMP, MES domain, Risk-based decision making"}}, "d498772d-d8c7-4837-95c2-f527dd609a65": {"node_ids": ["38561274-168f-42f3-b972-5411c139a871"], "metadata": {"page_label": "23", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "GAMP 5 Project Phases for Implementing Manufacturing Execution Systems", "questions_this_excerpt_can_answer": "1. What is the GAMP 5 approach to categorizing software in the context of implementing Manufacturing Execution Systems, and how does it differentiate between the levels of risk associated with each category?\n   \n2. How does the GAMP Good Practice Guide define the scope of non-configured products (Category 3) in terms of user-set parameters and their implications for manufacturing execution systems implementation?\n\n3. What specific examples of parameters are mentioned that might be included in a Category 3 non-configured product to allow it to perform built-in functions within a specific organizational IT or technical environment?", "prev_section_summary": "This section discusses the strategic integration of Manufacturing Execution Systems (MES) and Quality Risk Management in manufacturing operations. It covers the integration of individual system life cycles within the MES domain, the key components of the quality risk management process outlined in the GAMP 5 framework, and the structured approach recommended for implementing risk management within MES domains. The section emphasizes the importance of coordination, configuration management, and risk-based decision making throughout the entire computerized system life cycle in manufacturing environments.", "excerpt_keywords": "GAMP 5, Manufacturing Execution Systems, Quality Risk Management, Software Categories, Project Phases"}}, "626fef4c-b8ae-4bf8-b2c7-c947faec081e": {"node_ids": ["591d6f45-80c1-4820-bc88-e125c794aaca"], "metadata": {"page_label": "24", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Approach for Configured Product in MES Project Implementations: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What specific approach does the GAMP (Good Automated Manufacturing Practice) recommend for managing the complexity of designs or implementations in MES (Manufacturing Execution Systems) project implementations, particularly regarding configured products?\n\n2. How does the document suggest handling the documentation and activities for lower risk systems and equipment within MES project implementations, according to the ASTM 2500-07 reference?\n\n3. What categories of MES project implementations are identified in the document, and how are they differentiated in terms of integration and application within manufacturing environments?", "prev_section_summary": "This section discusses the GAMP 5 approach to categorizing software in the context of implementing Manufacturing Execution Systems. It outlines the different levels of risk associated with software categories, including infrastructure software, non-configured products, configured products, and custom applications. The section also defines the scope of non-configured products (Category 3) in terms of user-set parameters and their implications for manufacturing execution systems implementation. Specific examples of parameters that might be included in a Category 3 non-configured product are mentioned, such as database aliases, network addresses, and communication with peripheral equipment. The section provides a strategic and program management approach to project phases, emphasizing the importance of understanding the risk levels associated with different software and hardware categories.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, configured product, project implementations"}}, "83b30181-a9f4-48d4-9c1a-8fb8f7fd3ea2": {"node_ids": ["0f3a47b4-7931-436c-aa8a-c83be289ea59"], "metadata": {"page_label": "25", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Comprehensive Title: Strategic Risk Management and Planning for Manufacturing Execution Systems (MES): A Guide for Effective Implementation and Maintenance", "questions_this_excerpt_can_answer": "1. How does the GAMP (Good Automated Manufacturing Practice) guide categorize software applications used in manufacturing execution systems (MES), and what examples are provided for add-on configurable software packages within these categories?\n\n2. What factors should be considered during the planning phase to ensure an MES project meets compliant specifications and verification, according to the strategic risk management and planning guide for MES implementation?\n\n3. What steps are recommended for conducting an initial risk assessment in the context of implementing a Manufacturing Execution System (MES) in the life sciences sector, including the types of regulatory environments that should be considered?", "prev_section_summary": "The section discusses the approach for configured products in MES project implementations, as recommended by GAMP. It outlines the typical activities and documentation required for managing the complexity of designs or implementations, particularly for lower risk systems and equipment. The document identifies different categories of MES project implementations based on integration and application within manufacturing environments. It also highlights the importance of risk assessments in determining the scope and rigor of life cycle activities, as well as the verification approach for equipment and systems in integrated manufacturing environments. Key topics include planning, user requirements specification, reporting, primary responsibilities, and different categories of MES project implementations. Key entities mentioned are GAMP, ASTM 2500-07, configured products, documentation, activities, risk assessments, and integrated manufacturing environments.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, Risk Management, Strategic Planning"}}, "e1394254-9084-485a-b8a5-46188edb8815": {"node_ids": ["4ed5f1e0-b997-4cfb-bf08-4764d33f214c"], "metadata": {"page_label": "26", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Comprehensive Guide to Risk Assessment, GAMP Categorization, Supplier Assessment, and Validation Planning in Manufacturing Execution Systems", "questions_this_excerpt_can_answer": "1. How does the GAMP categorization approach allow for the differentiation of risk levels within the components of a Manufacturing Execution System (MES), and what examples are provided to illustrate how different software or system components might be categorized?\n\n2. What considerations should be taken into account during the supplier assessment phase for MES components, especially regarding the use of supplier documentation and the assessment of supplier quality management systems across multiple locations?\n\n3. In the context of validation planning for MES, how is the creation of a computerized system validation plan approached, particularly in terms of incorporating individual plans for systems and processes within the MES domain?", "prev_section_summary": "The section discusses the strategic risk management and planning for Manufacturing Execution Systems (MES) according to the GAMP guide. Key topics include categorization of software applications in MES, factors to consider during planning for compliant specifications and verification, steps for conducting an initial risk assessment, and the importance of addressing technical risks in overall safety and quality risk programs. Entities mentioned include add-on configurable software packages, system impact on patient safety and product quality, supplier assessment, technical risk management, and regulatory environments in the life sciences sector.", "excerpt_keywords": "Manufacturing Execution Systems, Risk Assessment, GAMP Categorization, Supplier Assessment, Validation Planning"}}, "28aa163d-a2df-4b4f-8794-f86f64f19833": {"node_ids": ["1e60cff7-52cc-42f5-8fe4-b46231a7430a"], "metadata": {"page_label": "27", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Execution Systems Validation and Compliance Roles and Responsibilities Document", "questions_this_excerpt_can_answer": "1. What specific criteria and considerations should be included in a computerized system validation plan for Manufacturing Execution Systems (MES) according to the GAMP good practice guide?\n   \n2. How does the GAMP good practice guide recommend handling the documentation and change control strategy for MES domains that span multiple sites, and what are the implications for central validation strategies?\n\n3. What are the defined roles and responsibilities for ensuring MES compliance, particularly in relation to the process owner, as outlined in the ISPE Manufacturing Execution Systems Validation and Compliance Roles and Responsibilities Document?", "prev_section_summary": "The section discusses the importance of risk assessment, GAMP categorization, supplier assessment, and validation planning in Manufacturing Execution Systems (MES). Key topics include the initial risk assessment to determine system impact, GAMP categorization for different software components, considerations for supplier assessment such as using supplier documentation and assessing supplier quality management systems, and the creation of a computerized system validation plan for the MES domain. Entities mentioned include GAMP categories, supplier documentation, supplier quality management systems, and individual validation plans for systems and processes within the MES domain.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP, Validation, Compliance"}}, "439727de-8e10-4a3b-8ab7-01a1f5d177ca": {"node_ids": ["c28b7626-324a-46d5-878b-ea5a283dbb9e"], "metadata": {"page_label": "28", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Roles and Responsibilities in Manufacturing Execution Systems (MES) Governance and Compliance", "questions_this_excerpt_can_answer": "1. What specific responsibilities does the system owner have in ensuring the Manufacturing Execution System (MES) meets GxP compliance and operational efficiency according to the GAMP\u00ae Good Practice Guide?\n   \n2. How does the quality unit contribute to the governance and compliance of MES, particularly in relation to patient safety, product quality, and data integrity, as outlined in the document?\n\n3. What are the defined roles and activities of Subject Matter Experts (SMEs) in the context of defining requirements and ensuring the effectiveness of MES, according to the GAMP\u00ae Good Practice Guide on Manufacturing Execution Systems?", "prev_section_summary": "This section discusses the criteria and considerations for creating a computerized system validation plan for Manufacturing Execution Systems (MES) according to the GAMP good practice guide. It also covers the documentation and change control strategy for MES domains that span multiple sites, as well as the defined roles and responsibilities for ensuring MES compliance, particularly focusing on the process owner. Key topics include validation plan details, multi-site system considerations, central validation strategies, and the responsibilities of the process owner in ensuring compliance and system operation. Key entities mentioned are the process owner, business process owners, system owner, and end users.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, compliance, governance"}}, "4e5b4198-f277-40f9-822e-097a40c0c0ac": {"node_ids": ["3c1fdc4b-1535-41de-8085-e32d7b7bbd8d"], "metadata": {"page_label": "29", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Roles and Responsibilities in Manufacturing Execution Systems (MES) Implementation Guide", "questions_this_excerpt_can_answer": "1. What specific roles do Subject Matter Experts (SMEs) play in the verification process of Manufacturing Execution Systems (MES) according to the GAMP Good Practice Guide?\n   \n2. How does the document outline the responsibilities of suppliers, including internal suppliers like IT or engineering departments, in supporting the compliance and fitness for intended use of MES?\n\n3. What activities are end users of MES expected to be involved in throughout the system's life cycle as per the ISPE Manufacturing Execution Systems Implementation Guide?", "prev_section_summary": "The section discusses the roles and responsibilities of key entities in Manufacturing Execution Systems (MES) governance and compliance. It covers the responsibilities of the system owner in ensuring MES meets GxP compliance and operational efficiency, the contribution of the quality unit in ensuring patient safety, product quality, and data integrity, and the defined roles and activities of Subject Matter Experts (SMEs) in defining requirements and ensuring the effectiveness of MES. Key topics include system ownership, quality unit involvement, and SME contributions to MES governance and compliance.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP Good Practice Guide, Subject Matter Experts, Compliance"}}, "ab6d6a45-7fbd-45d8-961a-d5c9a7f8b48c": {"node_ids": ["d5ca4be9-751e-49c0-ba48-cd57801942b9"], "metadata": {"page_label": "30", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "A Comprehensive Guide to Developing Manufacturing Execution Systems: Prototypes, Requirements, and Domain Approach", "questions_this_excerpt_can_answer": "1. How does the GAMP(r) Good Practice Guide define the use of prototype systems in the development and verification of manufacturing execution systems (MES), and what are the specific purposes for maintaining prototype systems as training simulators?\n\n2. What considerations does the guide suggest when testing software fixes or upgrades in a production system that is already online for GxP use, especially in continuous process environments or those with high levels of integration?\n\n3. According to the guide, how should user requirements for MES be gathered, and what role does the MES domain approach play in identifying risks and ensuring comprehensive coverage of business processes and regulatory requirements?", "prev_section_summary": "The section discusses the roles and responsibilities of Subject Matter Experts (SMEs) in the verification process of Manufacturing Execution Systems (MES) according to the GAMP Good Practice Guide. It also outlines the responsibilities of suppliers, including internal suppliers like IT or engineering departments, in supporting the compliance and fitness for intended use of MES. Additionally, it highlights the activities that end users of MES are expected to be involved in throughout the system's life cycle, such as providing input to user requirements, evaluating prototypes, testing, accepting the system, and identifying opportunities for improvement.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP Good Practice Guide, Prototype Systems, User Requirements"}}, "cf4be52a-675e-4aee-a487-3fe0cae9c022": {"node_ids": ["0a185f31-ad06-45f1-83a2-c91de6e5638d"], "metadata": {"page_label": "31", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Approach to Manufacturing Execution Systems: Ensuring Compliance and Risk Management in Manufacturing Operations", "questions_this_excerpt_can_answer": "1. What specific benefit does the implementation of MES (Manufacturing Execution Systems) provide in relation to RBE (Risk-Based Engineering), and where can one find detailed information about this benefit within the ISPE GAMP Good Practice Guide?\n   \n2. How does the ISPE document suggest handling the security of logon and signature entries for MES, and what are the recommended methods for identifying an individual based on the system design?\n\n3. What approach does the document recommend for conducting risk assessments during the purchase of complex systems like MES, and how should these assessments address functional risks according to the identified functional domains?", "prev_section_summary": "This section discusses the use of prototype systems in the development and verification of manufacturing execution systems (MES), considerations for testing software fixes or upgrades in production systems, and the gathering of user requirements for MES. Key topics include the definition and maintenance of prototype systems, the importance of understanding user requirements, the MES domain approach for identifying risks, and the development of data flow designs during requirements definition. Entities mentioned include GAMP(r) Good Practice Guide, prototype systems, production systems, user requirements, business processes, regulatory requirements, critical process parameters (CPPs), data flow design, and MES program.", "excerpt_keywords": "MES, Manufacturing Execution Systems, Risk-Based Engineering, ISPE, GAMP"}}, "4bb6c97e-c9bd-4773-9f60-43e4eab27032": {"node_ids": ["55083db6-5d67-4a17-829b-8709035a580c"], "metadata": {"page_label": "32", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Design and Configuration of Manufacturing Execution Systems: A Comprehensive Approach", "questions_this_excerpt_can_answer": "1. What specific aspects should be reviewed during the design review phase to ensure a Manufacturing Execution System (MES) meets its intended use and complies with GMP and other applicable regulations, according to the GAMP(r) Good Practice Guide?\n\n2. How does the GAMP(r) Good Practice Guide suggest handling the balance between system specification and design customization for MES to ensure both compliance and functionality, particularly in relation to supplier-developed products?\n\n3. What role does risk management play in the selection of hardware and infrastructure for MES, as outlined in the GAMP(r) Good Practice Guide, and what specific appendix provides further information on this process?", "prev_section_summary": "This section discusses the strategic approach to Manufacturing Execution Systems (MES) with a focus on ensuring compliance and risk management in manufacturing operations. Key topics covered include the benefits of MES in relation to Risk-Based Engineering (RBE), handling security of logon and signature entries, conducting risk assessments during the purchase of complex systems like MES, and specification and design considerations for MES implementation. The section emphasizes the importance of addressing functional risks, involving major users in defining risks and requirements, and creating a hierarchical and traceable system specification approach for MES. It also references the ISPE GAMP Good Practice Guide for further information on electronic records and signatures compliance and risk assessments.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP Good Practice Guide, Risk Management, System Configuration"}}, "97c2dd1e-3713-44a6-b609-b8aaac93cf4b": {"node_ids": ["1cff1862-d811-4cc3-9c6f-f994988be2d7"], "metadata": {"page_label": "33", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Customization and Implementation of Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the specific categories designated for software and hardware customization within the context of Manufacturing Execution Systems (MES) implementation, and how do these categories influence the required level of testing and validation strategy?\n\n2. How does the GAMP (Good Automated Manufacturing Practice) guide suggest assessing the risks associated with customization of software, infrastructure, or system hardware in MES, and what factors should be considered in determining the impact of these customizations on production and system functionality?\n\n3. What factors should be considered in the approach to implementing an MES domain to ensure an effective validation strategy, and what are the recommended steps for resolving issues related to the rollout of additional functionality within an MES environment?", "prev_section_summary": "This section discusses the strategic design and configuration of Manufacturing Execution Systems (MES) according to the GAMP(r) Good Practice Guide. Key topics include the importance of design review to ensure compliance with regulations and intended use, the balance between system specification and design customization, risk management in selecting hardware and infrastructure, and the role of suppliers in design review activities. The section also covers system build, installation, and configuration, as well as the configuration of system parameters to align with business processes. Key entities mentioned include system specifications, design practices, user requirements, regulatory requirements, risks, suppliers, and hardware and infrastructure selection.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Customization, GAMP, Validation Strategy"}}, "40d92323-2c48-4af3-a974-0f01bc540d65": {"node_ids": ["7b57e779-f2d4-4bd1-9dcb-5b95df366ff4"], "metadata": {"page_label": "34", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Deployment and Verification of Manufacturing Execution Systems: A Comprehensive Approach", "questions_this_excerpt_can_answer": "1. What are the recommended approaches for deploying Manufacturing Execution Systems (MES) across multiple sites, including how to manage configuration, verification, and support according to the GAMP\u00ae Good Practice Guide?\n   \n2. How does the GAMP\u00ae Good Practice Guide suggest maintaining validated MES when integrating and validating new functionalities, especially in terms of data management and migration strategies?\n\n3. What specific guidance does the GAMP\u00ae Good Practice Guide provide regarding the development of a test strategy for MES, including considerations for supplier documentation, the involvement of subject matter experts (SMEs), and the handling of suppliers performing non-routine activities?", "prev_section_summary": "The section discusses the customization and implementation of Manufacturing Execution Systems (MES) with a focus on risk assessment, validation strategy, and impact on production and system functionality. Key topics include the GAMP guide's recommendations for assessing risks associated with customization, categorization of software and hardware customization, factors to consider in implementing an MES domain, and steps for resolving issues related to the rollout of additional functionality within an MES environment. Entities mentioned include software customization categories, risk-based approaches, validation strategies, hardware categories, control responsibilities, testing environments, training, and future development.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP Good Practice Guide, Verification, Test Strategy"}}, "5ad7a32e-dacd-442b-8a92-749ea0c937d3": {"node_ids": ["e547bd29-0631-4c35-8f33-1998d2247310"], "metadata": {"page_label": "35", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Testing Approach for Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the GAMP(r) Good Practice Guide suggest addressing the diverse functionality span of MES between process control, operational control, and business systems in terms of testing strategy?\n   \n2. What specific steps does the document recommend for establishing traceability within the MES domain to define the scope of testing, and how does it suggest linking various specifications to testing across the MES domain's components?\n\n3. According to the document, what are the stages of testing recommended for MES systems classified as GAMP category 4, and how should the testing focus be adjusted based on the complexity and impact of the system?", "prev_section_summary": "The section discusses the strategic deployment and verification of Manufacturing Execution Systems (MES) according to the GAMP\u00ae Good Practice Guide. Key topics include approaches for deploying MES across multiple sites, ownership of configuration and support, maintaining validated systems when integrating new functionalities, data management and migration strategies, and verification processes such as factory acceptance tests and site acceptance tests. The section also emphasizes the importance of developing a test strategy for MES, considering factors such as risk, complexity, supplier documentation, involvement of subject matter experts (SMEs), and handling of suppliers performing non-routine activities.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, testing strategy, traceability"}}, "9964a8b8-efcc-45c0-80a4-0ca7addc4122": {"node_ids": ["9d6fae7d-4a85-4671-8564-e7f24329a8b7"], "metadata": {"page_label": "36", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Testing Considerations for Manufacturing Execution Systems (MES) in the Manufacturing Industry", "questions_this_excerpt_can_answer": "1. What specific tests are recommended for Manufacturing Execution Systems (MES) to ensure they meet contractual acceptance before and after delivery, according to the GAMP (r) Good Practice Guide?\n   \n2. How does the GAMP (r) Good Practice Guide categorize custom software required as part of MES in terms of testing rigor, and what appendix provides detailed information on test strategy, execution, reporting, supplier, and automated testing?\n\n3. What are the key aspects that require particular consideration to ensure adequate testing of MES to prevent critical data loss, ensure system security, and maintain operational integrity, as outlined in the GAMP (r) Good Practice Guide?", "prev_section_summary": "The section discusses the strategic testing approach for Manufacturing Execution Systems (MES) as outlined in the GAMP(r) Good Practice Guide. It covers the need to address the diverse functionality span of MES between process control, operational control, and business systems in testing strategy. The use of traceability is emphasized to define the scope of testing within the MES domain, linking user requirements to testing across applications, systems, databases, and integration components. The stages of testing for MES systems classified as GAMP category 4 are outlined, including installation testing, configuration testing, functional testing, and requirements testing. The focus is on ensuring system components are installed correctly, configurations are accurate, functionality supports business processes, and requirements are met for intended use.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP, Testing Considerations, Data Integrity"}}, "a54b2868-70e1-45a3-93f1-3c85c38ae1a9": {"node_ids": ["1a56a5f2-33b4-4825-aa48-092cc7e095d1"], "metadata": {"page_label": "37", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Testing and Data Migration in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the key considerations for planning integration and interface testing within the Manufacturing Execution Systems (MES) domain as outlined in the GAMP Good Practice Guide?\n   \n2. How does the document suggest handling the verification of interfaces once installed in a production environment, especially concerning data integrity, performance under load, and error reporting?\n\n3. What specific guidance does the document provide for planning and executing data migration projects in MES, including the use of data migration tools and the development of scripts?", "prev_section_summary": "The section discusses testing considerations for Manufacturing Execution Systems (MES) in the manufacturing industry, as outlined in the GAMP (r) Good Practice Guide. It covers specific tests recommended for MES to ensure contractual acceptance, categorization of custom software in terms of testing rigor, key aspects requiring consideration for adequate testing to prevent data loss and ensure system security, and operational integrity. Topics include delivery and acceptance of documentation, factory acceptance tests (FATs), site acceptance tests (SATs), custom software testing, power failure testing, data integrity, system access and security features, audit trails, electronic signatures, alarms and error messages, data transfers, backup and restore, data archival and retrieval, and handling high volume loads.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Integration Testing, Data Migration, GAMP Good Practice Guide"}}, "6ed9cd22-e81d-4d35-b28f-71964c582828": {"node_ids": ["b8e96097-b775-45a0-ba97-49fb14a57ec1"], "metadata": {"page_label": "38", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Data Migration and Verification in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What specific steps and considerations are outlined in the GAMP(r) Good Practice Guide for ensuring data and referential integrity during the migration of data to a Manufacturing Execution System (MES)?\n\n2. How does the document recommend verifying migrated data in a Manufacturing Execution System environment, including the tools and approaches for ensuring the accuracy and integrity of the data post-migration?\n\n3. What procedural and technical controls does the guide suggest implementing to prevent unauthorized modification of data during the migration process to a Manufacturing Execution System, especially in the context of static versus dynamic data types?", "prev_section_summary": "This section discusses key considerations for integration and interface testing within Manufacturing Execution Systems (MES), including the importance of change management, test strategy for interfaces, and testing for data integrity, performance, and error reporting. It also covers data migration planning, including the use of data migration tools, development of scripts, and cutover strategy from test to production systems. The section emphasizes the need for a comprehensive approach to testing and data migration in MES projects.", "excerpt_keywords": "Data Migration, Manufacturing Execution Systems, GAMP, Data Integrity, Verification"}}, "502f302a-03ca-41fc-bf1e-ab1e4e9dabdc": {"node_ids": ["72843d1b-3cff-4354-a474-cd1a48dd4d86"], "metadata": {"page_label": "39", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Execution Systems: Strategic Program Management and System Release Best Practices Guide", "questions_this_excerpt_can_answer": "1. What specific types of data tables are identified in the GAMP Good Practice Guide for Manufacturing Execution Systems, and how are they categorized in terms of their dynamic or static nature?\n\n2. According to the document, what are the essential components and considerations for a well-managed system handover from the project team to the operational users in the context of Manufacturing Execution Systems?\n\n3. What criteria and documentation are emphasized for ensuring a controlled and documented cutover process from development and testing to production within the framework of Manufacturing Execution Systems as outlined in the guide?", "prev_section_summary": "This section discusses the importance of data migration and verification in Manufacturing Execution Systems (MES). It outlines specific steps and considerations outlined in the GAMP(r) Good Practice Guide for ensuring data and referential integrity during data migration. The document recommends verifying migrated data in MES environments, including tools and approaches for ensuring accuracy and integrity post-migration. It also discusses procedural and technical controls to prevent unauthorized modification of data during migration, especially in the context of static versus dynamic data types. Key topics include data migration execution and verification, data types, and procedural and technical controls for ensuring data integrity during migration.", "excerpt_keywords": "Manufacturing Execution Systems, GAMP, System Handover, Data Migration, Cutover Process"}}, "6c781fd6-d3ee-40d6-8094-e231fe53c5a6": {"node_ids": ["8367a2c6-236b-4352-a6f6-45989fee9a8e"], "metadata": {"page_label": "40", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Execution Systems: Strategic Risk Management and Supporting Processes in Manufacturing Operations", "questions_this_excerpt_can_answer": "1. What are the key steps outlined in the GAMP(r) Good Practice Guide for ensuring data integrity and system efficiency in the context of Manufacturing Execution Systems (MES)?\n   \n2. How does the document describe the role of risk management in the development and implementation of Manufacturing Execution Systems, specifically in relation to patient safety, product quality, and data integrity?\n\n3. What specific methodologies or frameworks does the document recommend for conducting risk assessments within the MES project lifecycle, and how are these assessments integrated into the overall system development process?", "prev_section_summary": "The section discusses the GAMP Good Practice Guide for Manufacturing Execution Systems, focusing on static and dynamic system specifications, reporting and release processes, system handover, and cutover criteria. Key topics include static and dynamic specification tables, system handover considerations, reporting requirements, and cutover criteria such as verification activities, addressing outstanding actions, and closeout requirements. The section emphasizes the importance of a well-managed system handover and a controlled cutover process for ensuring compliance and system integrity in Manufacturing Execution Systems.", "excerpt_keywords": "Manufacturing Execution Systems, GAMP, Risk Management, Data Integrity, System Efficiency"}}, "d1ab3221-0c6e-4e95-ab29-c76f6f6dc4e0": {"node_ids": ["57723f8a-3147-4206-bc9f-4e1545fc7d90"], "metadata": {"page_label": "41", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Risk Assessment and Management in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the GAMP (Good Automated Manufacturing Practice) guide suggest managing risks for configured products in the context of Manufacturing Execution Systems (MES)?\n   \n2. What is the difference between an MES domain and a functional domain as outlined in the \"Risk Assessment and Management in Manufacturing Execution Systems: A Comprehensive Guide,\" and how does this distinction aid in risk management?\n\n3. What are the key considerations outlined in the guide for assessing risks associated with a functional domain within MES implementations, and how does the guide suggest using a matrix to facilitate this process?", "prev_section_summary": "The excerpt discusses the key steps outlined in the GAMP(r) Good Practice Guide for ensuring data integrity and system efficiency in Manufacturing Execution Systems (MES). It emphasizes the importance of risk management in the development and implementation of MES, particularly in relation to patient safety, product quality, and data integrity. The document recommends specific methodologies and frameworks for conducting risk assessments within the MES project lifecycle, integrating them into the overall system development process. Key supporting processes for MES project development include risk management, configuration management, and release management. Quality risk management is highlighted as a systematic process for assessing, controlling, communicating, and reviewing risks, with a focus on identifying and reducing risks to an acceptable level. The excerpt also mentions the importance of an initial risk assessment followed by functional risk assessments as the system specification and design progress.", "excerpt_keywords": "Keywords: GAMP, Manufacturing Execution Systems, Risk Assessment, MES Domain, Functional Domain"}}, "4429682f-8611-4e07-969d-a9e9c3b780b0": {"node_ids": ["273bbdaf-2f0c-40ca-ac00-20bd501e490e"], "metadata": {"page_label": "42", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Configuration Management in Manufacturing Execution Systems: Ensuring Reliability and Control", "questions_this_excerpt_can_answer": "1. How does the GAMP (Good Automated Manufacturing Practice) guide suggest handling the increased risk associated with custom components, such as scripts or linked code, in Manufacturing Execution Systems (MES)?\n   \n2. What specific example risk controls does the GAMP guide recommend for ensuring the reliability and availability of MES and their data, particularly in the face of system or communications interruptions?\n\n3. What are the key activities involved in configuration management for MES as outlined in the GAMP guide, and how do these activities contribute to the control and documentation of MES components throughout their life cycles?", "prev_section_summary": "This section discusses the risk assessment and management in Manufacturing Execution Systems (MES) using a comprehensive guide. It covers the GAMP guide's suggestions for managing risks for configured products, the distinction between MES domain and functional domain for risk management, and key considerations for assessing risks associated with functional domains within MES implementations. The section also highlights the challenges posed by MES functionality during the project life cycle and the use of a matrix to facilitate risk assessment and management. Key topics include system impact assessment, user testing of controls and procedures, grouping related functions and data, and developing risk assessments for functional domains.", "excerpt_keywords": "Keywords: GAMP, Manufacturing Execution Systems, Configuration Management, Risk Controls, Functional Domain"}}, "24223b8d-779d-4814-a317-b1abbe19ecc1": {"node_ids": ["6ddbe8f6-6754-45ee-9bfc-1fbd37e93d38"], "metadata": {"page_label": "43", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Comprehensive Title: \"Optimizing Configuration and Release Management Processes for Manufacturing Execution Systems\"", "questions_this_excerpt_can_answer": "1. What specific guidance does the GAMP (Good Automated Manufacturing Practice) provide for managing the configuration of Manufacturing Execution Systems (MES) and ensuring their compliance with required characteristics?\n\n2. How does the document suggest handling the complexity of configuration management when multiple suppliers and integrators are involved in the MES or integrated systems setup?\n\n3. What are the recommended practices for release management in the context of MES implementation, particularly regarding the determination of system boundaries and interfaces to assess the impact of new or altered components?", "prev_section_summary": "This section discusses the importance of configuration management in Manufacturing Execution Systems (MES) to ensure reliability and control. It covers topics such as understanding customization versus configuration, handling custom components like scripts or linked code, and the risks associated with MES. The section also provides examples of risk controls for ensuring the reliability and availability of MES and their data, such as redundancies in systems, operational recovery, and automatic data resynchronization. Additionally, it outlines the key activities involved in configuration management for MES, including the identification and documentation of system elements throughout their life cycles.", "excerpt_keywords": "MES, Manufacturing Execution Systems, Configuration Management, Release Management, GAMP"}}, "b0d65257-6718-4695-93ac-5cdd31e55ce6": {"node_ids": ["69de20d2-5106-4d95-9037-20d02efecd2b"], "metadata": {"page_label": "44", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Blank Canvas: A Collection of Diverse Entities\"", "questions_this_excerpt_can_answer": "Based on the provided context, here are three questions that the context can provide specific answers to, which are unlikely to be found elsewhere:\n\n1. **What is the specific file size of the \"ISPE Manufacturing Execution Systems\" document stored in the PharmaWise Engineer project within the PharmaWise CSV & Data Integrity raw data directory?**\n   - This question targets the unique attribute of the document's file size, which is detailed in the context.\n\n2. **What are the creation and last modification dates of the document titled \"Blank Canvas: A Collection of Diverse Entities\" found in the PharmaWise Engineer project's raw data directory?**\n   - This question seeks information on the document's metadata, specifically its creation and last modification dates, which are explicitly mentioned in the context.\n\n3. **Under what file name and path can the \"ISPE Manufacturing Execution Systems\" PDF be located within the PharmaWise Engineer project's directory structure, and what is its relevance to the project?**\n   - This question is designed to extract detailed information about the document's storage location and its potential relevance or role within the broader PharmaWise Engineer project, inferred from its detailed file path and name. The context provides specific details about the file's location and its format, which might hint at its importance within the project's scope.\n\nThese questions are tailored to extract unique information provided in the context, which would be difficult to find in other sources without access to the specific document or project details mentioned.", "prev_section_summary": "The section discusses the importance of configuration and release management processes for Manufacturing Execution Systems (MES). Key topics include status accounting of system configuration items, reconciliation of system configuration versus required characteristics, controlling change via project change control, establishing a configuration baseline for each rollout of the MES program, periodic system quality audits, definitions of status nomenclature, criteria for status achievement, status management processes, challenges of configuration management with multiple suppliers and integrators, and release management methods for defining criteria and responsibilities for releasing equipment, applications, system modules, and systems at each stage of implementation. Key entities mentioned include GAMP (Good Automated Manufacturing Practice), suppliers, integrators, and system boundaries.", "excerpt_keywords": "MES, Configuration Management, Release Management, GAMP, Suppliers"}}, "547825fd-11de-410e-8470-c3f008bd2d01": {"node_ids": ["ae32f035-2eb6-4753-aa00-a60aa0fb38ec"], "metadata": {"page_label": "45", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Operational Change Control and Configuration Management in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the operational phase of Manufacturing Execution Systems (MES) ensure compliance and fitness for intended use throughout the systems' operational life, according to the GAMP\u00ae Good Practice Guide?\n   \n2. What specific steps and considerations does the formal change control process entail for operational changes in MES, as outlined in the document?\n\n3. How is configuration management defined in the context of MES lifecycle, and what are the procedures for managing configuration items as per the guidelines provided in the document?", "prev_section_summary": "The section provides metadata details about a document titled \"Blank Canvas: A Collection of Diverse Entities\" within the PharmaWise Engineer project's raw data directory. It includes information such as the file size, creation date, last modification date, file name, file path, and relevance to the project. The section also outlines specific questions that can be answered based on the context provided, focusing on unique attributes of the document and its storage location within the project directory.", "excerpt_keywords": "Operational Change Control, Configuration Management, Manufacturing Execution Systems, GAMP Good Practice Guide, Compliance"}}, "4462e2c6-dd74-49bf-8180-453e8ccf6a94": {"node_ids": ["e5123704-9e5b-4bc3-90b7-191c348cc6f5"], "metadata": {"page_label": "46", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Best Practices for Managing Manufacturing Execution Systems: Security, Performance Monitoring, Backup and Recovery, Record Retention, and Business Continuity", "questions_this_excerpt_can_answer": "1. What specific security measures are recommended for aseptic production lines, parenteral manufacturing, and cell culture production areas within the context of Manufacturing Execution Systems (MES) to ensure both personnel and system security?\n   \n2. How does the document suggest handling the backup and recovery of software, records, and data within MES to comply with regulatory requirements, and what specific guides does it refer to for further information on establishing, testing, and documenting restore procedures?\n\n3. What are the key components and considerations outlined in the document for effective business continuity and contingency planning in the context of Manufacturing Execution Systems, and how does it suggest organizations prepare to respond to failures and disruptions?", "prev_section_summary": "The section discusses the operational phase of Manufacturing Execution Systems (MES) and focuses on operational change control and configuration management. Key topics include the importance of compliance and fitness for intended use throughout the operational life of MES, the formal change control process for operational changes, and the definition and procedures of configuration management in the context of MES lifecycle. Entities mentioned include change control teams or committees, system users, process owners, system owners, technical subject matter experts (SMEs), process SMEs, and personnel qualified to assess risks to product and patients.", "excerpt_keywords": "Manufacturing Execution Systems, Security, Performance Monitoring, Backup and Recovery, Record Retention, Business Continuity"}}, "81deb07c-763c-4690-820f-cf027ea1c7f2": {"node_ids": ["4fe2f75f-543e-4802-ab7f-14e6fb3772cb"], "metadata": {"page_label": "47", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Comprehensive Business Continuity Planning and Periodic Reviews for Manufacturing Execution Systems", "questions_this_excerpt_can_answer": "1. What specific strategies does the GAMP\u00ae Good Practice Guide recommend for ensuring the continuity of critical business processes and systems in the event of a failure or disruption within Manufacturing Execution Systems (MES)?\n\n2. How does the document suggest handling data generated during a system outage or disruption, particularly in relation to business continuity planning (BCP) and the resumption of MES operations?\n\n3. What are the key considerations and recommended practices for conducting periodic reviews of MES to ensure compliance with regulatory requirements, fitness for intended use, and adherence to organizational policies and procedures, as outlined in the document?", "prev_section_summary": "The section discusses key topics related to managing Manufacturing Execution Systems (MES), including security measures for aseptic production lines, parenteral manufacturing, and cell culture production areas, performance monitoring, backup and recovery of software and data, record retention, archive, and retrieval, and business continuity and contingency planning. It emphasizes the importance of defining security controls, monitoring system performance, establishing backup and recovery procedures, defining record retention policies, and preparing for business continuity in the event of failures and disruptions. The section also references the ISPE GAMP Good Practice Guide for further information on these topics.", "excerpt_keywords": "Manufacturing Execution Systems, Business Continuity Planning, GAMP Good Practice Guide, Periodic Reviews, Regulatory Compliance"}}, "70f19e9b-0546-4abd-98ab-8a088a1463ea": {"node_ids": ["a9583643-f037-420b-8df2-f0b7dcef988d"], "metadata": {"page_label": "48", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Blank Canvas: A Collection of Absence\"", "questions_this_excerpt_can_answer": "Based on the provided context, here are three questions that this specific context can provide specific answers to, which are unlikely to be found elsewhere:\n\n1. **What is the file size of the \"ISPE Manufacturing Execution Systems\" PDF document stored in the PharmaWise Engineer project within the PharmaWise CSV & Data Integrity raw data directory?**\n   - This question is specific to the document's metadata, including its file size, which is detailed in the provided context.\n\n2. **What are the creation and last modification dates of the document titled \"Blank Canvas: A Collection of Absence\" found in the PharmaWise Engineer project's raw data directory?**\n   - The context provides unique information regarding the document's creation and last modification dates, which is not likely to be found in other sources.\n\n3. **How does the document titled \"Blank Canvas: A Collection of Absence\" relate to the ISPE Manufacturing Execution Systems within the context of the PharmaWise Engineer project?**\n   - This question seeks to understand the relationship or relevance between the document's content (or lack thereof, as suggested by the title and the \"no_content_here\" excerpt) and its placement within a collection that includes a document on Manufacturing Execution Systems, specifically within a pharmaceutical development context. This is a unique inquiry that combines the document's metadata with its thematic or content-based placement within a specific project directory.", "prev_section_summary": "The section discusses the importance of comprehensive business continuity planning for Manufacturing Execution Systems (MES), including the identification of critical business processes, establishment of a business continuity plan (BCP), management of data during system outages, and considerations for manual operation. It also covers the use of hot standby systems, periodic reviews of MES to ensure compliance with regulatory requirements, and the auditing of calibration, maintenance, incident, and change records. The section emphasizes the need for proactive measures to ensure the continuity and effectiveness of MES operations in the event of disruptions or failures.", "excerpt_keywords": "Keywords: ISPE, Manufacturing Execution Systems, business continuity planning, MES operations, regulatory compliance"}}, "c455a66f-da42-40c3-bf6f-0e8774fd70a5": {"node_ids": ["9e864463-75b6-472e-9559-28a8001ca310"], "metadata": {"page_label": "49", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Ensuring Effective Governance and Oversight for MES Implementation in the Life Sciences Industry\"", "questions_this_excerpt_can_answer": "1. What are the three major foundation models that MES programs are designed to coordinate within the life sciences industry, as outlined in the document?\n   \n2. How does the document recommend ensuring that MES systems remain compliant with regulations and evolve with organizational requirements and the business environment in the life sciences sector?\n\n3. What methodologies does the document suggest for relating elements of program foundation models during the implementation of MES in the life sciences industry?", "prev_section_summary": "The section provides metadata information about a PDF document titled \"ISPE Manufacturing Execution Systems\" stored in the PharmaWise Engineer project within the PharmaWise CSV & Data Integrity raw data directory. It includes details such as file size, creation date, and last modification date. Additionally, it mentions a document titled \"Blank Canvas: A Collection of Absence\" and poses questions about the relationship between this document and the ISPE Manufacturing Execution Systems document within the project context. The section focuses on document metadata and their thematic relevance within a pharmaceutical development project.", "excerpt_keywords": "MES, governance, oversight, compliance, life sciences, implementation"}}, "b5f0cae3-6a76-4181-9730-cc8e800d1963": {"node_ids": ["0cb81ed9-5912-4dc1-a158-21182452aaf1"], "metadata": {"page_label": "50", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Execution Systems Program Management and Responsibilities Guide", "questions_this_excerpt_can_answer": "1. What specific roles and responsibilities does GAMP 5 and the ISPE GAMP Good Practice Guide assign to technical organizations in the context of managing quality systems for computerized systems in life sciences regulation?\n\n2. How does the document define the relationship and division of responsibilities between process owners and system owners within the framework of Manufacturing Execution Systems (MES) program management?\n\n3. What are the responsibilities of technical SMEs (Subject Matter Experts) in ensuring the reliability and compliance of MES, according to the guidelines provided in the document?", "prev_section_summary": "This section discusses the importance of effective governance and oversight for MES implementation in the life sciences industry. It emphasizes the need for coordinated activities across compliance, project, and operations functions within organizations. The document suggests structuring a program to oversee planning, implementation, and ongoing maintenance of MES systems, with a focus on remaining compliant with regulations and evolving with organizational requirements. The three major foundation models for MES programs are identified as life cycle, quality systems, and execution. The document recommends using methodologies such as GAMP, IEEE, and ASTM guidance to coordinate these concepts into a cohesive structure. It also mentions alternative methods for relating elements of program foundation models, such as rapid application development and structured analysis and design. The section highlights the importance of establishing operational definitions and using a phased or staged plan for implementing MES systems in manageable subsets.", "excerpt_keywords": "Manufacturing Execution Systems, Program Management, Responsibilities, GAMP 5, ISPE GAMP Good Practice Guide"}}, "818c84de-463d-47a9-b561-d6587b6ce5a4": {"node_ids": ["d5d58316-f9f8-44d9-af98-a0fe83adbfdd"], "metadata": {"page_label": "51", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Program Management for Manufacturing Execution Systems Lifecycle and Quality Systems Governance Strategy Document", "questions_this_excerpt_can_answer": "1. How does the document outline the integration of document control within the lifecycle of Manufacturing Execution Systems (MES) as part of its strategic program management approach?\n\n2. What specific strategies does the document propose for managing the transition and retirement phases of MES within the context of quality systems and governance?\n\n3. In the context of executing MES projects, how does the document detail the process for conducting independent program compliance auditing, and how is this integrated with configuration management and change control processes?", "prev_section_summary": "The section discusses the program responsibilities related to Manufacturing Execution Systems (MES) program management, as defined by GAMP 5 and the ISPE GAMP Good Practice Guide. It outlines the roles and responsibilities of process owners, system owners, domain owners, and technical Subject Matter Experts (SMEs) in ensuring compliance, reliability, and quality of MES systems. Key topics include defining responsibilities, division of responsibilities between process and system owners, and the importance of technical SMEs in maintaining reliable systems.", "excerpt_keywords": "Manufacturing Execution Systems, Strategic Program Management, Lifecycle, Quality Systems Governance, Compliance Auditing"}}, "5994e642-2977-4149-ba58-c98d123c3446": {"node_ids": ["c9e1ebca-87cc-4bfc-bdda-bb52335caa8f"], "metadata": {"page_label": "52", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Integrated Life Cycle Management Strategies for Manufacturing Execution Systems\"", "questions_this_excerpt_can_answer": "1. How does the ASTM life cycle integrate with the GAMP 5 life cycle for manufacturing execution systems, particularly in the context of project activities and changes during the operation phase?\n   \n2. What specific guidance does the unified approach, as described in the document, offer for developing life cycle policies and procedures for manufacturing execution systems using ASTM terminology within GAMP 5 framework?\n\n3. How does the document describe the application of unified risk management concepts from ASTM 2500-07 and GAMP 5 in the development of specifications and verifications for manufacturing execution systems, particularly in terms of assessing risks based on novelty, complexity, and supplier quality?", "prev_section_summary": "The section outlines a strategic program management approach for Manufacturing Execution Systems (MES) lifecycle and quality systems governance. It discusses the integration of document control within the MES lifecycle, strategies for managing transition and retirement phases, conducting independent program compliance auditing, and integrating document control with configuration management. Key topics include project planning, implementation, quality systems, governance, configuration management, change control, testing, and decommissioning. Key entities mentioned are operations, retirement, compliance auditing, document control, configuration management, project change control, operational change control, development, design review, testing, release, and decommissioning.", "excerpt_keywords": "Manufacturing Execution Systems, ASTM, GAMP 5, life cycle management, risk management"}}, "85c40455-cd98-4fe5-80eb-1b401672bc6c": {"node_ids": ["a49624dc-e514-4109-9a42-fa51f45f011f"], "metadata": {"page_label": "53", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Strategic MES Planning Process: A Comprehensive Approach and Implementation Guidance\"", "questions_this_excerpt_can_answer": "1. What are the key factors that should guide the focus of an MES (Manufacturing Execution System) project according to the \"Strategic MES Planning Process: A Comprehensive Approach and Implementation Guidance\" document?\n\n2. How does the document suggest organizations should manage risks during the development and implementation of MES strategies?\n\n3. What tools and exercises does the \"Strategic MES Planning Process: A Comprehensive Approach and Implementation Guidance\" recommend for identifying an organization's relevant business drivers and the associated functional areas for MES implementation?", "prev_section_summary": "The section discusses the integration of ASTM and GAMP 5 life cycle approaches for manufacturing execution systems, focusing on project activities, changes during operation, and risk management concepts. It provides a mapping of activities from both standards to create a unified approach for life cycle management. The section emphasizes the project-oriented nature of the ASTM life cycle within the GAMP 5 framework, the development of life cycle policies using ASTM terminology, and the application of unified risk management concepts for specification and verification based on risk assessment criteria such as novelty, complexity, and supplier quality.", "excerpt_keywords": "MES, Planning Process, Implementation Guidance, Risk Management, Business Drivers"}}, "54ea8ad7-5b13-418d-8c5b-c360aa6906d9": {"node_ids": ["38acbe58-aaba-43db-88b4-9894d3e25606"], "metadata": {"page_label": "54", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Planning Functions and Challenges of MES in Manufacturing Pharmaceutical and Life Sciences Organizations", "questions_this_excerpt_can_answer": "1. How does the document outline the strategic planning functions necessary for implementing Manufacturing Execution Systems (MES) in pharmaceutical and life sciences organizations, specifically in terms of existing organizational models and business drivers?\n\n2. What specific challenges related to manufacturing processes, patent management, and compliance requirements are highlighted for pharmaceutical and life sciences organizations in the adoption of MES, as per the document?\n\n3. How does the document propose to address the gap between current and desired processes within pharmaceutical and life sciences organizations through MES strategic and tactical planning, including the consideration of global standards and best practices?", "prev_section_summary": "The section provides guidance on the MES planning process, including program, strategic, and implementation planning. It emphasizes the importance of aligning MES projects with organizational objectives and priorities such as cost reduction, quality improvement, and time-to-market reduction. The focus of the MES effort should be determined by business drivers, regulatory environments, and customer demands. Risk management principles should be applied throughout development and implementation to mitigate risks effectively. Organizations may choose elements of functional domains to include in their implementation strategy based on factors like complexity, cost, compliance, culture, or resource constraints. Business planning exercises should identify relevant business drivers and associated functional areas using tools like gap analysis, audits, and flowcharting. Quantifiable benefit metrics should be identified to determine the MES domain functionality to be implemented. Finally, a recommended project strategy should be developed for submission to management.", "excerpt_keywords": "MES, strategic planning, pharmaceutical, life sciences, challenges"}}, "e5238ab0-3dec-4c15-8c43-149594147fc4": {"node_ids": ["dc67aeb2-d0e9-4235-86da-5a57a9b657e7"], "metadata": {"page_label": "55", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Business Drivers and Key Performance Indicators in Manufacturing Execution Systems Strategy: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the GAMP (Good Automated Manufacturing Practice) guide suggest Manufacturing Execution Systems (MES) can address the challenge of increasing regulatory impacts on specification and verification activities within the pharmaceutical industry?\n\n2. What specific business drivers are identified in the document as critical for senior management to agree upon when developing a Manufacturing Execution Systems (MES) strategy to enhance operational efficiency and regulatory compliance in the pharmaceutical sector?\n\n3. According to the document, how are Key Performance Indicators (KPIs) and business drivers integrated within the ANSI/ISA-95 framework to justify the investment in MES projects, and what benefits are highlighted as being derived from MES implementations that align with these business drivers?", "prev_section_summary": "The section discusses the strategic planning functions necessary for implementing Manufacturing Execution Systems (MES) in pharmaceutical and life sciences organizations. It outlines existing organizational models, business drivers, challenges related to manufacturing processes, patent management, and compliance requirements. The document also proposes addressing the gap between current and desired processes through MES strategic and tactical planning, considering global standards and best practices. Key topics include strategic assessment, business drivers, technology, challenges in accommodating different manufacturing processes, patent expiration, record and audit trail requirements, and material tracking. Key entities mentioned are organizational policies and procedures, quality and compliance, business/mfg process definitions, and MES strategic and tactical plans.", "excerpt_keywords": "GAMP, Manufacturing Execution Systems, Strategic Business Drivers, Key Performance Indicators, Regulatory Compliance"}}, "3888fc2b-e016-478e-8305-42b31f7b8a3a": {"node_ids": ["e4b2c4ed-e2ba-41e0-80ae-9c8d7e859e9c"], "metadata": {"page_label": "56", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Planning for MES Implementation in Manufacturing Operations: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the key components that should be included in an MES tactical implementation plan according to the GAMP(r) Good Practice Guide?\n   \n2. How does the GAMP(r) Good Practice Guide suggest organizations should approach the identification and planning of MES projects within their strategic and program management framework?\n\n3. What process does the GAMP(r) Good Practice Guide recommend for capturing current and evolving information regarding business objectives and manufacturing operations in the context of strategic planning for MES implementation?", "prev_section_summary": "The section discusses the strategic business drivers and key performance indicators in Manufacturing Execution Systems (MES) strategy within the pharmaceutical industry. It highlights the challenges faced, such as increasing regulatory impacts, complexity of forecasting, and the need for regulatory approvals. The document identifies specific business drivers critical for senior management to agree upon, including reducing production costs, improving customer service, and maintaining regulatory compliance. It also emphasizes the integration of Key Performance Indicators (KPIs) and business drivers within the ANSI/ISA-95 framework to justify MES investments and outlines the benefits derived from MES implementations aligned with these drivers.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, strategic planning, program management"}}, "5be321be-fbfd-46c9-84e1-eec91033c2f1": {"node_ids": ["57307ebc-92ef-469d-b042-183cbed8bd55"], "metadata": {"page_label": "57", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Business Planning and Gap Analysis for MES Implementation", "questions_this_excerpt_can_answer": "1. How does the GAMP Good Practice Guide suggest integrating existing organizational business drivers and best practices into the strategic assessment for MES project goals?\n   \n2. What are the key components of a business strategy as outlined in the context, and how do they contribute to the successful implementation of a Manufacturing Execution System (MES) in regulated organizations?\n\n3. How does the document propose using gap analysis in the context of MES implementation, and what specific steps are recommended for identifying and addressing gaps in the supply chain?", "prev_section_summary": "This section discusses the strategic planning and program management approach for implementing Manufacturing Execution Systems (MES) in manufacturing operations. Key topics include program planning, strategic planning, functions and concepts, and considerations such as governance, project goals, resource requirements, risk management, regulatory compliance, data management planning, system architecture, and funding. The section emphasizes the importance of developing strategic business and MES plans, capturing current and evolving information regarding business objectives and manufacturing operations, and aligning individual project plans with corporate goals. The GAMP(r) Good Practice Guide provides guidance on identifying options, addressing complexities, and establishing a structured approach to MES implementation.", "excerpt_keywords": "MES, Manufacturing Execution Systems, Strategic Business Planning, Program Management, GAMP Good Practice Guide"}}, "1278a942-95bb-4665-99a9-ec9964a054b9": {"node_ids": ["fcaade37-870e-4bd9-9b37-f0b46174c99c"], "metadata": {"page_label": "58", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Strategic Planning for Manufacturing Execution Systems: A Holistic Approach to Achieving Business Goals\"", "questions_this_excerpt_can_answer": "1. How does the GAMP (Good Automated Manufacturing Practice) guide suggest MES (Manufacturing Execution Systems) strategic planning should align with business objectives, and what specific areas of impact are considered crucial in this alignment?\n   \n2. What are the key components and strategies outlined in the GAMP guide for developing an MES strategic plan, particularly in terms of organizational and technology strategies, to improve supply chain operations?\n\n3. According to the GAMP guide, what process should be initiated to justify the implementation of an MES solution, and how should the benefits of executing the MES strategic plan be quantified in relation to business objectives?", "prev_section_summary": "This section discusses the strategic business planning and gap analysis for MES implementation in regulated organizations. It covers the integration of organizational business drivers and best practices into the strategic assessment for MES project goals, key components of a business strategy, such as vision, objectives, and plan, and the use of gap analysis to identify and address gaps in the supply chain. The section emphasizes the importance of developing a cohesive corporate strategy that aligns with organizational resources and circumstances to successfully implement an MES program.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, strategic planning, supply chain operations"}}, "a956128c-3972-42d3-af85-44c759c22364": {"node_ids": ["b8dffd39-d7a2-49d5-a22c-7b219df9581a"], "metadata": {"page_label": "59", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Strategic Planning and Implementation for Manufacturing Execution Systems: A Comprehensive Approach\"", "questions_this_excerpt_can_answer": "1. What are the three major groups into which the benefits of implementing a Manufacturing Execution System (MES) can be organized according to the GAMP Good Practice Guide, and what are examples of benefits in each group?\n\n2. How does the GAMP Good Practice Guide suggest addressing the challenges of globalization in the strategic planning for MES, including specific aspects like culture, language, and regulatory environments?\n\n3. What are the recommended steps for creating an MES strategic plan as outlined in the GAMP Good Practice Guide, including the approach to risk analysis and the prioritization of implementation methods?", "prev_section_summary": "The section discusses the strategic planning process for Manufacturing Execution Systems (MES) as outlined in the GAMP guide. Key topics include the development of an MES strategic plan, alignment with business objectives, gap analysis, organizational and technology strategies, and quantifying the benefits of implementing the plan. The section emphasizes the importance of considering economy, efficiency, safety, reliability, consistency, quality, and regulatory compliance in the strategic planning process. It also highlights the need for reorganization of departments, re-engineering human activities, and prioritizing technology integration to improve supply chain operations.", "excerpt_keywords": "MES, Manufacturing Execution Systems, Strategic Planning, GAMP Good Practice Guide, Globalization"}}, "0a242e3c-db5c-43b9-9231-3b7f6f9ee936": {"node_ids": ["37dd367e-5f2e-41fe-a989-de108641cf11"], "metadata": {"page_label": "60", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Best Practices for Implementing MES Programs", "questions_this_excerpt_can_answer": "1. What are the key considerations for selecting applications and systems during the implementation of a Manufacturing Execution System (MES) according to the ISPE guide?\n   \n2. How does the ISPE guide recommend managing risks associated with MES implementation to ensure patient safety, product quality, data integrity, and organizational integrity?\n\n3. According to the ISPE guide, what strategies are suggested for establishing roles and responsibilities within an MES program, including the management of contract personnel involved in critical functions?", "prev_section_summary": "The section discusses the strategic planning and implementation of Manufacturing Execution Systems (MES) according to the GAMP Good Practice Guide. Key topics include the benefits of implementing MES, addressing challenges of globalization, creating an MES strategic plan, degree of globalization, governance, implementation and deployment options, data management, risk analysis, and documentation. The section emphasizes the importance of evaluating benefits, considering global factors, prioritizing deployment methods, and documenting the MES strategic plan for review and approval.", "excerpt_keywords": "MES, Manufacturing Execution Systems, ISPE, implementation, risk management"}}, "32b42e4a-47a6-44b9-93b1-70e6048610db": {"node_ids": ["e8cab95b-78ce-4f3c-93b5-8face600b1bb"], "metadata": {"page_label": "61", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Team Organization and Quality Unit Responsibilities in MES Projects: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the key roles and responsibilities identified for a team involved in MES (Manufacturing Execution Systems) projects, and how do they contribute to the project's success according to the document from ISPE Manufacturing Execution Systems?\n\n2. How does the document describe the importance of cross-functional team organization in MES projects, and what specific examples does it provide to illustrate the need for such a team structure?\n\n3. What specific responsibilities does the quality unit have in MES projects, especially concerning electronic production records (EPRs), as outlined in the document from ISPE Manufacturing Execution Systems?", "prev_section_summary": "The key topics covered in this section include functional domains, application selection, MES implementation plan, risk considerations, and roles and responsibilities in implementing a Manufacturing Execution System (MES) according to the ISPE guide. The section emphasizes the importance of identifying functional domains, selecting applications and systems based on production and process requirements, managing risks to patient safety, product quality, data integrity, and the organization, and establishing roles and responsibilities within an MES program. It also highlights the need for proper planning, risk assessment, and control throughout the project lifecycle to optimize resources and achieve project objectives. Additionally, the section mentions the use of risk management tools such as FMEA, HACCP, and HAZOP, as well as the importance of documenting roles and responsibilities, especially for contract personnel involved in critical functions.", "excerpt_keywords": "Manufacturing Execution Systems, MES projects, Team organization, Quality unit responsibilities, Electronic production records"}}, "27df8cbe-0a57-41b5-b9e9-6ae5bfcbcd10": {"node_ids": ["441a094a-6ed9-425a-adbd-e7ec873f1c33"], "metadata": {"page_label": "62", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Planning Guide for Successful Manufacturing Execution Systems (MES) Implementation", "questions_this_excerpt_can_answer": "1. What role does the quality unit play in the implementation of a Manufacturing Execution System (MES) according to the Strategic Planning Guide for Successful Manufacturing Execution Systems Implementation?\n\n2. How does the document suggest handling regulatory compliance issues when implementing an MES solution, particularly in relation to GMP relevant production records and data management?\n\n3. What approach does the document recommend for data management planning and system architecture in the context of MES implementation, including the use of data modeling practices and consideration of system architectures?", "prev_section_summary": "The section discusses the key roles and responsibilities in Manufacturing Execution Systems (MES) projects, emphasizing the importance of cross-functional team organization. It outlines various roles such as executive sponsors, project managers, subject matter experts, and external organizations involved in MES projects. The document highlights the need for a team structure that bridges functional areas and organizational groups to ensure project success. Additionally, it emphasizes the quality unit's responsibilities in MES projects, particularly concerning electronic production records (EPRs) like electronic batch records (EBRs) or electronic device history records (EDHRs). The quality unit is described as providing quality supervision, input to tasks, and documentation, playing a crucial role in the overall success of MES implementations.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Strategic Planning, Regulatory Compliance, Data Management"}}, "551558c4-a2a8-471d-8759-a1e5241adcfd": {"node_ids": ["626abba2-e0ca-4d6e-b0b6-71b62efede7a"], "metadata": {"page_label": "63", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Securing Funding for Manufacturing Execution Systems: A Strategic Approach", "questions_this_excerpt_can_answer": "1. What is the primary strategy recommended by the ISPE Good Practice Guide for securing funding for Manufacturing Execution Systems (MES) projects?\n   \n2. According to the document titled \"Securing Funding for Manufacturing Execution Systems: A Strategic Approach,\" what is considered essential for the completion of a successful MES project?\n\n3. In the context of the ISPE Manufacturing Execution Systems guide, what is the basis for obtaining approval for funding as outlined in Appendix 2, section 6.14?", "prev_section_summary": "The section discusses the strategic and program management approach to implementing Manufacturing Execution Systems (MES). Key topics include the role of the quality unit in MES implementation, handling regulatory compliance issues, data management planning, and system architecture considerations. The quality unit is highlighted as the supervisory and approval body for documents and methods in the implementation process. Regulatory compliance issues such as managing workflow processes, creating and storing GMP relevant production records, and using EPR functionality are emphasized. Data management planning involves employing data modeling practices and tools to capture data flow, while system architecture considerations involve choosing the appropriate architecture to meet organizational goals. The section provides guidance on addressing these key topics to ensure successful MES implementation.", "excerpt_keywords": "ISPE, Manufacturing Execution Systems, MES, funding, strategic approach"}}, "da00acf9-e55e-447f-8538-fa6305f31bbf": {"node_ids": ["84e6080c-bc9a-485b-90cc-f2735b3fbb44"], "metadata": {"page_label": "64", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Blank Canvas: A Collection of Absence\"", "questions_this_excerpt_can_answer": "Based on the provided context, here are three questions that the context can provide specific answers to, which are unlikely to be found elsewhere:\n\n1. **What is the file size of the \"ISPE Manufacturing Execution Systems\" PDF document stored in the PharmaWise Engineer project within the PharmaWise CSV & Data Integrity raw data directory?**\n   - This question is specific to the metadata provided in the context, such as the file size, which is detailed as 7322258 bytes. This information is unique to this document and its storage specifics, making it unlikely to be found in other sources.\n\n2. **What are the creation and last modification dates of the document titled \"Blank Canvas: A Collection of Absence\" found in the ISPE Manufacturing Execution Systems PDF?**\n   - The context provides specific dates for the creation and last modification of the document, which are April 7, 2024, and April 4, 2024, respectively. These details are unique to this document's version and revision history, making them highly specific and not likely to be available from other sources without access to the document's metadata.\n\n3. **Under what directory path is the \"ISPE Manufacturing Execution Systems\" PDF located within the PharmaWise Engineer project, and what is its significance in the context of PharmaWise CSV & Data Integrity raw data?**\n   - The question targets the specific file path provided (/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf) and asks for its significance. This question assumes that the document plays a role within the broader context of the PharmaWise Engineer project's focus on CSV (Computer System Validation) & Data Integrity within the pharmaceutical development sector. The specificity of the file path and its contextual relevance to the project's goals are details not likely to be found outside of this particular context.\n\nThese questions are tailored to extract information that is uniquely available from the provided context, leveraging the specific details about the document's metadata and its placement within a larger project framework.", "prev_section_summary": "The section discusses the importance of securing funding for Manufacturing Execution Systems (MES) projects, as outlined in the ISPE Good Practice Guide. It emphasizes the need for a strong business case with justification for requested funds to ensure the successful completion of the project. The document provides strategic and program management approaches for obtaining adequate funding for MES projects.", "excerpt_keywords": "Keywords: ISPE, Manufacturing Execution Systems, MES, funding, business case"}}, "78ba35dd-c7df-4d64-95c1-24f08ee56f57": {"node_ids": ["cb8e1c1c-a419-4d5c-9566-d461fb83c78c"], "metadata": {"page_label": "65", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "The Domain Approach in Manufacturing Execution Systems: Enhancing Specification, Risk Assessment, and Systems Management", "questions_this_excerpt_can_answer": "1. How does the domain approach within the GAMP good practice guide for manufacturing execution systems (MES) redefine the relationship between MES and traditional ISA functional hierarchy levels?\n   \n2. What are the key benefits of adopting a domain approach in the specification, risk assessment, verification, and systems management of MES, as outlined in the GAMP good practice guide?\n\n3. How does the GAMP good practice guide suggest handling the variability in GxP impact across different functionalities within a single computer system or MES, particularly in relation to risk assessment and lifecycle activities?", "prev_section_summary": "The key topics of this section include the metadata of a PDF document titled \"ISPE Manufacturing Execution Systems\" stored in the PharmaWise Engineer project within the PharmaWise CSV & Data Integrity raw data directory. The section provides information on the file size, creation date, last modification date, document title, and file path of the PDF document. The entities mentioned in the section are the document title, file size, creation date, last modification date, and file path, all of which are specific to the context of the document within the PharmaWise Engineer project.", "excerpt_keywords": "GAMP, Manufacturing Execution Systems, Domain Approach, Risk Assessment, Systems Management"}}, "7fcfbeff-20e9-4ed1-9dc8-1bc609d19488": {"node_ids": ["80cdb8b8-438d-4a76-8ccf-7a54ab264158"], "metadata": {"page_label": "66", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "A Comprehensive Approach to Designing Manufacturing Execution Systems Using Functional Domains", "questions_this_excerpt_can_answer": "1. How does the domain approach in designing Manufacturing Execution Systems (MES) facilitate the integration of new and existing systems to meet the requirements of an MES domain?\n   \n2. In what ways does the domain approach assist in the coordination of computer systems and related quality systems throughout the overall facility lifecycle, particularly in the context of Manufacturing Execution Systems?\n\n3. How can organizations leverage the domain approach to mitigate risks associated with the implementation of new technologies or methods of manufacturing within the MES framework?", "prev_section_summary": "The section discusses the domain approach in Manufacturing Execution Systems (MES) as outlined in the GAMP good practice guide. Key topics include the redefinition of the relationship between MES and traditional ISA functional hierarchy levels, the benefits of adopting a domain approach in specification, risk assessment, verification, and systems management of MES, and handling variability in GxP impact across different functionalities within a single computer system or MES. The section emphasizes the importance of defining an MES domain to enhance activities related to complex systems, such as specification, risk assessment, and verification. It also highlights the advantages of taking a higher-level view of MES as a domain encompassing the entire manufacturing system, including processes, computer systems, equipment, materials, and human activities. The domain approach allows for flexibility in combining existing systems and adding new functionalities to create a systems-based manufacturing environment.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Domain Approach, Systems Design, Functional Domains"}}, "222cf63d-544f-47ef-9659-71fbe1551bb5": {"node_ids": ["a77ad469-a0d6-4c98-a1da-f991babed245"], "metadata": {"page_label": "67", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Approach to Manufacturing Execution Systems Design and Risk Management: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the document propose using functional domains in the design and risk management of Manufacturing Execution Systems (MES)?\n   \n2. What specific approach does the document recommend for mapping functional domains to risk-based testing in the context of MES design and implementation?\n\n3. How does the document suggest ensuring that MES systems meet end user requirements upon first implementation, particularly in terms of reducing rework or contractual disagreements?", "prev_section_summary": "This section discusses the application of domains in designing Manufacturing Execution Systems (MES) to facilitate the integration of new and existing systems. It outlines scenarios for MES domain implementations, such as first-time implementation, integration of existing systems, and a combination of new and existing systems. The domain approach involves developing requirements for the overall domain and individual system requirements as subsets. It helps coordinate computer systems and quality systems throughout the facility lifecycle and mitigate risks associated with implementing new technologies. Functional domains are defined based on common attributes, goals, activities, data, and risks, and are implemented across system boundaries. The MES domain encompasses all functional domains required for business and manufacturing processes. The section emphasizes the importance of specifying requirements and documentation for each system within the domain approach.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Design, Risk Management, Functional Domains"}}, "e75c9a94-894e-4e6c-920d-eb5844edc937": {"node_ids": ["c781877e-2e50-4951-9d1a-966f70f7982f"], "metadata": {"page_label": "68", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Risk Management and Verification in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the GAMP 5 framework guide the assignment of risk levels to functionality within Manufacturing Execution Systems (MES) domains, and what factors are considered in this risk assessment process?\n   \n2. In what ways does the application of ASTM 2500-07 standards, as referenced in the document, facilitate the reduction of verification efforts for equipment within the same category in MES, and how does this impact the overall functional domain risk level?\n\n3. How does the document propose the use of modular testing documentation and automated test scripts to enhance the efficiency and cost-effectiveness of risk management and verification processes in MES functional domains, and what are the expected benefits of such an approach in terms of standardization and reusability?", "prev_section_summary": "The section discusses a strategic approach to designing and managing Manufacturing Execution Systems (MES) by using functional domains. It outlines how to map functional domains to risk-based testing, ensuring that MES systems meet end user requirements upon first implementation. The approach involves grouping functions into domains, creating application/system designs, and conducting testing based on risks. The goal is to clarify requirements for suppliers/integrators and reduce rework or contractual disagreements. Key topics include using functional domains for design and risk management, concurrent specification/design and test planning processes, and ensuring appropriate development methods and testing. Key entities mentioned are production planning, production control, sampling-testing, disposition, electronic production records, materials/product genealogy, and process management and control.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Risk Management, Verification, GAMP 5"}}, "d15c5b92-2aaf-41e0-8306-8ec99a4d911e": {"node_ids": ["36f9391f-160a-4e67-a44b-18b75a33eb0c"], "metadata": {"page_label": "69", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Maximizing Efficiency and Performance: Leveraging Domain Approach for Manufacturing Execution Systems\"", "questions_this_excerpt_can_answer": "1. How does the domain approach implementation for existing Manufacturing Execution Systems (MES) address the challenge of integrating domain functionality into systems that were previously tested without a focus on domain-specific features?\n\n2. What are the specific benefits of applying a domain approach to the design and testing phases of MES development, as outlined in the document, and how does this approach facilitate change management and control?\n\n3. Can you detail how the domain approach aids in the accurate assessment of risk values for different functional domains within MES, particularly in terms of commonality of typical factors such as impact, frequency, and detection?", "prev_section_summary": "This section discusses the strategic risk management and verification in Manufacturing Execution Systems (MES) by mapping functional domains to appropriate applications, systems, or equipment. It explains how risk levels are assigned to functionality within MES domains based on factors such as product impact, system complexity, and supplier audit results. The application of quality risk management techniques and standards like GAMP 5 and ASTM 2500-07 helps in reducing verification efforts for equipment within the same category. The use of modular testing documentation and automated test scripts is proposed to enhance efficiency and cost-effectiveness in risk management and verification processes, promoting standardization and reusability. Overall, the section emphasizes the importance of standardized risk and testing approaches for improved management of MES functional domains.", "excerpt_keywords": "Manufacturing Execution Systems, Domain Approach, Risk Assessment, Change Management, Verification Planning"}}, "066836c8-2e37-45bd-8878-748d1c570bb1": {"node_ids": ["09c3598d-2340-4c7c-a077-f89699caa88c"], "metadata": {"page_label": "70", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Optimizing Manufacturing Operations: A Strategic Approach to Manufacturing Execution Systems and Genealogy Expansion\"", "questions_this_excerpt_can_answer": "1. How does the GAMP\u00ae Good Practice Guide suggest incorporating genealogy into the functional domain of manufacturing execution systems, and what are the key functions associated with material and product genealogy as outlined in the guide?\n\n2. What role does risk management play in the design and implementation of manufacturing execution systems according to the GAMP\u00ae Good Practice Guide, particularly in relation to the functional domain of material and product genealogy?\n\n3. How does the guide recommend handling master and operational data within the domain creation and analysis process for manufacturing execution systems, and what impact does this data have on the risk factors associated with the functional domain?", "prev_section_summary": "The section discusses the implementation of a domain approach for existing Manufacturing Execution Systems (MES) to address challenges in integrating domain functionality. It highlights the benefits of applying a domain approach in design and testing phases, such as facilitating change management and control, enabling early traceability, and coordinating phased delivery of functionality. The section also emphasizes the importance of accurately assessing risk values for different functional domains within MES based on common factors like impact, frequency, and detection. Additionally, it mentions the importance of documenting system and application functions, establishing relationships among them, and integrating interdependent entities and activities into a single design.", "excerpt_keywords": "Manufacturing Execution Systems, Genealogy Expansion, GAMP Good Practice Guide, Risk Management, Domain Analysis"}}, "41effd14-d5dc-4494-a940-cb731e8a1d01": {"node_ids": ["d5e9f945-822b-4612-adea-9858643f8449"], "metadata": {"page_label": "71", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Exploring MES Implementation Strategy Approaches: Horizontal, Vertical, and Hybrid Approaches\"", "questions_this_excerpt_can_answer": "1. What are the two primary methods for implementing a Manufacturing Execution System (MES) as outlined in the document, and how do they differ in terms of scope and compliance validation?\n   \n2. How does the document describe the process and considerations for choosing between a horizontal or vertical MES implementation strategy, particularly in terms of organizational size, the scope of integration, and compliance requirements?\n\n3. Can the document provide insights into how a hybrid MES implementation strategy combines elements of both horizontal and vertical approaches, and what factors might influence an organization to choose this method over a purely horizontal or vertical strategy?", "prev_section_summary": "The section discusses the strategic approach to manufacturing execution systems and genealogy expansion, focusing on domain analysis and creation, material and product genealogy functions, risk management, master and operational data handling, and the iterative process of developing requirements, specifications, and designs. Key topics include the role of genealogy in manufacturing operations, functions associated with material and product genealogy, risk factors affecting system design, data management considerations, and the optimization of risk management activities within the GXP life cycle process.", "excerpt_keywords": "MES, Implementation Strategy, Horizontal, Vertical, Hybrid Approach"}}, "eb784b4a-f1f2-4574-a21c-dc441e5f0e45": {"node_ids": ["c6b0515d-a5cc-41c2-88eb-1d74f68626a6"], "metadata": {"page_label": "72", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Implementing Manufacturing Execution Systems: A Horizontal Strategy for Success\"", "questions_this_excerpt_can_answer": "1. What are the primary advantages and disadvantages of adopting a horizontal implementation strategy for Manufacturing Execution Systems (MES) as outlined in the document \"Implementing Manufacturing Execution Systems: A Horizontal Strategy for Success\"?\n\n2. How does the document \"Implementing Manufacturing Execution Systems: A Horizontal Strategy for Success\" describe the approach to achieving cost control or solving critical functional issues through horizontal implementation strategies for MES across multiple sites or products?\n\n3. In the context of MES implementation strategies discussed in \"Implementing Manufacturing Execution Systems: A Horizontal Strategy for Success,\" how does a horizontal implementation strategy differ in its approach to adding functionality compared to a vertical implementation strategy, particularly in terms of scope and integration across manufacturing or business processes?", "prev_section_summary": "The section discusses the development of a Manufacturing Execution System (MES) implementation strategy, outlining two primary methods: horizontal and vertical implementations. Horizontal implementations involve implementing layers of functionality across multiple areas, facilities, processes, or products, while vertical implementations are top-to-bottom through a selected area, facility, process, or product. The document describes considerations for choosing between these approaches based on organizational size, integration scope, and compliance requirements. It also mentions a hybrid approach that combines elements of both horizontal and vertical strategies for multiple products or facilities. Factors such as re-engineering, downtime, and project scope segmentation are highlighted as considerations for MES implementation.", "excerpt_keywords": "Manufacturing Execution Systems, MES, implementation strategy, horizontal, cost control"}}, "60e2e5f4-6316-40cc-88be-6855d3aefbb8": {"node_ids": ["c62fd0f3-5502-4ce1-81b1-aad8905a0fd1"], "metadata": {"page_label": "73", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "A Comparative Analysis of Vertical and Horizontal Implementation Strategies in Manufacturing Execution Systems", "questions_this_excerpt_can_answer": "1. What are the specific advantages and disadvantages of adopting a horizontal implementation strategy for Manufacturing Execution Systems (MES) as outlined in the document \"A Comparative Analysis of Vertical and Horizontal Implementation Strategies in Manufacturing Execution Systems\"?\n\n2. How does the document compare the impact of horizontal and vertical implementation strategies on team deployment, site operations, and system integration within the context of Manufacturing Execution Systems?\n\n3. In the context of exploring and developing a comprehensive MES approach, what does the document suggest about the use of a vertical implementation strategy, particularly in environments where there is no impact on commercial product or validated processes?", "prev_section_summary": "The section discusses the strategic and program management approach to implementing Manufacturing Execution Systems (MES) with a focus on horizontal implementation strategies. It compares vertical and horizontal implementation strategies, highlighting the advantages and disadvantages of the horizontal approach. The key topics covered include achieving cost control, solving critical functional issues, implementing limited functionality across multiple areas, facilities, or products, and gradually building additional layers of functionality to achieve the desired scope of systems and business process integration. The section emphasizes the importance of common process functionality and improving compliance or efficiency in a horizontal implementation strategy for MES.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Implementation Strategies, Vertical, Horizontal"}}, "b319e5be-f02d-458c-beca-a2424394e5b8": {"node_ids": ["15cf87f9-9136-4d62-9ceb-6aa88bf951a3"], "metadata": {"page_label": "74", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Program Management and Application Control Strategies for Manufacturing Execution Systems", "questions_this_excerpt_can_answer": "1. What are the key advantages and disadvantages of implementing Manufacturing Execution Systems (MES) using a strategic and program management approach as outlined in the ISPE GAMP Good Practice Guide's Appendix 4?\n\n2. How does the ISPE GAMP Good Practice Guide suggest managing the prototype system approach for MES to ensure it accurately represents the production environment, including hardware and software specifications?\n\n3. According to the document, what are the considerations for ensuring hardware and software equivalency in a prototype system for MES, and how does this approach facilitate the early stages of project life cycle without intending the prototype for production use?", "prev_section_summary": "The section discusses the advantages and disadvantages of adopting horizontal and vertical implementation strategies for Manufacturing Execution Systems (MES). \n\nKey topics include:\n- Advantages and disadvantages of horizontal implementation strategy\n- Impact on team deployment, site operations, and system integration\n- Advantages and disadvantages of vertical implementation strategy for exploring and developing a comprehensive MES approach\n\nKey entities mentioned:\n- Manufacturing Execution Systems (MES)\n- Horizontal implementation strategy\n- Vertical implementation strategy\n- Team deployment\n- Site operations\n- System integration\n- Prototype development\n- Commercial product\n- Validated processes", "excerpt_keywords": "Manufacturing Execution Systems, MES, ISPE GAMP, Program Management, Application Control Strategies"}}, "1bf871d6-e95d-4fa8-8e06-e129651cc273": {"node_ids": ["ea9dcf7c-985d-4a86-a733-cf4b80c8ba43"], "metadata": {"page_label": "75", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Approaches to Manufacturing Execution Systems Governance and Control: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the key components and considerations for setting up a pilot or test Manufacturing Execution System (MES) environment according to the GAMP (Good Automated Manufacturing Practice) guide, and how does it differ from the production system configuration?\n   \n2. How does the GAMP guide recommend managing the control of MES domain applications in a centralized manner, including the specifics of application hosting, change control, data management, and verification processes?\n\n3. What are the guidelines provided by the GAMP guide for individual site application control within MES, including the authorization, functionality control, change control, data management, and verification processes at the site level?", "prev_section_summary": "The section discusses the advantages and disadvantages of implementing Manufacturing Execution Systems (MES) using a strategic and program management approach as outlined in the ISPE GAMP Good Practice Guide's Appendix 4. It highlights the benefits of lower overall cost, shorter implementation time, and early benefits, but also mentions challenges such as high resource loading and delays in benefits to sites. The document also addresses the management of prototype systems for MES, emphasizing the importance of ensuring hardware and software equivalency to accurately represent the production environment. Key considerations include processor class/speed, memory and storage requirements, and input/output specifications. The prototype system is created early in the project life cycle for testing purposes and is not intended for production use.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP, Governance, Control"}}, "cab7ef02-5aa2-4aee-b95b-750ae7517bce": {"node_ids": ["58c8316f-5970-45e5-aa34-27c98e2e5555"], "metadata": {"page_label": "76", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Approach to Manufacturing Execution Systems Implementation and Core Team Activities: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What is the hybrid approach to the control of applications in Manufacturing Execution Systems (MES) as outlined in the GAMP(r) Good Practice Guide, and what are the responsibilities of local sites under this approach?\n\n2. Who are the typical members of a core implementation team for large MES projects, according to the strategic approach detailed in the document?\n\n3. How does the document suggest handling the balance between leveraging core MES functionality and accommodating site-specific requirements during the implementation process?", "prev_section_summary": "The section discusses key components and considerations for setting up a pilot or test Manufacturing Execution System (MES) environment according to the GAMP guide, including network connectivity, database configuration, equipment, application versions, and interfaces to other systems. It also covers the differences between pilot/test and production system configurations, as well as recommendations for central control of MES domain applications and individual site application control. Key topics include centralized hosting of applications, change control, data management, verification processes, and decentralized authorization and functionality control at individual sites.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP, Implementation, Core Team"}}, "29c2cce6-133c-4093-9879-8f254853bb17": {"node_ids": ["198f5220-4a16-49a4-aa78-b7f559075d96"], "metadata": {"page_label": "77", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Deployment and Verification of MES Core Functionality in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the GAMP Good Practice Guide suggest MES core functionality enhancements should be shared across development and deployment organizations to facilitate knowledge sharing and innovation?\n\n2. What are the recommended practices for documenting and verifying MES core functionality according to the GAMP Good Practice Guide, including the types of documentation that should be made accessible for each deployment?\n\n3. What benefits does the GAMP Good Practice Guide highlight regarding the configuration of standard applications over customization in the context of MES deployment, and how does this approach contribute to cost and time savings in verification?", "prev_section_summary": "The section discusses the hybrid approach to control applications in Manufacturing Execution Systems (MES) as outlined in the GAMP(r) Good Practice Guide, where central organization controls core functionality and local sites are responsible for maintenance and local configuration. It also outlines the typical members of a core implementation team for large MES projects, including representatives from corporate quality units, regulatory affairs, validation, information technology, and site quality and user communities. The document suggests balancing core MES functionality with site-specific requirements during implementation by developing a common set of functionality for the MES core development and allowing for additional configuration or customizations at the site level.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP Good Practice Guide, core functionality, verification"}}, "d61484fb-7c96-4246-9808-c9e9a48e58c9": {"node_ids": ["184128fc-4a51-4b9c-a29f-ba638a3af57f"], "metadata": {"page_label": "78", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Best Practices for MES Implementation and Deployment: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the recommended practices for issuing an interim validation report during the phased deployment of a Manufacturing Execution System (MES) according to the GAMP good practice guide?\n   \n2. How does the document suggest handling the localization of MES core components during the rollout to multiple sites, and what is the importance of documentation in this process?\n\n3. What are the advantages of having a separate MES system from production systems during the domain-based manufacturing implementation, especially in terms of testing, training, and problem-solving, as outlined in the guide?", "prev_section_summary": "The section discusses the strategic deployment and verification of MES core functionality in Manufacturing Execution Systems according to the GAMP Good Practice Guide. Key topics include sharing innovations and enhancements across development and deployment organizations, documenting and verifying MES core functionality, the benefits of configuration over customization, and the verification process for MES core functionality. Entities mentioned include the core team, customized enhancements, standard applications, testing procedures, and documentation requirements.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, validation report, phased deployment"}}, "5b28bedb-2f4c-44d2-8c9b-9b6b98413544": {"node_ids": ["f346835d-8aab-41f3-a49c-363ee57dca00"], "metadata": {"page_label": "79", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"System Controls and Considerations in MES Deployments: A Comprehensive Guide\"", "questions_this_excerpt_can_answer": "1. What are the recommended mechanisms to maintain a Manufacturing Execution System (MES) in a compliant state during testing phases, as outlined in the GAMP Good Practice Guide: Manufacturing Execution Systems?\n   \n2. How does the document suggest handling the implementation of local functionality within MES deployments to ensure business benefits and compliance, especially in terms of validation costs and time?\n\n3. What challenges are identified in the document regarding system integration across organizational boundaries in MES deployments, and how do these challenges impact data consistency and transaction timing?", "prev_section_summary": "The section discusses best practices for MES implementation and deployment, focusing on issuing interim validation reports, site localization during rollout, and the advantages of having a separate MES system from production systems. Key topics include the use of interim validation reports to support phased deployment, testing and documentation of localized configurations, and the benefits of separate MES systems for testing, training, and problem-solving. Entities mentioned include GAMP good practice guide, MES core components, validation plan, localization, phased deployment, domain-based manufacturing, testing, training, production systems, and supporting software.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, system controls, deployment"}}, "bccd7345-006c-434a-9674-b599e9fa9104": {"node_ids": ["735cecce-0c47-4101-adc0-0a7a82d590e0"], "metadata": {"page_label": "80", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Implementation and Program Management of Manufacturing Execution Systems", "questions_this_excerpt_can_answer": "1. What strategies are recommended for managing changes or modifications to the original scope of work during the implementation of Manufacturing Execution Systems (MES) to avoid disputes, cost over-runs, and schedule delays?\n   \n2. How does the document suggest handling the overlap of phases during the implementation of system components in MES projects, particularly in relation to accommodating project constraints and ensuring the smooth transition of hardware and software components through various execution phases?\n\n3. What are the specific procedures recommended for establishing status nomenclature and transition criteria for hardware and software components in MES projects, as outlined in the strategic implementation and program management approach for MES?", "prev_section_summary": "The section discusses system controls and considerations during Manufacturing Execution System (MES) deployments. Key topics include maintaining a compliant state during testing phases, handling local functionality implementation, challenges of system integration across organizational boundaries, and life cycle phase relationships. Entities mentioned include configurable MES core functionality, manual procedures, run time modules, system patches, installation qualification/operational qualification supplements, regression analysis, business benefits, local functionality, validation costs and time, organizational boundaries, data consistency, transaction timing, language issues, manufacturing portals, GUI screen displays, shared systems, core team, large integrated systems, database instances, and data groups.", "excerpt_keywords": "Manufacturing Execution Systems, Program Management, Scope of Work, Project Milestones, Change Control"}}, "dd2fc027-2bf4-44a7-ae42-1f3566e1c936": {"node_ids": ["de3fc44b-8d40-4746-920e-78b66952b5b0"], "metadata": {"page_label": "81", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Approach to Application and System Selection in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What strategic approach does the GAMP Good Practice Guide recommend for selecting and implementing Manufacturing Execution Systems (MES) to meet the needs of different organizations?\n   \n2. How does the GAMP Good Practice Guide classify system implementations within the MES domain, and what are the key differences between \"best in class\" point solutions and \"single source\" solution suites?\n\n3. What are the identified advantages of opting for solution suite systems over point solutions when implementing MES according to the GAMP Good Practice Guide, and how do these advantages impact system architecture and user interface consistency?", "prev_section_summary": "The section discusses the strategic implementation and program management approach for Manufacturing Execution Systems (MES). Key topics include defining the scope of work, managing changes or modifications to the original scope, establishing project milestones, handling overlap of phases during implementation, defining status nomenclature and transition criteria for hardware and software components, and following appropriate change control procedures. The section emphasizes the importance of avoiding disputes, cost over-runs, and schedule delays during MES implementation.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP Good Practice Guide, System Selection, Solution Suite"}}, "3e7bd989-b231-4d24-89f0-87bf85e1dfcf": {"node_ids": ["3dfec74f-918b-4614-a58a-23a14d60803b"], "metadata": {"page_label": "82", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Comparison of Solution Suite Systems and Point Solution Systems in Manufacturing Execution Systems: A Comprehensive Analysis", "questions_this_excerpt_can_answer": "1. What are the identified disadvantages of relying on solution suite systems for critical business operations in the context of Manufacturing Execution Systems (MES) as outlined in the ISPE Good Practice Guide?\n\n2. How does the document describe the advantages of adopting point solution systems over solution suite systems in the realm of MES, particularly in terms of flexibility and supplier competition?\n\n3. What specific challenges and risks are associated with the implementation and maintenance of point solution systems in MES, as detailed in the ISPE Manufacturing Execution Systems guide, and how do these challenges impact system integration and support?", "prev_section_summary": "The section discusses the strategic approach recommended by the GAMP Good Practice Guide for selecting and implementing Manufacturing Execution Systems (MES) to meet the needs of different organizations. It covers the classification of system implementations within the MES domain as either \"best in class\" point solutions or \"single source\" solution suites. The advantages of opting for solution suite systems over point solutions are highlighted, including fewer suppliers and contracts for support, more integrated functionality, consistent human interface approach, and fewer system architectures to support. The section emphasizes the importance of defining a strategy for the business before choosing or integrating solutions to avoid re-engineering or replacing solutions later in MES domain implementation. It also mentions the evaluation of suppliers in the MES domain and the need for supplier audits to ensure appropriate systems are used.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Solution Suite Systems, Point Solution Systems, GAMP Good Practice Guide"}}, "916388b6-5e79-40ba-97cd-45cb21992229": {"node_ids": ["3ef6bea2-32f9-4721-b0e4-d95e342cdfe9"], "metadata": {"page_label": "83", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Considerations for Manufacturing Execution Systems (MES) Solution Selection and Implementation: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the document describe the strategic considerations for minimizing customization during the gap analysis phase of MES solution selection and implementation?\n   \n2. What are the specific advantages and disadvantages outlined in the document for choosing between point solution systems and solution suite systems in the context of Manufacturing Execution Systems (MES)?\n\n3. According to the document, what is the \"control domain - up approach\" in MES implementation, and how does it enhance batch management and recipe control functionalities?", "prev_section_summary": "The section discusses the comparison between solution suite systems and point solution systems in Manufacturing Execution Systems (MES). It outlines the disadvantages of relying on solution suite systems, such as lack of competition among suppliers, lack of required functionality, and potential system lagging behind current technology. On the other hand, it highlights the advantages of adopting point solution systems, including competition among suppliers, flexibility in selecting optimized solutions, and easier response to changes in product or business model. However, it also mentions the challenges associated with point solution systems, such as complexity in implementation and maintenance, potential lack of required functionality, and higher risk of system support loss from smaller specialized suppliers. The section emphasizes the importance of a risk-based approach in choosing the systems architecture for MES to address specific user requirements.", "excerpt_keywords": "MES, Manufacturing Execution Systems, Solution Selection, Implementation, Strategic Considerations"}}, "61e0cccc-c3c2-46ca-8a63-311634cad289": {"node_ids": ["4fda996f-7fb1-49b3-9196-14207048813f"], "metadata": {"page_label": "84", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Approach to Manufacturing Execution Systems Integration and Implementation: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What strategic approach does the GAMP\u00ae Good Practice Guide suggest for minimizing risk during the initial stages of Manufacturing Execution Systems (MES) implementation, and how does it prioritize the integration of systems across different levels of the manufacturing process?\n\n2. How does the \"enterprise-down approach\" to MES integration differ in its initial focus and implementation strategy compared to other approaches, particularly in terms of functionality and interfaces with enterprise systems like ERP, and what are the expected benefits at different levels of the enterprise?\n\n3. In the context of MES implementation, how should the distribution of business functions be approached to ensure high levels of compliance and operational efficiency, especially concerning WIP material management and the integration of ERP/MRP systems with MES and other control domain automation software systems?", "prev_section_summary": "The section discusses strategic considerations for selecting and implementing Manufacturing Execution Systems (MES). It covers the importance of minimizing customization during the gap analysis phase, comparing point solution systems and solution suite systems, and the control domain - up approach in MES implementation. Key topics include gap analysis, software selection, functionality analysis, advantages and disadvantages of different system types, integration of business processes, and the control domain - up approach for enhancing batch management and recipe control functionalities. Key entities mentioned are IT SMEs, engineering groups, systems integrators, point solution systems, solution suite systems, batch management, batch reporting, data distribution, recipe control, and higher-level recipe management.", "excerpt_keywords": "Manufacturing Execution Systems, MES implementation, GAMP Good Practice Guide, Enterprise-down approach, Business functions"}}, "7772ffc2-68ed-4346-a8c7-f9ac132f316a": {"node_ids": ["ce0841b8-48f1-4edb-a305-bafb37c1e882"], "metadata": {"page_label": "85", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Integration of Manufacturing Execution Systems and Electronic Production Records: Approaches and Best Practices", "questions_this_excerpt_can_answer": "1. What are the considerations and strategies for integrating alarm and exception processing within Manufacturing Execution Systems (MES) and Electronic Production Records (EPRs) as outlined in the GAMP 5 guide?\n   \n2. How does the document suggest handling the integration of automation and MES to prevent duplicate operator entries and enhance workflow efficiency in the context of alarm and event processing?\n\n3. What are the specific strategies recommended for implementing batch/order management and operational sequencing when automation is introduced before Electronic Production Records (EPRs), according to the strategic integration guide provided in the document?", "prev_section_summary": "This section discusses the strategic approach to Manufacturing Execution Systems (MES) integration and implementation, focusing on minimizing risks, the enterprise-down approach, scope and justification, and business functions in MES implementation. Key topics include risk minimization, integration with enterprise systems like ERP, project scope, business functionality distribution, WIP material management, and system independence. Key entities mentioned are GAMP\u00ae Good Practice Guide, MES, ERP, WIP material management, enterprise systems, project scope, and compliance.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Electronic Production Records, Integration, Automation"}}, "481a08b4-cc8c-4629-a795-2c335698986a": {"node_ids": ["8be391b8-b244-4688-811f-ec4d5c1b5c6b"], "metadata": {"page_label": "86", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Optimizing Manufacturing Execution Systems: Ensuring Data Availability, Redundancy, and Integration", "questions_this_excerpt_can_answer": "1. How does the document propose to quantify the success of implementing Manufacturing Execution Systems (MES) in terms of operator-caused non-conformances, work-in-progress (WIP) reduction, and batch release time improvements?\n   \n2. What strategies does the document recommend for ensuring the availability and redundancy of manufacturing data when integrating MES with other systems like ERP/MRP, LIMS, and warehouse management systems?\n\n3. What considerations does the document outline for deciding between deploying point solution systems versus a solution suite in the context of system planned downtime and fault isolation, especially for organizations with multiple MES sites?", "prev_section_summary": "The section discusses the strategic integration of Manufacturing Execution Systems (MES) and Electronic Production Records (EPRs) with a focus on alarm and exception processing. Key topics include considerations for integrating alarm processing, strategies for preventing duplicate operator entries, and recommendations for implementing batch/order management and operational sequencing. The section also outlines possible strategies for integrating automation and MES, as well as considerations for implementing technology across multiple products, processes, or facilities.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Data Availability, Redundancy, Integration"}}, "fd19e49b-4092-4817-b333-684c38638120": {"node_ids": ["e167b465-be5a-456f-a751-05290729b2e1"], "metadata": {"page_label": "87", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Comprehensive Guide to System Integration Testing: Interfaces, Data, and Middleware", "questions_this_excerpt_can_answer": "1. What are the key considerations for maintaining the integrity and stability of system or application interfaces in the context of MES domain verification, as outlined in the \"Comprehensive Guide to System Integration Testing: Interfaces, Data, and Middleware\"?\n\n2. How does the document suggest handling the complexities of testing integration for complex or near real-time transactions within MES systems, particularly in relation to auditing and verifying these transactions?\n\n3. What specific approach does the \"Comprehensive Guide to System Integration Testing: Interfaces, Data, and Middleware\" recommend for testing middleware integration in MES systems, including the types of tests and the documentation required for customization and configuration management?", "prev_section_summary": "The section discusses the strategic and program management approach to implementing Manufacturing Execution Systems (MES) in a manufacturing facility. Key topics include setting optimistic goals for MES implementation, quantifying success through metrics like reduction of non-conformances and batch release time improvements, ensuring availability and redundancy of manufacturing data when integrating MES with other systems, and considerations for deploying point solution systems versus a solution suite. The section emphasizes the importance of defining ownership and management of master data, integrating MES with systems like ERP/MRP and LIMS, and the need for high availability and redundancy of data for time-critical or hazardous manufacturing processes. It also highlights the considerations for system planned downtime and fault isolation when choosing between point solution systems and a solution suite, especially for organizations with multiple MES sites.", "excerpt_keywords": "MES, System Integration Testing, Interfaces, Data, Middleware"}}, "ae1fd92c-304e-42d1-8aa6-282bca046798": {"node_ids": ["0d9c53cc-eb80-4ec6-a836-8b90f2e205c4"], "metadata": {"page_label": "88", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Integration of ERP and MES for Efficient Manufacturing Operations: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the key considerations for minimizing the impact on requirements to re-verify or re-validate the ERP system when integrating it with MES functionality in manufacturing operations?\n\n2. How does the integration of ERP and MES systems facilitate the management of material receiving, lot and container or sub-lot tracking, and inventory control in the context of manufacturing execution systems?\n\n3. What specific functions and processes are involved in the integration of ERP and MES for effective batch management and production order management using recipes, according to the comprehensive guide on efficient manufacturing operations?", "prev_section_summary": "The section discusses system integration testing in the context of Manufacturing Execution Systems (MES), focusing on interfaces, data, and middleware. Key topics include the importance of maintaining the integrity and stability of system interfaces, considerations for testing complex or near real-time transactions, and the testing approach for middleware integration. Entities mentioned include ERP systems, automation systems, production systems, batch systems, hardware platforms, operating systems, programming languages, middleware, data classes, configuration management, and verification processes.", "excerpt_keywords": "ERP, MES, integration, manufacturing operations, batch management"}}, "0c410eae-6854-4314-ba5e-a624854c0438": {"node_ids": ["27fa65bb-c601-4ba9-a9be-936a081295e1"], "metadata": {"page_label": "89", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Enhancing Manufacturing Execution Systems through Integrated MES Domain Approach and Process Automation Testing\"", "questions_this_excerpt_can_answer": "1. What specific areas of focus are outlined in the GAMP (r) Good Practice Guide for enhancing Manufacturing Execution Systems (MES) through a strategic and program management approach, as detailed in the \"Enhancing Manufacturing Execution Systems through Integrated MES Domain Approach and Process Automation Testing\" document?\n\n2. How does the document suggest testing the integration functionality of MES operations that are dependent on multiple systems, including considerations for shared data and product/process structures, within the context of an integrated MES domain approach?\n\n3. What are the recommended considerations and test protocols for ensuring data integrity and effective process automation integration within MES, particularly in relation to electronic record and signature requirements and the prevention of data loss, as outlined in the document?", "prev_section_summary": "The section discusses the integration of ERP and MES systems in manufacturing operations, focusing on key considerations for minimizing the impact on requirements to re-verify or re-validate the ERP system. It also covers how this integration facilitates material receiving, lot tracking, inventory control, batch management, and production order management using recipes. The section highlights the importance of interface functions such as purchasing, inventory management, quality assurance, recipe management, batch management, and tracking of materials, equipment, and human resources. Overall, the section emphasizes the strategic and program management approach to integrating ERP and MES systems for efficient manufacturing operations.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Integrated MES Domain Approach, Process Automation Testing, GAMP Good Practice Guide"}}, "30d135ab-d1ee-42f0-ab2d-7ccd7bd2a761": {"node_ids": ["f69039ab-0149-46c0-a171-e0875c9615b1"], "metadata": {"page_label": "90", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Integration and Testing Considerations for Manufacturing Execution Systems, Batch Systems, and Laboratory Information Management Systems (LIMS) in Manufacturing Operations", "questions_this_excerpt_can_answer": "1. What specific aspects of PLC program management are emphasized in the integration and testing considerations for Manufacturing Execution Systems (MES) as outlined in the ISPE document?\n   \n2. How does the document suggest handling the overlap of functionality between MES and batch systems, particularly in terms of data exchange and change control issues?\n\n3. What are the key focus areas for testing Laboratory Information Management Systems (LIMS) in relation to their interaction with the MES domain, as per the guidelines provided in the document?", "prev_section_summary": "The section discusses enhancing Manufacturing Execution Systems (MES) through a strategic and program management approach, focusing on specific areas outlined in the GAMP (r) Good Practice Guide. It emphasizes testing the integration functionality of MES operations dependent on multiple systems, shared data, and product/process structures within an integrated MES domain approach. The document also recommends considerations and test protocols for ensuring data integrity and effective process automation integration within MES, particularly in relation to electronic record and signature requirements and the prevention of data loss. Key topics include electronic production record creation, plant floor management, data and event collection, packaging scheduling, quality assurance, document management, and process automation systems interfacing with MES applications. Key entities mentioned are test protocols, test cases, test data sets, integration functionality, data relationships, product and process structures, electronic record and signature requirements, and data sharing touch points.", "excerpt_keywords": "Keywords: Manufacturing Execution Systems, Integration, Testing Considerations, Batch Systems, Laboratory Information Management Systems"}}, "2bbe912b-668a-4019-8ff9-8374e0a81d5b": {"node_ids": ["e64566ae-dccf-45a4-a091-aac1f85207b0"], "metadata": {"page_label": "91", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Best Practices for Manufacturing Execution Systems Integration and Electronic Record Management", "questions_this_excerpt_can_answer": "1. What specific functionalities should be reviewed for testing and change control issues when integrating Manufacturing Execution Systems (MES) with Enterprise Resource Planning (ERP) modules, according to the GAMP Good Practice Guide?\n\n2. How does the GAMP Good Practice Guide recommend handling the synchronization of Laboratory Information Management Systems (LIMS) interfaces during the preparation for testing of LIMS integration in the context of MES?\n\n3. What are the guidelines provided by the GAMP Good Practice Guide regarding the management of electronic records and signatures, especially in terms of audit trails and system interface verifications, when integrating MES with other systems?", "prev_section_summary": "The section discusses integration and testing considerations for Manufacturing Execution Systems (MES), batch systems, and Laboratory Information Management Systems (LIMS) in manufacturing operations. Key topics include PLC program management, overlap of functionality between MES and batch systems, data exchange, change control issues, security access, reporting capabilities, batch and production validation, errors and alarms verification, redundancy, backup, and recovery process testing for MES and batch systems. The section also highlights testing focus areas for LIMS, such as raw and intermediate materials release to manufacturing.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Integration, Electronic Record Management, GAMP Good Practice Guide"}}, "6b254e05-ed01-4040-812e-7f3aa677ad67": {"node_ids": ["6c2ead06-06be-4ea0-b11a-d0323207803e"], "metadata": {"page_label": "92", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Ensuring Data Integrity and Control in Manufacturing Execution Systems", "questions_this_excerpt_can_answer": "1. What is the typical approach for managing the entry, approval, and control of critical parameters in manufacturing execution systems, especially when these parameters are entered into supervisory or recipe applications?\n   \n2. How are critical parameters that are entered directly into lower-level systems or equipment, such as Programmable Logic Controllers (PLCs), managed and controlled to ensure data integrity within manufacturing execution systems?\n\n3. What specific types of controls are recommended for managing critical parameters that are configured directly into lower-level systems or equipment in manufacturing execution systems to maintain data integrity and control?", "prev_section_summary": "The section discusses the integration of Manufacturing Execution Systems (MES) with Enterprise Resource Planning (ERP) modules and Laboratory Information Management Systems (LIMS) in the context of electronic record management. Key topics include functionalities to review for testing and change control issues, synchronization of LIMS interfaces, management of electronic records and signatures, audit trails, system interface verifications, and data integrity. The section emphasizes the importance of maintaining data integrity, security access, reporting capabilities, and proper handling of electronic records and signatures during system integration.", "excerpt_keywords": "Manufacturing Execution Systems, Data Integrity, Control, Critical Parameters, System Integration"}}, "2767ef0c-110c-4380-b9fd-6bb9547b1a50": {"node_ids": ["1b42d956-98a8-419f-98bf-f61d7db25639"], "metadata": {"page_label": "93", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Advantages of Implementing an Electronic Production Record System in Manufacturing Operations", "questions_this_excerpt_can_answer": "1. What specific advantages does implementing an electronic production record system (EPRS) offer in pharmaceutical and medical device manufacturing operations, according to the ISPE Manufacturing Execution Systems document?\n\n2. How does the ISPE document describe the integration and role of electronic batch records (EBRs) and electronic device history records (EDHRs) within the broader framework of electronic production record systems in enhancing manufacturing operations?\n\n3. In the context of the ISPE Manufacturing Execution Systems document, how are data and signatures recorded in an electronic production record system to improve compliance and operational efficiency in manufacturing environments?", "prev_section_summary": "The section discusses the management of critical parameters in manufacturing execution systems, focusing on the entry, approval, and control of parameters in supervisory or recipe applications. It also addresses the handling of critical parameters entered directly into lower-level systems or equipment, such as Programmable Logic Controllers (PLCs), emphasizing the need for technical and procedural controls, including change control, to ensure data integrity and control. The section highlights the importance of maintaining data integrity as values are passed between systems within manufacturing execution systems.", "excerpt_keywords": "Keywords: Electronic Production Record Systems, ISPE, Manufacturing Execution Systems, EBRs, EDHRs"}}, "8fcc695b-5307-499e-a0c1-c527bb235755": {"node_ids": ["a1a3e43e-c58d-456d-ab44-7c05a0d4f368"], "metadata": {"page_label": "94", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Transitioning from Paper to Electronic Production Records in Manufacturing Execution Systems", "questions_this_excerpt_can_answer": "1. How does the appendix of the ISPE Manufacturing Execution Systems document suggest transitioning from paper-based production records to electronic production records (EPRs) in terms of meeting regulatory and process requirements?\n\n2. What specific recommendations does the document make regarding the establishment of terminology for electronic equivalents to paper production records and functionality within manufacturing execution systems?\n\n3. According to the document, what reference is suggested for further understanding the recommended equivalents for master and production records in the context of transitioning to electronic production records within manufacturing execution systems?", "prev_section_summary": "The section discusses the advantages of implementing an Electronic Production Record System (EPRS) in pharmaceutical and medical device manufacturing operations, as outlined in the ISPE Manufacturing Execution Systems document. It highlights the integration and role of Electronic Batch Records (EBRs) and Electronic Device History Records (EDHRs) within EPRS, emphasizing improved compliance and operational efficiency through electronic review and approval of master recipes, automated distribution of recipes, enforced sequence control of tasks, recording of data and signatures with timestamps, database recording of production data, and elimination of paper-based processes. The section also mentions the complexity of modern manufacturing systems and the benefits of EPRS in reducing errors and enhancing operational control.", "excerpt_keywords": "Manufacturing Execution Systems, Electronic Production Records, EPRS, Electronic Batch Records, Electronic Device History Records"}}, "80c1f84d-ca94-4639-ac5e-8188b1ede13c": {"node_ids": ["ea391790-6704-4ef1-b135-e910bfeff10a"], "metadata": {"page_label": "95", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Execution Systems: Master Batch Records, Production Batch Records, and Recipe Types Guide", "questions_this_excerpt_can_answer": "1. What are the key components included in a Master Batch Record (MBR) when translated into an electronic system equivalent, and how do they differ from the components of a Production Batch Record in the same context?\n   \n2. How does the document differentiate between product recipes and non-product recipes within the context of manufacturing execution systems, and can you provide examples of each type as mentioned in the document?\n\n3. What specific types of information or data are included in an electronic production record as opposed to a batch (production) report, according to the guidelines provided in the document on manufacturing execution systems?", "prev_section_summary": "The section discusses transitioning from paper-based production records to electronic production records (EPRs) in Manufacturing Execution Systems (MES). It outlines the importance of establishing terminology and defining electronic equivalents to paper production records before documenting requirements. The document suggests specific recommendations for establishing electronic functionality and provides recommended equivalents for master and production records. Additionally, it references ISA S88 batch control for further understanding of transitioning to electronic production records within MES.", "excerpt_keywords": "Manufacturing Execution Systems, Master Batch Record, Production Batch Record, Recipe Types, Electronic Production Record"}}, "10862d42-40a8-45e1-8ecf-b352ba1f85da": {"node_ids": ["1bf6bd57-ba07-45a3-9f47-9d239baad35d"], "metadata": {"page_label": "96", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Recipe Management and Testing in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the document describe the approach to managing and testing recipes within Manufacturing Execution Systems (MES), specifically in relation to the use of Electronic Process Recipe Systems (EPRS)?\n   \n2. What are the benefits of using a module-based approach for recipe management in MES, as outlined in the document, and how does it relate to the ISA S88 standard's recommendations on recipe size and complexity?\n\n3. According to the document, what are the key considerations for ensuring robust version control in electronic recipe authoring within MES, and how does this process facilitate compliance and operational efficiency?", "prev_section_summary": "The section discusses the key components of Manufacturing Execution Systems (MES) in the context of Master Batch Records (MBR) and Production Batch Records. It outlines the structure and contents of electronic equivalents to paper-based systems, such as master recipes and control recipes. The document also differentiates between product and non-product recipes within MES, providing examples of each type. Additionally, it highlights the types of information included in electronic production records compared to batch reports, emphasizing the importance of data storage and accessibility in manufacturing processes.", "excerpt_keywords": "Manufacturing Execution Systems, Recipe Management, Electronic Process Recipe Systems, Version Control, ISA S88 Standard"}}, "fac28d0e-4216-4221-93c3-3eb39c4a9d74": {"node_ids": ["08945998-28eb-4cd2-b262-08ca4dbd84db"], "metadata": {"page_label": "97", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Recipe Management and Testing in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the GAMP Good Practice Guide suggest managing the version and status attributes of recipes in Manufacturing Execution Systems to ensure traceability and appropriate use in production environments?\n   \n2. What are the recommended practices for testing recipes in Manufacturing Execution Systems according to the GAMP Good Practice Guide, particularly in terms of static and dynamic testing requirements?\n\n3. According to the GAMP Good Practice Guide, how should recipes be managed to accommodate multiple valid versions for the same product, ensuring the correct recipe is used for varying production scenarios?", "prev_section_summary": "The section discusses the strategic and program management approach to manufacturing execution systems (MES), focusing on recipe management and testing. Key topics include the use of Electronic Process Recipe Systems (EPRS) for building blocks in recipes, the benefits of a module-based approach for recipe management, the importance of robust version control in electronic recipe authoring, and the relationship to the ISA S88 standard's recommendations on recipe size and complexity. The section emphasizes the risk-based approach to testing EPRS operations, the need for a combination of production and testing-only recipes, and the advantages of creating smaller recipes for easier control, testing, and portability of verified process steps. It also highlights the role of operations or process developers in recipe authoring and the classification of recipes to focus on specific steps, phases, and operations.", "excerpt_keywords": "Manufacturing Execution Systems, Recipe Management, Testing, GAMP Good Practice Guide, Electronic Process Recipe Systems"}}, "12210eae-9d4d-417c-ab80-40be37230caf": {"node_ids": ["4c0cadfc-d808-4090-a4a5-c7906b6a5f0e"], "metadata": {"page_label": "98", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Enhancing Efficiency and Integration of Manufacturing Execution Systems with EPRS Base Functionality", "questions_this_excerpt_can_answer": "1. What are the key components of EPRS functionality as outlined in the ISPE Manufacturing Execution Systems document, and how do they compare to traditional ERP systems in managing production schedules and performance?\n\n2. How does the document describe the integration of Batch Execution Systems (BES) with EPRS to enhance manufacturing execution, and what specific challenges does it address regarding operator interaction and system interface design?\n\n3. What specific base functionalities does EPRS offer to improve data collection and management in manufacturing execution systems, according to the ISPE document, and how does it propose handling electronic signatures and SOP cataloging?", "prev_section_summary": "This section discusses recipe management and testing in Manufacturing Execution Systems according to the GAMP Good Practice Guide. Key topics include the use of version and status attributes for traceability, testing requirements such as static and dynamic testing, managing multiple valid versions of recipes for the same product, and the importance of controlled environments for final testing. Entities mentioned include recipe controls, recipe versions, recipe status attributes, testing procedures, software modules, and building blocks for recipes.", "excerpt_keywords": "Manufacturing Execution Systems, EPRS, Batch Execution Systems, Electronic Signatures, SOP Cataloging"}}, "59436194-2cf9-4d4b-83c8-a8aa4d0cc495": {"node_ids": ["8de9301c-dfa0-441e-9682-1bb8e848489c"], "metadata": {"page_label": "99", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Execution Systems: Integration and Validation of Functional Domains", "questions_this_excerpt_can_answer": "1. What types of data and systems are integrated within a Manufacturing Execution System (MES) as outlined in the GAMP\u00ae Good Practice Guide, specifically in the context of pharmaceutical manufacturing?\n\n2. How does the document describe the approach to modularizing functions within an MES to facilitate the validation process, particularly in the creation of master recipes?\n\n3. What specific examples of domain functionality are mentioned as being part of the Electronic Process Recipe System (EPRS) in the context of enhancing manufacturing execution and validation efforts?", "prev_section_summary": "The section discusses the key components of EPRS functionality compared to traditional ERP systems in managing production schedules and performance. It also covers the integration of Batch Execution Systems (BES) with EPRS to enhance manufacturing execution, addressing challenges related to operator interaction and system interface design. The document outlines the base functionalities of EPRS, including product definition management, production execution data collection, work instructions, SOP cataloging, electronic signatures, and data collection and management from disparate systems. It emphasizes the importance of good manufacturing area interface design to reduce errors and streamline operations.", "excerpt_keywords": "Manufacturing Execution Systems, Integration, Validation, Functional Domains, Electronic Process Recipe System"}}, "0e0b2c27-4bce-4fc3-9cc4-7d8e57b48644": {"node_ids": ["fac7215a-52ed-4dd5-bdff-4bea32e800dd"], "metadata": {"page_label": "100", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Maximizing Compliance and Efficiency: Leveraging Electronic Production Records and Workflow Optimization\"", "questions_this_excerpt_can_answer": "1. How does the transition from paper production records to electronic production records (EPRs) potentially impact the efficiency and compliance of manufacturing execution systems in the pharmaceutical industry, according to the ISPE guidelines?\n\n2. What specific types of in-process checks are recommended by the ISPE for ensuring compliance and efficiency in manufacturing execution systems, and how do electronic production records facilitate these checks?\n\n3. In what ways does integrating automation with electronic production records (EPRs) enhance manufacturing efficiencies and compliance, particularly in relation to handling alarms and events, as outlined in the ISPE Manufacturing Execution Systems document?", "prev_section_summary": "The section discusses the integration of various types of data and systems within a Manufacturing Execution System (MES) as outlined in the GAMP\u00ae Good Practice Guide for pharmaceutical manufacturing. It describes the approach to modularizing functions within an MES to facilitate the validation process, particularly in the creation of master recipes. Specific examples of domain functionality mentioned include traditional process data, alarms and events, binary objects from instrumentation, XML schema for spectral data, manual data entry, electronic forms, CAPA systems, material verification, equipment verification, cleaning data, process control algorithms, personnel verification, production control, and interfaces to other enterprise systems. The section also highlights the concept of combining functions into modules or objects for easier validation in the master recipe creation process.", "excerpt_keywords": "Manufacturing Execution Systems, Electronic Production Records, Compliance, Efficiency, Workflow Optimization"}}, "977850a0-a184-4d00-b3ad-5bc463f1c766": {"node_ids": ["23820eee-a0a8-44b6-b050-b54cfadc24e9"], "metadata": {"page_label": "101", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "EPRS Approaches in Manufacturing Execution Systems: A Comprehensive Overview", "questions_this_excerpt_can_answer": "1. What are the primary differences between paper replica EPRS and database-driven EPRS in terms of data integration and analysis capabilities as outlined in the \"EPRS Approaches in Manufacturing Execution Systems: A Comprehensive Overview\" document?\n\n2. How does the document \"EPRS Approaches in Manufacturing Execution Systems: A Comprehensive Overview\" describe the process and benefits of transitioning from a paper replica system to a database-driven EPRS in terms of improving compliance opportunities and operational efficiency?\n\n3. According to the \"EPRS Approaches in Manufacturing Execution Systems: A Comprehensive Overview,\" how are electronic signatures utilized in database-driven EPRS for the approval and disposition of master recipes and production records, and what advantages does this method offer over traditional paper-based systems?", "prev_section_summary": "The section discusses the transition from paper production records to electronic production records (EPRs) and its impact on efficiency and compliance in manufacturing execution systems in the pharmaceutical industry, according to ISPE guidelines. It covers specific types of in-process checks recommended by ISPE, the integration of automation with EPRs to enhance efficiencies and compliance, and the importance of streamlining the production record process. Key topics include start-up checks, process parameters, electronic signature capture, data corrections, audit trails, electronic review and approval of master data, and production status tracking. The section emphasizes the importance of electronic production records in defining workflow detail for human-machine interactions and highlights the advantages of automation integration for compliance and manufacturing efficiencies.", "excerpt_keywords": "Manufacturing Execution Systems, EPRS Approaches, Database-driven systems, Electronic signatures, Compliance opportunities"}}, "1ec2b529-5f49-43cb-b371-b355f48dfbf0": {"node_ids": ["600db562-3cb9-4d06-936f-fb6ad7a904b6"], "metadata": {"page_label": "102", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Object Driven EPRs in Manufacturing Execution Systems: Advantages and Implementation", "questions_this_excerpt_can_answer": "1. What are the specific challenges associated with managing data and ensuring compliance in decentralized Electronic Product Records (EPRs) within manufacturing execution systems, as outlined in the ISPE Manufacturing Execution Systems guide?\n\n2. How do object-driven EPRs, such as those utilizing XML, integrate the benefits of paper replica and database-driven approaches to enhance data analysis and system integration in manufacturing execution systems, according to the document?\n\n3. What are the unique advantages of using object-driven EPRs in manufacturing execution systems for managing production records, including aspects of portability, reporting, and real-time instructional adjustments, as detailed in the ISPE guide?", "prev_section_summary": "The section discusses the different approaches to Electronic Production Record Systems (EPRS) in Manufacturing Execution Systems, specifically focusing on paper replica EPRS and database-driven EPRS. \n\nKey topics covered include:\n- Description of paper replica EPRS systems, their limitations in data integration and analysis capabilities, and their manual data entry requirements.\n- Description of database-driven EPRS systems, their advantages in terms of real-time data presentation, flexibility in altering instructions, and comprehensive data analysis capabilities.\n- Comparison of the benefits and drawbacks of both types of EPRS systems in terms of compliance opportunities, operational efficiency, and data availability for analysis.\n- Utilization of electronic signatures in database-driven EPRS for approval and disposition of master recipes and production records.\n\nEntities discussed include:\n- Master Batch Records (MBR)\n- Production Records\n- Electronic signatures\n- Automation systems\n- Document control systems\n- Laboratory Information Management Systems (LIMS)\n- Enterprise Resource Planning (ERP) systems\n\nOverall, the section provides a comprehensive overview of EPRS approaches in Manufacturing Execution Systems and highlights the advantages of transitioning from paper replica systems to database-driven systems for improved efficiency and compliance opportunities.", "excerpt_keywords": "Manufacturing Execution Systems, Object-driven EPRs, XML, Data integration, Electronic signatures"}}, "a70c6aff-b162-4e78-bc2f-298089d30297": {"node_ids": ["b7fdc136-c7de-4409-8b7f-a6ac9884125b"], "metadata": {"page_label": "103", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Advantages of Electronic Production Record Systems (EPRS) in Manufacturing Execution Systems: A Comprehensive Overview", "questions_this_excerpt_can_answer": "1. How does the implementation of Electronic Production Record Systems (EPRS) in Manufacturing Execution Systems (MES) contribute to the reduction or elimination of human data transcription errors in pharmaceutical manufacturing processes?\n\n2. In what ways do Electronic Production Record Systems (EPRS) enforce sequence control of work instructions within Manufacturing Execution Systems, and how does this benefit the overall manufacturing workflow?\n\n3. Can you detail the specific advantages of using Electronic Production Record Systems (EPRS) over traditional paper-based systems in terms of recipe data approval, data distribution, and the management of Standard Operating Procedures (SOPs) within a pharmaceutical manufacturing environment?", "prev_section_summary": "This section discusses the advantages and implementation of object-driven Electronic Product Records (EPRs) in Manufacturing Execution Systems. It highlights the challenges associated with managing data and ensuring compliance in decentralized EPRs, as well as the benefits of object-driven EPRs, such as integration with other systems, data analysis, and real-time instructional adjustments. The section also covers the strategic and program management approach to Manufacturing Execution Systems, emphasizing the use of object-driven EPRs like XML. Key topics include the structure of object-driven EPRs, data collection, decision logic, portability, reporting, real-time instructional adjustments, and integration with other systems. Key entities mentioned are master records, recipes, sequences, control parameters, process parameters, work instructions, SOPs, and various systems like automation, document control, LIMS, and ERP.", "excerpt_keywords": "Electronic Production Record Systems, EPRS, Manufacturing Execution Systems, recipe data approval, SOPs"}}, "4241c530-36b6-4173-acae-dd54ee236712": {"node_ids": ["6ec899b6-27f3-4eb6-9847-43c9101a0060"], "metadata": {"page_label": "104", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Blank Canvas: A Collection of Empty Spaces\"", "questions_this_excerpt_can_answer": "Based on the provided context, here are three questions that this specific context can provide answers to, which might be difficult to find elsewhere:\n\n1. **What is the file size of the \"ISPE Manufacturing Execution Systems\" PDF document stored in the PharmaWise Engineer project within the PharmaWise CSV & Data Integrity raw data directory?**\n   - This question is specific to the document's metadata, including its file size, which is detailed in the provided context.\n\n2. **What are the creation and last modification dates of the document titled \"Blank Canvas: A Collection of Empty Spaces\" found in the PharmaWise Engineer project's raw data directory?**\n   - The context provides unique information regarding the document's creation and last modification dates, which are specific to this document's version and would not be easily found elsewhere.\n\n3. **Under what file path and name can the \"ISPE Manufacturing Execution Systems\" document be located within the PharmaWise Engineer project's directory structure?**\n   - This question targets the specific location and naming convention used for storing the document within a project's directory, information that is unique to the project's file management system and provided in the context.\n\nThese questions are tailored to extract information directly related to the document's metadata and storage details within a specific project environment, leveraging the unique identifiers and timestamps provided in the context.", "prev_section_summary": "The section discusses the advantages of Electronic Production Record Systems (EPRS) in Manufacturing Execution Systems (MES) in pharmaceutical manufacturing processes. Key topics include electronic approval of recipe data, automated distribution of data, reduction of human data transcription errors, enforced sequence control of work instructions, recording electronic data and signatures, accessibility and protection of data in databases, enforcement of workflow sequencing, reduced requirements for external Standard Operating Procedures (SOPs), elimination of paper constraints, and unique characteristics of EPRS. Key entities mentioned are EPRS, recipe data, work instructions, electronic data, signatures, time and date stamp, metadata, databases, reports, batch control, sequencing of workflow, SOPs, and manufacturing area.", "excerpt_keywords": "ISPE, Manufacturing Execution Systems, Electronic Production Record Systems, EPRS, pharmaceutical manufacturing"}}, "57c6e948-6276-45d5-9649-a4744bcf1f53": {"node_ids": ["4ca2fbcb-965b-400f-b801-63f6ae8aeb93"], "metadata": {"page_label": "105", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Review of Exception Reports in Production Operations", "questions_this_excerpt_can_answer": "1. How does the Review by Exception (RBE) method ensure the accuracy and reliability of filtering and reporting software for production data in pharmaceutical manufacturing, according to the ISPE Manufacturing Execution Systems guidelines?\n\n2. What are the specific regulatory requirements for the quality unit review of exception reports in production operations, as accepted by guidelines for the inspection of computerized systems, detailed in the ISPE Manufacturing Execution Systems document?\n\n3. How does the GAMP approach enable RBE functionality in pharmaceutical manufacturing operations, and what are the advantages of using computerized systems for data review and analysis as outlined in the ISPE Manufacturing Execution Systems guidelines?", "prev_section_summary": "This section provides metadata details about a specific PDF document titled \"ISPE Manufacturing Execution Systems\" stored in the PharmaWise Engineer project within the PharmaWise CSV & Data Integrity raw data directory. The key topics covered include the file size, creation date, last modification date, file path, and file name of the document. The section also highlights three specific questions that can be answered based on the provided context, focusing on the document's metadata and storage location within the project directory structure.", "excerpt_keywords": "ISPE, Manufacturing Execution Systems, Review by Exception, GAMP, Pharmaceutical Manufacturing"}}, "25a3c965-76d8-4e3a-9a03-b6809f845c7b": {"node_ids": ["76d05f83-331d-402d-acfe-bcdf0dc12434"], "metadata": {"page_label": "106", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Execution Systems: Critical Operating Data and Alarm Limits Analysis", "questions_this_excerpt_can_answer": "1. What are the two levels of test points around targets or set points identified for critical process parameters (CPPs) in the context of manufacturing execution systems, and how do they differ in terms of their inclusion in production reports for review by exception (RBE)?\n\n2. How does the document describe the process and requirements for recording and analyzing exceptions to critical process parameter (CPP) action limits, including the specific types of information that must be included in production records and reports for each exception?\n\n3. According to the excerpt from the ISPE Manufacturing Execution Systems guide, what specific roles do validated systems play in the context of alert limit alarms and action limit alarms, and how are these alarms utilized in investigations, Corrective and Preventive Actions (CAPA) support, audits, and Process Analytical Technology (PAT)?", "prev_section_summary": "The section discusses the concept of Review by Exception (RBE) in pharmaceutical manufacturing operations, as outlined in the ISPE Manufacturing Execution Systems guidelines. It explains how RBE methods ensure the accuracy and reliability of filtering and reporting software for production data. The section also covers regulatory requirements for quality unit review of exception reports, the advantages of using computerized systems for data review and analysis, and the role of the GAMP approach in enabling RBE functionality. Additionally, it highlights the importance of including textual information in production reports for effective review and decision-making processes.", "excerpt_keywords": "Manufacturing Execution Systems, Critical Operating Data, Alarm Limits, Review by Exception, Process Analytical Technology"}}, "8e5c525f-3175-461f-81ef-6c52955d05fc": {"node_ids": ["bf552138-df23-4270-b024-2179f2289759"], "metadata": {"page_label": "107", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Execution Systems: Event Reporting, Report Signing, and Considerations for New Systems", "questions_this_excerpt_can_answer": "1. What criteria differentiate critical events from non-critical events in the context of RBE reports within manufacturing execution systems, according to the GAMP\u00ae Good Practice Guide?\n   \n2. How should manufacturing execution systems handle the reporting and retention of RBE reports to meet regulatory submission or rule compliance requirements, as outlined in the GAMP\u00ae Good Practice Guide?\n\n3. What specific considerations are recommended for the validation documentation of new or upgraded systems affecting critical data or RBE functionality, based on the strategic and program management approach provided in the GAMP\u00ae Good Practice Guide?", "prev_section_summary": "This section discusses the critical operating data and alarm limits analysis in the context of Manufacturing Execution Systems (MES). It covers the identification of critical process parameters (CPPs) and the two levels of test points around targets or set points, namely alert limit alarms and action limit alarms. The document describes the process and requirements for recording and analyzing exceptions to CPP action limits, including the information that must be included in production records and reports for each exception. It also highlights the roles of validated systems in alert limit alarms and action limit alarms, and how these alarms are utilized in investigations, Corrective and Preventive Actions (CAPA) support, audits, and Process Analytical Technology (PAT). The section emphasizes the importance of appropriate tools for data retrieval, organization, and presentation, as well as the need for system or procedural controls to ensure all required activities for review and disposition are completed.", "excerpt_keywords": "Manufacturing Execution Systems, Event Reporting, Report Signing, GAMP Good Practice Guide, Validation Documentation"}}, "b52ef2c3-351e-44a1-a152-bc1e744431de": {"node_ids": ["88dfee9e-6b50-4483-83fb-5f287b240d6a"], "metadata": {"page_label": "108", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Optimizing Manufacturing Operations: An Integrated Approach to MES Deployment and Reassessment\"", "questions_this_excerpt_can_answer": "1. What is the recommended approach for integrating various data sources, such as paper, LIMS, ERP, MES, and SCADA, to maximize the benefits of RBE (Risk-Based Execution) in the initial deployment of MES (Manufacturing Execution Systems)?\n\n2. How should companies manage the integration of paper exception reports into the MES environment, especially when dealing with existing or legacy systems that cannot be directly configured to provide electronic outputs?\n\n3. What are the key components of a periodic systems reassessment for MES deployments, particularly in terms of evaluating the impact of changes and verifying the accuracy of RBE functionality through the review of production reports and data samples?", "prev_section_summary": "This section discusses the criteria for differentiating critical events from non-critical events in the context of RBE reports within manufacturing execution systems, as outlined in the GAMP\u00ae Good Practice Guide. It also covers how manufacturing execution systems should handle the reporting and retention of RBE reports to meet regulatory submission or rule compliance requirements. Additionally, specific considerations for the validation documentation of new or upgraded systems affecting critical data or RBE functionality are provided based on a strategic and program management approach. Key topics include event reporting, report signing and retention, and considerations for new or upgraded systems. Key entities mentioned include critical events, non-critical events, RBE reports, process exceptions, system faults, data integrity, product quality, report signing, retention, regulatory submissions, and validation documentation.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Integration, RBE, Data Sources"}}, "c67f674d-9203-455b-8dba-0438ffa9caaf": {"node_ids": ["35aa6f10-4428-44a6-83e9-81cfbf75d9e0"], "metadata": {"page_label": "109", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Electronic Signatures and User Identification in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the GAMP Good Practice Guide differentiate between the requirements for electronic signatures and the identification of individuals in the context of Manufacturing Execution Systems (MES), particularly in relation to GxP electronic signatures and regulatory compliance?\n\n2. What specific guidance does the FDA provide regarding the application of 21 CFR Part 11 to electronic signatures in MES, and how should organizations determine whether specific records and signature events fall under this regulation according to the document?\n\n3. What are the recommended practices for managing user identification and authentication in MES environments, including the use of biometric devices and character-based identification systems, as outlined in the document?", "prev_section_summary": "The section discusses the strategic and program management approach to deploying Manufacturing Execution Systems (MES) in a phased manner. It emphasizes the coordination of information from various sources such as paper, LIMS, ERP, MES, and SCADA to maximize the benefits of Risk-Based Execution (RBE). The excerpt highlights the importance of integrating paper exception reports into the MES environment, especially when dealing with existing or legacy systems. It also mentions the need for periodic systems reassessment to evaluate the impact of changes and verify the accuracy of RBE functionality through the review of production reports and data samples. Key topics include phased deployment, integration of data sources, managing paper exception reports, and periodic systems reassessment. Key entities mentioned are MES, RBE, paper reports, electronic systems, and data samples.", "excerpt_keywords": "Manufacturing Execution Systems, Electronic Signatures, User Identification, GAMP Good Practice Guide, FDA Guidance"}}, "5d26e628-8193-4687-9db1-a2166bcd994d": {"node_ids": ["189d546e-b13c-4dd1-ad3c-eff1b111c64a"], "metadata": {"page_label": "110", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Ensuring Security and User Identification in Manufacturing Execution Systems: Strategies and Best Practices\"", "questions_this_excerpt_can_answer": "1. What are the specific advantages and disadvantages of using an identification-only strategy for user authentication in Manufacturing Execution Systems (MES) as outlined in the ISPE Good Practice Guide?\n\n2. How does the combined logon/identification strategy for user authentication in MES differ from the identification-only strategy in terms of user responsibility and system navigation privileges, according to the ISPE Manufacturing Execution Systems document?\n\n3. According to the GAMP(r) Good Practice Guide's appendix on Manufacturing Execution Systems, what are the recommended controls for using tokens such as barcodes or RFID tags for user identification and password management in environments where touch screens or other highly visible entry methods are employed?", "prev_section_summary": "The section discusses the importance of logon, identification, and signature methods in Manufacturing Execution Systems (MES). It highlights the distinction between signature events and the identification of individuals, particularly in relation to GxP electronic signatures and regulatory compliance. The section also covers the definition of electronic signatures according to 21 CFR Part 11, recommendations for managing user identification and authentication in MES environments, including the use of biometric devices and character-based identification systems. It emphasizes the need for system requirements to define which activities require an electronic signature and how to meet applicable international regulatory requirements. Additionally, it mentions the administrative support required for security systems and the procedures needed for security maintenance in MES environments.", "excerpt_keywords": "Manufacturing Execution Systems, User Identification, Security, GAMP, Authentication"}}, "53bf709b-2c17-42e5-b1be-5adb3da5d2bc": {"node_ids": ["6f098676-bef1-450c-a5b5-667f648a8bf4"], "metadata": {"page_label": "111", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Identification Strategies in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the specific disadvantages of using manufacturing execution systems (MES) when multiple users need to access short system functions in succession, according to the GAMP Good Practice Guide?\n\n2. How does the document suggest handling identification requirements for personnel completing a small table of entries on a screen within a manufacturing execution system?\n\n3. What criteria does the document recommend for determining when operator identification is necessary versus when it is not required in the context of manufacturing execution systems?", "prev_section_summary": "The section discusses strategies and best practices for ensuring security and user identification in Manufacturing Execution Systems (MES). It covers the use of tokens such as barcodes or RFID tags for user identification, the importance of stringent controls for tokens, and the need for physical separation of user identification and passwords. It also compares the identification-only strategy with the combined logon/identification strategy in terms of user responsibility and system navigation privileges. Additionally, it mentions the advantages and disadvantages of each strategy, highlighting the importance of user authentication and security measures in MES.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Identification Strategies, User Authentication, Security Measures"}}, "0109e567-027c-44ed-a9c8-7e6414c64141": {"node_ids": ["42acd762-54f1-49b2-8333-c6398979fde9"], "metadata": {"page_label": "112", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Access Control in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the conditions under which logons may not be required for accessing certain functions within a Manufacturing Execution System (MES) as outlined in the GAMP (r) Good Practice Guide's appendix on MES?\n\n2. How does the GAMP (r) Good Practice Guide suggest handling access to read-only functions in MES for operators in physically or electronically controlled areas?\n\n3. What specific measures are recommended by the GAMP (r) Good Practice Guide for ensuring secure access to MES functions when a signature mechanism is in place and the workstation or device is located in a controlled area?", "prev_section_summary": "This section discusses identification strategies in Manufacturing Execution Systems (MES) and provides guidelines for handling identification requirements for personnel using the system. Key topics include disadvantages of using MES when multiple users need to access short system functions, frequency of identification entries during system operations, and applying identification strategies based on organizational procedures and regulatory requirements. The section also outlines criteria for determining when operator identification is necessary versus when it is not required in the context of MES. Key entities mentioned include system designers, personnel completing data entries, quality unit, operations supervision, and regulated organizations.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP, Access Control, Identification Strategies"}}, "4e5919a2-0aa8-4d75-8164-953f384aee5c": {"node_ids": ["4e7253d0-ea29-49b3-9cca-883cb19a1258"], "metadata": {"page_label": "113", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Optimizing Workflow Efficiency and Compliance with MES Technology and Enforced Operational Sequences\"", "questions_this_excerpt_can_answer": "1. How does the implementation of MES technology specifically aim to optimize the workflow within the manufacturing process, according to the GAMP Good Practice Guide: Manufacturing Execution Systems?\n   \n2. What are the two major cost-saving approaches highlighted in the GAMP Good Practice Guide for employing MES technology, and how do they contribute to reducing training time and ensuring compliance?\n\n3. In what ways does the enforced operational sequences feature of MES technology facilitate a more flexible workforce, and how does it prevent job monotony and potential errors as described in the document?", "prev_section_summary": "The section discusses access control in Manufacturing Execution Systems (MES) as outlined in the GAMP (r) Good Practice Guide's appendix on MES. It covers conditions under which logons may not be required for accessing certain functions, handling access to read-only functions for operators in controlled areas, and measures for ensuring secure access to MES functions with a signature mechanism in place. Key topics include user group restrictions, access to read-only functions, and secure access in controlled areas. Key entities mentioned are operators, workstations, devices, and signature mechanisms.", "excerpt_keywords": "MES technology, workflow optimization, compliance, enforced operational sequences, cost-saving approaches"}}, "5def2501-4ba2-4508-86b9-e9f44bbcd18c": {"node_ids": ["a95f4470-63c8-4cd1-9e87-68185dedd7c2"], "metadata": {"page_label": "114", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Implementing Manufacturing Execution Systems: Addressing Psychological and Cultural Aspects, User Interface Design, and Portable Devices", "questions_this_excerpt_can_answer": "1. How does the GAMP Good Practice Guide suggest addressing the psychological and cultural aspects when implementing Manufacturing Execution Systems (MES) in a workplace?\n   \n2. What specific user interface considerations does the GAMP Good Practice Guide recommend for integrating technology into manual operations within the context of Manufacturing Execution Systems?\n\n3. According to the GAMP Good Practice Guide, what are the recommended practices for the use of portable devices in Manufacturing Execution Systems, particularly in relation to their size, weight, power consumption, and functionality?", "prev_section_summary": "This section discusses the benefits of implementing Manufacturing Execution Systems (MES) technology in optimizing workflow efficiency and compliance within the manufacturing process. It highlights the importance of modifying current workflows to leverage the functionality of MES systems, rather than simply automating existing manual operations. The section also emphasizes the two major cost-saving approaches of standardized interfaces and enforced operational sequences, such as electronic production records and work instructions. These approaches contribute to reducing training time, ensuring compliance, preventing errors, and facilitating a more flexible workforce. MES technology enables consistent actions, detailed instructions at the point of action, automatic documentation, and increased process compliance. It also allows for the sharing of personnel among different functions or processes and prevents job monotony by enabling personnel to perform diverse actions within a process.", "excerpt_keywords": "Manufacturing Execution Systems, GAMP Good Practice Guide, User Interface Design, Portable Devices, Workforce Flexibility"}}, "8154f83d-5749-4b5a-9d12-86644f8c8c8c": {"node_ids": ["fd0a37ac-6844-45fa-8c8f-d9a84a9e931a"], "metadata": {"page_label": "115", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Revolutionizing Manufacturing Execution Systems: Integrating Portable Devices and Wireless Technology for Enhanced Efficiency\"", "questions_this_excerpt_can_answer": "1. What are the limitations of using data-storing portable devices that are docked to a workstation within manufacturing execution systems, especially in terms of real-time data checking and updating data acceptance criteria?\n\n2. How does wireless technology enhance the functionality of portable devices in manufacturing execution systems, particularly in relation to security functions and real-time data verification?\n\n3. What considerations should be taken into account to ensure interface consistency when integrating portable devices with manufacturing execution systems, and how can these considerations help minimize operational errors and improve efficiency in manufacturing operations?", "prev_section_summary": "This section discusses the psychological and cultural aspects that need to be addressed when implementing Manufacturing Execution Systems (MES) in a workplace. It emphasizes the importance of involving manufacturing personnel in the design process to build confidence in the outcome and dispel false perceptions of risk for new technologies. The section also highlights the user interface considerations, such as physical constraints and the use of portable devices, in integrating technology into manual operations within the context of MES. Key topics include addressing anxiety related to technology introduction, involving human resources in managing acceptance of changes, considering physical limitations of personnel, and balancing size, weight, power consumption, and functionality of portable devices.", "excerpt_keywords": "Manufacturing Execution Systems, Portable Devices, Wireless Technology, Data Integrity, Interface Consistency"}}, "71a77891-e647-4597-8e01-a00cc16c627d": {"node_ids": ["63fea5dc-bc29-4aa9-9daf-c7acce773b44"], "metadata": {"page_label": "116", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Blank Canvas: A Collection of Unique Entities and Themes\"", "questions_this_excerpt_can_answer": "Based on the provided context, here are three questions that this specific context can provide specific answers to, which are unlikely to be found elsewhere:\n\n1. **What is the file size of the \"ISPE Manufacturing Execution Systems\" PDF document stored in the PharmaWise Engineer project within the PharmaWise CSV & Data Integrity directory?**\n   - This question is directly answered by the provided context, which specifies the file size as 7322258 bytes.\n\n2. **What are the creation and last modification dates of the document titled \"Blank Canvas: A Collection of Unique Entities and Themes\" found in the PharmaWise Engineer project's raw data directory?**\n   - The context provides specific dates for both the creation (2024-04-07) and last modification (2024-04-04) of the document, which is a detail unique to this document and unlikely to be found elsewhere.\n\n3. **Under what file path and name can the \"ISPE Manufacturing Execution Systems\" document be located within the PharmaWise CSV & Data Integrity project's raw data directory?**\n   - The context gives a precise file path (/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf) and file name ([10] ISPE Manufacturing Execution Systems.pdf), which is specific information not likely to be replicated in other sources.\n\nThese questions are tailored to extract unique information provided by the context, focusing on details such as file specifics and document metadata that are unlikely to be found in other sources or documents.", "prev_section_summary": "The section discusses the limitations of using data-storing portable devices docked to workstations in manufacturing execution systems, the benefits of wireless technology in enhancing functionality and security, and considerations for interface consistency when integrating portable devices. Key topics include real-time data checking, updating data acceptance criteria, wireless technology for security and verification, and interface design considerations for minimizing operational errors and improving efficiency in manufacturing operations. Key entities mentioned are data-storing portable devices, wireless technology, infrastructure, security, verification, data/signal integrity, interface consistency, common display functions, and minimizing the need to toggle between applications.", "excerpt_keywords": "ISPE, Manufacturing Execution Systems, Portable Devices, Wireless Technology, Interface Design"}}, "6bcee7f3-99c7-4167-9899-6c6251925cac": {"node_ids": ["6d5a0f9c-3842-4467-ab0a-7eef13175a49"], "metadata": {"page_label": "117", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Comprehensive Guide to Compliant WIP Materials Management and Inventory Control in Manufacturing Operations", "questions_this_excerpt_can_answer": "1. How do resource management systems like ERP differ from GxP-compliant systems in handling materials in the context of manufacturing execution systems, specifically regarding the timing and conditions under which materials are considered consumed?\n\n2. What are the specific considerations and benefits of using container tracking in WIP materials management within complex manufacturing operations, as outlined in the ISPE Manufacturing Execution Systems guide?\n\n3. What are the key status attributes that should be checked during consumption activities for materials in dispensing or manufacturing processes to ensure compliance with GxP regulations, according to the comprehensive guide on WIP materials management and inventory control in manufacturing operations?", "prev_section_summary": "The key topics and entities of this section include the file size, creation date, last modification date, document title, file path, and file name of the \"ISPE Manufacturing Execution Systems\" PDF document stored in the PharmaWise Engineer project within the PharmaWise CSV & Data Integrity directory. The section provides specific details about the document, such as its unique identifiers and metadata, which are unlikely to be found elsewhere.", "excerpt_keywords": "Compliant WIP Materials Management, Inventory Control, Manufacturing Execution Systems, Container Tracking, GxP Regulations"}}, "0ec4214d-d73c-4b2f-8435-8ea4e2de1b82": {"node_ids": ["faf396e4-6464-4233-92f8-eebd06bade83"], "metadata": {"page_label": "118", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Best Practices for Material Tracking and Dispensing in Manufacturing Operations", "questions_this_excerpt_can_answer": "1. What specific strategies does the GAMP (r) Good Practice Guide suggest for ensuring the correct material is dispensed in manufacturing operations where multiple weigh stations are present in a dispense room?\n\n2. How does the document recommend handling the genealogy of lots and sub-lots in manufacturing execution systems, particularly in relation to the system of record and the system of genealogy between WIP management systems and MRP/ERP systems?\n\n3. What are the best practices for material tracking and dispensing in manufacturing operations to prevent cross-contamination or the physical dispensing of incorrect materials, as outlined in the \"Best Practices for Material Tracking and Dispensing in Manufacturing Operations\" document?", "prev_section_summary": "This section discusses the differences between resource management systems like ERP and GxP-compliant systems in handling materials in manufacturing operations. It highlights the importance of executing material transactions contemporaneously with physical activities, managing material inventory and status in WIP, and the benefits of container tracking in complex manufacturing operations. Key topics include the handling of dispensed materials, managing material inventory, choosing the appropriate system for managing materials, and the importance of checking material status attributes during consumption activities. Key entities mentioned include ERP systems, GxP regulations, dispensing operations, WIP inventory, container tracking, and material status attributes.", "excerpt_keywords": "GAMP, Manufacturing Execution Systems, Material Tracking, Dispensing, Genealogy"}}, "040281ef-fc1c-4cad-8997-ecb2fa128c7e": {"node_ids": ["d53f1fd4-ba42-4363-989f-5097b1f9eeaf"], "metadata": {"page_label": "119", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Configuration Management in an Integrated Manufacturing Environment: Best Practices and Strategies", "questions_this_excerpt_can_answer": "1. What are the primary elements of configuration management as outlined in the ISPE Manufacturing Execution Systems document, specifically within the context of an integrated manufacturing environment?\n\n2. How does the document describe the role of the quality unit in overseeing configuration management processes, particularly in relation to GAMP 5, the ISPE GAMP Good Practice Guide, and ASTM 2500-07?\n\n3. What operational definitions and key aspects does the document provide for managing design change control, project change control, and operations change control within the MES domain's lifecycle?", "prev_section_summary": "The section discusses best practices for material tracking and dispensing in manufacturing operations, focusing on strategies for ensuring the correct material is dispensed, handling genealogy of lots and sub-lots in manufacturing execution systems, and preventing cross-contamination or dispensing of incorrect materials. Key topics include assigning status to intermediates or stock materials, establishing systems of record and genealogy, utilizing barcode scanning for material verification, and implementing isolated areas for dispensing and production to ensure material accuracy. Key entities mentioned include GAMP (r) Good Practice Guide, WIP management systems, MRP/ERP systems, and barcode scanning technology.", "excerpt_keywords": "Configuration Management, Manufacturing Execution Systems, ISPE, GAMP 5, ASTM 2500-07"}}, "8c270c6e-4db4-4392-a013-9461c74a41b1": {"node_ids": ["334481f7-f654-4d3d-bed5-75f22e282729"], "metadata": {"page_label": "120", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Ownership and Life Cycle Management of Manufacturing Execution Systems Domain", "questions_this_excerpt_can_answer": "1. What specific roles and responsibilities does a Program Management Office (PMO) have in the context of managing the Manufacturing Execution Systems (MES) domain, according to the GAMP\u00ae Good Practice Guide?\n\n2. How does the GAMP\u00ae Good Practice Guide suggest differentiating between the life cycle management of the MES domain as a whole versus the life cycle management of individual systems and equipment within that domain?\n\n3. What criteria and considerations does the GAMP\u00ae Good Practice Guide recommend for including members in the PMO responsible for overseeing the MES domain, and how does it suggest these members contribute to the integrity of the manufacturing environment?", "prev_section_summary": "The section discusses configuration management in an integrated manufacturing environment, focusing on maintaining documentation, systems, equipment, and supporting components in a known state throughout the life cycle of an MES domain. It outlines the elements of configuration management such as project change control and operations change control, and the role of the quality unit in overseeing these processes. The document provides operational definitions for design change control, project change control, and operations change control within the MES domain's lifecycle. Additionally, it highlights the program responsibilities outlined in GAMP 5, the ISPE GAMP Good Practice Guide, and ASTM 2500-07 for managing quality systems related to equipment and computer systems in manufacturing.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, Program Management Office, Life Cycle Management"}}, "97a5ff30-a980-43d4-89ee-dfc47745b382": {"node_ids": ["61dbbfaa-ef0a-42ab-870e-6d9ce2b56533"], "metadata": {"page_label": "121", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Comprehensive Guide to Manufacturing Execution Systems Configuration and Release Processes\"", "questions_this_excerpt_can_answer": "1. What are the key elements involved in the functional and product configuration of systems within the MES domain to ensure they operate as effective manufacturing tools?\n   \n2. How does the GAMP good practice guide suggest managing changes in systems versus product and process changes within the MES domain to maintain quality and operational integrity?\n\n3. What are the recommended practices for the coordinated systems release processes, including validation planning and testing stages, for MES domain systems as outlined in the \"Comprehensive Guide to Manufacturing Execution Systems Configuration and Release Processes\"?", "prev_section_summary": "The section discusses the ownership and life cycle management of Manufacturing Execution Systems (MES) domain, emphasizing the importance of coordinating the individual life cycles of systems within the MES domain. It highlights the role of a Program Management Office (PMO) in overseeing the MES domain and includes key members such as manufacturing operations, product process owners, business process owners, quality unit, personnel safety organization, and individual system owners. The PMO is responsible for ensuring a coordinated approach within and among sites for various activities such as major facility changes, system implementations, and updates to validation master plans. The focus is on systems-related topics and business process impact, rather than day-to-day activities of the MES domain.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, Configuration Management, Validation Planning"}}, "70bd2e34-229a-426a-b584-5b764e6140b8": {"node_ids": ["955a2505-05fe-48ce-afeb-0323c89db8f2"], "metadata": {"page_label": "122", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Configuration Management in Manufacturing Execution Systems Domain", "questions_this_excerpt_can_answer": "1. What specific guidance does the GAMP (Good Automated Manufacturing Practice) provide for managing configuration in Manufacturing Execution Systems (MES) domains, particularly regarding the integration and documentation of systems?\n   \n2. How does the document suggest handling the complexity of documentation in global MES deployments, especially considering variations in local site processes, languages, manufacturing, and regulatory policies?\n\n3. What hierarchical approach does the document recommend for documenting systems within an MES domain to ensure clarity for internal management and compliance with regulatory agencies?", "prev_section_summary": "The section discusses the functional and product configuration of systems within the Manufacturing Execution Systems (MES) domain, emphasizing the importance of setting up systems to operate effectively as manufacturing tools. It highlights the key elements involved in system configuration, such as application setup, network infrastructure, database schema, access, and interfaces. The section also addresses the management of changes in systems versus product and process changes within the MES domain to maintain quality and operational integrity, as recommended by the GAMP good practice guide. Additionally, it outlines the recommended practices for coordinated systems release processes, including validation planning and testing stages, for MES domain systems. The section emphasizes the need for strict controls on product changes, ownership of quality system maintenance, and the release of equipment, applications, and system modules through sequential verification and testing stages. It also discusses the potential for customization of functionality at the site level and the considerations for implementing and maintaining such customization in a compliant manner.", "excerpt_keywords": "Configuration Management, Manufacturing Execution Systems, GAMP, Documentation, Global Deployments"}}, "de095da1-630b-49e4-916c-6004dade9a7a": {"node_ids": ["ebc9d715-a668-446b-8e26-2ea48bd8ff2d"], "metadata": {"page_label": "123", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Effective Configuration and Identification Management in MES Systems: Best Practices and Strategies", "questions_this_excerpt_can_answer": "1. What are the fundamental programs that support configuration management in the context of Manufacturing Execution Systems (MES) as outlined in the GAMP Good Practice Guide?\n   \n2. How does the document suggest tracking software or application changes within MES systems to ensure service continuity and disaster recovery?\n\n3. What approach does the document recommend for establishing a unified equipment identification system within an MES domain, and how does it suggest tracking changes and updates to this system?", "prev_section_summary": "The section discusses the importance of configuration management in Manufacturing Execution Systems (MES) domains, particularly focusing on documentation, release processes, and system integration. Key topics include defining release points, maintaining current documentation, considering the impact of changes on related systems, establishing relationships among integrated systems, and using a hierarchical approach for documenting systems within an MES domain. The section emphasizes the need for clear documentation to ensure internal management clarity and compliance with regulatory agencies.", "excerpt_keywords": "MES, Configuration Management, GAMP Good Practice Guide, Equipment Identification, System Integration"}}, "46380758-bc58-4a80-8ae4-00351c21b692": {"node_ids": ["7e4a5e96-b517-4daa-8ea0-079f9ad01a1b"], "metadata": {"page_label": "124", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Change Management and Unique Identification in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What is the recommended approach for assigning unique identifications or designations to systems and major components within a Manufacturing Execution System (MES) domain to facilitate tracking, as outlined in the ISPE Manufacturing Execution Systems guide?\n\n2. How does the GAMP\u00ae Good Practice Guide suggest handling change management for integrated systems within an MES domain, particularly in terms of assessing and documenting the impacts of changes on related systems?\n\n3. Can you describe an example of a technique for assigning equipment location IDs within an MES environment, as illustrated in the document \"Change Management and Unique Identification in Manufacturing Execution Systems: A Comprehensive Guide\"?", "prev_section_summary": "The section discusses effective configuration and identification management in Manufacturing Execution Systems (MES) based on the GAMP Good Practice Guide. Key topics include configuration management supported by programs such as project change control, operational change control, preventive maintenance, and corrective maintenance. The document suggests tracking software changes, including supplier releases, modifications, upgrades, and patches, to ensure service continuity and disaster recovery. It also recommends establishing a unified equipment identification system within an MES domain using equipment tags (IDs) and tracking changes and updates electronically for efficient information distribution and reporting.", "excerpt_keywords": "Keywords: Manufacturing Execution Systems, Change Management, Unique Identification, GAMP Good Practice Guide, Equipment Location IDs"}}, "7b0af4b7-6c50-4293-9684-81909536a846": {"node_ids": ["5bdf0067-32e3-4678-84fe-67b1714199b3"], "metadata": {"page_label": "125", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Optimizing Manufacturing Execution Systems through Effective Nomenclature and Tracking", "questions_this_excerpt_can_answer": "1. How does the GAMP Good Practice Guide suggest tracking changes to each locator ID within a Manufacturing Execution System (MES), and what specific information should be included in the change control record for each locator number?\n   \n2. What are the benefits of employing a smart number designator for locator IDs in engineering documentation as mentioned in the GAMP Good Practice Guide, and how does this approach facilitate database management and information retrieval within MES environments?\n\n3. According to the GAMP Good Practice Guide, how can the application of consistent nomenclature for facility buildings, equipment, and support systems across IT, engineering, and facility documentation improve maintenance operations and configuration management within a manufacturing execution system domain?", "prev_section_summary": "The section discusses the importance of change management and unique identification in Manufacturing Execution Systems (MES). It highlights the recommended approach for assigning unique identifications to systems and major components within an MES domain to facilitate tracking. The GAMP\u00ae Good Practice Guide suggests handling change management for integrated systems within an MES domain by assessing and documenting the impacts of changes on related systems. An example technique for assigning equipment location IDs within an MES environment is also provided in the document. The section emphasizes the use of unique identifications or designations for systems and major components, and recommends avoiding serial numbers or model numbers for this purpose. It also mentions the concept of related systems in change management for integrated systems within an MES domain.", "excerpt_keywords": "Manufacturing Execution Systems, GAMP Good Practice Guide, Change Control, Nomenclature, Database Management"}}, "12c531cb-0473-40f1-aa5e-79efcd9f4977": {"node_ids": ["a441c6d2-59ac-4295-84ea-7a98c8e2e88f"], "metadata": {"page_label": "126", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "MES System Locator ID Designators and Installation Nomenclature Guide", "questions_this_excerpt_can_answer": "1. What specific examples of MES system locator ID designators are provided in the document, and how are they related to the equipment and data they represent?\n   \n2. How does the document suggest handling the division of responsibilities and ownership for MES systems within a manufacturing environment, particularly regarding the integration of systems like automation and ERP?\n\n3. What are the advantages and disadvantages of assigning each system in the MES domain a unique system designator versus assigning a single MES designator to the collection of systems, according to the document?", "prev_section_summary": "The section discusses the importance of effective nomenclature and tracking in Manufacturing Execution Systems (MES) as outlined in the GAMP Good Practice Guide. Key topics include tracking changes to locator IDs, benefits of smart number designators, consistent nomenclature for facility buildings, equipment, and support systems, and the application of database techniques for information retrieval. Entities mentioned include locator IDs, change control records, model and serial numbers, facility buildings, equipment, support systems, and maintenance operations.", "excerpt_keywords": "MES, Manufacturing Execution Systems, Locator ID, Designators, Nomenclature"}}, "9d058edc-29f6-4802-922b-dfaad5e569be": {"node_ids": ["9c70a365-319a-490b-9fbc-9b7db1a57935"], "metadata": {"page_label": "127", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Establishing Rules for Configuration and Infrastructure Tracking in MES Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the GAMP (Good Automated Manufacturing Practice) guide recommend handling the designation of individual system designators within the MES (Manufacturing Execution Systems) domain to ensure effective relationship mapping between systems?\n\n2. What specific strategies does the document suggest for managing infrastructure tracking within an MES domain to minimize the impact of changes on related systems and applications, particularly in terms of distinguishing between infrastructure and system software components?\n\n3. In the context of MES system support maintenance and configuration, how does the document differentiate between routine maintenance operations and significant changes, and what guidelines does it provide for treating scripts or modules, especially in terms of assessing risk based on the complexity and functionality impacted within the MES domain?", "prev_section_summary": "The section discusses MES system locator ID designators and installation nomenclature in manufacturing environments. It provides examples of specific designators related to equipment and data, and suggests approaches for dividing responsibilities and ownership for MES systems, including assigning each system a unique designator or a single MES designator for the collection of systems. The advantages and disadvantages of each approach are also highlighted. Key topics include system designators, division of responsibilities, ownership, integration of systems, and the importance of consistent numbering and documentation for maintenance and change systems.", "excerpt_keywords": "MES, Manufacturing Execution Systems, GAMP, infrastructure tracking, configuration rules"}}, "76fb4e4e-7950-4a8e-b5d0-7ad92d378a77": {"node_ids": ["0b5d9564-f8d1-4a3e-af88-0d2423a0fa4e"], "metadata": {"page_label": "128", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Best Practices for Manufacturing Execution Systems Configuration Management and Script Testing", "questions_this_excerpt_can_answer": "1. How does the GAMP 5 framework influence the configuration management programs for Manufacturing Execution Systems (MES) according to the ISPE guide?\n   \n2. What criteria are suggested by the ISPE guide for determining the level of testing required for scripts used in MES, and how does this relate to the complexity and functionality of the scripts?\n\n3. What specific strategies does the ISPE guide recommend for ensuring the reproducibility and accountability of script and module creation and modification within MES environments?", "prev_section_summary": "This section discusses the establishment of rules for configuration and infrastructure tracking in Manufacturing Execution Systems (MES). Key topics include assigning system designators, managing infrastructure changes, differentiating between routine maintenance and significant changes, and establishing rules for configuration in MES systems. The section also addresses the impact of scripts or modules on system functionality and provides guidelines for assessing risk based on complexity and functionality within the MES domain. Key entities mentioned include GAMP (Good Automated Manufacturing Practice) guidelines, system support maintenance procedures, change management systems, and configuration rules for hardware and software components in MES systems.", "excerpt_keywords": "ISPE, Manufacturing Execution Systems, Configuration Management, Script Testing, GAMP 5"}}, "0109fe07-ecbc-41fa-89d8-4a0b1b0077cc": {"node_ids": ["03f98a20-2b93-47bd-8f9e-6e702ee62d2d"], "metadata": {"page_label": "129", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Standards and Models for Manufacturing Execution Systems: A Comprehensive Overview", "questions_this_excerpt_can_answer": "1. What specific standards and models are recommended for defining the interrelationships and activities within manufacturing execution systems (MES) as outlined in the \"GAMP (R) Good Practice Guide: Manufacturing Execution Systems - A Strategic and Program Management Approach\"?\n\n2. How does the document suggest MES models can contribute to meeting business goals and addressing cultural aspects within an organization, particularly in the context of manufacturing operations?\n\n3. What criteria does the document propose for selecting MES functionality or product suites, and how does it recommend comparing different MES offerings in terms of functionality, ease of integration, system interfaces, and compatibility with existing legacy systems?", "prev_section_summary": "The section discusses the influence of the GAMP 5 framework on configuration management programs for Manufacturing Execution Systems (MES) according to the ISPE guide. It also covers the criteria suggested for determining the level of testing required for scripts used in MES, based on the complexity and functionality of the scripts. Additionally, the section recommends specific strategies for ensuring reproducibility and accountability of script and module creation and modification within MES environments. Key topics include configuration management programs, testing of scripts, verification of retrieved data, script and module creation and modification tracking, peer review, and testing in conjunction with larger systems functionality. Key entities mentioned are GAMP 5 framework, ISPE guide, scripts, modules, and MES environments.", "excerpt_keywords": "GAMP, Manufacturing Execution Systems, MES modeling, ANSI/ISA95, Supply Chain Council Scor Model"}}, "6765bb1b-3a02-40fb-83fe-a1aad1d57c07": {"node_ids": ["7f889b10-ae38-4821-9242-a5d1a8d9a0d6"], "metadata": {"page_label": "130", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Optimizing Manufacturing Operations: A Strategic Approach to MES Functions and ANSI/ISA-95 Integration\"", "questions_this_excerpt_can_answer": "1. How does the GAMP(r) Good Practice Guide suggest organizations can address industry challenges through MES functions and manufacturing operations activities?\n   \n2. What specific models and standards does the document recommend for understanding the requirements associated with corporate objectives in the context of MES implementation?\n\n3. Can you detail the functional hierarchy model as described by ANSI/ISA-95 for integrating enterprise and control systems within manufacturing operations?", "prev_section_summary": "This section provides an overview of standards and models for Manufacturing Execution Systems (MES) and their importance in defining interrelationships and activities within manufacturing operations. Key topics covered include MES modeling, functionality modeling, data and information flow, and various standards such as ANSI/ISA95, ANSI/ISA88, the Supply Chain Council SCOR model, and MESA International. The section emphasizes the role of MES models in meeting business goals and addressing cultural aspects within an organization. It also discusses criteria for selecting MES functionality or product suites, comparing different MES offerings, and integrating with existing legacy systems. Compliance with standards and support for specific standards are highlighted as important considerations in MES implementation.", "excerpt_keywords": "Manufacturing Execution Systems, MES, GAMP, ANSI/ISA-95, functional hierarchy model"}}, "44b32104-6048-49b3-b256-0faa2db47069": {"node_ids": ["5af9d6f9-0a63-4b1f-b4b2-102095693a5f"], "metadata": {"page_label": "131", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Operations and Control in Level 3 Activities: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What specific functions and responsibilities are attributed to Level 3 activities in the ISA-95.00.01-2000 functional hierarchy for manufacturing execution systems as outlined in the \"Manufacturing Operations and Control in Level 3 Activities: A Comprehensive Guide\"?\n\n2. How does the document describe the role of Level 3 activities in optimizing costs for individual production areas within the manufacturing execution systems framework, and what specific tasks are involved in this optimization process?\n\n3. What are the detailed responsibilities of Level 3 activities in terms of personnel functions within the manufacturing operations and control framework, as specified in the \"Manufacturing Operations and Control in Level 3 Activities: A Comprehensive Guide\"?", "prev_section_summary": "The section discusses the strategic approach to Manufacturing Execution Systems (MES) functions and ANSI/ISA-95 integration. It highlights how organizations can address industry challenges through MES functions and manufacturing operations activities, using models and standards to understand requirements associated with corporate objectives. The section also details the functional hierarchy model as described by ANSI/ISA-95 for integrating enterprise and control systems within manufacturing operations. Key topics include MES functions, industry profiles, order generation, process running, ANSI/ISA-95 standard, and functional hierarchy model.", "excerpt_keywords": "Manufacturing Execution Systems, ISA-95, Operational Management, Production Scheduling, Personnel Functions"}}, "45f0b6e4-19ac-4fb1-ba1c-5ebc78c48a64": {"node_ids": ["7301ccf9-dba2-4446-b8c3-a53f3fe7ab01"], "metadata": {"page_label": "132", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Functional Data Flow Model in Manufacturing Execution Systems: Information Exchange and Organizational Structure", "questions_this_excerpt_can_answer": "1. How does the ANSI/ISA-95 functional enterprise-control model categorize the types of information necessary for manufacturing execution systems (MES) to support production processes, according to the GAMP(r) Good Practice Guide: Appendix 13?\n\n2. What specific types of operational and performance-related information are identified as critical for the exchange between manufacturing control systems and other business systems in the context of MES, as illustrated in the ANSI/ISA-95.00.03-2005 Figure 4?\n\n3. How does the document \"Functional Data Flow Model in Manufacturing Execution Systems: Information Exchange and Organizational Structure\" describe the role of organizational structure in determining the placement and flow of information within MES, and what implications does this have for different organizations implementing MES according to their unique operational groups?", "prev_section_summary": "The section discusses manufacturing operations and control in Level 3 activities within the ISA-95.00.01-2000 functional hierarchy for manufacturing execution systems. Key topics include reporting on area production, data collection and maintenance, personnel functions, detailed production scheduling, cost optimization, and modifying production schedules. Entities mentioned include variable manufacturing costs, area data on production, inventory, manpower, raw materials, spare parts, energy usage, work period statistics, vacation scheduling, work force scheduling, in-house training, maintenance, transportation, production interruptions, and level 4 functions.", "excerpt_keywords": "Manufacturing Execution Systems, ANSI/ISA-95, Information Exchange, Organizational Structure, Functional Data Flow Model"}}, "7198b60f-6dde-4014-800d-618666abc6bb": {"node_ids": ["846a8491-7138-40c4-a7cb-cd8ec36ce09d"], "metadata": {"page_label": "133", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Integration of Standards and Models in Manufacturing Operations: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What specific XML-based language is mentioned as an implementation of the ANSI/ISA-95 standards for enabling the exchange of data between manufacturing systems, and how is it structured?\n   \n2. How does the ANSI/ISA-S88 standard contribute to the improvement and control of batch manufacturing plants, and what are the specific parts and focus areas of this standard as outlined in the document?\n\n3. What is the role of the Supply Chain Operations Reference (SCOR) model as developed by the Supply Chain Council in manufacturing operations, and what are the top-level process types included in SCOR version 9.0 as mentioned in the document?", "prev_section_summary": "The section discusses the functional data flow model in Manufacturing Execution Systems (MES) according to the ANSI/ISA-95 functional enterprise-control model. It categorizes the types of information necessary for MES to support production processes, including information required to produce a product, information about production capability, information about actual production, and information relating to production performance. The document also describes the role of organizational structure in determining the placement and flow of information within MES, highlighting the implications for different organizations implementing MES based on their unique operational groups. The section includes a diagram illustrating the categories of information exchange between manufacturing control systems and other business systems in the context of MES.", "excerpt_keywords": "Manufacturing Execution Systems, ANSI/ISA-95, B2MML, ANSI/ISA-S88, SCOR Model"}}, "55b8a25c-3c1b-427f-a4b8-b5fbbfd54258": {"node_ids": ["456acd62-a67a-48ac-8188-c143b1ff2705"], "metadata": {"page_label": "134", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "MESA International: Promoting Best Practices in Manufacturing Execution Systems", "questions_this_excerpt_can_answer": "1. What is the role of the Manufacturing Enterprise Solutions Association (MESA) in the context of Manufacturing Execution Systems (MES)?\n   \n2. Can you detail the types of resources MESA International provides for understanding MES, specifically mentioning any high-level vision documents for executives?\n\n3. How does the GAMP\u00ae Good Practice Guide: Appendix 13 contribute to the strategic and program management approach of Manufacturing Execution Systems, and how is MESA International involved in this context?", "prev_section_summary": "This section discusses the integration of standards and models in manufacturing operations, focusing on XML-based language, ANSI/ISA-95 standards, ANSI/ISA-S88 standard for batch manufacturing plants, and the Supply Chain Operations Reference (SCOR) model. Key topics include the use of XML and B2MML for data exchange, the benefits of ANSI/ISA-S88 standards for batch control, and the role of SCOR model in assessing and improving supply chain management. The section also outlines specific standards and models such as ISA-88.01, ISA-88.02, ISA-88.03, and ISA-88.00.04 for batch control.", "excerpt_keywords": "Manufacturing Execution Systems, MESA International, standards, models, GAMP\u00ae Good Practice Guide"}}, "609165c3-5c2f-4e6d-880e-332f8d3dd8ee": {"node_ids": ["da70a9ca-025b-4c0e-8f98-f1d7763860df"], "metadata": {"page_label": "135", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Execution Systems: Regulatory Standards and Best Practices in the Pharmaceutical Industry", "questions_this_excerpt_can_answer": "1. What are the specific ANSI/ISA standards referenced in the document for batch control and enterprise-control system integration within the pharmaceutical manufacturing execution systems, and what do they cover in terms of content and guidelines?\n\n2. How does the ISPE GAMP\u00ae 5 guide propose a risk-based approach to compliant GXP computerized systems, and what are the publication dates and focus areas of the ISPE GAMP\u00ae Good Practice Guides mentioned in the document?\n\n3. What editions and publication dates are provided for the ISPE Baseline\u00ae Pharmaceutical Engineering Guide series volumes on active pharmaceutical ingredients and oral solid dosage forms, and how might these resources contribute to understanding regulatory standards and best practices in the pharmaceutical industry?", "prev_section_summary": "The section discusses the role of the Manufacturing Enterprise Solutions Association (MESA) in promoting best practices, strategies, and innovation in Manufacturing Execution Systems (MES). MESA provides standard methodologies, approaches, and resources for understanding MES, including high-level vision documents for executives. The GAMP\u00ae Good Practice Guide: Appendix 13 contributes to the strategic and program management approach of MES, with MESA International being involved in this context.", "excerpt_keywords": "Manufacturing Execution Systems, ANSI/ISA standards, GAMP\u00ae 5 guide, ISPE Baseline\u00ae Pharmaceutical Engineering Guide, pharmaceutical industry"}}, "788c1007-dee3-4e91-8b8d-3c82b476297f": {"node_ids": ["3616b589-5d76-49e6-8f6c-e15905fc1821"], "metadata": {"page_label": "136", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Pharmaceutical Manufacturing Systems and Regulations: A Comprehensive Guide\"", "questions_this_excerpt_can_answer": "1. What specific ASTM standard guide is recommended for the specification, design, and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipment, including its publication year?\n   \n2. Can you list any resources or guides that provide a strategic and program management approach to Manufacturing Execution Systems (MES) within the pharmaceutical industry, as outlined in the GAMP (r) Good Practice Guide's appendix?\n\n3. What are the publication years and focus areas of the first editions of volumes 3 through 6 as mentioned in the context, specifically relating to pharmaceutical manufacturing facilities and their associated systems?", "prev_section_summary": "The section discusses Manufacturing Execution Systems in the pharmaceutical industry, focusing on regulatory standards and best practices. Key topics include ANSI/ISA standards for batch control and enterprise-control system integration, ISPE GAMP\u00ae 5 guide's risk-based approach to compliant GXP computerized systems, and ISPE Baseline\u00ae Pharmaceutical Engineering Guide series volumes on active pharmaceutical ingredients and oral solid dosage forms. Entities mentioned include ANSI/ISA, ISPE, ICH, and ISO.", "excerpt_keywords": "Manufacturing Execution Systems, Pharmaceutical Industry, GAMP Good Practice Guide, ASTM Standard, MES Vision"}}, "f63a41a5-da42-45d8-8385-10c490fd5315": {"node_ids": ["b65eb375-73c5-46d4-b3f0-515156d55d18"], "metadata": {"page_label": "137", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Abbreviations and Acronyms in Manufacturing and Quality Control Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What does the acronym \"CAPA\" stand for in the context of manufacturing and quality control systems, as outlined in the ISPE Manufacturing Execution Systems guide?\n   \n2. In the comprehensive guide on abbreviations and acronyms in manufacturing and quality control systems provided by the ISPE document, how is \"PAT\" defined, and what does it signify within the pharmaceutical manufacturing industry?\n\n3. According to the glossary appendix in the ISPE Manufacturing Execution Systems document, what is the meaning of \"EBR\" and how does it relate to the documentation processes within pharmaceutical manufacturing environments?", "prev_section_summary": "The section provides information on Manufacturing Execution Systems (MES) within the pharmaceutical industry, including recommended resources and guides for strategic and program management approaches. It also mentions specific ASTM standards for pharmaceutical manufacturing systems and equipment, as well as references to regulatory guidelines from organizations such as the US FDA and the European Commission. The section covers topics such as validation, quality control, and good manufacturing practices in pharmaceutical facilities. Key entities mentioned include ASTM International, GAMP (r) Good Practice Guide, US FDA, Commission of the European Communities, and World Health Organization.", "excerpt_keywords": "Manufacturing Execution Systems, MES, Abbreviations, Acronyms, Pharmaceutical Industry"}}, "4a6b9a9d-6219-4b69-9934-eb72a3effbfd": {"node_ids": ["a318aa1f-2c33-4d24-b239-fa48cce554e7"], "metadata": {"page_label": "138", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Manufacturing Execution Systems: Strategic Program Management and Best Practices", "questions_this_excerpt_can_answer": "1. What specific appendix in the GAMP (Good Automated Manufacturing Practice) guide focuses on Manufacturing Execution Systems from a strategic and program management approach?\n   \n2. As of the document's last update in 2024, what are the standard abbreviations used in the context of Manufacturing Execution Systems, specifically for terms like \"standard operating procedure,\" \"visual basic for applications,\" \"validation master plan,\" and \"work in progress\"?\n\n3. What document provides detailed insights into strategic program management and best practices for Manufacturing Execution Systems, including a specific appendix dedicated to these systems within the GAMP guide?", "prev_section_summary": "The section provides a glossary of abbreviations and acronyms commonly used in manufacturing and quality control systems within the pharmaceutical industry. Key topics covered include electronic batch records (EBR), corrective and preventive actions (CAPA), process analytical technology (PAT), and various system and record types such as electronic production records (EPR) and master batch records (MBR). The glossary also includes terms related to control systems, documentation processes, and quality management practices.", "excerpt_keywords": "Manufacturing Execution Systems, GAMP, strategic program management, appendix, best practices"}}, "e99c39bb-8b55-46e0-bb34-71f2f9a8dae4": {"node_ids": ["637ce344-ca85-41a0-985b-441e52fa6e5d"], "metadata": {"page_label": "139", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Understanding Manufacturing Execution Systems: Key Definitions and Functions", "questions_this_excerpt_can_answer": "1. What specific functions does the GAMP(r) Good Practice Guide associate with the term \"dispatching production units\" in the context of Manufacturing Execution Systems, and how does it describe the ability of these systems to adapt to real-time changes on the factory floor?\n\n2. How does the document define \"document control\" within Manufacturing Execution Systems, particularly in relation to maintaining production unit records/forms and ensuring compliance with environmental, health, and safety regulations?\n\n3. In the context of Manufacturing Execution Systems as outlined in the GAMP(r) Good Practice Guide, how is \"effluent management\" described in terms of its growing importance and its specific relevance to the pharmaceutical manufacturing sector?", "prev_section_summary": "The section discusses Manufacturing Execution Systems from a strategic and program management perspective, focusing on best practices and insights provided in the GAMP guide. It includes standard abbreviations used in the context of Manufacturing Execution Systems such as \"sop\" for standard operating procedure, \"vba\" for visual basic for applications, \"vmp\" for validation master plan, and \"wip\" for work in progress. The specific appendix in the GAMP guide, \"Appendix 15 Manufacturing Execution Systems - A Strategic and Program Management Approach,\" is highlighted as a key resource for detailed insights into this topic.", "excerpt_keywords": "Manufacturing Execution Systems, GAMP, Dispatching Production Units, Document Control, Effluent Management"}}, "d6b99cfc-37eb-4d6c-ad59-881ba655d35f": {"node_ids": ["6926015e-2169-4766-b5a7-5bcb1a799768"], "metadata": {"page_label": "140", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Strategic Management of Electronic Device History Records in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the GAMP(r) Good Practice Guide define the term \"Electronic Production Record (EPR)\" in the context of manufacturing execution systems for medical device manufacture, and what does it encompass?\n\n2. What specific functionalities does the Labor Management module provide within a Manufacturing Execution System (MES) as outlined in the ISPE Manufacturing Execution Systems guide, and how does it contribute to activity-based costing?\n\n3. According to the document \"Strategic Management of Electronic Device History Records in Manufacturing Execution Systems: A Comprehensive Guide,\" how does the Performance Analysis module in an MES environment contribute to the evaluation of manufacturing operations, and what key performance indicators does it track?", "prev_section_summary": "The section provides definitions and explanations related to Manufacturing Execution Systems (MES) as outlined in the GAMP(r) Good Practice Guide. Key topics include automation, data collection/acquisition, dispatching production units, document control, effluent management, electronic batch record (EBR), and electronic batch record system (EBRS). These definitions cover the monitoring and control of production processes, the management of production unit flow, the control of records/forms, the importance of effluent management for environmental impact, and the use of electronic records in MES. The section emphasizes the importance of real-time adaptability, compliance with regulations, and the efficient management of production processes in the pharmaceutical manufacturing sector.", "excerpt_keywords": "Manufacturing Execution Systems, Electronic Device History Records, GAMP Good Practice Guide, Labor Management, Performance Analysis"}}, "b98be6f3-0d02-4110-b225-95e243a5d6bf": {"node_ids": ["89d03d87-b133-433b-a74c-1c067c0584e9"], "metadata": {"page_label": "141", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Integration of Process Analytical Technology (PAT) in Manufacturing Execution Systems: Key Components and Benefits\"", "questions_this_excerpt_can_answer": "1. How does the GAMP\u00ae Good Practice Guide define the role of Process Analytical Technology (PAT) in the context of Manufacturing Execution Systems (MES), particularly in ensuring final product quality?\n   \n2. What specific functionalities does the document describe as essential for effective product tracking and genealogy within Manufacturing Execution Systems, and how do these functionalities contribute to maintaining product quality and traceability?\n\n3. Can you detail the \"Review by Exception (RBE)\" approach as outlined in the document, including how it streamlines the review and approval process in validated manufacturing operations within the context of Manufacturing Execution Systems?", "prev_section_summary": "The section discusses the strategic management of Electronic Device History Records (EDHR) in Manufacturing Execution Systems (MES). Key topics include the definition of Electronic Production Record (EPR), the functionalities of Labor Management and Maintenance Management modules within an MES, the role of Enterprise Resource Planning (ERP) in integrating organizational data, and the importance of Performance Analysis in evaluating manufacturing operations. The section also mentions the MES functional model entities and their functions, such as operations/detail scheduling for sequencing production units and performance analysis for reporting actual manufacturing results.", "excerpt_keywords": "Process Analytical Technology, Manufacturing Execution Systems, Product Tracking, Genealogy, Review by Exception"}}, "27b84373-5038-4c3a-a8c8-59dca150a65b": {"node_ids": ["38f88134-1375-425d-b038-e116575e90f0"], "metadata": {"page_label": "142", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "Validation and Verification in Manufacturing Execution Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What specific ASTM standard is referenced in the document for the application of continuous quality verification to pharmaceutical and biopharmaceutical manufacturing, and what is its main purpose?\n   \n2. How does the document differentiate between the terms \"validation\" and \"verification\" in the context of Manufacturing Execution Systems, according to ISO 9000-3 guidelines?\n\n3. What is the definition of \"Work in Progress\" (WIP) as described in the document, and how does it relate to the manufacturing process within the pharmaceutical and biopharmaceutical industry?", "prev_section_summary": "The section discusses the integration of Process Analytical Technology (PAT) in Manufacturing Execution Systems (MES) and highlights key components such as process management, product tracking and genealogy, quality management, resource allocation and status management, and review by exception (RBE). PAT is defined as a system for designing, analyzing, and controlling manufacturing through timely measurements of critical quality and performance attributes. Process management involves monitoring production and providing decision support to operators, while product tracking and genealogy ensures visibility and traceability of work and components. Quality management focuses on real-time analysis of measurements to assure product quality control. Resource allocation and status management involves managing resources and ensuring equipment is properly set up. Review by exception streamlines the review and approval process by presenting critical process exceptions for review and disposition.", "excerpt_keywords": "Manufacturing Execution Systems, Validation, Verification, ASTM standard, Work in Progress (WIP)"}}, "11c6bb37-290e-46f2-bf56-0bbefee9114f": {"node_ids": ["9cde98f2-1acb-4972-8761-f2bae8a20ee7"], "metadata": {"page_label": "143", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Quanta-cs: Change Comes from Within - A Comprehensive Guide to Personal Transformation\"", "questions_this_excerpt_can_answer": "1. What is the contact information for Quanta-cs, including their physical address, telephone number, fax number, and website URL?\n2. As of the document's last modification in April 2024, what is the title of the comprehensive guide focused on personal transformation published by Quanta-cs?\n3. In which town and county is Quanta-cs's office located, according to the document titled \"Quanta-cs: Change Comes from Within - A Comprehensive Guide to Personal Transformation\"?", "prev_section_summary": "The section discusses the concepts of validation and verification in Manufacturing Execution Systems, referencing ASTM standards and ISO guidelines. It explains the difference between the two terms and highlights the importance of continuous quality verification in pharmaceutical and biopharmaceutical manufacturing. The document also defines \"Work in Progress\" (WIP) as materials in the process of being converted into finished products within the industry.", "excerpt_keywords": "Quanta-cs, personal transformation, validation, verification, pharmaceutical manufacturing"}}, "69abe77a-980e-45dd-afac-e297441427a1": {"node_ids": ["15145626-ec74-4e02-b1ab-92b603c439b3"], "metadata": {"page_label": "144", "file_name": "[10] ISPE Manufacturing Execution Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[10] ISPE Manufacturing Execution Systems.pdf", "file_type": "application/pdf", "file_size": 7322258, "creation_date": "2024-04-07", "last_modified_date": "2024-04-04", "document_title": "\"Optimizing Efficiency and Ensuring Compliance in Bio-Pharma Manufacturing with PAS-X\"", "questions_this_excerpt_can_answer": "1. What is the primary goal of bio-pharma companies in terms of paperwork and productivity as outlined in the document titled \"Optimizing Efficiency and Ensuring Compliance in Bio-Pharma Manufacturing with PAS-X\"?\n\n2. How many of the world's top 30 pharmaceutical and biotech companies have chosen Werum's MES product suite PAS-X for their manufacturing business, according to the document?\n\n3. What are the locations of Werum's headquarters and its regional headquarters in the U.S. and Asia-Pacific, as mentioned in the document \"Optimizing Efficiency and Ensuring Compliance in Bio-Pharma Manufacturing with PAS-X\"?", "prev_section_summary": "The key topics and entities of the section include Quanta-cs, a company focused on personal transformation, their contact information such as physical address, telephone number, fax number, and website URL, and the title of their comprehensive guide on personal transformation titled \"Change Comes from Within.\" The location of Quanta-cs's office is also mentioned in the excerpt.", "excerpt_keywords": "bio-pharma, manufacturing, efficiency, compliance, PAS-X"}}}}