{"docstore/data": {"d0e27440-0a14-41f9-b91e-d4b0f66baf57": {"__data__": {"id_": "d0e27440-0a14-41f9-b91e-d4b0f66baf57", "embedding": null, "metadata": {"page_label": "1", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "ISPE Headquarters and European Office Contact Information", "questions_this_excerpt_can_answer": "1. What are the contact details for the ISPE headquarters located in Tampa, Florida, as provided in the \"ISPE Validation of Laboratory Computerized Systems 2005\" document?\n   \n2. How can one contact the ISPE European Office in Brussels, Belgium, including telephone and fax numbers, as outlined in the \"ISPE Validation of Laboratory Computerized Systems 2005\" document?\n\n3. What is the ISBN associated with the \"ISPE Validation of Laboratory Computerized Systems 2005\" document, and where can additional information about ISPE be found online according to this document?", "excerpt_keywords": "ISPE, Validation, Laboratory, Computerized Systems, Contact Information"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n|ispe headquarters| |\n|---|---|\n|3109 w. dr. martin luther king jr blvd, suite 250| |\n|tampa, fl 33607 usa| |\n|tel: 1813/960-2105|fax: 1-813/264-2816|\n|ispe european office| |\n|avenue de tervueren, 300, b-1150| |\n|brussels, belgium| |\n|tel: 32-2-743-4422|fax: 32 2-743-1550|\n|website: www.ispe.org|isbn: 1-931879-39-7|", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "51b62fb0-f240-4795-8d1d-9acdbd21cb98": {"__data__": {"id_": "51b62fb0-f240-4795-8d1d-9acdbd21cb98", "embedding": null, "metadata": {"page_label": "2", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "GAMP Good Practice Guide for Validation of Laboratory Computerized Systems", "questions_this_excerpt_can_answer": "1. What specific approach does the GAMP Good Practice Guide for Validation of Laboratory Computerized Systems recommend for categorizing and managing the risk of laboratory computerized systems, and how does it build upon the principles outlined in GAMP 4?\n   \n2. Can you detail the role of the Laboratory Systems Special Interest Group (SIG) within the GAMP forum in the production of the GAMP Good Practice Guide for Validation of Laboratory Computerized Systems, and how does this guide aim to address the unique validation requirements of laboratory computerized systems?\n\n3. What are the limitations and disclaimers provided by the GAMP Good Practice Guide regarding the validation of laboratory computerized systems, specifically in terms of liability and the guide's ability to guarantee regulatory acceptance of a system managed according to its recommendations?", "prev_section_summary": "The key topics of the section include the contact details for the ISPE headquarters in Tampa, Florida, and the ISPE European Office in Brussels, Belgium. The section also mentions the telephone and fax numbers for both offices, as well as the website for ISPE and the ISBN associated with the \"ISPE Validation of Laboratory Computerized Systems 2005\" document.", "excerpt_keywords": "GAMP, Validation, Laboratory, Computerized Systems, Risk Management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## good practice guide: validation of laboratory computerized systems\n\nthis document, the gamp good practice guide: validation of laboratory computerized systems, is intended as a supplement to guide for validation of automated systems (gamp 4). it provides an approach to laboratory computerized system categorization and risk management processes that can be used to determine a rational, scalable approach to the validation of laboratory computerized systems by building upon the gamp 4 software categories.\n\nthis document has been designed so that it may be used in conjunction with guidance provided in gamp 4 and other ispe publications, such as the ispe baseline guides.\n\nexamples on how to apply gamp principles to laboratory computerized systems are included in order to clarify what is considered to be recommended practice within a particular regulatory area or equipment type.\n\nthe laboratory systems special interest group (sig) of the gamp forum, which was set up to address the special requirements for validation of laboratory computerized systems, has produced this gamp good practice guide.\n\ndisclaimer:\n\nthis guide is meant to assist pharmaceutical companies in managing the validation of laboratory computerized systems. the gamp forum cannot ensure and does not warrant that a system 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\nin no event shall ispe or any of its affiliates (including the gamp forum), 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 nor caused 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 2005. all 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. all trademarks used are acknowledged. isbn 1-931879-39-7", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "50d2b1a0-3c20-4271-8ce9-4a1f577a91c8": {"__data__": {"id_": "50d2b1a0-3c20-4271-8ce9-4a1f577a91c8", "embedding": null, "metadata": {"page_label": "3", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "GAMP Good Practice Guide: Validation of Laboratory Computerized Systems - Acknowledgements", "questions_this_excerpt_can_answer": "1. Who were the initial and subsequent chairs of the special interest group responsible for the production of the GAMP Good Practice Guide: Validation of Laboratory Computerized Systems, and which companies did they represent?\n   \n2. Over how many years did the GAMP Forum Laboratory Systems Special Interest Group (SIG) work on the GAMP Good Practice Guide: Validation of Laboratory Computerized Systems, and what was the nature of their contribution to the guide's development?\n\n3. Can you list the locations and hosting organizations for the face-to-face meetings that were part of the production process for the GAMP Good Practice Guide: Validation of Laboratory Computerized Systems?", "prev_section_summary": "The section discusses the GAMP Good Practice Guide for Validation of Laboratory Computerized Systems, which provides an approach to categorizing and managing the risk of laboratory computerized systems based on GAMP 4 principles. It highlights the role of the Laboratory Systems Special Interest Group (SIG) in producing the guide and addresses the unique validation requirements of laboratory systems. The document includes examples of applying GAMP principles to laboratory systems and provides limitations and disclaimers regarding regulatory acceptance and liability. The guide is intended to assist pharmaceutical companies in managing system validation but does not guarantee regulatory acceptance, and it emphasizes the need for professional expertise.", "excerpt_keywords": "GAMP, Validation, Laboratory Computerized Systems, Pharmaceutical, Risk Management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## acknowledgements\n\nthe production of the gamp good practice guide: validation of laboratory computerized systems was initiated by the gamp americas forum steering committee, and governed by a special interest group chaired initially by jeffrey beck of ortho-mcneil pharmaceutical, inc. and subsequently by lorrie vuolo-schuessler of glaxosmithkline, assisted by kathy gniecko of hoffmann-la roche.\n\n### table of contents\n\n|introduction|6|\n|---|---|\n|1.1 overview|6|\n|1.2 purpose|7|\n|1.3 scope|7|\n|1.4 benefits|7|\n|1.5 objectives|8|\n|1.6 structure of this guide|9|\n|1.7 key concepts| |\n|2 laboratory computerized system categorization|9|\n|2.1 selecting the appropriate categorization scheme|10|\n|3 development versus implementation life cycle|14|\n|3.1 qualification or validation|15|\n|3.2 sdlc or silc|15|\n|4 specifications and traceability|20|\n|4.1 user requirements specification| |\n|4.2 detailed design specification|24|\n|4.3 traceability| |\n|5 risk management model|25|\n|6 supplier assessment|33|\n|7 project planning and initiation|34|\n|8 validation plan|36|\n|9 coding and construction|38|\n|10 qualification, testing, and release|39|\n|10.1 testing elements|42|\n|10.2 categories|43|\n|10.3 testing principles| |\n|11 validation report|45|\n|12 configuration management, change control, and problem reporting| |\n|12.1 configuration management|47|\n|12.2 change control|48|\n|12.3 problem reporting|49|\n|12.4 maintenance and maintenance log| |\n|12.5 use log|49|\n\nthe following members of the gamp forum laboratory systems special interest group (sig) worked on one or more sections of this guide and volunteered countless hours to attend meetings and review the many drafts produced over a four year period:\n\n- jeffrey beck - ortho-mcneil pharmaceutical, inc. (chair - initial)\n- lorrie vuolo-schuessler - glaxosmithkline (chair - current and editorial team member)\n- kathy gniecko - hoffmann-la roche (editorial team member)\n- chris wubbolt - qa and computing validation consulting\n- echeazu ogu - bonscicnce, inc.\n- ed johnson - stclex\n- kiet t. luong - glaxosmithkline\n- leonard thibodeau - brookfield engineering laboratories, inc.\n- maryellen london - cephalon inc.\n- rachel adler - johnson & johnson pharmaceutical research & development, llc\n- ron barnett - laboratory expertise center\n\nthe gamp forum laboratory systems sig would like to acknowledge the support of their direct management and companies in this endeavor. members of the gamp forum council and steering committees, along with the ispe technical documents committees, are thanked for their participation in the review of this guide. the gamp editorial review board assisted with the final review. the laboratory systems sig would like to thank ispe for the services of ispes technical writer, gail evans, throughout the process.\n\nthe leaders of the gamp forum laboratory systems sig wish to thank everyone for their contributions and commitment throughout the production of this guide. it has been informative and satisfying to work with such a dedicated group of professionals on this project.\n\nspecial thanks to those individuals and organizations who hosted face-to-face meetings:\n\n- jeffrey beck - ortho-mcneil pharmaceutical, inc., titusville, new jersey\n- kathy gniecko - hoffmann-la roche, nutley, new jersey\n- lorrie vuolo-schuessler - glaxosmithkline, upper merion, pennsylvania", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "9391cedb-def1-44aa-845b-e939b0844df3": {"__data__": {"id_": "9391cedb-def1-44aa-845b-e939b0844df3", "embedding": null, "metadata": {"page_label": "4", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Laboratory Computerized Systems Validation and Security Measures: Ensuring Compliance and Data Integrity", "questions_this_excerpt_can_answer": "1. What specific security considerations are outlined for the administration of laboratory computerized systems in the ISPE Validation of Laboratory Computerized Systems 2005 document?\n\n2. How does the ISPE Validation of Laboratory Computerized Systems 2005 document recommend handling the retirement of laboratory computerized systems, including both the retirement plan and the retirement report?\n\n3. What are the key components of the backup, archive, and business continuity planning as detailed in the ISPE Validation of Laboratory Computerized Systems 2005 document, and how do they contribute to ensuring compliance and data integrity in laboratory environments?", "prev_section_summary": "The section acknowledges the individuals and organizations involved in the production of the GAMP Good Practice Guide: Validation of Laboratory Computerized Systems. It mentions the initial and subsequent chairs of the special interest group, the members who contributed to the guide over a four-year period, and the hosting organizations for face-to-face meetings. The section also expresses gratitude to the support received from various companies, committees, and individuals involved in the review and production process. Overall, the section highlights the collaborative effort and dedication of professionals in developing the guide.", "excerpt_keywords": "Laboratory Computerized Systems, Validation, Security Measures, Data Integrity, ISPE"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## validation of laboratory computerized systems\n\n|page 5|page 4|\n|---|---|\n|13 system administration security|50 table of appendices|\n|14 14.1 system security considerations|52 appendix 1 determining system impact|\n|15 back up, archive, and business continuity planning|55|\n|15.1 backup and restore| |\n|15.2 archival|appendix 2 testing priority|\n|16 training|58|\n|17 periodic review|59 appendix 3 supplier assessment scheme|\n|18 retirement|62|\n|18.1 system retirement plan| |\n|18.2 system retirement repo|appendix 4 glossary|\n|19 summary and conclusions|65 appendix 5 references|", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "86c0cb55-77e6-467b-9b8b-141b346d5263": {"__data__": {"id_": "86c0cb55-77e6-467b-9b8b-141b346d5263", "embedding": null, "metadata": {"page_label": "5", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation of Laboratory Computerized Systems: A Risk-Based Approach for Regulated Life Science Industries", "questions_this_excerpt_can_answer": "1. How does the GAMP Good Practice Guide propose to handle the diversity and complexity of laboratory computerized systems in terms of validation, considering the varying levels of sophistication among systems like a Chromatography Data System (CDS) and a pH meter?\n\n2. What specific audience is the GAMP Good Practice Guide on the validation of laboratory computerized systems aimed at, and how does it intend to benefit these groups, particularly in regulated life science industries?\n\n3. How does the GAMP Good Practice Guide suggest organizations assess and manage the risks associated with data integrity in laboratory computerized systems, and what strategies does it recommend for mitigating unacceptable risks to data integrity, product quality, and patient safety?", "prev_section_summary": "The section discusses the validation of laboratory computerized systems, focusing on system administration security, system security considerations, backup, archive, and business continuity planning, training, periodic review, retirement plan, retirement report, and references. Specific security considerations for the administration of laboratory computerized systems are outlined, recommendations for handling system retirement are provided, and key components of backup, archive, and business continuity planning are detailed to ensure compliance and data integrity in laboratory environments.", "excerpt_keywords": "Validation, Laboratory, Computerized Systems, GAMP, Risk-Based Approach"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n# page 6\n\ngamp good practice guide: validation of laboratory computerized systems\n\n## 1 introduction\n\n1.1 overview\n\nduring the last few years, both the automation of laboratory testing and data management operations have reached new levels of sophistication and complexity. widespread reliance on these technologies, along with their potential impact on data integrity, has brought an increased focus on the importance of implementing laboratory computerized systems that have been built and maintained following good software and hardware engineering, validation, and quality management practices.\n\nthe diversity of systems found in a typical laboratory indicates that a single validation approach for all systems would be neither practical nor cost-effective. for example, a chromatography data system (cds) is much more complex than a ph meter and, therefore, its implementation, use, and maintenance require a correspondingly more detailed approach.\n\n## 1.2 purpose\n\nthis guide is intended as a supplement to gamp 4 and provides a harmonized overview of the key elements involved in the life cycle of laboratory computerized systems, from initiation to retirement. this guide provides an approach to laboratory computerized systems categorization and risk assessment processes which can be used to determine a rational, scalable approach to the validation of laboratory computerized systems, by building upon the gamp 4 software categories.\n\nthe intended audience for this guide includes laboratory, quality, and computer validation professionals responsible for defining and managing laboratory validation practices in regulated life science industries. information technology (it) personnel supporting these systems, management, and laboratory computerized systems users (who are an integral part of the validation process), software developers, and suppliers of laboratory computerized systems are also expected to find benefit in using this guide.\n\n## 1.3 scope\n\nthis guide addresses laboratory computerized systems used within the regulated life science industries, including pharmaceutical, biological, and medical devices that are subject to good manufacturing practice (gmp), good laboratory practice (glp), or good clinical practice (gcp). the focus of the guide is computerized laboratory instrumentation, data management, and analysis systems. infrastructure qualification and control are outside the scope of this guide, except in reference to specific issues related to laboratory computerized systems and operations.\n\nat the time of publication, a new usp general information chapter has been proposed, which is aimed at defining very high-level principles, rather than the practical aspects covered by this good practice guide. it covers only some of the instrument categories in this good practice guide, which is more extensive in scope.\n\n## 1.4 benefits\n\nthis gamp good practice guide applies a risk-based approach to the validation of laboratory computerized systems in a regulated gxp context. the guidance discusses the various stages of the validation life cycle and relates the activities to the technical complexity of the system. the level of testing and controls of a laboratory computerized system should be commensurate with:\n- the use of the system - both business and regulatory complexity\n- the technical complexity of the system including the degree of customization of the system\n- the hazards to the system and the potential impact to the system of these hazards\n\nthe risk analysis should allow the organization to determine whether the risk associated with a systems data is acceptable or if mitigation strategies are required. these strategies would include the implementation of technical and procedural controls appropriate to the risk to data integrity. a pragmatic approach is, therefore, presented that can be applied to laboratory computerized systems. this overall philosophy is intended to encourage the use of innovation and technological advances while avoiding unacceptable risk to data integrity, product quality, and patient safety.\n\n## 1.5 objectives\n\nthis guide seeks to develop a rational approach to laboratory computerized systems validation and to provide guidance to address strategic and tactical computer system validation issues of current interest to validation practitioners, including:\n- examine the traditional system development life cycle (sdlc) and its applicability for most laboratory computerized systems.\n- identify characteristics that distinguish various laboratory computerized systems.\n- develop a rationale for scaling the effort associated with the validation of laboratory computerized systems.\n\n# page 7\n\ngamp good practice guide: validation of laboratory computerized systems", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "74724ab5-1631-4f70-aa14-4832551c3ae3": {"__data__": {"id_": "74724ab5-1631-4f70-aa14-4832551c3ae3", "embedding": null, "metadata": {"page_label": "6", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Enhancing Validation of Laboratory Computerized Systems: Supplier Assessment, Risk Management, and System Categorization", "questions_this_excerpt_can_answer": "1. How does the ISPE Validation of Laboratory Computerized Systems 2005 guide propose to refine the GAMP 4 risk assessment approach specifically for laboratory computerized systems, and what are the key differences in application compared to the original GAMP 4 approach?\n\n2. What unique categorization scheme does the ISPE Validation of Laboratory Computerized Systems 2005 guide introduce for laboratory computerized systems, and how does it differ from the categorization defined in GAMP 4, particularly in the context of integrating hardware and software components?\n\n3. Can you detail the process outlined in the ISPE Validation of Laboratory Computerized Systems 2005 guide for maintaining laboratory computerized systems in a validated state throughout their lifecycle, including the transition process recommended when a system is deemed no longer suitable for its intended use?", "prev_section_summary": "This section from the document \"Validation of Laboratory Computerized Systems: A Risk-Based Approach for Regulated Life Science Industries\" discusses the increasing complexity and sophistication of laboratory computerized systems, the need for a risk-based approach to validation, and the intended audience and scope of the GAMP Good Practice Guide. It covers the purpose, benefits, and objectives of the guide, emphasizing the importance of implementing good software and hardware engineering practices, validation, and quality management in laboratory computerized systems. The guide provides a rational approach to categorizing and assessing risks in laboratory computerized systems, with a focus on data integrity, product quality, and patient safety. It also addresses the validation life cycle, system complexity, and the need for mitigation strategies to manage risks effectively.", "excerpt_keywords": "Validation, Laboratory Computerized Systems, Risk Management, System Categorization, Supplier Assessment"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## validation of laboratory computerized systems\n\ndevelop a strategy for supplier assessment to supplement company specific validation activities.\n\nrefine the gamp 4 risk assessment approach to be more easily applied to laboratory computerized systems.\n\ndefine necessary controls to maintain laboratory computerized systems in a validated state.\n\nrecommend activities to be performed when a laboratory computerized system is no longer suitable for its intended use.\n\n## key concepts\n\nsystem categorization\n\ngamp 4 describes a method of categorizing individual software and hardware components, based on the degree of standardization of a component, and general risk of component failure. in this guide, laboratory computerized systems are considered as complete systems, consisting of various software and hardware components, and categorization applied at the system level.\n\nto support this, a series of laboratory computerized systems categories has been defined and is described in detail in section 2 of this guide. these categories are used throughout this document in place of the categories defined in gamp 4. for example, a category c gas chromatograph (gc) is given a single category assignment that encompasses software (configurable firmware) and hardware (interfaces, sensors, detectors, etc.).\n\nlife cycle approach\n\nthe majority of laboratory computerized systems are commercially available systems where the traditional system development life cycle (sdlc) may often not be appropriate. in section 3, this guide describes an alternative system implementation life cycle (silc) and discusses when the sdlc and silc apply.\n\nrisk management\n\nrisk management is a continuous process, spanning the entire computerized system life cycle and should be linked with the business process if it is to be meaningful. section 5 of this guide outlines a process by which risks to laboratory computerized systems at both the system and functional levels may be analyzed, evaluated, and controlled.\n\n## laboratory computerized system\n\n### categorization\n\nselecting the appropriate categorization scheme\n\nlaboratory computerized systems typically consist of integrated hardware and software so inextricably linked that the system can be challenged only as an integrated unit. for example, it would be impractical to test a near infrared (nir) spectrophotometers hardware without utilizing the software.\n\nthe less sophisticated the degree of automation within a system, the greater the difficulty in separating the hardware from the software for the purpose of validation. for this reason, the gamp software categories and gamp hardware categories alone contain insufficient detail to validate appropriately and consistently the wide diversity of systems encountered in laboratories.\n\n## appendices\n\nappendix 1: determining system impact\n\nthe impact assessment described in this appendix allows the selection of the appropriate approach to risk management for a system.\n\nappendix 2: testing priority\n\nthis appendix provides a structured method for determining the extent of testing required for different types of laboratory computerized systems.\n\nappendix 3: supplier assessment scheme\n\nthis appendix describes a supplier assessment scheme based upon the three dimensions of risk that affect data integrity: technical complexity, business risk, and gxp risk.\n\nappendix 4: glossary\n\nappendix 5: references", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "1bf99a17-a019-4e81-b424-899b09d90d8b": {"__data__": {"id_": "1bf99a17-a019-4e81-b424-899b09d90d8b", "embedding": null, "metadata": {"page_label": "7", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Ensuring Data Integrity and Compliance through Laboratory Computerized System Validation and Categorization", "questions_this_excerpt_can_answer": "1. How does the ISPE Validation of Laboratory Computerized Systems 2005 guide refine the existing GAMP software categories for laboratory computerized systems, and what criteria are used for this categorization?\n   \n2. What considerations should be taken into account when deciding whether to use the standard GAMP 4 categories or a different approach for the validation of a Chromatography Data System (CDS) based on its deployment and integration?\n\n3. How does the guide suggest handling the validation and documentation of systems that interface with other systems or computers, using the example of a balance interfaced to a Laboratory Information Management System (LIMS)?", "prev_section_summary": "This section discusses the validation of laboratory computerized systems, focusing on supplier assessment, risk management, system categorization, and maintaining systems in a validated state throughout their lifecycle. Key concepts include system categorization at the system level, the use of a system implementation life cycle (SILC) for commercially available systems, and the importance of risk management linked with business processes. The section also addresses the challenges of categorizing integrated hardware and software components in laboratory systems and provides appendices on determining system impact, testing priority, supplier assessment, and a glossary of terms.", "excerpt_keywords": "ISPE, Validation, Laboratory Computerized Systems, Data Integrity, Categorization"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## validation of laboratory computerized systems\n\nthe processing of laboratory data, however, is not the sole determinator of whether the laboratory categories described in the next section should be used in lieu of the established gamp 4 categories.\n\na laboratory information management system (lims), for example, is a complex database system that is not particularly unique in architecture, and should be typically approached using the standard gamp 4 categories.\n\na cds on the other hand, could fall into either camp. a cds that resides on a benchtop and is directly integrated with a few chromatographs is probably best handled as category f. the same software, however, might be used as an enterprise solution, with the control software and database residing on a remote server and with data stored to an enterprise storage area network. in this case, the standard gamp 4 categories may be more appropriate.\n\nthe key factor when deciding which approach to choose is a thorough understanding of the complexity of the architecture and the mode of use.\n\n## laboratory computerized system categories\n\nthis guide further refines the existing gamp software categories into seven categories (a through g), based upon the systems intended use and ability to generate, save, reprocess or analyze data, as depicted in table 2.1, laboratory computerized systems categorization.\n\nthis level of granularity is intended to evaluate and categorize a system, to determine appropriate validation activities and deliverables. once a system is evaluated as a whole, the functionality of individual components can be assessed for potential risk to data integrity, and tested accordingly.\n\nexamples listed within table 2.2 are purely for guidance, and it cannot be assumed that all laboratory systems of a particular type always fit into a particular category. for example, nir spectrophotometers could be category c, category d, or category e, depending upon the use of the system as well as its technical complexity.\n\nindividual organizations may choose to modify the approach described in this guide, based upon their individual business environments.\n\nin determining the categorization of a system, laboratory computerized system validation practitioners need to consider both the functionality of the system and the intended use of the system.\n\nwhen a system uses an interface to another system or computer, consideration should be given to the original system, the interfaced system, and to the interface itself. for example, a balance interfaced to a lims would require procedures and documentation to ensure that the balance and the interface are operating correctly, in addition to a separate consideration of the lims.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "81ac561a-a555-49b3-8032-987177947a58": {"__data__": {"id_": "81ac561a-a555-49b3-8032-987177947a58", "embedding": null, "metadata": {"page_label": "8", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation of Laboratory Computerized Systems Categories and Guidelines", "questions_this_excerpt_can_answer": "1. What distinguishes Category E laboratory computerized systems from Category D in terms of data handling and processing capabilities, according to the ISPE Validation of Laboratory Computerized Systems 2005 guidelines?\n   \n2. How does the ISPE Validation of Laboratory Computerized Systems 2005 document categorize laboratory computerized systems that are customized for specific organizational needs, and what examples does it provide for such systems?\n\n3. According to the ISPE Validation of Laboratory Computerized Systems 2005 guidelines, what are the key characteristics and examples of Category B digital systems, and how do they differ from Category A systems in terms of data production and storage?", "prev_section_summary": "The section discusses the validation of laboratory computerized systems, including the refinement of GAMP software categories for laboratory systems and the categorization of systems based on their complexity and mode of use. It introduces seven categories (a through g) for laboratory computerized systems and emphasizes the importance of understanding system architecture and intended use when determining the appropriate validation approach. The section also highlights the need to consider interfaces between systems, using the example of a balance interfaced to a Laboratory Information Management System (LIMS). Overall, the section provides guidance on ensuring data integrity and compliance through proper validation and categorization of laboratory computerized systems.", "excerpt_keywords": "Validation, Laboratory, Computerized Systems, ISPE, Guidelines"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## validation of laboratory computerized systems\n\n|category a:|these are digital systems that do not produce raw data, test results, or process records. these systems may require calibration, but do not use a computer interface. examples include laboratory ovens, centrifuges, incubators, temperature controllers, environmental chambers, sonicators, and glassware washers. this category of system typically contains software components that would be categorized as gamp software category 2.|\n|---|---|\n|category b:|these are digital systems that produce raw data, test results, or process records but the results are not stored. these systems require calibration and the calibration information may be stored. these systems do not use a computer interface and the software is not modifiable by the system user. examples include laboratory balances, ph meters, electronic thermometers, viscometers, conductivity meters, titrators, and chart recorders. this category of system typically contains software components that would be categorized as gamp software category 2.|\n|category c:|these are systems that produce raw data, test results, or process records but these results are not stored. these systems have the ability to store and reuse configuration or process parameters. these systems do not use a computer interface. examples include polymerase chain reaction (pcr) thermal cyclers, particle counters, simple robotics systems, pulse field gel equipment, and some simple high performance liquid chromatography (hplc) or gas chromatography systems. this category of system typically contains software components that would be categorized as gamp software category 3.|\n|category d:|these are systems that produce raw data, test results, or process records and these are stored. these systems have a 1 to 1 ratio of computer to instrument interface. though these systems have the ability to store and reuse configuration or process parameters, data is manipulated outside the system. examples include simple spectrophotometers, microplate readers, and integrated robotic systems. this category of system typically contains software components that would be categorized as gamp software category 3.|\n|category e:|these are systems that produce raw data, test results, or process records and these records are stored. process and configuration parameters can be input, stored and reused. these systems are capable of post-acquisition processing, often using a proprietary data handling system. examples include dna sequencers, hplcs, integrated robotics systems with data acquisition and data processing, mass spectrometers, nuclear magnetic resonance (nmr) spectrometers, and electrocardiogram (ecg) equipment. this category of system typically contains software components that would be categorized as gamp software category 3.|\n|category f:|these systems have the ability to produce raw data, test results, or process records and these records are stored. process parameters and configuration parameters can be input, stored and reused. these systems are capable of post-acquisition processing, often using proprietary data handling systems. these systems have programmable elements, but this configuration does not change the core code. examples of this type of system include the use of spreadsheet templates using native functionality, or statistical analysis software templates. this category of system typically contains software components that would be categorized as gamp software category 4.|\n|category g:|these systems are customized systems specific to a particular laboratory and may have originated as a category e or a category f system that required customization to meet the specific requirements of an organization. these systems could be built by personnel within the user organization, or could be contracted to a third-party provider. examples of this category of system include custom spreadsheets, custom statistical analysis software code, custom databases including custom macros, and sophisticated logic or lookup functions. this category of system typically contains software components, which would be categorized as gamp software category 5.|", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "c647fa2e-6827-4de5-9aab-8fa5a0924201": {"__data__": {"id_": "c647fa2e-6827-4de5-9aab-8fa5a0924201", "embedding": null, "metadata": {"page_label": "9", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation and Implementation of Laboratory Computerized Systems: A Comparison of System Development Life Cycle (SDL) and Software Implementation Life Cycle (SILC) Approaches", "questions_this_excerpt_can_answer": "1. How does the guide differentiate between the validation processes for commercially available laboratory computerized systems and those requiring custom coding or configuration, in terms of the division of responsibility between the supplier and the user organization?\n\n2. What specific guidance does the document provide for implementing a Software Implementation Life Cycle (SILC) approach compared to a traditional System Development Life Cycle (SDLC) for laboratory computerized systems, especially in terms of validation deliverables?\n\n3. How does the document address the industry debate over the use of the terms \"validated\" versus \"qualified\" in the context of analytical laboratory equipment and the overall validation process, including the FDA's definition of validation?", "prev_section_summary": "The section discusses the categorization of laboratory computerized systems based on their data handling and processing capabilities according to the ISPE Validation of Laboratory Computerized Systems 2005 guidelines. The categories range from Category A systems that do not produce raw data to Category G systems that are customized for specific organizational needs. Each category is defined by the type of data produced, stored, and processed, as well as the level of user interface and software modifiability. Examples of systems in each category are provided, along with the corresponding GAMP software category classification. The section emphasizes the importance of understanding the characteristics of different system categories to ensure proper validation and compliance with regulatory requirements.", "excerpt_keywords": "Validation, Laboratory Computerized Systems, System Development Life Cycle, Software Implementation Life Cycle, FDA Definition"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## development versus implementation\n\nlife cycle\n\nas described in section 2, the majority of laboratory computerized systems are commercially available systems, comprising integrated hardware, firmware, and software. this guide applies the institute of electrical and electronics engineers (ieee) concept of validation comprising of individual qualifications of all aspects of a system (hardware, software, people, processes, etc.). in many laboratory computerized systems, it may be difficult to distinguish between software, firmware, and hardware. for these systems, the information that can be obtained from suppliers varies. this lack of access to basic elements of a systems design or construction may make it impossible to follow a traditional sdlc.\n\nthis section describes a method for system implementation based on what is known or can be developed for a commercially available system, considering the risk to data integrity. there are elements of the traditional development/validation process that may not be available or relevant to the validation practitioner in the users environment. depending upon the intended use of the system, the effort necessary to create these supplier elements may not be reasonable, practical, or necessary. for example, a full sdlc would drive a validation effort to obtain design detail and evidence of unit testing regardless of the system complexity in order for the system to be considered validated.\n\n## qualification or validation\n\nthere is a great deal of discussion within the industry concerning the use of the terms validated versus qualified. when dealing with analytical laboratory equipment (a subset of all laboratory computerized systems), it is traditionally stated that the equipment is qualified and the method is validated, and those activities together form a validated process.\n\nfor many systems which do not require separate methods but rely directly on system requirements for their operation and, therefore, for their testing, it was felt that the use of the term qualified had the implication of less comprehensive and less rigorous activities and was not appropriate, as the activities performed reflect the long-established fda definition of validation:\n\nestablishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes (fda, 1987)\n\nthe process described and the supporting documentation will provide the necessary evidence and the systems should be considered validated. this will eliminate a common source of confusion within the industry and technical community as to how to describe the state of small to medium-sized systems.\n\n## sdlc or silc\n\nfigure 3.1 depicts the differences between deliverables in the validation path for a system using either an sdlc or combined with user procedures this can provide a system that can be used and maintained in a manner compliant an silc, starting with the identification of the need for a system.\n\nan understanding of the differences between an sdlc and silc is important as it defines the validation process to be followed for laboratory computerized systems of various technical complexities.\n\nusers may be faced with choices in technology that would equally satisfy the business need for the system but would influence the validation efforts required before the system can be used. subsequent sections of this guide will provide specific guidance for the deliverables for an silc when compared to a traditional sdlc.\n\n## responsibility\n\nresponsibility for the process is divided between the supplier and the user organization. considering certain validation activities as implementation and not development allows the end-user community to understand that for these commercially available systems, the compliant state of the system relies more on the day-to-day activities of the users than on the activities of the system developers. as the complexity of a system increases to include custom coding or configuration, the traditional sdlc deliverables for these custom elements become more important.\n\nafter a company has established a process for bringing laboratory computerized systems into service, those systems should be considered validated and not simply qualified, as all areas of the system that can be assessed will have been assessed.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "bee718e8-ce26-4708-8332-9f160158131b": {"__data__": {"id_": "bee718e8-ce26-4708-8332-9f160158131b", "embedding": null, "metadata": {"page_label": "10", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation and Documentation Procedures for Laboratory Computerized Systems", "questions_this_excerpt_can_answer": "1. How does the ISPE Validation of Laboratory Computerized Systems 2005 document categorize the complexity of laboratory computerized systems, and what are the implications for the validation process across different complexity categories?\n   \n2. What specific documentation and procedural controls does the ISPE 2005 guide recommend for maintaining the validated state of laboratory computerized systems, particularly in relation to systems of varying complexity?\n\n3. According to the ISPE 2005 guide, how should companies approach the validation of low complexity laboratory computerized systems to ensure rapid procurement and validation, and what role do master sets of documentation, templates, or forms play in this process?", "prev_section_summary": "The section discusses the differences between the System Development Life Cycle (SDLC) and Software Implementation Life Cycle (SILC) approaches for validating laboratory computerized systems. It addresses the division of responsibility between suppliers and user organizations, the industry debate over the terms \"validated\" versus \"qualified,\" and the importance of understanding the validation process for systems of varying complexities. The section emphasizes the need for specific guidance on validation deliverables for SILC compared to traditional SDLC, and highlights the importance of considering systems as validated rather than just qualified once all areas have been assessed.", "excerpt_keywords": "ISPE, Validation, Laboratory Computerized Systems, Documentation Procedures, Complexity Categories"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## validation of laboratory computerized systems\n\nusing the laboratory systems categorization described in section 2, the following general statements may be made based on the technical complexity of a system as to whether a system should have a defined sdlc or an silc and the typical documents to be produced.\n\n|sdlc|silc|\n|---|---|\n|for systems at the lower levels of complexity (categories a through e), the ability to challenge the software independent of the firmware and hardware adds little value to the validation of a system.|categories c through e: systems may allow users to store and re-use parameters and may provide the ability to save data, although data manipulation capabilities are limited. commercially available systems, such as the software in categories d and e may contain elements of configuration, but it is typically performed by users using supplier provided process parameter set points.|\n\ntable 3.1 lists elements relevant to the validation of laboratory computerized systems in relation to their degree of complexity. the table defines the elements of validation that are important for demonstrating a systems fitness for use.\n\ntable 3.2 defines the procedures important for maintaining the validated state of the system. there is a fundamental core of information that is necessary for a system regardless of the complexity. the ability to deliver validated systems quickly depends on how the process and the documentation are executed.\n\ntables 3.1 and 3.2 are also intended as a guide for the sequencing of deliverables. regardless of the size of the system, a logical sequence should be followed, e.g., installation qualification (iq) before performance qualification (pq). some elements, such as design qualification (dq) (referred to as design review in gamp 4) or traceability analysis, however, may be performed at various stages of a project.\n\ncompanies should consider developing documentation for the less complex systems in such a manner that a system can be purchased and validated rapidly. the validation of low complexity systems may be accomplished by creating a master set of documentation and templates or forms that can be completed for each newly purchased system.\n\nprocedural controls should be established such that they may be leveraged across systems where possible. for example, change control, periodic review, or continuity planning standard operating procedures (sops) may be written to be applicable to all systems.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "d27fbbe8-b6a3-4f68-a1ff-99bde7cf82a5": {"__data__": {"id_": "d27fbbe8-b6a3-4f68-a1ff-99bde7cf82a5", "embedding": null, "metadata": {"page_label": "11", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation and System SOPs Framework: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the key components of a comprehensive validation plan for laboratory computerized systems as outlined in the ISPE Validation of Laboratory Computerized Systems 2005 guide?\n\n2. How does the ISPE 2005 guide categorize the essential Standard Operating Procedures (SOPs) necessary for the effective management and operation of laboratory computerized systems?\n\n3. What specific stages of software development and system validation does the ISPE 2005 guide recommend for ensuring the integrity and functionality of laboratory computerized systems, including both the development and operational phases?", "prev_section_summary": "The section discusses the validation of laboratory computerized systems based on their complexity categories, with a focus on the documentation and procedural controls recommended by the ISPE 2005 guide. It outlines the differences between systems requiring a Software Development Life Cycle (SDLC) or a Supplier Integrated Life Cycle (SILC) based on complexity levels. The importance of maintaining the validated state of systems, regardless of complexity, is emphasized, along with the use of master sets of documentation and templates for rapid procurement and validation of low complexity systems. Procedural controls such as change control and standard operating procedures are also highlighted as essential for maintaining validated systems.", "excerpt_keywords": "Validation, Laboratory Computerized Systems, ISPE, Standard Operating Procedures, Software Development Life Cycle"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n|validation deliverables|\n|---|\n|validation plan|validation plan|validation plan|validation plan|validation plan|\n|requirements specification|requirements specification|requirements specification|requirements specification|user requirements|user requirements|\n|risk|risk|risk|risk|risk|risk|\n|supplier assessment|supplier assessment|supplier assessment|supplier assessment|supplier assessment|supplier assessment|\n|detailed design specification|detailed design specification|code development|code review|unit and integration testing|unit and integration testing|\n|design/installation qualification|design/installation qualification|design/installation qualification|design/installation qualification|design/installation qualification|design/installation qualification|\n|calibration/performance qualification|calibration/performance qualification|operational/performance qualification|operational/performance qualification|operational/performance qualification|operational/performance qualification|\n|traceability|traceability|traceability|traceability|traceability|traceability|\n|validation report|validation report|validation report|validation report|validation report|validation report|\n\n|system sops|\n|---|\n|use sops|use sops|use sops|use sops|use sops|use sops|\n|change control|change control|change control|change control|change control|change control|\n|back-up, restore and archival sops|back-up, restore and archival sops|back-up, restore and archival sops|back-up, restore and archival sops|back-up, restore and archival sops|back-up, restore and archival sops|\n|security system administration|security system administration|security system administration|security system administration|security system administration|security system administration|\n|business continuity plan|business continuity plan|business continuity plan|business continuity plan|business continuity plan|business continuity plan|\n|training|training|training|training|training|training|\n|maintenance and use logs|maintenance and use logs|maintenance and use logs|maintenance and use logs|maintenance and use logs|maintenance and use logs|\n|problem reporting|problem reporting|problem reporting|problem reporting|problem reporting|problem reporting|\n|periodic review|periodic review|periodic review|periodic review|periodic review|periodic review|\n|retirement|retirement|retirement|retirement|retirement|retirement|", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "19b96856-be21-4bba-882a-c342cd9d3488": {"__data__": {"id_": "19b96856-be21-4bba-882a-c342cd9d3488", "embedding": null, "metadata": {"page_label": "12", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Laboratory Computerized Systems Requirements and Traceability Guidelines", "questions_this_excerpt_can_answer": "1. How does the complexity of laboratory computerized systems influence the requirements documents, particularly in terms of data handling and security features?\n   \n2. What are the key differences between User Requirements Specifications (URS) and Functional Specifications (FS) in the context of laboratory computerized systems, and how does the integration of these documents vary across system categories?\n\n3. What strategies are recommended for defining the requirements of simple laboratory computerized systems (categories A through E) to ensure they are tested appropriately based on their intended use and the functions that will be utilized?", "prev_section_summary": "The section discusses the key components of a comprehensive validation plan for laboratory computerized systems as outlined in the ISPE Validation of Laboratory Computerized Systems 2005 guide. It categorizes essential Standard Operating Procedures (SOPs) necessary for effective management and operation of laboratory computerized systems. The section also outlines specific stages of software development and system validation recommended by the ISPE 2005 guide to ensure the integrity and functionality of laboratory computerized systems, including development and operational phases. Key topics include validation deliverables such as validation plan, requirements specification, risk assessment, supplier assessment, design and installation qualification, calibration and performance qualification, traceability, and validation report. Additionally, system SOPs discussed include use SOPs, change control, back-up, restore and archival SOPs, security system administration, business continuity plan, training, maintenance and use logs, problem reporting, periodic review, and retirement.", "excerpt_keywords": "Laboratory Computerized Systems, Requirements, Traceability, User Requirements Specification, Functional Specification"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## specifications and traceability\n\nsystems with greater technical complexity will have greater available functionality and the requirements documents will reflect this complexity. for example, systems in category d have data storage capabilities. laboratory computerized systems in categories d through f (and in some cases category g) will have requirements for data handling, data storage, data security, data backup and possibly electronic records (if regulated by 21 cfr part 11 or other applicable regulations).\n\n### user requirements specification\n\nuser requirements specifications (urss) should be generated for all laboratory computerized systems. the requirements should include both the hardware and software functions. in addition to functional needs, the requirements should include any specific technical or procedural controls that may be required by applicable gxp or other regulations. the requirements should address:\n\n- which controls will not be used and the justification for not using those controls\n- any procedural controls that will be used to address those needed, but not supported by the system\n\nthe urs focuses on what the user wants the system to do, whereas the functional specification (fs) describes how the system will function from a technical perspective and what functions the system provides. the fs for purchased systems is usually derived from a combination of specific laboratory requirements and information obtained from the supplier. care should be taken when reviewing supplier-provided manuals to ensure that errors in manuals do not result in errors in specifications. for simple purchased systems, laboratory computerized system categories a through e, the user requirements specification, and fs may be merged into a single document: the requirements specification (rs).\n\nclear, unambiguous requirements are essential to the ability to deliver a validated system that meets the users intended needs. the rs should capture all the necessary elements, functions, inputs, processes, and outputs of the system. the rs should describe what the system should do, based solely on the intended use of the system. the requirements are usually stated in a manner that is independent of hardware and software.\n\nfor less technically complex systems (categories a through e), it is usually not necessary to develop technology-independent requirements due to the limited number of suppliers and the commercial nature of the products. additionally, for the least complex systems (categories a and b), a separate requirements document need not be generated if the information is contained elsewhere, such as in purchasing documentation.\n\nthe challenge in the development of requirements for simple laboratory computerized systems (categories a through e) is not in the development of a list of required functionality; those functions are generally identified during the project initiation as part of the purchasing process. the challenge becomes to define from the full list of functions of the system, those functions available in the system that will be used and, therefore, should be tested as opposed to the functions that will not be used and not normally tested, unless the need for testing is indicated by an assessment of risk and potential impact of inadvertent use.\n\nif the system does not provide the capability to inactivate the functions that will not be used, procedural controls should be instituted.\n\nthe process of defining requirements for a simple system should include the systems functions and an assessment of the use of each function. this documented verification that the system is suitable for the intended purpose forms the systems dq.\n\nfor all systems, the development of the requirements should define the intended limits of operation for the equipment and intended use in the specific laboratory. for example, an hplc pump that is capable of delivering fluids at speeds between 0 and 20 ml/min may never need to be used at the upper range. the system should not be considered unusable if the pump cannot be verified to operate at that upper range, if it was only intended to operate between 1-5 ml/min.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "012ddb71-634e-488d-9ac9-581ea444c0b7": {"__data__": {"id_": "012ddb71-634e-488d-9ac9-581ea444c0b7", "embedding": null, "metadata": {"page_label": "13", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation of Laboratory Computerized Systems: Design Specifications and Documentation", "questions_this_excerpt_can_answer": "1. What specific documentation is recommended for inclusion in the system validation packages for in-house developed systems and customized off-the-shelf systems according to the ISPE Validation of Laboratory Computerized Systems 2005 guide?\n\n2. How does the ISPE Validation of Laboratory Computerized Systems 2005 guide suggest handling updates to design specifications throughout the full life cycle of a computerized system to ensure compliance with regulatory expectations and company policies?\n\n3. What are the key components and considerations outlined in the detailed design specification section of the ISPE Validation of Laboratory Computerized Systems 2005 guide for creating a system that meets both the functional specifications and user requirements specifications?", "prev_section_summary": "The section discusses the requirements and traceability guidelines for laboratory computerized systems, particularly focusing on the complexity of systems and the documents needed for validation. It explains the differences between User Requirements Specifications (URS) and Functional Specifications (FS) and how they are integrated across system categories. The importance of clear and unambiguous requirements, as well as the need for defining the intended use and functions of simple laboratory computerized systems, is emphasized. The section also highlights the process of developing requirements, assessing the use of system functions, and ensuring the system is suitable for its intended purpose. Additionally, it mentions the need for procedural controls if certain functions will not be used and the importance of defining the limits of operation for equipment.", "excerpt_keywords": "ISPE, Validation, Laboratory Computerized Systems, Design Specifications, Documentation"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## gamp good practice guide: validation of laboratory computerized systems\n\ndocumentation required upon delivery, e.g., manuals, certifications\n\nany other applicable requirements\n\nthe design specifications are the responsibility of the developer or supplier. purchasers of off-the-shelf systems are not expected to recreate design documentation. moreover, supplier-developed design documents are not usually available for distribution to purchasers. for complex systems with high business impact, however, the design specification should be reviewed during on-site supplier audits. system validation packages for in-house developed systems and customized off-the-shelf systems (categories f and g) should include design specifications for the customized portions.\n\nscope\npurpose\ndescription of pe system\nconcept of operation\nuser description\napprovals\nrevision history\n\nthe design specifications should be completed and approved after the urs and fs or rs are completed and approved. the authors are typically developers or implementers. knowledgeable users and system owners should review the document. approvers may include system administrators, developers, database administrators, system engineers, and the project leader. reviewers and approvers should be defined by an organizations policies, standards, and international regulations. the document should be approved before development commences.\n\nthe design specifications should be kept up-to-date throughout the full life cycle of the system. approved updates should be made using a document change control process as described above for requirements documents.\n\nthe design specification details all aspects of the system as defined in the user requirements specification and ps or rs. design specifications should also be written to describe individual modules that trace to specific and related user requirements. the design specifications should be organized by subsystem (e.g., reports, inputs, and database).\n\nfor systems in category g, the requirements document should be approved before system development activities commence. if using rapid application development (rad) or prototyping, the requirements should be finalized before starting validation testing. for systems in category f, the system may consist of an existing core product onto which custom configured functionality is added. in these systems, the requirements for the customizations should be finalized prior to their development. approvers should include the system owner, but typically include the system owner, project manager, qa representative, system administrator, and others as defined by company policies and standards. the qa representative signs to indicate that the requirements document complies with regulatory expectations and company policies and standards.\n\nrequirements documentation should be viewed as dynamic. approved updates can be made during the system development process and during the life of the system. requirements documentation should reflect the current system, so it is crucial to review this document during the change control process. before system acceptance, all approved changes should be captured in versions that are tracked through a revision table in the document. after system acceptance, all changes continue to be tracked within the document, but should also be linked to a system change control process. changes to the requirements should be traceable to the corresponding changes in the fs, design specification (if applicable), and testing documents.\n\nfurther guidance on the production of urss is provided in appendix d1 of gamp 4.\n\n## detailed design specification\n\nthe detailed design specifications are the blueprint to create a system that meets the fs and therefore the user requirements specification. the hardware design specification, software design specification, and the instrument specification together address the fs. as with the requirements, the complexity and size of design documentation should be proportional to that of the systems being developed.\n\nsystem architecture\n\nsystem and data flow diagrams\n\nmodule design (e.g., for each object/worksheet):\n\n- functional description\n- inputs, outputs\n- user interface\n- processing logic\n- communication/interfaces with other components\n- processes\n- user interface - screen and window design\n- report layout\n- module hierarchy (e.g., relationships of worksheets, workbooks, macros, methods, objects)\n- data storage requirements\n- error handling conventions\n- system limitations and expandability", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "ed403e01-086a-482e-ba6d-7069b6e5235d": {"__data__": {"id_": "ed403e01-086a-482e-ba6d-7069b6e5235d", "embedding": null, "metadata": {"page_label": "14", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation and Risk Management for Laboratory Computerized Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the complexity of a laboratory computerized system influence the components included in its traceability matrix, and what specific elements are added as the system's complexity increases from categories A to G?\n\n2. What are the key components and information that should be included in the design specification documents for laboratory computerized systems, and how do these components contribute to the development process?\n\n3. Based on the guide's approach to risk management for laboratory computerized systems, how should an organization balance the risks to data integrity and business continuity, and what adjustments might be necessary if an organization prioritizes one over the other?", "prev_section_summary": "The section discusses the documentation required for the validation of laboratory computerized systems, including design specifications for in-house developed systems and customized off-the-shelf systems. It outlines the key components of design specifications, such as scope, purpose, system description, concept of operation, user description, approvals, and revision history. The section emphasizes the importance of keeping design specifications up-to-date throughout the system's life cycle and outlines the process for making approved updates. Additionally, it provides guidance on the detailed design specification, including system architecture, system and data flow diagrams, module design elements, and error handling conventions. The section highlights the importance of aligning the detailed design specifications with the user requirements specification to create a system that meets functional and user requirements.", "excerpt_keywords": "Validation, Risk Management, Laboratory Computerized Systems, Traceability Matrix, Design Specifications"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## validation of laboratory computerized systems\n\nproduction environment:\nphysical configuration\nhardware environment\nsoftware environment\nsafety and environment\nsecurity\n\nthe complexity of the traceability matrix is proportional to the complexity of the system. categories a through c may only be able to trace from the urs straight through to the test reference. as the complexity of the system increases to categories d and e, fs may enter the traceability matrix, and for categories f and g, design specifications will need to be traceable. all requirements should be listed, and requirements not met by the system should reference the means by which the requirement will be fulfilled, such as an sop providing a procedural control. in the event that a requirement cannot be successfully met, an explanation describing the impact on the systems acceptability for use should be provided.\n\nthe traceability matrix should be started in parallel with the urs and should be updated throughout the life cycle of the system in conjunction with the document change control process. the authors are typically developers or implementers. the matrix should be kept current throughout the entire life cycle of the system.\n\nthe design specification document(s) should include approvals, revision history, and a table of contents. components of the document(s) may include (but are not limited to): introduction, scope, overview, general design, design decisions (e.g., regulatory, security), technical standards (e.g., format for code, comment/documentation) and description of the development environment.\n\na successful set of detailed design specifications will provide a sufficiently knowledgeable developer with all the instructions necessary to build the system.\n\nrisk management model\n\nthe extent and rigor of validation of laboratory computerized systems used in a regulated environment should be commensurate with the risks to data integrity, product quality and patient safety. there are multiple dimensions of risk that can be assessed, but the focus should be on the risk to data integrity and the risk to business continuity. this guide assumes that these two factors are of equal importance. if an organization does not consider these two factors equal, all tables may need to be adjusted to reflect the different perspective. it is up to individual organizations to evaluate and determine their individual business risk tolerance.\n\n### traceability\n\ntraceability is the establishment of the relationship between two or more products of the development process, and supports the ability to locate the critical validation evidence for any feature of a system. for example, if a system supports the ability to locate the critical validation evidence for any feature of a system. for example, if a system is required to print a report, a reviewer should be able to locate easily the specification, design, and testing documentation for the function of printing that report.\n\ntraceability should be maintained between urs and/or fs, system design specification (if available), and testing documentation. required documentation will depend upon the laboratory computerized system categorization. traceability is best achieved using a traceability matrix, which is a tabular method of recording the relationships. the matrix typically consists of the following columns:\n\n|rs|urs (preferably identified by a reference number)|\n|---|---|\n| |user requirements brief description (optional)|\n| |ps reference (if applicable to categories a through g)|\n| |detailed design specification reference (if custom developed or custom modified, e.g., categories f and g)|\n| |test or verification reference (e.g., test script, iq, operational qualification (oq), pq)|\n| |comments (optional)|\n\nthis section describes an approach to manage risk for laboratory computerized systems of varying impact, size, and complexity. note, however, that a risk-free environment, process, or system is not attainable. the following terms are used in this section, based on terminology and concepts defined in iso 14971 medical devices - application of risk management to medical devices (see appendix 5, reference 4):\n\n- harm: physical injury or damage to the health of people, or damage to property or the environment\n- hazard: potential source of harm", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "bca9bc48-c43b-43ba-a773-ae3fbfe0e089": {"__data__": {"id_": "bca9bc48-c43b-43ba-a773-ae3fbfe0e089", "embedding": null, "metadata": {"page_label": "15", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Risk Management in Laboratory Computerized Systems Validation: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the ISPE Validation of Laboratory Computerized Systems 2005 guide categorize the impact of different types of systems on data integrity, product quality, or patient safety?\n   \n2. What is the modified ISO 14971 definition of risk evaluation as presented in the ISPE Validation of Laboratory Computerized Systems 2005 guide, and how does it relate to the process of risk management in laboratory computerized system validation?\n\n3. According to the ISPE Validation of Laboratory Computerized Systems 2005 guide, what are the steps involved in applying risk management principles during the validation activities of a newly purchased system following an SDLC or SLLC path, and how do these steps relate to maintaining the validated state of the system based on its complexity?", "prev_section_summary": "The section discusses the validation of laboratory computerized systems, including the components of the traceability matrix, design specification documents, and risk management model. It emphasizes the importance of maintaining traceability between user requirements, system design specifications, and testing documentation. The section also introduces a risk management approach based on ISO 14971 terminology, focusing on risks to data integrity and business continuity. Key topics include traceability, risk assessment, and the components of design specifications for laboratory computerized systems.", "excerpt_keywords": "ISPE, Validation, Laboratory Computerized Systems, Risk Management, ISO 14971"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## validation of laboratory computerized systems\n\nimpact: measure of the possible consequences of loss or corruption of a system. gamp philosophy is to establish the impact for different types of systems as one of high impact, medium impact, or low impact.\n\n- high impact systems or functions typically have a direct impact on data integrity, product quality, or patient safety.\n- medium impact systems or functions typically have an indirect impact on data integrity, product quality, or patient safety.\n- low impact system or functions typically have negligible impact on data integrity, product quality, or patient safety.\n\nrisk: combination of the probability of occurrence of harm and the severity of that harm.\n\nrisk assessment: overall process comprising a risk analysis and a risk evaluation:\n\n- risk analysis: systematic use of available information to identify hazards and to estimate the risk.\n- risk evaluation: judgment, on the basis of risk analysis, of whether a risk which is acceptable has been achieved in a given context. (iso 14971 definition modified by gamp)\n\nrisk control: process through which decisions are reached and protective measures are implemented for reducing risks to, or maintaining risks within, specified levels.\n\nrisk management: systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, and controlling risk.\n\nseverity: measure of the possible consequences of a hazard.\n\nrisk management is a process rather than a single event. figure 5.1 shows the validation activities for a newly purchased system following an sdlc or sllc path, and the stages of that process where principles of risk management should be applied and the elements (system or functional risk assessments) to be addressed.\n\nfigure 5.2 shows the risk management process, as it would be experienced during a project, and its relationship to the iso 14971 model.\n\nstep 1\n\nstep 2\n\nstep 3\n\nstep 4\n\nstep 5\n\ngood practice refers to the elements of validation and the procedures important for maintaining the validated state based upon the complexity of the system as described within table 3.1 and table 3.2 of this guide.\n\nin addition to good practice.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "8558ccdc-cc4a-4206-b11b-b26b360525a7": {"__data__": {"id_": "8558ccdc-cc4a-4206-b11b-b26b360525a7", "embedding": null, "metadata": {"page_label": "16", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Comprehensive Risk Management Approach for Laboratory Computerized Systems Validation", "questions_this_excerpt_can_answer": "1. What is the step-by-step risk management approach recommended by the ISPE Validation of Laboratory Computerized Systems 2005 for assessing and managing risks associated with laboratory computerized systems?\n\n2. How does the ISPE guide categorize laboratory computerized systems based on their impact, and what specific approaches does it recommend for systems identified as low, medium, and high impact in terms of validation and risk management?\n\n3. What criteria and methodological approach does the ISPE Validation of Laboratory Computerized Systems 2005 guide suggest for determining the system impact during the validation process of laboratory computerized systems, including considerations for business risk, GxP risk, and system categorization?", "prev_section_summary": "The section discusses risk management in laboratory computerized systems validation, including the impact of different types of systems on data integrity, product quality, and patient safety. It defines terms such as impact, risk, risk assessment, risk control, and severity. The section outlines the steps involved in applying risk management principles during the validation activities of a newly purchased system following an SDLC or SLLC path. It emphasizes the importance of good practice in maintaining the validated state of the system based on its complexity. The section also includes figures illustrating the risk management process and its relationship to the ISO 14971 model.", "excerpt_keywords": "Laboratory Computerized Systems, Risk Management, Validation, Impact Assessment, GxP"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## validation of laboratory computerized systems\n\nsubsequent sub-sections provide more detailed guidance on each of the steps shown in figure 5.2:\n\n|step 1:|determine laboratory system categorization|\n|---|---|\n|step 2:|assess system impact|\n|step 3:|assess risks based upon system impact|\n|step 4:|implement and test controls to manage identified risks|\n|step 5:|monitor effectiveness of controls during operation|\n\nthis risk management approach provides an organization with the tools to determine the impact of laboratory computerized systems throughout its entire organization as well as evaluating the amount of testing of individual requirements to mitigate risk to system data integrity. in particular, it should allow the organization to determine whether the risk to data integrity is acceptable or if mitigation strategies are required. possible responses to the risk assessment may include changes to the project scope and resource, changes in the technology used to meet the requirements, reassessment of a suitable supplier, or changes in the design of the system, process, or product.\n\n### approach for systems identified as low impact\n\ntypically, these will be very simple systems, with limited functionality. all the functionality provided by the supplier will typically be used, thus there is no need to analyze the functionality further. the procedures to validate these systems have been defined in table 3.1 and table 3.2 of this guide. these systems will follow the procedures described as good practice and addressed in step 4.\n\n### approach for systems identified as medium impact\n\nfor medium impact systems, in addition to good practice, individual or grouped requirements or functionality should be considered and appropriate controls selected. where substantially less than the provided functionality is used, a functional risk assessment for individual or grouped requirements may be appropriate. possible controls to apply to medium impact systems are described and discussed in step 4.\n\n### approach for systems identified as high impact\n\nin addition to the implementation of good practice, high impact systems should be subject to functional risk assessment as part of the overall risk management approach. an example of a rigorous risk assessment process is described in appendix m3, guideline for risk assessment of gamp 4.\n\n## step 1: determine laboratory computerized system categorization\n\nthe first step is to determine the system categorization and based on this select the life cycle, silc, or sdlc. discussions of laboratory categorization provide those responsible for validation with an objective tool to identify system complexity and issues related to data integrity, product quality, and patient safety. this analysis requires defined user requirements covering the intended use of the system.\n\n## step 2: assess system impact\n\nimpact assessment allows the selection of the appropriate approach to risk management for the system. the conclusions of the impact assessment should be documented. systems should be classified as one of high, medium, or low impact, based upon consideration of the systems business risk, the systems gxp risk, and the laboratory computerized systems categorization.\n\nappendix 1 of this guide provides a methodical approach to determining the system impact, taking into account business risk, gxp risk, and the system categorization. it is also recognized that organizations may apply different methods to determining system impact, consistent with their policies and ways of working.\n\n## step 3: assess risks based upon system impact\n\nthis step involves analyzing and evaluating risks to decide if any controls are required to manage those risks. the risk management approach is scalable, becoming increasingly more rigorous with greater impact. for example, functional risk assessments may be performed. the user requirements specification should be under change control at this stage. the more complex the system, the more likely the functions implemented to meet evolving requirements are likely to be released in later stages of the systems life cycle, therefore the assessment of relative risk may need to be an iterative process.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "0555aa57-19b0-4606-adf7-ad54a4fb6e1c": {"__data__": {"id_": "0555aa57-19b0-4606-adf7-ad54a4fb6e1c", "embedding": null, "metadata": {"page_label": "17", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Assessment of Hazards to System Functions and Criticality: A Comprehensive Analysis", "questions_this_excerpt_can_answer": "1. What specific types of hazards are identified in the ISPE Validation of Laboratory Computerized Systems 2005 document for laboratory computerized systems, and what are their potential consequences on system and data integrity?\n\n2. How does the document suggest an organization should approach the assessment of the criticality of individual or grouped requirements and the probability of detection of failure of a function within laboratory computerized systems?\n\n3. According to the ISPE Validation of Laboratory Computerized Systems 2005 document, what factors should be considered when evaluating hazards to functions of laboratory computerized systems, and how should these considerations influence the documentation and assessment processes within an organization?", "prev_section_summary": "The section discusses the comprehensive risk management approach recommended by the ISPE Validation of Laboratory Computerized Systems 2005 for assessing and managing risks associated with laboratory computerized systems. It outlines a step-by-step process including determining system categorization, assessing system impact, assessing risks based on impact, implementing controls, and monitoring effectiveness. The guide categorizes systems based on impact as low, medium, or high, with specific approaches recommended for each category. It also provides a methodical approach for determining system impact, considering business risk, GxP risk, and system categorization. The section emphasizes the importance of risk assessment and control implementation to ensure data integrity, product quality, and patient safety in laboratory computerized systems validation.", "excerpt_keywords": "ISPE, Validation, Laboratory, Computerized Systems, Risk Management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n|hazard|consequence|\n|---|---|\n|physical/environmental| |\n|power surge|loss of system and/or data integrity|\n|power failure|loss of system and/or data integrity|\n|water damage|loss of system and/or data integrity|\n|fire damage|loss of system and/or data integrity|\n|loss of a system component|loss of system and/or data integrity|\n|computer-related| |\n|hardware undersized|inability to run software|\n|hardware loss|loss of system and data integrity|\n|software fails or stops|inability to meet testing commitments|\n|software deleted|inability to meet testing commitments|\n| |inability to view historical data|\n|loss of connectivity|none to loss of access to data and software|\n|human-related (accidental or deliberate)| |\n|operator error|varies from loss of data integrity to business inefficiencies|\n|inaccurate sop|varies from loss of data integrity to business inefficiencies|\n|unauthorized change|loss of data integrity|\n|undetectable change|loss of data integrity|\n|incorrect access rights|loss of data integrity|\n\nfactors to consider when considering hazards to functions include:\n\n- importance of the function\n- relationship to gxp requirements\n- frequency of use of the function\n- novelty and complexity of the function\n- number of users using the function\n\nthe user organization should define and document the criteria used to assess both the criticality of individual or grouped requirements and the probability of detection of failure of a function. these criteria should be established and documented at a corporate level to allow an organization to assess the functionality within systems of varying complexity based on the same scale.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "1472ff90-0ed0-4bec-8955-e87885514846": {"__data__": {"id_": "1472ff90-0ed0-4bec-8955-e87885514846", "embedding": null, "metadata": {"page_label": "18", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation and Monitoring of Laboratory Computerized Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the core elements of good practice procedures recommended for the validation of laboratory computerized systems, regardless of the system's complexity, as outlined in the ISPE Validation of Laboratory Computerized Systems 2005 guide?\n\n2. How does the ISPE Validation of Laboratory Computerized Systems 2005 guide suggest organizations should monitor the effectiveness of controls for laboratory computerized systems during operation, especially in terms of change control activities and periodic reviews?\n\n3. According to the ISPE Validation of Laboratory Computerized Systems 2005 guide, what factors should be considered when determining the extent of supplier assessment for laboratory computerized systems, and how does the categorization of the system impact this assessment?", "prev_section_summary": "The section discusses the assessment of hazards to system functions and criticality in laboratory computerized systems. It identifies specific types of hazards such as physical/environmental, computer-related, and human-related, along with their potential consequences on system and data integrity. The document suggests considering factors like the importance of the function, relationship to GxP requirements, frequency of use, novelty, complexity, and number of users when evaluating hazards. It also recommends defining and documenting criteria for assessing the criticality of requirements and the probability of detecting function failures at a corporate level to ensure consistency across systems of varying complexity.", "excerpt_keywords": "Validation, Laboratory Computerized Systems, ISPE, Good Practice Procedures, Supplier Assessment"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## validation of laboratory computerized systems\n\napproach for systems identified as low impact\n\ngood practice refers to the elements of validation and the procedures important for maintaining the validated state based upon the complexity of the system as shown in table 3.1 and table 3.2 of this guide. these tables show that there is a core set of documentation and procedures that are necessary for a system regardless of the system complexity, and are considered the good practice procedures.\n\nelements of good practice include:\n\n- use sops\n- change control\n- business continuity\n- training\n- maintenance and use logs\n- problem reporting\n- periodic review\n- retirement\n- validation deliverables\n- requirements specifications\n- design qualification/installation qualification\n- traceability\n- validation report\n\nindividual organizations should evaluate the extent and rigor of application of these elements in light of their corporate policies and risk tolerance.\n\napproach for systems identified as medium or high impact\n\nsystems identified as medium or high impact would require those elements defined as good practice procedures plus those additional elements identified based upon the laboratory system categorization. those procedures necessary to maintain the system in a validated state are defined within table 3.2. based upon the laboratory system categorization, the appropriate procedures should be established to ensure the system is controlled.\n\nstep 5: monitor effectiveness of controls during operation\n\nduring change control activities, periodic review of systems or at other suitable defined stages, the company should review the risks to systems. it should be verified that controls established during system development or implementation and validation are still effective. the company should consider:\n\n- the criticality of the system\n- the risks to data integrity associated with use of the system\n- the ability to verify system functionality within the laboratory\n\nit is recommended that the laboratory systems categorization, in conjunction with the business impact of the system, be used to determine the need for and the extent of supplier assessment.\n\nother factors to consider when determining the extent of supplier assessment include:\n\n- maturity of the product\n- the history of the use of the supplier within a regulated industry\n- existing knowledge of the supplier\n- knowledge of the suppliers quality management practices\n- period of time since previous assessment\n- results from previous assessments\n- complexity", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "c7e720eb-8516-48fb-bad6-41f39cf1b7dc": {"__data__": {"id_": "c7e720eb-8516-48fb-bad6-41f39cf1b7dc", "embedding": null, "metadata": {"page_label": "19", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Comprehensive Project Management Guide: Planning, Supplier Assessments, and System Validation", "questions_this_excerpt_can_answer": "1. How does the ISPE Validation of Laboratory Computerized Systems 2005 guide suggest managing changes to the project plan during the early phases of a project, and what is the significance of documenting these changes?\n   \n2. What criteria does the ISPE Validation of Laboratory Computerized Systems 2005 guide recommend for deciding when a project plan is necessary based on the categorization of computerized systems (categories A through G), and how does the complexity and scale of the system influence this decision?\n\n3. According to the ISPE Validation of Laboratory Computerized Systems 2005 guide, how can supplier assessments reduce the extent of in-house testing and technical reviews during the validation process, and under what conditions might additional activities be integrated into the validation plan based on the outcomes of these assessments?", "prev_section_summary": "The section discusses the validation of laboratory computerized systems, outlining good practice procedures for systems of varying complexity. It emphasizes the core elements of validation, such as SOPs, change control, training, and periodic review. The guide suggests monitoring the effectiveness of controls during operation, considering factors like system criticality and data integrity risks. It also highlights the importance of supplier assessment based on factors like product maturity, supplier history, and quality management practices. The section provides a comprehensive approach for maintaining the validated state of laboratory computerized systems.", "excerpt_keywords": "project planning, supplier assessments, validation, laboratory computerized systems, ISPE"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## project planning and initiation\n\nfollowing the determination that a system is required, and the drafting of the user requirements, the next phase of a project is the project planning and initiation phase. the need for a project plan depends upon the nature of the system, the scale and scope of the project, and how many people will be involved in the development or implementation and the validation. during this phase, the project is analyzed, resources allocated and the scope of the project clearly defined. the project planning process is a valuable tool to help anticipate issues that may need to be addressed to successfully complete the system development and/or implementation. the preparation required to generate the plan often provides valuable information.\n\nplanning allows management to anticipate and provide for the needs of the project, and establish a baseline against which to track progress. maintaining control of a project not only affects its economics, but ultimately its validation status. if, for example, a project should get into financial difficulties, it is possible to reduce the scope and cut functionality in an attempt to finish on time and within budget. if functionality is cut too severely, the finished system may fall so short of the original user requirements as to be unfit for its intended use. early in a project, the project plan can be expected to undergo frequent revision, but it is still important to document the plan to provide a baseline against which planning for validation can take place and project resources can begin to be identified and retained.\n\nproject plans may be incorporated into the validation plans for less complex projects. if the project plan is produced separately, it should explicitly provide for the activities and deliverables that will be managed under the validation plan. validation deliverables should only be featured in one of the documents and where necessary cross-referenced.\n\n## supplier assessments\n\nsupplier assessments offer the most value when performed pre-purchase. the assessment produces information for the company to use when deciding whether to purchase the system and may enable a supplier with a well-documented quality management system to be leveraged. supplier assessments complement, and may be able to reduce, the in-house testing program and the extent of other technical reviews that take place as part of validation when it can be verified that the supplier has performed the necessary comprehensive testing. they cannot, however, eliminate the need for these activities.\n\nin some cases, if the assessment indicates gaps in the suppliers quality system or poor compliance to established processes, these deficiencies can be remedied by building other activities (e.g., technical reviews or additional testing) into the validation plan. on the other hand, the assessment might indicate that the supplier has done extensive and well-documented system testing, which may justify reduced testing by the client in the oq or pq phases of qualification.\n\nsupplier assessments should be part of an ongoing process of discovery and improvement that forms the basis for a good supplier-client relationship. depending upon the criticality and complexity of the system, it may be appropriate to conduct supplier assessments throughout the system development or implementation life cycle and may include system implementers, as well as the supplier if not one and the same.\n\n## validation of laboratory computerized systems\n\nfor systems in categories a and b, a project plan will not usually be required as the time and resources required to deploy the systems will be limited. for the implementation of systems categorized as categories c, d, or e, developing and following a project plan may be an important tool for keeping large scale or multiple implementations on track, but will not normally be warranted. the implementation of large, complex systems (category f or category g) usually requires a project plan. the need for the plan in these cases is justified by the fact that new software or a new configuration of a highly flexible application development environment is being undertaken, which usually affects a large number of users and requires extensive resource planning and management.\n\nsimple, custom statistical analysis software code, laboratory spreadsheets, or databases though also categorized as category f or category g, would probably not require project plans unless they are large complex systems, because the number of users is normally somewhat limited, and the development and validation of these systems does not require extensive resources.\n\nproject planning has many benefits and purposes, but the key aspects of this activity are:\n\n- the project vision should be defined, including purpose, objectives, and anticipated benefit.\n- the scope and scale of the project should be defined including budget and schedule estimates, system deliverables and features, and staffing.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "4e2a1284-dfbd-4bcf-bc1e-5f399c764c37": {"__data__": {"id_": "4e2a1284-dfbd-4bcf-bc1e-5f399c764c37", "embedding": null, "metadata": {"page_label": "19", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Comprehensive Project Management Guide: Planning, Supplier Assessments, and System Validation", "questions_this_excerpt_can_answer": "1. What are the key components that should be included in the initial project plan for the validation of laboratory computerized systems according to the ISPE 2005 guidelines?\n   \n2. How does the ISPE 2005 guide suggest ensuring effective communication and problem resolution within project teams involved in the validation of laboratory computerized systems?\n\n3. What specific roles and organizational structures does the ISPE 2005 document recommend for project teams tasked with the validation of laboratory computerized systems, and how does it propose to monitor project progress and return on investment?", "prev_section_summary": "The section discusses project planning and initiation, supplier assessments, and validation of laboratory computerized systems according to the ISPE Validation of Laboratory Computerized Systems 2005 guide. Key topics include the importance of project planning in anticipating issues, managing resources, and establishing a baseline for progress tracking. Supplier assessments are highlighted as valuable for decision-making in system purchases and reducing in-house testing. The categorization of computerized systems (categories A through G) is discussed in relation to the need for project plans based on complexity and scale. The section emphasizes the significance of documenting changes to the project plan and integrating additional activities based on supplier assessments.", "excerpt_keywords": "ISPE, Validation, Laboratory, Computerized Systems, Project Management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\nthe initial project plan should make it clear that budget, resource, and schedule figures are estimates that will be refined as more is learned about project requirements.\n- sponsorship of the project should be identified. many projects fail for lack of sponsorship at the appropriate levels in an organization.\n- project team organization, and roles and responsibilities should be defined and described.\n- resource requirements and the effective deployment of project personnel should be addressed. resource planning should strive to enhance team members competencies (either by providing additional depth or breadth) through project responsibilities.\n- project communication plans should be included. it is important to ensure that progress, status, and issues are highly visible to enable team members and management to address problems promptly.\n- management and control of work products and corresponding documentation should be addressed. the successful control of project deliverables and the ability to retrieve documents is a critical success factor for validation projects.\n- project metrics and monitoring processes should be established. how will management know if the project is on track? how will costs and benefits be quantified and tracked to ensure a reasonable return on investment?\n\nfor any large-scale or complex project, the project team should develop the project plan. the project team should include:\n\nproject management\nsystem owner\nqa representatives\ndevelopment organization\nsystem engineering group", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "f75ee1a6-2e94-45e8-8aa0-f232405f0174": {"__data__": {"id_": "f75ee1a6-2e94-45e8-8aa0-f232405f0174", "embedding": null, "metadata": {"page_label": "20", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Comprehensive Validation Plan for Laboratory Computerized System", "questions_this_excerpt_can_answer": "1. What specific elements should be included in the scope section of a validation plan for a laboratory computerized system according to the ISPE guidelines from 2005?\n   \n2. How does the ISPE Validation of Laboratory Computerized Systems 2005 document recommend handling changes in validation plans, particularly in relation to change control and capturing procedure and activity changes?\n\n3. According to the 2005 ISPE guidelines, what is the recommended process for establishing validation roles and responsibilities within the team, and how should exceptions to standard roles be documented in the validation plan?", "prev_section_summary": "The section discusses key components that should be included in the initial project plan for the validation of laboratory computerized systems according to the ISPE 2005 guidelines. It emphasizes the importance of budget, resource, and schedule estimates, sponsorship, project team organization, resource planning, communication plans, management and control of work products, project metrics, and monitoring processes. The section also outlines the roles and responsibilities of project team members, including project management, system owner, QA representatives, development organization, and system engineering group. Effective communication, problem resolution, and monitoring of project progress and return on investment are highlighted as essential aspects of successful project management.", "excerpt_keywords": "Validation, Laboratory Computerized Systems, ISPE, Guidelines, Validation Plan"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## validation plan\n\nthe validation plan specifies the strategy, approach, responsibilities, activities, and deliverables for the overall validation effort of the laboratory computerized system throughout its life cycle. the validation plan should include:\n\n- scope: the validation plan should contain the scope and a definition of the project. within the scope section, there should be a discussion of the assumptions, exclusions, and limitations of the validation, to help set both the scope of the validation and any acceptance criteria.\n- system description: the validation plan should, if possible, contain a complete system description including hardware, software, and system diagram. in some cases, complete information is not available at this point in the planning process and the system description could then be produced as a separate deliverable or the validation plan updated as the information becomes available. the system description should also include an overview of how the system will be used and may contain a description of the boundaries of the system.\n- validation strategies: reference should be made to any applicable computerized system validation policies and procedures, management policies, procedures, or reference guidelines to be followed during the validation project. any exceptions from the established procedures, including deviations from the expected deliverables due to the specifics of the system being validated, should be described and explained. information about how change control and configuration management will be performed during validation should be provided.\n- responsibilities and team membership: the validation plan is the mechanism for establishing all necessary validation roles and responsibilities, based upon the selected validation methodology. specific functional areas should be assigned to the various roles. specific individuals may be assigned to specific roles if determined necessary. additional roles that may not be defined within the validation methodology or templates may also be included, if necessary. likewise, roles not required for a specific project do not need to be included. however, an explanation for not including the role should be added to the validation plan.\n- activities and deliverables: deliverables for the project should be specified and should include a description of the expected deliverables based upon the evaluation of the risk associated with the use of the system. the validation deliverables need to be listed and explained to ensure the completeness of the validation strategy.\n\nfurther guidance on project and quality planning is provided in appendix m6 of gamp 4.\n\nvalidation plan should be created contemporaneously with the finalization of the requirements specification of the system. it is important to create the validation plan in the early stages of the project to clearly identify the strategy and resources necessary for the validation effort. because the validation plan contains guidelines for the validation approach, the project manager should develop the plan with input from the developers, users, system support managers, and the sponsor. the involvement of qa is very important. appropriate levels of management should approve the validation plan to assure adequate support and sponsorship for the validation effort. the validation plan should be maintained under change control to capture all procedure and activity changes. the validation plan should include, or reference, all necessary information to follow the validation strategy and recommendations. approval requirements for the specific project should represent an agreement of management and the team to the validation strategy and requirements for the specific project.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "3d609d32-d9c1-4d16-a804-08c3be2c932d": {"__data__": {"id_": "3d609d32-d9c1-4d16-a804-08c3be2c932d", "embedding": null, "metadata": {"page_label": "21", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Best Practices for Validating and Coding Laboratory Computerized Systems", "questions_this_excerpt_can_answer": "1. What specific testing methodologies are recommended for Category F systems in laboratory computerized systems validation, considering their highly configurable nature and the potential inability to test code independently of the core software?\n\n2. How does the document suggest managing the coding and construction phase for proprietary configurable elements in Category F systems, including the approach to code review and change control procedures?\n\n3. What are the guidelines provided in the document for archiving validation documentation, and how does it relate to the guidance provided in appendix ML of GAMP 4 for validation planning?", "prev_section_summary": "The section discusses the elements that should be included in a validation plan for a laboratory computerized system according to ISPE guidelines from 2005. It covers the scope, system description, validation strategies, responsibilities and team membership, activities and deliverables, and the importance of creating the validation plan early in the project. It emphasizes the need for input from various stakeholders, approval from management, and maintaining the plan under change control to capture all procedure and activity changes. The section also mentions the importance of following validation strategy and recommendations, and ensuring agreement on the validation strategy and requirements for the specific project.", "excerpt_keywords": "Validation, Laboratory, Computerized Systems, Coding, Traceability"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## validation of laboratory computerized systems\n\ntraceability matrix: unless generic procedures are followed, the validation plan should include requirements for documenting the traceability of system requirements and specifications to the testing. category f systems are highly configurable and often include built-in customization capabilities. these customizations usually do not involve modification of the core code of the application. often the coding language may be proprietary to the software, and the code is normally not compiled. the core software acts as an interpreter for the customizations. in some cases, the code may be converted to a compressed format, similar to microsoft p-code, to facilitate interpretation. the individual \"modules\" may be very small, in some cases consisting of only a single line of code. depending upon the software, it may not be possible to test the code independently of the core software. therefore, unit and integration testing that is distinct from oq testing may not be possible. for category f systems, some configuration and oq testing of the core product related to the custom module functionality may be necessary before integration testing can be performed. some regression testing at the oq level may also be required after module integration. based upon the risk assessment of the urs items, more extensive oq testing may be warranted.\n\nrecord management: the validation plan should describe how and where the validation documentation should be archived. further guidance on validation planning is provided in appendix ml of gamp 4.\n\n## coding and construction\n\nas stated earlier, the traditional sdlc is not applicable for the implementation of systems in categories a through f as these are not custom systems. the traditional sdlc is applicable only to category g and new proprietary configurable elements for category f.\n\nany code development should be based upon documented and reviewed design specifications following established programming practices, and should include error recovery procedures. for category f, the design specifications for the proprietary configurable modules may be included within the fs. coding standards and file naming conventions should be referenced in the validation plan. all code and any command files for build management should be managed under change control procedures. the code should be reviewed for conformance to coding standards and the design specifications, in addition to clarity and ease of maintenance. this review should be performed by someone other than the person(s) writing the code. the results of the source code review should be documented. the procedure for code review should be referenced in the validation plan, though there may be a generic procedure. modules should be identified by versions, along with all the information needed for change history. module testing should not proceed until the review process is completed, and all issues are resolved and documented.\n\ninitially, coding units are built and tested. unit testing verifies that the individual units or software components conform to the requirements of the design specifications. these units are then assembled into modules which can be tested. integration testing can proceed after modules have been built and the integration test plans have been approved. remediation of any incidents or failures of unit testing, modular testing, or integration testing may require recoding and rebuilding of the units and should be documented. the code should be under change control. integration testing can proceed only after previous testing has been successfully completed. it verifies that the modules work together as required by the design specifications and traces to the fss. remediation of any incidents or failures in integration testing may require recoding and rebuilding of the modules and regression testing at the module level. as during unit and module testing, remediation activities should be documented and include formal change control on the code. system level and acceptance testing should be performed after integration testing has been successfully completed.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "f45ab542-d700-434d-a48c-e333d7d294c6": {"__data__": {"id_": "f45ab542-d700-434d-a48c-e333d7d294c6", "embedding": null, "metadata": {"page_label": "22", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation of Laboratory Computerized Systems: Testing Elements and Portability", "questions_this_excerpt_can_answer": "1. How does the Design Qualification (DQ) process, as outlined in the ISPE Validation of Laboratory Computerized Systems 2005 document, ensure that a system's design meets operational and regulatory expectations before proceeding to further qualification stages?\n\n2. In the context of the ISPE guidelines from 2005, what specific steps or documentation are recommended to verify the portability of laboratory computerized systems, especially those classified as Category A and B, to ensure they meet installation and operational standards after being moved?\n\n3. According to the 2005 ISPE Validation of Laboratory Computerized Systems guidelines, how does the Performance Qualification (PQ) process differ from the Operational Qualification (OQ) in terms of objectives, and what role does user acceptance testing play in the PQ stage?", "prev_section_summary": "The section discusses the validation of laboratory computerized systems, focusing on Category F systems that are highly configurable and may require unique testing methodologies. It emphasizes the importance of traceability, record management, coding, and construction practices for these systems. Key topics include the challenges of testing configurable elements, the need for proper documentation and archiving of validation documentation, coding standards, code review procedures, unit testing, integration testing, and system level testing. Entities mentioned include validation plan, traceability matrix, core software, customizations, coding language, code review, change control procedures, design specifications, coding standards, unit testing, integration testing, and acceptance testing.", "excerpt_keywords": "Validation, Laboratory, Computerized Systems, Testing, Portability"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## validation of laboratory computerized systems\n\n10.1 testing elements\n\ndesign qualification (dq)\n\nthe objective of the design qualification (dq), referred to as design review in gamp 4, is to provide a documented review of the design, at an appropriate stage in a project, for conformance to operational and regulatory expectations.\n\ninstallation qualification (iq)\n\nthe objective of the installation qualification (iq) is to provide documented evidence that the system is installed in accordance with engineering and supplier specifications. it also verifies that the installation satisfies those design specifications that may be available. the iq demonstrates successful installation of a system in the production environment, and in the test environment if relevant.\n\noperational qualification (oq)\n\noperational qualification (oq) provides documented verification that the system will function according to its operational specifications throughout the anticipated operational range in the selected environment. for purchased systems, the oq should be based upon the information supplied by the supplier as to the specifications for the system often obtained in the user manual documentation.\n\nthe oq for systems of categories a and b, such as ph meters, balances, stirrers, water baths, and thermometers, may be the performance of a calibration. for moderately complex systems (categories c, d, and e), the user should provide verification of correct operation of the hardware, software, and firmware, in addition to formal calibration.\n\nperformance qualification (pq)\n\nthe objective of the performance qualification (pq) is to provide documented evidence that the system reliably meets user requirements in the installed, production environment. often the testing performed during pq is referred to as user acceptance testing, as it is the evidence that the system is acceptable to the users. the pq is the final qualification performed. the performance qualification scripts should be traceable to the user requirements in these broad categories.\n\nportability\n\nunlike large manufacturing systems, many category a and category b systems, such as balances, ph meters, and water baths are likely to be moved during their lifetime. this ability to be considered portable poses challenges for laboratory computerized systems, especially for iq.\n\nthe ability to classify systems or components of a system as portable is predicated on the ability to leverage the information documented in building utilities qualification. in such cases, good inventory control via a logbook or change control process may suffice. if building utilities have not been qualified, then an organization should consider potential effects of fluctuating utilities, which may negatively affect the systems performance.\n\nthe need for portability should be identified as a requirement of the system; the portability should be verified as part of the dq for the system. an iq for laboratory systems likely to be moved should be constructed to provide for this movement. the iq should enable the system owner the ability to adequately qualify and set up the installation, without adding any undue burden. change control/configuration management records may be an adequate tool to document changes in portable equipment.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "c591d535-7196-4dca-98ad-4b69f3d388c2": {"__data__": {"id_": "c591d535-7196-4dca-98ad-4b69f3d388c2", "embedding": null, "metadata": {"page_label": "23", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation and Testing Procedures for Laboratory Computerized Systems: Roles, Responsibilities, and Change Control.", "questions_this_excerpt_can_answer": "1. What specific steps are recommended for validating laboratory computerized systems in categories A and B, according to the ISPE Validation of Laboratory Computerized Systems 2005 document, and how do these steps differ from the validation process for systems in categories C, D, and E?\n\n2. How does the ISPE Validation of Laboratory Computerized Systems 2005 document suggest handling the installation qualification (IQ) for equipment supplied with adequate IQ packages from the manufacturer, particularly in the context of systems classified as category A and B?\n\n3. According to the ISPE Validation of Laboratory Computerized Systems 2005 document, what are the key components of the testing principles that should be communicated to all individuals involved in the testing process of laboratory computerized systems, and how do these principles contribute to the overall validation and testing procedures?", "prev_section_summary": "The section discusses the testing elements involved in the validation of laboratory computerized systems, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). It highlights the importance of verifying the portability of laboratory systems, especially Category A and B systems, and the challenges it poses for IQ. The document emphasizes the need to classify systems as portable, leverage information from building utilities qualification, and document changes in portable equipment through change control/configuration management records.", "excerpt_keywords": "Validation, Laboratory Computerized Systems, Testing Procedures, Change Control, ISPE"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## validation of laboratory computerized systems\n\ntesting of pe systems backup and restore (as required)\nsecurity\nactual application of pe system in pe production environment (e.g., sample analysis)\n\nsystems in category d or category e may also require some limited communications verification. for example, after each component of the hplc is installed and its ability to meet established specifications verified, it is necessary to confirm that communication between the components is established. the purpose of such a test within the confines of an iq is not to assure that the pump is delivering mobile phase at the correct rate or that the wavelength set was accurate, but rather to be certain that the pump and detector could be manipulated from the control panel. it is prudent to verify communications between components prior to any subsequent qualification.\n\n### categories\n\nthese categories will be discussed as they apply to laboratory systems categories. for a comprehensive discussion on the principles of testing as they apply to systems classified as categories f and g, see the gamp 4.\n\n#### laboratory computerized systems categories a and b\n\nvalidation testing activities of the least complex of laboratory computerized systems should be considered complete after the completion of a dq/iq and pq. for systems in category a and category b, iq may be performed under the guidance of equipment manufacturers specific iq or according to a generic sop. the procedures should contain a form with the critical elements to be verified (temperature, voltage, lighting, and auxiliary components), details as to who should review the completed form and direction on where the completed forms should be filed. completed iq forms may be filed in the equipment use log for purposes of preparing a concise documentation package. this strategy allows the systems to have their installation documented on a pre-approved form, and re-executed as necessary.\n\nif the equipment supplier provides adequate iq packages, the sop should direct that the executed supplier qualification is reviewed and used to complete the qualification requirements for the system. the pq is the verification that the system is capable of performing its intended function(s) and may consist of calibration. after the completion of the calibration, the system should be officially released for use. systems of such low risk and complexity should also have a mechanism for release for use that is proportional to the qualification activities.\n\n#### laboratory computerized systems category c\n\nsystems with slightly greater complexity, or risk to data integrity, which by their design, allow for the user to provide instrument control parameters via a keypad will likely require limited challenges of the control system in addition to the dq/iq and pq (calibration) mentioned for less complex systems. these tests, while usually considered oq testing, may be run during the pq testing. once the challenges have been performed for a specific version of firmware/software, the range of testing need not be repeated for each unit of the same firmware or software purchased by the organization. the decision not to repeat this testing should be documented. for subsequent units pq tests should be constructed to verify that the system has been assembled on site correctly and that the communication from the keypad to the element being controlled is established. these procedures should be governed by local documented practices. once the system hardware and the control system has undergone dq/iq and pq, the system may be released for use.\n\n#### laboratory computerized systems categories d and e\n\nthese systems may likely have more than one component that will require dq and iq with each component needing to have critical elements verified (e.g., voltage or auxiliary components) in addition to verification of environmental specifications for the system. these systems are usually less portable and more complex. the modular construction of documents that verify the installation of each component of a multi-component system will ensure reusability of the document in the event components are replaced.\n\n### testing principles\n\nall portions of testing require a core set of testing rules or policies. these rules may be set at a corporate or departmental level and also may be developed for each system tested if there are project-specific needs to modify established rules. these rules should describe the roles and responsibilities of people involved in a testing event, the process for documenting and resolving a problem or deviation encountered during testing, documentation standards, and acceptable test evidence standards. they may be an expansion of the details provided in a project or validation plan. the communication of all of these testing principles to all people involved in the process is critical.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "e61c91cc-0765-4d67-817a-407bd6ca8c51": {"__data__": {"id_": "e61c91cc-0765-4d67-817a-407bd6ca8c51", "embedding": null, "metadata": {"page_label": "23", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation and Testing Procedures for Laboratory Computerized Systems: Roles, Responsibilities, and Change Control.", "questions_this_excerpt_can_answer": "1. What specific procedural distinction does the document suggest for project change control in complex laboratory systems compared to the procedure followed post-production?\n   \n2. How does the document propose handling the roles and responsibilities within the validation testing process for laboratory computerized systems, particularly in terms of organizational separation and activity definition?\n\n3. According to the document, what is the recommended approach for addressing the involvement of Quality Assurance (QA) in the validation testing process for laboratory computerized systems, and how should the relationship between the creator, executor, and reviewer of test scripts be managed?", "prev_section_summary": "The section discusses the validation and testing procedures for laboratory computerized systems, focusing on categories A, B, C, D, and E. It outlines specific steps for validating systems in categories A and B, including installation qualification (IQ) for equipment with adequate IQ packages. The document suggests testing principles that should be communicated to all individuals involved in the testing process, emphasizing the importance of documentation, communication, and resolving problems or deviations encountered during testing. The section also highlights the different testing requirements for systems of varying complexity and risk levels, with categories D and E being more complex and requiring verification of multiple components. Overall, the section emphasizes the importance of following testing principles and procedures to ensure the successful validation of laboratory computerized systems.", "excerpt_keywords": "Validation, Testing Procedures, Laboratory Computerized Systems, Change Control, Roles and Responsibilities"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\nfor complex laboratory systems, there may be a need for a project change control procedure different from the procedure to be followed once the system is placed into production. if not addressed in corporate standards, testing procedures should also define the minimum elements of a test script.\n\n#### roles and responsibilities\n\nit is necessary to outline the responsibilities of all the roles within the validation testing. persons performing the validation testing, reviewing the testing, and, if different from the reviewer, the persons approving the testing should have their activities defined. there should be adequate separation between the individuals performing these activities and the acceptable organizational separation should be detailed e.g., the person that created the test script may not execute the test, but may or may not be the person that reviews the executed script. the role of qa should be covered in this section.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "3edea033-7293-47d0-ac75-13a42b2bbd79": {"__data__": {"id_": "3edea033-7293-47d0-ac75-13a42b2bbd79", "embedding": null, "metadata": {"page_label": "24", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation and Documentation Handling Standards for Laboratory Computerized Systems", "questions_this_excerpt_can_answer": "1. What specific documentation practices does the GAMP Good Practice Guide recommend for handling approved test scripts in laboratory computerized system validation?\n   \n2. How does the GAMP Good Practice Guide suggest handling deviations, exceptions, or failures encountered during the testing of laboratory computerized systems, including the categorization and review process?\n\n3. What are the minimum elements that should be included in a test script according to the GAMP Good Practice Guide for the validation of laboratory computerized systems, and how should test evidence be documented and supported?", "prev_section_summary": "The section discusses the importance of having a specific project change control procedure for complex laboratory systems compared to post-production procedures. It also emphasizes the need to define roles and responsibilities within the validation testing process, including separation between individuals performing different activities. The document recommends addressing the involvement of Quality Assurance (QA) in the validation testing process and managing the relationship between the creator, executor, and reviewer of test scripts.", "excerpt_keywords": "Validation, Laboratory, Computerized Systems, GAMP, Documentation"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## page 44\n\ngamp good practice guide:\ngamp good practice guide:\nvalidation of laboratory computerized systems\n\n10.3.2 documentation handling standards\n\nthe process for handling approved test scripts in addition to the process for modifying approved test scripts should be described. if testing is to be recorded on the original document or on a copy of the script, or on an attachment to a document, those procedures should be described. the storage location of all original test evidence (both paper and electronic) should be described. if company practices require a second copy of all original documents, the location and process for storage of secondary copies of the documents should be detailed as well.\n\n10.3.3 deviation process\n\ntesting regardless of how well constructed will generate deviations, exceptions or failures. testing failures can range from typographical errors in the test script to system failure or deviations from the expected results. a scale for the deviations should be developed describing differing categories of test failures. these categories should be identified and the date the testing was performed should be recorded. provisions should be made within each test script to signify that a person other than the person performing the test has reviewed the script post execution.\n\n10.3.4 test evidence\n\ntest scripts should be written such that completion of the results should be objective and reproducible. test evidence is documentation that supplements the completed test script. whenever possible and where there is value, screen captures, and other output should be generated to support the test findings. at a minimum documented evidence of test script execution should be created for all critical functions tested and should enable an independent reviewer to arrive at the same conclusion as the tester.\n\n11 validation report\n\na validation report (also called validation summary report) should be generated at the completion of the project and should include a brief discussion of each major project activity and documentation defined in the validation plan. a validation report should be issued in order to review all preceding validation activities and indicate the status of the system prior to implementation into a production environment.\n\n10.3.5 change control\n\nin the event that system components (hardware, software or documentation) require changing during the validation effort, the changes should be evaluated prior to being implemented. change control processes for use in production provide more levels of review and approval than is warranted for a development project. an approved validation report is a prerequisite for releasing the system for operation in production and for routine use.\n\n10.3.6 minimum elements of a test script\n\nelements of a test script should include:\n\n- a short description of the test\n- linkage to the requirements challenged\n\n## page 45\n\nvalidation of laboratory computerized systems\n\nacceptance criteria for the test\n\nprerequisites and or assumptions\n\nspecific steps of the script that describe the command or action\n\nexpected results\n\nprovision for capturing actual results\n\nvalidation report\n\n...", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "04f5ce48-b338-4ca0-88c0-11762f6c68f9": {"__data__": {"id_": "04f5ce48-b338-4ca0-88c0-11762f6c68f9", "embedding": null, "metadata": {"page_label": "25", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Configuration Management and Change Control in Computer Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the GAMP 4 guideline define the purpose and process of change control in the context of computer system validation within laboratory environments, and what are the key objectives of documenting changes according to this guideline?\n\n2. What specific elements are considered essential for effective configuration management as outlined in the GAMP 4 guideline, and how do these elements contribute to maintaining control over a computer system throughout its lifecycle?\n\n3. In what ways does the document differentiate between project change control and operational change control within the framework of managing computer systems in a laboratory setting, and what precautions are recommended when implementing like-for-like changes to ensure system integrity?", "prev_section_summary": "This section discusses the documentation handling standards, deviation process, test evidence, validation report, change control, and minimum elements of a test script for the validation of laboratory computerized systems according to the GAMP Good Practice Guide. It emphasizes the importance of describing the process for handling approved test scripts, categorizing and reviewing deviations, documenting test evidence, generating a validation report, and implementing change control processes. The minimum elements of a test script include a description of the test, linkage to requirements, acceptance criteria, prerequisites, specific steps, expected results, provision for capturing actual results, and validation report.", "excerpt_keywords": "configuration management, change control, GAMP 4, laboratory computerized systems, validation."}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## configuration management, change control, and problem reporting\n\nchange control is: \"a formal process by which qualified representatives from appropriate disciplines review proposed or actual changes to a computer system. the main objective is to document the changes and ensure that the system is maintained in a state of control.\" (gamp 4, section 12, glossary and acronyms).\n\nconfiguration management is defined within gamp 4 as those activities necessary to be able to define precisely a system at any point during its life cycle.\n\nthe elements to be considered and assessed include:\n\n- documentation (e.g., validation, requirements, testing, project plan, design documentation, user documentation)\n- hardware (e.g., computer clients and servers, printers, etc.)\n- software (e.g., 3rd party or in-house developed)\n- infrastructure (e.g., lans, wans, routers and switches)\n- architecture information (e.g., data models, process models, system maps)\n- environments (e.g., development, testing and production)\n- system static data or set-up data (e.g., set points)\n\n### change control\n\nin support of configuration management, change control is carried out during all phases of the systems development (project change control) and in the operational or maintenance phase (operational change control) of the system. the change control processes implemented during the different phases may be different. all changes - major, minor, cosmetic, or the replacement of seemingly identical components, affect the computer system and may introduce problems. care should be taken when exchanging like-for-like, that the elements are truly identical and that the exchange is documented. all changes should therefore be managed and documented including system relocation and decommissioning activities. the change control process should include all elements of the system under configuration management, including any addition to, deletion of, or modification of controlled documentation, application software, operating system software, firmware, hardware, or system configuration data.\n\n### configuration management\n\nconfiguration management, closely related to and interwoven with change control, provides the ability to identify the makeup of the initial set-up of a system composition and at any time during the life cycle of the system. configuration management is critical in ensuring the traceability of the components of a development, test, or production environment at any point. configuration management provides the unique identification of configuration items, their versions, and relationship to other deliverables both within and outside a defined configuration.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "b7197b72-783f-49f3-821d-aefadfb48275": {"__data__": {"id_": "b7197b72-783f-49f3-821d-aefadfb48275", "embedding": null, "metadata": {"page_label": "26", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation and Maintenance of Laboratory Computerized Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What specific documentation should be included in problem reporting for laboratory computerized systems according to the ISPE Validation of Laboratory Computerized Systems 2005 guide?\n   \n2. How does the ISPE 2005 guide recommend handling emergency changes in laboratory computerized systems to ensure compliance with change control requirements?\n\n3. What are the recommended steps outlined in the ISPE Validation of Laboratory Computerized Systems 2005 guide for integrating problem reporting with the change control process in the context of laboratory computerized systems maintenance and validation?", "prev_section_summary": "The section discusses the importance of configuration management, change control, and problem reporting in computer systems validation within laboratory environments. It defines change control as a formal process to document and maintain system control, while configuration management involves activities to define a system at any point during its lifecycle. Key elements considered for effective configuration management include documentation, hardware, software, infrastructure, architecture information, environments, and system static data. Change control is carried out during system development and operational phases, with all changes, including like-for-like exchanges, requiring careful documentation. Configuration management is critical for identifying system composition and ensuring traceability of components throughout the system's lifecycle. It provides unique identification of configuration items, their versions, and relationships to other deliverables.", "excerpt_keywords": "Validation, Laboratory, Computerized Systems, Maintenance, Change Control"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## validation of laboratory computerized systems\n\nmaintaining appropriate documentation, e.g., urs\n\nback out plans\n\nemergency changes may, due to time constraints, deviate from the recommended chronology of change control, but all relevant change control requirements should be met expediently following such changes.\n\n### problem reporting\n\nproblem reporting is a critical element of an organizations configuration management and periodic review programs. properly documented and addressed, problem reports can provide inputs into the change control process in that they may be evidence of necessary changes to the system. these reports should be reviewed regularly, along with the change records, as part of the periodic review and audit program.\n\nthe relationship between problem reporting and change control processes may be outlined chronologically as:\n\n- problem reporting and analysis\n- remedial recommendations and link to change control process\n- change evaluated for impact\n- change authorization by management\n- change testing and documentation in test area if possible\n- change implementation\n- review and updating of validation documentation, as necessary\n- change approval\n\nprocedures for documentation and follow-up of all problems including system failures or malfunctions should be in place as well as a mechanism for ensuring timely follow-up of documented problems. problem reporting documentation should include the following:\n\n- statement of the problem\n- date and time of problems occurrence\n- identity of person discovering the problem\n- potential impact on operations or data\n- postulated causes, if known\n- suggested corrective actions, based on supplier and user input\n\n### maintenance and maintenance log\n\nevery validated laboratory computerized system will require some level of maintenance throughout its life cycle. maintenance may be routine and planned, preventive or unplanned. maintenance and calibration procedures can often be obtained from the supplier. maintenance should be documented, and a maintenance log should be kept for all planned, preventive, and unplanned maintenance. maintenance logs for each component of a multi-component system may be required.\n\nmaintenance should be carried out in a manner that minimizes potential impact and downtime for users. any potential changes either contemplated as part of emergency or planned maintenance should be managed and implemented through the change control process.\n\n### use log\n\nin addition to or in conjunction with a maintenance log, a use log may be established for validated laboratory computerized systems, containing the date, the identity of the user, and what actions were performed. the use log can help assess potential impact on data and provide input into the problem reporting and change control process.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "b3f4877c-fc30-46d8-94d1-cc5a6b969c51": {"__data__": {"id_": "b3f4877c-fc30-46d8-94d1-cc5a6b969c51", "embedding": null, "metadata": {"page_label": "27", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "System Administration and Data Management in Laboratory Computerized Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the recommended practices for establishing standard operating procedures (SOPs) for system administration in laboratory computerized systems, particularly in relation to regulatory compliance and password management?\n   \n2. How does the complexity of a laboratory computerized system (categorized from A to F) influence the approach to system administration, especially in terms of the division of administrative tasks and the role of the system administrator in maintaining data integrity?\n\n3. What specific guidelines does the document provide for the backup and restoration of data in laboratory computerized systems, including the identification of backup media locations and the verification of backup execution?", "prev_section_summary": "The section discusses the validation, maintenance, problem reporting, and use logs of laboratory computerized systems according to the ISPE Validation of Laboratory Computerized Systems 2005 guide. Key topics include the importance of documentation, handling emergency changes, integrating problem reporting with change control, maintenance procedures, and the use log for tracking user actions. Entities mentioned include problem reporting, change control processes, maintenance logs, use logs, and the necessary documentation for reporting and addressing system issues.", "excerpt_keywords": "system administration, laboratory computerized systems, standard operating procedures, data integrity, backup and restoration"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## system administration\n\nsystem administrators provide support for the production use of laboratory computerized systems. this includes support for the general computing environment as well as support for individual systems. the scope of system administration activities will depend on the nature of the system and the organization implementing the system. the support for the application software.\n\nstandard operating procedures (sops) for system administration should be established and challenged during qualification testing.\n\nsops should be developed to describe all necessary functions including control and management of any unique features of the particular system, as well as controls necessary for regulatory compliance. when possible, available system functions should be used to provide the necessary controls. for example, if the intention is to have users change their passwords every 90 days, this setting should be implemented by the computer system, so that passwords automatically expire every 90 days. if appropriate system controls are not available, procedural controls should be developed to supplement the functions of the laboratory computerized system.\n\nfor systems in categories a through d, the boundaries of the laboratory computerized system are easily defined and system administration is frequently performed by a single system expert. for more technically complex systems with networked environments, it may be more difficult to define the boundaries of any single system since many systems share the same network infrastructure and system administration tasks are often dispersed among different departments.\n\ndecisions should be made as to how system support will be handled before sops are written. such decisions should consider understanding the size, capacities, and capabilities of the computing environment. large organizations may need to deploy a more sophisticated administrative model, with multiple roles and possibly multiple departments defined to perform subsets of administrative functions. smaller organizations may consolidate functions based upon the amount of work required and the staff available.\n\na category a or category b system may require only minimal system administration attention. often, support involves the administrator contacting the supplier should an issue arise. even for these simple systems, it is best to have a defined system administrator so that there is a single point of control for issues from the laboratory and from the supplier.\n\ncategory c or category d systems often consist of a laboratory instrument with a personal computer running software to control the instrument and acquire data. the system supplier is frequently relied upon to provide training in system administration procedures for these systems. often, it is the scientist (user) with the most expertise in the use of the system who performs the system administrator functions.\n\nfor systems in which the system administrator can affect critical functions, this role should be given to an individual with no vested interest in the system output so that they can maintain their impartiality. where there is no dedicated it support for these systems, additional procedures may be necessary to assure that data integrity can be maintained.\n\nin the event that the system administrator role is assumed by a system user, unique user identification should be established for each role. in this way, the audit trail would attribute the actions with the correct individual and role. specific system roles are often established to ensure system security.\n\nfor more complex systems (category e and category f), often operating in a network environment, there are typically many applications running in the common computing environment. these systems often consist of a software application and all supporting software and hardware, personal computers, analytical instruments, interfaces, and servers. in a networked environment, therefore, system administration procedures are likely to be divided into general procedures to support the network environment, plus application-specific procedures.\n\n### data storage locations\n\nthe procedure should identify the location for backup media generated by the system.\n\n### backup/restore\n\nthe procedure should define how backups are performed and how to verify that they were properly executed. there should also be a process for restoring an entire system, or for users to request restoring individual files.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "df591679-5ebe-4d2c-94d7-48839e85c14f": {"__data__": {"id_": "df591679-5ebe-4d2c-94d7-48839e85c14f", "embedding": null, "metadata": {"page_label": "28", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Laboratory Computerized System Security and User Identity Verification Guidelines and Procedures", "questions_this_excerpt_can_answer": "1. What specific measures does the ISPE Validation of Laboratory Computerized Systems 2005 guide recommend for monitoring and reporting suspected security breaches in laboratory computerized systems?\n   \n2. How does the guide suggest handling password security, including length and frequency of changes, to balance between security and user convenience in laboratory computerized systems?\n\n3. According to the ISPE Validation of Laboratory Computerized Systems 2005 guide, what are the recommended practices for maintaining physical and logical security of standalone laboratory computerized systems to ensure data integrity and prevent unauthorized access?", "prev_section_summary": "The section discusses system administration in laboratory computerized systems, including the role of system administrators, the establishment of standard operating procedures (SOPs), and the division of administrative tasks based on the complexity of the system. It emphasizes the importance of regulatory compliance, password management, and data integrity. The section also covers the backup and restoration of data, including guidelines for identifying backup media locations, verifying backup execution, and restoring systems or individual files. The complexity of systems (categorized from A to F) influences the approach to system administration, with more complex systems requiring a networked environment and specific application-specific procedures. The role of system administrators, the need for impartiality in critical functions, and the establishment of unique user identification for audit trail purposes are also highlighted.", "excerpt_keywords": "ISPE, Validation, Laboratory Computerized Systems, Security, User Identity Verification"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## page 52\n\n|validation of laboratory computerized systems|validation of laboratory computerized systems|\n|---|---|\n|security administration and monitoring|security administration and monitoring|\n|the procedure should address how the system administrator will monitor and report suspected security breaches. it should also provide for procedures to monitor and apply security patches and maintain updated virus protection for the system. if a company policy allows for remote dial-in support of a system, the system security procedures should define how access is granted and removed and how remote user actions are monitored.| |\n|physical security|the computerized system and the system software should be located in a limited access area or the facility. this is especially important for stand-alone systems. the system owners should be responsible for approving who is granted access to this area.|\n|access to manuals|access to manuals should be controlled.|\n|physical media|disks, tapes, and other media used to store electronic records should be clearly and accurately labeled and stored in areas with appropriate environmental and access controls.|\n|logical security|in addition to preventing unauthorized access or damage to the application or operating system, access controls should be enabled to prevent access to modify the system clock, operating system permissions, and application system files.|\n|user accounts|user accounts should be set up at both the operating system and the application levels. when possible, the security implications for systems using the operating system user accounting and security for application access control should be understood and associated risks managed. users should be granted the minimum set of privileges necessary to perform their job. in order to be effective, user accounts should require a unique combination of user name and password.|\n|user names|a convention for assigning user names should be established to ensure that each name is unique.|\n|minimum password length|longer passwords are more secure but are also more difficult to remember. imposing undue restrictions or complexity on password length will typically result in users writing down the password and keeping it near the computer. this is compounded as a laboratory analyst is required to use multiple computerized systems each with a unique logon and password. this can defeat the purpose of the password and results in decreased security. a typical compromise is to require passwords to be at least six (6) alphanumeric characters long.|\n|password age|passwords should be changed regularly. when possible, the software should be configured to force the password to be changed. the system should detect and prevent previously used passwords. passwords should be modified by the user immediately after being assigned. forcing passwords to be changed too frequently may result in some confusion in users ability to remember their new password. in that situation, users might write down the new password and leave it near the computer for convenience. this practice would compromise security.|\n\n## security\n\nthis section provides guidance on the development of security procedures for laboratory computerized systems. security measures should be implemented to ensure that only authorized individuals may access the system and the data, and that the data are accurate and available when needed. security includes both physical security and logical security. this guide considers security issues pertaining to standalone laboratory computerized systems and simple, isolated laboratory networks.\n\njust as data integrity is influenced by technology, the need for and ability to provide security is linked to the technology of the system. for small standalone laboratory computerized systems, physical security may be the only element that can be provided. providing guidance on security for large corporate networks is beyond the scope of this guide.\n\nfor most laboratory computerized systems, a single global security procedure would be sufficient to ensure system security as long as the needs of the individual system can be accommodated to ensure accountability and non-repudiation of records.\n\nmaintaining a validated system in a secure state is a dynamic process. the goal of computer system security is to protect the system from unauthorized access, intentional or accidental damage, and loss or unauthorized modification of data.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "e38a5278-a921-4019-ab1d-42241457d1dc": {"__data__": {"id_": "e38a5278-a921-4019-ab1d-42241457d1dc", "embedding": null, "metadata": {"page_label": "28", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Laboratory Computerized System Security and User Identity Verification Guidelines and Procedures", "questions_this_excerpt_can_answer": "1. What are the four key security procedures that should be developed to ensure the security of laboratory computerized systems according to the ISPE Validation of Laboratory Computerized Systems 2005 guidelines?\n\n2. How does the ISPE Validation of Laboratory Computerized Systems 2005 document suggest verifying the identity of authorized users in a laboratory setting when a company ID policy is not in place?\n\n3. According to the ISPE Validation of Laboratory Computerized Systems 2005 guidelines, what documentation should be maintained in a secure, confidential file when verifying a user's identity through an official, government-issued ID in a laboratory environment?", "prev_section_summary": "The section discusses security measures for laboratory computerized systems, including physical security, logical security, user account management, password security, and monitoring of security breaches. Key topics include monitoring and reporting suspected security breaches, physical security measures for standalone systems, access controls, user account setup, password length and age requirements, and the importance of balancing security with user convenience. The section emphasizes the need for security procedures to ensure only authorized individuals access the system and data, and that data integrity is maintained.", "excerpt_keywords": "Laboratory Computerized Systems, Security Procedures, User Identity Verification, ISPE Validation, Data Integrity"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\nto accomplish this, security procedures should be developed to address:\n\n- authentication: the process of reliably determining the true identity of the user\n- integrity: ensures that data are accurate and have not been improperly modified\n- confidentiality: ensures that only authorized persons can access data\n- availability: ensures that only authorized users can access the data they need, when they need it\n\n## system security considerations\n\n### 14.1.1 verification of user identity\n\nthe identity of each authorized user of a laboratory computerized system should be established. most companies require new employees to provide proof of identity before employment can begin, and a company identification card (id) is issued. if this is true, then possession of a company id should be sufficient to establish identity. in the absence of such a policy, the laboratory might establish user identity through an official, government-issued id (such as a passport or drivers license with a photograph). in that case, a photocopy of the document used to establish user identity should be maintained in a secure, confidential file.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "a4b4a31a-f91a-48a7-9cd6-56dba9439158": {"__data__": {"id_": "a4b4a31a-f91a-48a7-9cd6-56dba9439158", "embedding": null, "metadata": {"page_label": "29", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "User Account Security and Monitoring Best Practices", "questions_this_excerpt_can_answer": "1. What specific user account security measure is recommended for handling unsuccessful logon attempts in a laboratory computerized system, according to the ISPE Validation of Laboratory Computerized Systems 2005 guidelines, and how does it balance security with operational practicality?\n\n2. How does the ISPE Validation of Laboratory Computerized Systems 2005 document suggest managing user access privileges through groups, and what rationale does it provide for this approach in terms of security management efficiency?\n\n3. What considerations does the ISPE Validation of Laboratory Computerized Systems 2005 document recommend for setting audit policies in commercial operating systems to ensure they are manageable and effective, especially in the context of compliance with electronic record and signature requirements?", "prev_section_summary": "The section discusses the importance of security procedures in laboratory computerized systems, focusing on authentication, integrity, confidentiality, and availability. It emphasizes the verification of user identity, suggesting methods such as company ID cards or government-issued IDs. The need for maintaining documentation of user identity verification in a secure file is also highlighted. Key entities include authorized users, laboratory computerized systems, company ID policies, government-issued IDs, and secure documentation.", "excerpt_keywords": "ISPE, Validation, Laboratory Computerized Systems, User Account Security, Audit Policies"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n|content|page number|\n|---|---|\n|account lockout|54|\n|accounts should be locked out after a specified number of unsuccessful logon attempts. three attempts is a commonly used limit. depending on the work environment (and the software settings), the account might remain locked until the administrator resets it or the lockout counter may be reset after a certain period of time. if work is commonly performed during periods when no administrator will be present, then it might be necessary to reset the lockout counter after 10 or 20 minutes. the period should be long enough to discourage unauthorized access attempts, but still allow legitimate employees another chance to log on and complete their work. leaving the account locked until an administrator can be contacted provides more security and should be used when practical.| |\n|control of user accounts|54|\n|a system should be established to ensure that the appropriate level of management approvals is obtained for the creation, modification, and deletion or inactivation of all user accounts, and the level of access granted. this is commonly accomplished by the use of a controlled form.| |\n|groups|54|\n|common operating systems, and many applications, allow the creation of groups of user accounts. access privileges can then be assigned by group and users are simply placed into the appropriate group. this is a far easier way to manage security when large numbers of users are present. when used, the purpose of the groups should be defined so that it is clear who belongs in a given group.| |\n|system timeouts|54|\n|password-protected screen savers or other mechanisms to automatically time out the system after a period of inactivity should be utilized. automatically logging out of the application would be preferable, if available, to ensure accountability and non-repudiation of a record.| |\n|system clock|54|\n|the system clock should be secured to prevent users or suppliers from making inadvertent or intentional changes.| |\n|operating system folders and files|54|\n|the operating system folders and files, and the application folders and files, should be secured to prevent users or suppliers from making inadvertent or intentional changes.| |\n|audit policies|55|\n|common commercial operating systems enable the auditing of many functions performed on a computer. they are present as tools for monitoring the use and attempted misuse of system and network resources.| |\n|note:| |\n|these audit capabilities were not necessarily designed or intended to comply with 21 cfr part 11 or other electronic record and signature requirements (see appendix 5, reference 7).| |\n|audit policies should be set with care, since the corresponding logs can grow in size and quickly become unmanageable. a common strategy is to audit by exception. for example, logon failures or unsuccessful access of a network resource can be audited. this way, the logs are small enough that administrative personnel will regularly review them. alternatively, the system application could have audit trail functionality to ensure that all user activities are recorded.| |", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "3a77fe8b-3bdc-47f5-9620-43372ca22298": {"__data__": {"id_": "3a77fe8b-3bdc-47f5-9620-43372ca22298", "embedding": null, "metadata": {"page_label": "30", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Comprehensive Guide to Backup, Archival, and Disaster Recovery for Laboratory Computerized Systems", "questions_this_excerpt_can_answer": "1. What are the recommended strategies for backing up laboratory computerized systems as outlined in the ISPE Validation of Laboratory Computerized Systems 2005 guide, and how do they differ based on the criticality of the records produced by the system?\n\n2. How does the ISPE guide from 2005 suggest handling disaster recovery planning for laboratory computerized systems of varying complexities, and what specific considerations are recommended for systems falling into category D?\n\n3. According to the 2005 ISPE guide, what are the roles and responsibilities of the system owner versus the IT department in the context of backup, archival, and disaster recovery processes for laboratory computerized systems?", "prev_section_summary": "The key topics covered in this section include user account security measures such as account lockout after unsuccessful logon attempts, control of user accounts through management approvals, managing access privileges through groups, system timeouts for inactivity, securing the system clock, securing operating system and application folders, and setting audit policies in commercial operating systems. The section emphasizes the importance of balancing security with operational practicality, efficient security management through group access privileges, and setting manageable audit policies to ensure compliance with electronic record and signature requirements.", "excerpt_keywords": "ISPE, Validation, Laboratory Computerized Systems, Backup, Disaster Recovery"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n|content|page number|\n|---|---|\n|gamp good practice guide: gamp good practice guide:|56|\n|validation of laboratory computerized systems validation of laboratory computerized systems|57|\n\nfigure 15. 1: relationship between system backup, archival, and disaster recovery\n\nfor more complex systems assistance may be available from the supplier, through either a service level agreement (sla) or a maintenance agreement. depending upon the size of the organization and the complexity of the system there may also be internal slas between the system owner and those responsible for the network operations. for more complex computerized laboratory systems further guidance on archive, backup and disaster recovery is provided in gamp 4.\n\nlaboratory computerized systems falling into category d should be reviewed on an individual basis, as factors such as budgets and available expertise will drive decisions on whether a system should be \"recovered\" or a replacement unit purchased.\n\n15.1 backup and restore\n\nwhere a backup process is required, the process established should be tested periodically. backup procedures typically require data, operating system files, configuration parameters, and application files to be copied onto external media at regular intervals to prevent the accidental deletion or physical loss of the system and/or the data.\n\nthe criticality of the records produced by the system should be the primary driver for determining the backup interval. the available technology (e.g., roll backs, mirrored systems) should also be considered.\n\nbackup procedures should take into account defined configuration items. this may range from paper records of the configuration up to the use of system imaging. these procedures should consider the verification of the data transfer and the refresh procedures necessary for the media as well as the environmental specifications and procedures for monitoring the records. duplicate copies of backup information are often maintained in two locations, locally and remotely, to ensure the information is available should it be needed as a result of a localized disaster. the information should be protected from fire, water, or any other hazard.\n\nthese processes are all ultimately the responsibility of the system owner, but the owner often requires the technical expertise of the it department.\n\ntwo of the most common backup strategies are full backup and incremental backup. during a full backup or restore cycle, users generally will not have access to their data. incremental backups are not as time-consuming and offer greater flexibility for the backup administrators. the interval for performing incremental backups should be determined and documented. often, incremental backups are performed on a daily basis. the term incremental backup itself implies that only new or changed files are copied to a secondary storage device. this allows the enterprise to protect newly created or changed files much more efficiently without having to run full backups every day. an assessment needs to be performed to determine the frequency necessary to perform such backups based upon risk, i.e., the amount of data that could potentially be lost and would need to be regenerated.\n\nin addition to periodic testing of the ability to restore data that has been backed up, procedures should be established which describe the process for requesting and authorization of the restoration of previously backed up data.\n\nfurther guidance on backup is provided in appendix 07 of gamp 4.\n\ndisaster plans, archival, and restoration of backup media should be tested during the validation process. for laboratory computerized systems in categories a, b, and c, disaster recovery planning may be more important than the processes for backup, archive, and restore. for such low complexity systems, the software/hardware form an integrated unit that does not store data; therefore, there is no need to consider archive, data backup or restoration. traditional processes governing the paper records generated should apply. these systems are often easily replaced, can be ordered from multiple suppliers, and are likely to be in operation in several laboratories within a department. consequently, the plan for continued operation in the face of loss of the system may simply be to use another system or to purchase a new system. if an organization is small or the equipment is unique, a means to continue to operate while the system is being replaced should be considered.\n\nin the event that a laboratory disaster occurs, for low complexity systems (categories a, b, c, and d) the only practical option to address the disaster will be to purchase a new unit. as a system grows in technical complexity, and data is stored to durable media for purposes of re-processing, traditional elements of processes for backup, archive, and restore should be addressed.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "553b3be7-a4a2-46b7-8ff5-dc1539749015": {"__data__": {"id_": "553b3be7-a4a2-46b7-8ff5-dc1539749015", "embedding": null, "metadata": {"page_label": "31", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Guidelines for Archival and Training in Laboratory Computerized Systems Validation, System Review Frequency and Triggers", "questions_this_excerpt_can_answer": "1. What distinguishes archival from backup in the context of laboratory computerized systems validation, and what specific measures should be taken to ensure the integrity and retrievability of archived records according to the ISPE guidelines from 2005?\n\n2. How does the ISPE Validation of Laboratory Computerized Systems 2005 document recommend structuring a training program for personnel involved in the use or support of laboratory computer systems, including the types of training that should be provided?\n\n3. According to the 2005 ISPE guidelines, what is the recommended frequency for conducting periodic reviews of laboratory computerized systems to ensure they remain in a validated state, and how does this frequency vary based on the system's categorization and stability?", "prev_section_summary": "The section discusses the recommended strategies for backing up laboratory computerized systems, disaster recovery planning, roles and responsibilities of system owners and IT departments, backup and restore processes, backup strategies (full backup and incremental backup), testing of backup and restoration procedures, disaster plans, archival, and restoration of backup media. It also mentions the importance of considering the criticality of records produced by the system, the complexity of the system, and the need for periodic testing and documentation of backup procedures. The section emphasizes the ultimate responsibility of the system owner in ensuring data protection and the technical expertise required from the IT department.", "excerpt_keywords": "ISPE, Validation, Laboratory Computerized Systems, Archival, Training"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## page 58\n\n15.2 archival\n\n|archival|is the act of removing data/records from daily operational use for the purpose of record retention and generally involves offline storage. archival differs from backup in that records that are backed up typically remain available for daily operational use and therefore are subject to change. records once archived cannot be changed without restoring the records to an active system following established procedures. archived records should be secured, protected from corruption, damage, loss, and unauthorized changes, and should be retrievable for record retention periods required by the applicable regulations and company policies and procedures. over time, archived records may require migration to new file formats. migration of records requires the establishment of validation procedures for the process. procedures should be established to examine the viability of archived records throughout the record retention period.|\n|---|---|\n|within the gxp regulations, good laboratory practice (glp) regulations are unique when addressing issues of archival, in that the data should be removed from the system and placed in the control of the archivist. archival of the software and data collected during a clinical study may be done in a more immediate time frame than many laboratory systems in the gmp environment. regardless of the timing of such an event, once the need for archival is identified, the process should assure access to the archival facilities is limited to authorized personnel and the records should be retained and retrievable for the retention period.| |\n|further guidance on archiving is provided in appendix 06 of galvlp 4.| |\n\n## training\n\nthis section is intended to define the role of training within the validation process and present guidance for developing and implementing a training program for those responsible for all aspects of laboratory computer system use or support. a training program ensures that the system is being used and supported by qualified and trained personnel. in order to realize the maximum potential of any system, users and those responsible for any aspect of a system should have the required knowledge. every program should be designed and tailored to meet the needs of users of a system including: implementers, validation personnel, end users, internal auditors, document control personnel, as well as third party consultants.\n\nstandard operating procedures alone are inadequate to guarantee that personnel are competent to perform their assigned tasks. a properly designed, implemented and documented training program should be established. the first step is to identify individual users of a system and their roles. each category of users requires training that is specific to their roles. types of training include:\n\n- company policies and sops\n- regulatory training\n- validation training\n- safety training\n- software/hardware training\n- laboratory test methods\n\n## page 59\n\nvalidation of laboratory computerized systems\n\ninstrument training\n\na training program should be developed prior to the implementation of a system and reviewed periodically. designing a training program should include all of the user groups. documentation of training can take the form of documented proof of classes attended or a process whereby individuals sign that they have read and understood the procedure. both internal and external training sources need to be considered to achieve the proper level of training. depending on the type of system being utilized it may be more appropriate to have the supplier train employees or train a trainer. documented proof should be kept up to date in a secure location and reviewed periodically to ensure a proper level of training has been maintained for each individual. documentation also needs to include personnel backgrounds including education, training, and experience.\n\ntraining may take the form of:\n\n- supplier supplied training using prepared training scripts\n- peer to peer training using prepared training scripts\n- expert user to peer training using prepared training scripts\n- independent review of procedure with built-in tests\n- e-learning with built-in tests\n\n### periodic review\n\nthe intention of a periodic review is to ensure that a system, once validated, remains in a validated state. a periodic review should assess the accumulated changes to a system over time and look for possible trends. the first periodic review should be conducted jointly by representatives of the system owner and qa. the final responsibility for ensuring the compliance and correct operation of the system lies with the system owner. typically, the review periods range from one to three years. the review period may vary depending upon the complexity of the system.\n\nsystems with a categorization of category a or category b that are stable with few or no updates should generally be reviewed every three years.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "280b7111-45d4-4386-bec0-9f8c9a66b252": {"__data__": {"id_": "280b7111-45d4-4386-bec0-9f8c9a66b252", "embedding": null, "metadata": {"page_label": "31", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Guidelines for Archival and Training in Laboratory Computerized Systems Validation, System Review Frequency and Triggers", "questions_this_excerpt_can_answer": "1. What is the recommended review frequency for complex laboratory computerized systems categorized under categories f or g, according to the ISPE Validation of Laboratory Computerized Systems 2005 guidelines?\n   \n2. According to the 2005 ISPE guidelines, what are some specific events that can trigger an additional review of laboratory computerized systems outside the regular review schedule?\n\n3. How does the ISPE Validation of Laboratory Computerized Systems 2005 document suggest management should formalize the review period for laboratory computerized systems?", "prev_section_summary": "This section discusses the concepts of archival and training in the context of laboratory computerized systems validation according to the ISPE guidelines from 2005. \n\nKey topics covered include:\n- Archival: The act of removing data/records from daily operational use for record retention, with specific measures to ensure integrity and retrievability of archived records.\n- Training: The importance of a structured training program for personnel involved in the use or support of laboratory computer systems, including different types of training that should be provided.\n- Periodic Review: The recommended frequency for conducting periodic reviews of laboratory computerized systems to ensure they remain in a validated state, with variations based on system categorization and stability. \n\nEntities discussed include the roles of different users of a system, the types of training required for each role, and the importance of periodic reviews to assess system changes and trends over time.", "excerpt_keywords": "Archival, Training, Laboratory Computerized Systems, Validation, ISPE"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\nsystems in category c, category d, or category e are more complex and, therefore, should be reviewed every two years. complex, purchased systems that have many components, many interfaces to other systems, or custom developed/custom modified systems in categories f or g, should be reviewed annually. in all cases, the review period should be established, documented, and approved by management. occasionally, periodic reviews can be triggered by planned or unplanned events. these reviews are usually in addition to the scheduled reviews. examples of triggering events include a relocation of facilities, a change of contract support firms, or a change in regulations.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "33debba4-8b81-4d84-9b30-03de84c6ba90": {"__data__": {"id_": "33debba4-8b81-4d84-9b30-03de84c6ba90", "embedding": null, "metadata": {"page_label": "32", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation and Retirement Procedures for Laboratory Computerized Systems", "questions_this_excerpt_can_answer": "1. What specific areas should be reviewed during the periodic review of a laboratory computerized system to ensure its validation status remains intact, according to the ISPE Validation of Laboratory Computerized Systems 2005 guidelines?\n\n2. How does the ISPE Validation of Laboratory Computerized Systems 2005 document recommend handling the retirement or decommissioning of laboratory computerized systems that do not store data, and what specific types of documentation should be archived during this process?\n\n3. According to the ISPE Validation of Laboratory Computerized Systems 2005 guidelines, what considerations and procedures should be implemented during the retirement phase of a laboratory computerized system to ensure the integrity and maintenance of electronic data records, especially in the context of increasing reliance on electronic laboratory records and rapid technological changes?", "prev_section_summary": "The section discusses the recommended review frequency for complex laboratory computerized systems categorized under categories f or g, according to the ISPE Validation of Laboratory Computerized Systems 2005 guidelines. It also mentions specific events that can trigger an additional review of laboratory computerized systems outside the regular review schedule, such as relocation of facilities, change of contract support firms, or change in regulations. The document suggests that the review period for laboratory computerized systems should be formalized, documented, and approved by management.", "excerpt_keywords": "Validation, Laboratory Computerized Systems, ISPE, Retirement Procedures, Electronic Data Records"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## validation of laboratory computerized systems\n\nthe periodic reviews content should be derived from an understanding of what is likely to change in a system and whether those changes could affect the systems validation status. the primary areas that should be reviewed, where applicable, are:\n\n- changes to firmware, hardware, and software:\n- the impact of changes to the systems hardware, firmware, and software should be assessed through a review of its change control documentation with an emphasis on recurring issues.\n- system maintenance and calibration records should be reviewed to ensure they are current and complete. the records should also be assessed for recurring failures.\n- the configuration and component list should be reviewed to see if it is up-to-date.\n- changes to the systems environment (location):\n- any changes to the location of the system or its environment should be assessed for any impact upon system integrity. examples could include temperature range, humidity level, building construction, electrical work, installation of other equipment, or even physically moving the equipment to another bench or room.\n- documentation to ensure it is current (including supporting policies and procedures):\n- the location of all documentation should be verified.\n- critical validation documents should be reviewed to see if they are current.\n- changes in policies or procedures regarding system operation should be reviewed for their impact on validation status. policies and procedures should be reviewed to see if they reflect current practice and are consistent with current regulatory expectations.\n- the business continuity plan, if relevant, should be reviewed to see if it is current.\n- user training:\n- training materials should be reviewed to see if they are current.\n- training records should be reviewed to see if users are being properly trained and training is properly documented. is there a need for additional training?\n- system operations:\n- the actual use of the system by the users should be reviewed to determine if the documented user requirements are consistent with current practices.\n- operating procedures, instructions, and/or manuals should be reviewed to see if they are current and consistent with current practices.\n- operating system, application software, and data backups should be assessed to determine if they are complete, occurring as scheduled, and occur at an appropriate frequency.\n\nfurther guidance on periodic reviews is provided in appendix o1 of gamp 4.\n\n## retirement\n\nthis guidance defines recommended system retirement/decommissioning procedures and practices for laboratory computerized systems. system retirement activities include all activities related to the removal of a system from use.\n\nfor systems that do not store data (categories a through c) the activities are limited to the archival of any system documentation and the removal of any associated hardware, software, and standard operating procedures.\n\nexamples of system documentation include but are not limited to sops, manuals, specifications, installation documentation, testing documentation, calibration records, as well as other documents that may be used to support system validation, operation, and retirement activities such as maintenance logs, change control records, and periodic review reports. the documentation collected should be indexed and maintained for the required retention period.\n\nin addition to this documentation, for systems where the company elects to maintain electronic records (categories d through g), the focus of the decommissioning activities is on the integrity and maintenance of the electronic data records generated by the system. this guidance will focus on the retirement of systems that have generated electronic records.\n\ndue to the increased use of and reliance on electronic laboratory records, along with the fast pace of technological change and system obsolescence, the need to carefully evaluate, plan, and control system retirement activities has become critical. procedures and controls should be implemented during the retirement or decommissioning phase of a laboratory computerized system, to provide a high degree of assurance that required regulatory electronic records, including any associated metadata required to preserve content and meaning, are retained for the duration of the applicable record retention period.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "476dfd74-eaf7-4aee-99f1-c7e578cb5a6b": {"__data__": {"id_": "476dfd74-eaf7-4aee-99f1-c7e578cb5a6b", "embedding": null, "metadata": {"page_label": "33", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Comprehensive Guide to System Retirement Planning and Activities", "questions_this_excerpt_can_answer": "1. What specific documentation and controls are recommended by the ISPE 2005 guide for retaining and retrieving electronic records during the system retirement process to ensure compliance with applicable regulations?\n\n2. How does the ISPE 2005 guide suggest handling data migration activities during the retirement of a GxP computerized laboratory system, especially concerning electronic records and metadata?\n\n3. According to the ISPE 2005 guide, what are the key sections that should be included in a formal system retirement (or decommissioning) plan, and what responsibilities do these sections outline for the system owner, user groups, and information technology departments?", "prev_section_summary": "The section discusses the validation and retirement procedures for laboratory computerized systems according to the ISPE Validation of Laboratory Computerized Systems 2005 guidelines. Key topics include periodic reviews of system components such as firmware, hardware, software, environment changes, documentation, user training, and system operations. The retirement process for systems that do not store data involves archiving documentation and removing hardware and software. For systems that do store data, the focus is on maintaining the integrity of electronic records during decommissioning. The importance of evaluating, planning, and controlling system retirement activities to ensure regulatory compliance and data integrity is emphasized.", "excerpt_keywords": "ISPE, Validation, Laboratory, Computerized Systems, System Retirement"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## page 62\n\nsystem retirement should provide an organization with a process that defines how records will be retained and retrieved during the required record retention period. the system retirement plan describes the documentation and controls, including verification activities, needed to allow an organization to retain and retrieve electronic records in compliance with any applicable regulations. a system retirement report should be generated to summarize the results of retirement activities and to provide any requirements that will be needed to monitor and control subsequent retirement activities. the organization should have documented procedures for the decommissioning or retirement of a system.\n\nretirement planning and related activities are typically completed when it is determined that a gxp computerized laboratory system will no longer be used for gxp related purposes. however, processes and controls implemented during earlier validation phases may also impact the scope of system retirement activities. for example, a well-defined and verified process to assure that electronic records generated by the system have been backed-up and archived during the life of system operation may impact retirement activities. procedures and controls verifying that backed-up or archived records can be restored may also impact the activities that occur during system retirement.\n\ndata migration activities, when needed based upon a risk assessment, to assure that electronic records, including metadata, may be converted or migrated to formats that may be read and processed by other software applications. in cases where the technology does not support the migration to electronic formats the data may need to be migrated to another (\"true copy\") format such as paper that preserves content and meaning.\n\nsystem retirement planning should be completed prior to the system being retired or replaced. several events may initiate the need for retirement planning, including, but not limited to, the following:\n\n- when a system is no longer needed or will be replaced by a different system.\n- when a software upgrade is contemplated.\n- retirement activities may be considered as early as during system purchase.\n\n## system retirement plan\n\nthe activities necessary to retire a system should be defined in a formal system retirement (or decommissioning) plan according to organizational procedures. the retirement plan should include the following sections:\n\n1. introduction: a section describing the purpose and history of the system, including the types of electronic records (including associated required metadata) generated by the system.\n2. responsibilities: this section describes the system owner, user groups, and other functional areas such as information technology that are responsible for system retirement activities.\n3. retirement activities: this section should be based upon the system retirement sop and describes the activities necessary to retire the system. such activities will include, but may not be limited to:", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "d24b1304-5c2b-4c47-8a67-0310b81b97f3": {"__data__": {"id_": "d24b1304-5c2b-4c47-8a67-0310b81b97f3", "embedding": null, "metadata": {"page_label": "34", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation and Retirement of Laboratory Computerized Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the ISPE Validation of Laboratory Computerized Systems 2005 guide propose to categorize laboratory computerized systems for validation efforts, and what criteria does it suggest for scaling these efforts?\n   \n2. What specific responsibilities are outlined in the ISPE guide for the development, completion, and monitoring of system retirement activities in the context of laboratory computerized systems?\n\n3. According to the ISPE Validation of Laboratory Computerized Systems 2005 guide, what are the recommended procedures and considerations for the destruction of electronic records and supporting documentation after the record retention period expires in the context of retiring laboratory computerized systems?", "prev_section_summary": "The section discusses the importance of system retirement planning in ensuring compliance with regulations and outlines the documentation and controls needed for retaining and retrieving electronic records during the retirement process. It emphasizes the need for a formal system retirement plan that includes sections such as introduction, responsibilities, and retirement activities. The entities involved in system retirement activities include the system owner, user groups, and information technology departments. Data migration activities and the impact of validation phases on retirement activities are also highlighted in the excerpt.", "excerpt_keywords": "Validation, Laboratory Computerized Systems, System Retirement, Electronic Records, Data Integrity"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## validation of laboratory computerized systems\n\n18.2 system retirement report\n\nthe system retirement report should include the following sections:\n\n- introduction\n- a section describing the purpose of the document and its relationship to the system retirement. a brief summary of the validation of laboratory computerized systems. these systems typically consist of integrated hardware and software that may not be sufficiently differentiated by the current gamp software categories to allow appropriate scaling of the validation efforts.\n- this guidance proposes to further categorize laboratory computerized systems based upon system complexity and intended use.\n- responsibilities\n- a section summarizing the functional areas responsible for development of the retirement report, completion of the retirement activities, and monitoring of subsequent retirement activities.\n- the extent of validation of laboratory computerized systems should be commensurate with the risks to the data associated with the use of the system. the purpose of performing a risk assessment during the validation process is to identify potential risks to data integrity, patient safety, product quality, or to the organizations business as a result of the systems failure.\n- record retention and destruction statement\n- a clear statement of how long the electronic records and supporting documentation are required to be retained, when they may be destroyed, and who is responsible for approving record destruction after the record retention period expires.\n- supporting documentation used to support system retirement activities, including the system retirement plan and report, may also be destroyed in accordance with a companys internal requirements for record systems design or construction.\n- summary of retirement activities\n- this section summarizes the results of system retirement activities completed as described by the system retirement plan. it includes identification of the hardware, software, media, environmental requirements, and storage location necessary to store the records for the required record retention time period.\n- it also includes an index of existing documentation collected or referenced that supports system validation, operation, and retirement activities.\n- a summary of data migration activities, the documentation generated to address specific requirements, and any follow-up recommendations or processes required to support system retirement activities.\n\nthe retirement phase is the last phase of the system life cycle. activities such as maintenance of environmental controls for storage media, verification of storage media lifespan, and training of new personnel on restoration procedures will continue throughout the record retention period. deletion or destruction of electronic records following the expiration of the record retention period should be conducted according to a defined and approved process.\n\nverification of any archival and restoration procedures should occur to demonstrate that electronic records, including required metadata, can be restored and, if necessary, processed, reviewed, copied, and inspected during the required record retention period. successful completion of the retirement phase requires establishing documented evidence to demonstrate this.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "719a8161-5952-4827-a2aa-8146eb3aab7e": {"__data__": {"id_": "719a8161-5952-4827-a2aa-8146eb3aab7e", "embedding": null, "metadata": {"page_label": "35", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation and Documentation Requirements for Laboratory Computerized Systems", "questions_this_excerpt_can_answer": "1. How does the GAMP Good Practice Guide suggest categorizing laboratory computerized systems during the validation process, and what factors should influence the scaling of project deliverables?\n   \n2. What specific types of audits does the GAMP Good Practice Guide differentiate between in the context of validating laboratory computerized systems, and how does it suggest using these audits throughout the system's life cycle?\n\n3. According to the GAMP Good Practice Guide, how should changes to the requirements of a laboratory computerized system be managed post-system acceptance to ensure data integrity, product quality, and patient safety?", "prev_section_summary": "The section discusses the system retirement report for laboratory computerized systems, including the categorization of systems based on complexity and intended use, responsibilities for retirement activities, record retention and destruction, summary of retirement activities, and verification of archival and restoration procedures. Key entities mentioned include the system retirement report, validation of laboratory computerized systems, electronic records, supporting documentation, data migration activities, hardware, software, media, environmental requirements, storage location, and record retention period.", "excerpt_keywords": "GAMP Good Practice Guide, Validation, Laboratory Computerized Systems, Requirements, Traceability Matrix"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## page 66\n\ngamp good practice guide: validation of laboratory computerized systems\n\nprocess audits focus on determining if key processes supporting the quality system are operating in compliance with pre-defined standards.\n\nproduct audits focus on the measurable quality attributes of a product or service, without regard to the quality system or the processes that supported the production of the product.\n\nin practice, no supplier assessment is ever purely of one type or another, but it is helpful to consider them as distinct approaches to establish a model for selecting different audit emphasis at different points in the life cycle.\n\nonce a system has been identified, the laboratory computerized system categorization determined, the requirements finalized, the risk assessment performed and the supplier assessed, the validation team is in the position to identify the necessary deliverables for the project and to scale those deliverables based upon the information determined during the earlier stages.\n\ndespite the diversity of laboratory computerized systems, requirements should be written for all laboratory computerized systems. because these systems contain hardware and software components integrally linked, requirements should be included for both the hardware and software functions. additionally, the requirements should include any procedural controls that may be required by applicable regulations (e.g., gxps, 21 cfr part 11).\n\nclear, unambiguous, and explicitly testable or verifiable requirements are essential to the delivery of a validated system that meets the users needs. the requirements capture all the necessary elements, functions, inputs, processing and outputs of the system. they describe what the system should do based solely on the systems intended use.\n\nthough often merged for laboratory computerized systems, the requirements can be split into user requirements specifications (what the system must do) and functional specifications (how the system will function). the requirements should take into consideration and define the intended use of the system. the complexity and size of the requirements documentation should be proportional to the complexity and size of the system being developed or validated. requirements documentation should be under document change control procedures. updates made after system acceptance should be tracked within the document but should also be linked to a system change control process. changes to the requirements should be traceable to the corresponding changes in the requirements, functional specification (fs) or design specifications (ds) (if applicable) and to the testing. changes to the requirements should lead to a new version of the traceability matrix.\n\nthe ds is the blueprint to create systems that meet requirements specifications and fs. the ds is the responsibility of the developer or supplier. for laboratory computerized systems categorized as for g, a ds should exist for the custom functions of the system. the design specifications should address each requirement and functional specification. the complexity and size of design documentation should be proportional to that of the systems being developed.\n\nthe traceability matrix is an important part of the validation process. this document shows the relationship between the requirements, functional specifications, design specifications, and testing. review of this document ensures that all requirements have the appropriate documentation and testing or verification.\n\nin summary, a pragmatic approach is presented that can be applied to laboratory computerized systems. this overall philosophy is intended to encourage the use of innovation and technological advances while avoiding unacceptable risk to data integrity, product quality, and patient safety.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "d6d085da-2eec-4dca-b532-dae434db405e": {"__data__": {"id_": "d6d085da-2eec-4dca-b532-dae434db405e", "embedding": null, "metadata": {"page_label": "36", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "System Impact Assessment: Appendices and References", "questions_this_excerpt_can_answer": "1. What specific appendices are included in the \"System Impact Assessment\" section of the ISPE Validation of Laboratory Computerized Systems 2005 document, and how are they organized in terms of content and page numbers?\n\n2. How does the ISPE Validation of Laboratory Computerized Systems 2005 guide propose to assess the impact of laboratory computerized systems, prioritize testing, and evaluate suppliers, as detailed in its appendices?\n\n3. What resources or references does the ISPE Validation of Laboratory Computerized Systems 2005 document provide for understanding terminology and concepts related to the validation of laboratory computerized systems, as indicated in its appendices?", "prev_section_summary": "The section discusses the validation and documentation requirements for laboratory computerized systems according to the GAMP Good Practice Guide. Key topics include categorizing systems, auditing processes, managing changes post-acceptance, writing requirements, creating design specifications, and using traceability matrices. Entities mentioned include validation teams, suppliers, hardware, software, procedural controls, user requirements specifications, functional specifications, design specifications, and traceability matrices. The overall philosophy is to encourage innovation while ensuring data integrity, product quality, and patient safety.", "excerpt_keywords": "ISPE, Validation, Laboratory, Computerized Systems, Impact Assessment"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n# page 68\n\n|content|page number|\n|---|---|\n|appendix 1 determining system impact| |\n|appendix 2 testing priority| |\n|appendix 3 supplier assessment scheme| |\n|appendix 4 glossary| |\n|appendix 5 references| |", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "a94b11ba-7671-4b2e-b653-76ea90e21617": {"__data__": {"id_": "a94b11ba-7671-4b2e-b653-76ea90e21617", "embedding": null, "metadata": {"page_label": "37", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation and Impact Assessment of Laboratory Computerized Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. How does the ISPE Validation of Laboratory Computerized Systems 2005 guide propose to classify systems based on their impact, and what criteria are used for this classification?\n   \n2. What examples of business risk are identified in the ISPE Validation of Laboratory Computerized Systems 2005 guide, specifically within section 4.2.2 in appendix m3 of GAMP 4, and how do these risks relate to a laboratory setting?\n\n3. How does the guide suggest plotting business impact against laboratory computerized systems categorization to determine the system's impact, and what does the resulting matrix indicate about the extent of validation effort required?", "prev_section_summary": "The section titled \"System Impact Assessment: Appendices and References\" in the ISPE Validation of Laboratory Computerized Systems 2005 document includes specific appendices such as determining system impact, testing priority, supplier assessment scheme, glossary, and references. These appendices provide guidance on assessing the impact of laboratory computerized systems, prioritizing testing, evaluating suppliers, understanding terminology, and referencing key concepts related to validation. The content is organized by page numbers, with each appendix addressing a different aspect of system validation and assessment.", "excerpt_keywords": "ISPE, Validation, Laboratory Computerized Systems, Impact Assessment, GAMP"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## appendix 1\n\nvalidation of laboratory computerized systems\n\nimpact assessment allows the selection of the appropriate approach to risk management for the system. systems should be classified as one of high, medium, or low impact, based upon consideration of the systems business risk, the systems gxp risk, and the laboratory computerized systems categorization.\n\nbusiness risk is an assessment of the effect of a system failure on the ability of the business to meet its commitments. examples of business risk are listed within section 4.2.2 in appendix m3 of gamp 4, and include corporate reputation, brand recognition, and risk to equipment.\n\nin a laboratory setting data integrity issues may lead to:\n\n- the loss of a clinical or preclinical study\n- the inability to release a product\n- financial loss resulting from product recall\n\ngxp risk is related to the use of the system in relation to the entire product from initial development through manufacture. examples of gxp risk to be considered are listed within section 4.2.1 in appendix m3 of gamp 4, and include the integrity of laboratory results, the safety of patients and consumers, the pharmaceutical quality of the finished product, and other regulatory concerns.\n\nonce established, the business impact may be plotted against the laboratory computerized systems categorization. the resulting matrix provides a method to determine the systems impact. the extent of the validation effort becomes greater as a function of increasing system complexity and increasing business impact.\n\nfigure a1.2: system impact laboratory system categorization\n\n|a|b|c|d|e|f|g|\n|---|---|---|---|---|---|---|\n|low impact|medium impact|high impact| | | | |\n|1|1|1|1|1|1|1|\n|2|1|1|1|1|1|1|\n|3|1|1|1|1|1|1|\n|4|1|1|1|1|1|1|\n|5|1|1|1|1|1|1|\n\nqualitative assessments of the business risk (low, medium, high) and gxp risk (low, medium, high) when plotted against each other provide five levels of business impact, represented as a numerical value. a higher business impact number indicates a business and/or gxp risk that is less acceptable without mitigation.\n\nfigure a1.1: business impact gxp risk\n\n| |business impact|gxp risk|\n|---|---|---|\n|0| |low|\n| | |medium|\n| | |high|\n| | |very high|", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "34b8818a-57df-4647-b1e7-6596c44740f4": {"__data__": {"id_": "34b8818a-57df-4647-b1e7-6596c44740f4", "embedding": null, "metadata": {"page_label": "38", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "\"Blank Canvas: A Collection of Diverse Entities\"", "questions_this_excerpt_can_answer": "Given 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 are the specific guidelines or best practices outlined in the \"ISPE Validation of Laboratory Computerized Systems 2005\" document for validating laboratory computerized systems within the pharmaceutical industry?\n\n2. How does the document titled \"Blank Canvas: A Collection of Diverse Entities\" relate to the content found in the \"ISPE Validation of Laboratory Computerized Systems 2005\" PDF, and what unique insights or perspectives does it offer on the subject of laboratory computerized system validation?\n\n3. Given the document's creation and last modified dates in 2024, what are the most recent updates or changes made to the \"ISPE Validation of Laboratory Computerized Systems 2005\" guidelines as reflected in this version, and how do these updates align with current trends or advancements in pharmaceutical laboratory practices?\n\nThese questions are tailored to extract unique information from the document based on its title, content type, and the specific context of its storage and modification dates, which suggests it may contain updated or specialized information on the topic of laboratory computerized system validation within the pharmaceutical industry.", "prev_section_summary": "The section discusses the validation and impact assessment of laboratory computerized systems, focusing on classifying systems based on their impact. It outlines the criteria for classification, including business risk and GXP risk, and provides examples of business risks such as corporate reputation and financial loss. The section also highlights the importance of plotting business impact against system categorization to determine the extent of validation effort required. The matrix provided helps in assessing the system's impact based on business and GXP risks.", "excerpt_keywords": "ISPE, Validation, Laboratory, Computerized Systems, Pharmaceutical Industry"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\nno_content_here", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "cfb60fe9-702c-4076-9078-2394c2610789": {"__data__": {"id_": "cfb60fe9-702c-4076-9078-2394c2610789", "embedding": null, "metadata": {"page_label": "39", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation of Laboratory Computerized Systems: Risk Classification, Test Priority, and Comprehensive Guidelines.", "questions_this_excerpt_can_answer": "1. How does the ISPE 2005 document propose to determine the test priority for validation of laboratory computerized systems based on risk classification and probability of detection?\n   \n2. What specific guidance does the ISPE 2005 document offer for establishing procedures to address hazards with a high likelihood of occurrence or low probability of detection during the validation of laboratory computerized systems?\n\n3. According to the ISPE 2005 document, how should the likelihood of an adverse event occurring due to systematic software faults be initially assessed, and under what conditions should its likelihood value be reassigned during the project progression?", "prev_section_summary": "The section provides metadata information about a document titled \"ISPE Validation of Laboratory Computerized Systems 2005\" stored in a PDF file. It highlights the document's creation and last modified dates in 2024, suggesting potential updates or changes to the guidelines for validating laboratory computerized systems in the pharmaceutical industry. The section also poses three specific questions that the document can answer, focusing on guidelines, the relationship with another document titled \"Blank Canvas: A Collection of Diverse Entities,\" and the alignment of updates with current trends in pharmaceutical laboratory practices.", "excerpt_keywords": "Validation, Laboratory Computerized Systems, Risk Classification, Test Priority, Hazard Mitigation"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## appendix 2\n\nvalidation of laboratory computerized systems\n\ntesting priority is determined by the combination of the risk classification and the probability of detection of a functionality failure or hazard condition. test priority is the tool used to focus or scale the validation testing effort and the establishment of controls. the test priority affords the validation team guidance on the extent of testing necessary to provide a high degree of assurance that the function consistently meets its predetermined specifications, or the hazard has been adequately mitigated.\n\nthe risk classification is obtained by plotting the criticality of the requirement, or effect of hazard, (high, medium, or low) against the risk likelihood (low, medium, or high) (see figure a2.1). procedures may need to be established to address hazards determined to have a high likelihood of occurrence.\n\n|risk classification|risk likelihood|\n|---|---|\n|high priority|level 1|\n|medium priority|level 2|\n|low priority|level 3|\n\na function assessed as being a risk classification of level three with a low probability of detection should be tested more rigorously than a function assessed as being a risk classification of level three with a high probability of detection.\n\nprocedures may need to be established to address hazards determined to have low probability of detection. during testing, the end user organization may revisit the test priority to determine mitigation strategies for failures encountered during testing. the re-assessment of test priority enables the end-user organization to assess, characterize, determine risk mitigation strategies for, or accept risks associated with system failures revealed during testing. these determinations should be documented and approved. the process of risk assessment should be an integral part of the life cycle of a system and should be reviewed as changes are made to the system.\n\nthe likelihood (frequency or probability) of an adverse event occurring should be determined. the likelihood of the adverse event occurring within a given time period or per a quantity of transactions should be estimated as low, medium, or high.\n\nin many instances adverse events may be as a result of systematic software faults and the team may be unable to estimate the likelihood of such an adverse event. in such instances, the likelihood default value of high should be assigned unless there is strong documentary evidence of a high-quality development process for the software under review. as the project progresses, and more information becomes available this value can be re-assigned, as required.\n\nthe test priority is obtained by plotting the risk classification (level i, level 2, or level 3) against the probability of detection of the functional failure or hazard (low, medium, or high) (see figure a2.2).", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "df89dbc9-905d-4859-9bf3-b6cf7195ceeb": {"__data__": {"id_": "df89dbc9-905d-4859-9bf3-b6cf7195ceeb", "embedding": null, "metadata": {"page_label": "40", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "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 Validation of Laboratory Computerized Systems 2005\" document as stored in the PharmaWise Engineer's PharmaWise CSV & Data Integrity raw data repository?**\n   - This question targets the specific detail of the file size (4617012 bytes) of the document within a particular storage location, which is a detail unlikely to be found in other sources.\n\n2. **What are the creation and last modified dates of the \"ISPE Validation of Laboratory Computerized Systems 2005\" PDF document as per its metadata in 2024?**\n   - This question seeks information on the document's metadata regarding its creation date (2024-04-07) and last modified date (2024-04-05), which are specific to this document's version and would not be available elsewhere, especially noting the future dates indicating a hypothetical or error scenario.\n\n3. **How is the document titled \"Blank Canvas: A Collection of Absence\" related to the \"ISPE Validation of Laboratory Computerized Systems 2005\" PDF in the PharmaWise Engineer's collection?**\n   - This question probes the relationship or relevance between the document title \"Blank Canvas: A Collection of Absence\" and the content or purpose of the \"ISPE Validation of Laboratory Computerized Systems 2005\" document within a specialized collection. The juxtaposition of a seemingly unrelated title with the document's content suggests there might be unique or contextual information provided in this collection that wouldn't be found elsewhere, especially considering the document title does not seem to match the expected content based on the file name.", "prev_section_summary": "The section discusses the validation of laboratory computerized systems, focusing on determining testing priority based on risk classification and probability of detection. It outlines how risk classification is determined by the criticality of requirements or hazard effects, and the likelihood of risks occurring. Procedures are recommended for addressing hazards with high likelihood of occurrence or low probability of detection. The document also emphasizes the importance of reassessing test priority during testing to mitigate failures and accept risks. Additionally, it highlights the assessment of the likelihood of adverse events and the default value assigned in the absence of sufficient evidence. The section provides guidance on establishing controls and documenting risk assessments throughout the system's life cycle.", "excerpt_keywords": "ISPE, Validation, Laboratory, Computerized Systems, Risk Classification"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\nno_content_here", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "f7c62155-98fe-48cc-8bbd-2680f6e43b95": {"__data__": {"id_": "f7c62155-98fe-48cc-8bbd-2680f6e43b95", "embedding": null, "metadata": {"page_label": "41", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Supplier Data Integrity Risk Assessment Framework", "questions_this_excerpt_can_answer": "1. What are the three dimensions of risk that the ISPE Validation of Laboratory Computerized Systems 2005 document identifies as affecting data integrity in the context of supplier assessment?\n   \n2. How does the document categorize laboratory computerized systems for the purpose of determining the extent of supplier assessment necessary, and what are the specific stages of supplier assessment outlined?\n\n3. According to the document, under what circumstances is no assessment of a supplier considered necessary, and what are the key activities involved in the preliminary assessment stage?", "prev_section_summary": "The key topics of this section include the file details of the \"ISPE Validation of Laboratory Computerized Systems 2005\" document, such as its file size, creation date, and last modified date. Additionally, the section discusses the relationship between the document title \"Blank Canvas: A Collection of Absence\" and the content of the ISPE document within the PharmaWise Engineer's collection. The juxtaposition of these titles suggests a unique or contextual connection that may provide specialized information not found elsewhere.", "excerpt_keywords": "ISPE, Validation, Laboratory Computerized Systems, Data Integrity, Supplier Assessment"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## appendix 3\n\nthis appendix describes a supplier assessment scheme based upon the three dimensions of risk that affect data integrity: technical complexity, business risk, and gxp risk. as described in appendix i, the business impact may be plotted against the laboratory computerized systems categorization (see figure a3.1), to determine the extent of supplier assessment necessary.\n\n|stages of supplier assessment|\n|---|\n|laboratory system categorization|\n|a|b|c|d|e|f|g|\n|0|1|1|1|1|1|1|\n|0|2|1|1|1| | |\n|e|3|1|1|1| | |\n| |4|1|1|1| | |\n| |5|1|1| | | |\n\nthis scheme defines three stages of supplier assessment:\n\n1. no assessment considered necessary\n2. preliminary assessment\n3. detailed audit\n\nonce any stage is performed, the assessment can proceed to the next stage if it is determined that more information is necessary to make informed decisions. however, it may be determined that a later stage assessment be conducted immediately, or that an assessment is not required.\n\nthe decision whether a supplier assessment should be performed and at what stage should be documented. organizations should also have documented procedures.\n\n### no assessment considered necessary\n\nno assessment is considered necessary for systems where the risks to data integrity associated with use of the system are minimal and the ability to verify system functionality within the laboratory is considered adequate.\n\n### preliminary assessment\n\nthe preliminary assessment stage requires contacting the supplier for information concerning their quality management practices. as described in gamp 4, this stage aims to gather enough information to make an initial evaluation of the suitability of prospective suppliers. this stage may be called:\n\n- request for information (rfi)\n- pre-audit questionnaire", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "504ed09f-bb03-4a0d-ad4c-7f00368b871a": {"__data__": {"id_": "504ed09f-bb03-4a0d-ad4c-7f00368b871a", "embedding": null, "metadata": {"page_label": "42", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Supplier Assessment and Quality Assurance for Laboratory Computerized Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What specific criteria should be used to evaluate a supplier's quality system during the initial audit of customized laboratory computerized systems categorized as categories F and G, and how does this evaluation impact the selection process?\n\n2. How does the guidance provided in the document differentiate the necessity and scope of supplier assessments for laboratory computerized systems across categories A through G, particularly in terms of the business impact and technical complexity of the systems?\n\n3. What are the recommended approaches and focuses for conducting product audits on laboratory computerized systems that already exist (categories C, D, and E) prior to purchase, and how should compliance with 21 CFR Part 11 be addressed during these audits?", "prev_section_summary": "The section discusses the Supplier Data Integrity Risk Assessment Framework outlined in the ISPE Validation of Laboratory Computerized Systems 2005 document. It identifies three dimensions of risk affecting data integrity: technical complexity, business risk, and GxP risk. The document categorizes laboratory computerized systems to determine the extent of supplier assessment needed, with three stages outlined: no assessment necessary, preliminary assessment, and detailed audit. The decision on whether to perform a supplier assessment and at what stage should be documented, with organizations required to have documented procedures. The preliminary assessment stage involves contacting the supplier for information on their quality management practices to evaluate their suitability as prospective suppliers.", "excerpt_keywords": "Supplier Assessment, Quality Assurance, Laboratory Computerized Systems, Customized Systems, Product Audits"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## appendix 3\n\n|phase/lab system categorization|purchased|customized|\n|---|---|---|\n|pre-purchase|pre-contract| |\n|post-purchase|pre-development| |\n| |development/test| |\n| |maintenance| |\n\nfor customized systems, laboratory computerized systems categorized as categories f and g, the key output of the initial audit is an evaluation of the suppliers quality system that should be a major factor in the selection process.\n\nwhen custom projects have entered development and testing, the assessment should provide insight into how well the developer is adhering to pre-established quality systems and procedures.\n\nas with any quality assessment, it is useful to provide the supplier with an agenda in advance of the assessment to ensure that needed documentation can be organized for review and that key people will be available to respond to questions. non-disclosure agreements are often required to ensure the open sharing of information.\n\nproduct audits can normally be conducted in a day or less. generally, a minimum of one day is required for system and process audits, often more if the system provided by the supplier is customized and extensive in scope. follow-up audits can be performed to monitor progress on issues raised in the detailed audit or to examine supplier support and change control systems.\n\nit is unrealistic and not necessary to conduct all of the audits shown in figure a3.2 for every system, but multiple audits may be required based upon the complexity of the system and duration of the project and the relationship. for example, for customized systems (categories f and g), product audits in the maintenance phase may be omitted, especially if there have been no software maintenance updates or changes to the system.\n\nthis guidance proposes that for laboratory computerized systems categorized as categories a or b, there is no risk to the use of the system or the data created by the system if a supplier assessment is not performed. due to the characteristics of these systems, the assurance of their proper function can be and is on a regularly scheduled basis (calibration) demonstrated and documented by the users.\n\nfor laboratory computerized systems categorized as categories c, d, e, or f, the determination of the need for performing a supplier assessment is based upon the business impact of the system and the technical complexity of the system. these decisions need to be documented according to established policies and procedures. for laboratory computerized systems categorized as g, custom or bespoke systems, a detailed audit should be performed to ensure that the system will meet their technical, commercial, and regulatory requirements. the focus of this audit (product, process, or system) will depend upon the timing of the audit in relation to the implementation life cycle.\n\nfor laboratory computerized systems categories c, d, and e, the computerized system already exists, therefore, information about the suppliers quality system and supporting processes are less actionable than quantifiable data about the actual quality of the product. as a result, initial assessments conducted prior to purchasing the system should emphasize the product audit approach. this audit should focus on the thoroughness and adequacy of the suppliers testing program, the degree to which systems defects were discovered and corrected, and the number and severity of post-release defect reports. compliance with 21 cfr part 11 should also be addressed at this time. after these systems have been purchased, it is appropriate to conduct quality system assessments of suppliers for which a long-term relationship is expected. the reason for this is that these types of audits are most likely to drive improvements in the suppliers quality system, which will directly impact the quality of future releases of their product.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "fc6b111b-8e21-4aa3-9ec5-15f46358f355": {"__data__": {"id_": "fc6b111b-8e21-4aa3-9ec5-15f46358f355", "embedding": null, "metadata": {"page_label": "43", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "\"Blank Canvas: Exploring the Absence of Content in Art and Design\"", "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 Validation of Laboratory Computerized Systems 2005\" document as stored in the PharmaWise Engineer's PharmaWise CSV & Data Integrity raw data repository?**\n   - This question is specific to the document's storage details within a particular repository, which is unlikely to be found in other sources. The context directly provides the file size as 4617012 bytes.\n\n2. **What are the creation and last modification dates of the document titled \"Blank Canvas: Exploring the Absence of Content in Art and Design\" found within the ISPE Validation of Laboratory Computerized Systems 2005 PDF?**\n   - The context uniquely specifies the creation and last modification dates (April 7, 2024, and April 5, 2024, respectively) of a document that, based on its title, seems unrelated to the expected content, suggesting a possible error or an interesting case of content mislabeling or repurposing.\n\n3. **How is the document \"ISPE Validation of Laboratory Computerized Systems 2005\" incorrectly titled or mislabeled in the PharmaWise Engineer's raw data repository, based on the document's title and content excerpt provided?**\n   - This question delves into the discrepancy between the expected content of a document concerning ISPE guidelines on validating laboratory computerized systems and the provided document title and excerpt, which suggest a focus on art and design. The context uniquely positions someone to explore issues of document management, labeling, and content expectation versus reality within this specific repository.\n\nThese questions leverage the detailed metadata and the apparent content mismatch provided in the context, focusing on specifics that would be challenging to ascertain without access to this particular document's metadata and storage details.", "prev_section_summary": "The section discusses the evaluation of supplier quality systems for laboratory computerized systems, categorized from A to G, during initial audits and throughout the development and testing phases. It emphasizes the importance of supplier assessments based on the business impact and technical complexity of the systems. The guidance provided differentiates the necessity and scope of audits for various system categories, with a focus on product audits for existing systems (categories C, D, and E) prior to purchase. Compliance with 21 CFR Part 11 is also addressed during these audits. The section highlights the need for detailed audits for customized systems (categories F and G) to ensure they meet technical, commercial, and regulatory requirements. Follow-up audits are recommended to monitor progress and drive improvements in supplier quality systems.", "excerpt_keywords": "Keywords: ISPE, Validation, Laboratory Computerized Systems, Supplier Quality Systems, Audits"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\nno_content_here", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "09c61c7d-dabf-4c82-9b62-aec475953684": {"__data__": {"id_": "09c61c7d-dabf-4c82-9b62-aec475953684", "embedding": null, "metadata": {"page_label": "44", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Laboratory Computerized Systems Validation Glossary and Guidelines", "questions_this_excerpt_can_answer": "1. How does the ISPE 2005 document define the term \"impact\" within the context of laboratory computerized systems validation, and what are the criteria for categorizing systems as high, medium, or low impact according to the GAMP philosophy?\n\n2. What specific criteria does the ISPE 2005 document provide for distinguishing between \"disaster\" and \"disaster recovery\" in the context of laboratory computerized systems, and how does it describe the proactive and reactive nature of business continuity planning versus disaster recovery planning?\n\n3. According to the ISPE 2005 document, what are the essential components and considerations involved in \"change control\" for maintaining the validated status of laboratory computerized systems, and how does it differentiate between \"logical access\" and \"interface\" in the context of system security and user interaction?", "prev_section_summary": "The key topics of this section include document storage details, file size, creation and modification dates, document labeling, and content mismatch. The entities mentioned are the document \"ISPE Validation of Laboratory Computerized Systems 2005,\" the document titled \"Blank Canvas: Exploring the Absence of Content in Art and Design,\" and the PharmaWise Engineer's PharmaWise CSV & Data Integrity raw data repository. The section highlights discrepancies in document content and labeling, prompting questions about document management and content accuracy within the repository.", "excerpt_keywords": "ISPE, Laboratory Computerized Systems, Validation, GAMP philosophy, Change Control"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n# validation of laboratory computerized systems\n\n## appendix 4\n\nglossary\n1. definitions\n\n|acceptance test (ieee)|testing conducted to determine whether or not a system satisfies its acceptance criteria and to enable the customer to determine whether or not to accept the system.|\n|---|---|\n|application software (iso)|software or a program that is specific to the solution of an application problem.|\n|assessment|investigation of processes, systems, or platforms by a subject matter expert or it quality.|\n|audit|systematic, independent, and documented process for obtaining evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled.|\n|business continuity planning|the act of planning for the continued operation of the laboratory in the event of a known adverse event occurring by identifying in advance additional redundant capacity in case a critical system fails.|\n|change control|a formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect a validated status.|\n|computerized system|all of the computers with their associated hardware, software, and documentation needed to satisfy specific user requirements, e.g., laboratory information management system.|\n|disaster|1. any accidental, natural, or malicious event which threatens or disrupts normal operations or services for sufficient time to affect significantly, or to cause failure of, the company. 2. the sudden and unanticipated loss of use of one or more system due to an adverse event which may involve the recovery of any or all of the system components, i.e., hardware, software, or data. a disaster is an event that if unmitigated, will interrupt business processes which the system supports.|\n|disaster recovery|the act of planning for the restoration of systems and facilities after a major incident, for example, the loss of telecommunications, power, buildings, or major computing facilities. it is essentially a reactive process.|\n\ndesign qualification (dq): a documented review of the design, at an appropriate stage in the project, for conformance to operational and regulatory expectations.\n\nfirmware: software (firmware) embedded in hardware components.\n\nharm: physical injury or damage to the health of people, or damage to property or the environment.\n\nhazard: potential source of harm.\n\nimpact: measure of the possible consequences of loss or corruption of a system. gamp philosophy is to establish the impact for different types of systems as one of high impact, medium impact, or low impact.\n\nhigh impact systems or functions typically have a direct impact on data integrity, product quality, or patient safety.\n\nmedium impact systems or functions typically have an indirect impact on data integrity, product quality, or patient safety.\n\nlow impact systems or functions typically have negligible impact on data integrity, product quality, or patient safety.\n\ninfrastructure platform: all of the computers with their associated hardware, software, and networks used to run the business other than the business applications and associated data.\n\ninterface (ansi/ieee): a shared boundary to interact or communicate with another system component.\n\nit infrastructure: an aggregation of platforms and services including their associated processes, procedures, and personnel.\n\nlogical access: a user-based authentication access to a platform or application and the data that is processed. the logical access is provided via human or computerized interface with the system or platform.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "96437710-68ce-46ad-add7-7f530a1084b4": {"__data__": {"id_": "96437710-68ce-46ad-add7-7f530a1084b4", "embedding": null, "metadata": {"page_label": "45", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation and Risk Management in Laboratory Computerized Systems: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What specific criteria does the ISPE guide suggest for determining the frequency of periodic reviews for laboratory computerized systems?\n   \n2. How does the ISPE guide define the role of a supplier in the context of validation of laboratory computerized systems, and what standards are referenced in relation to supplier qualifications?\n\n3. What are the specific acronyms and their meanings related to quality control and regulatory standards in laboratory environments as outlined in the ISPE guide's appendix?", "prev_section_summary": "The section discusses key concepts related to the validation of laboratory computerized systems, including definitions of terms such as acceptance test, application software, assessment, audit, business continuity planning, change control, computerized system, disaster, disaster recovery, design qualification, firmware, harm, hazard, impact, infrastructure platform, interface, IT infrastructure, and logical access. It also explains the criteria for categorizing systems as high, medium, or low impact according to the GAMP philosophy, as well as the distinction between disaster and disaster recovery planning. The section provides insights into the essential components and considerations involved in change control for maintaining the validated status of laboratory computerized systems, and differentiates between logical access and interface in the context of system security and user interaction.", "excerpt_keywords": "ISPE, Validation, Laboratory Computerized Systems, Risk Management, Supplier"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## appendix 4\n\n|periodic review|validation of laboratory computerized systems|\n|---|---|\n|a documented assessment of the documentation, records, and performance of computer systems to determine if it is still in a validated state and what actions, if any, are necessary to restore its validated state. the frequency of review is dependent upon systems complexity, criticality, and rate of change.|supplier (iso) any organization or individual contracted directly by the customer to supply a product.|\n|quality assurance/control|testing (ieee) the process of exercising or evaluating a system or system component by manual or automated means to verify that it satisfies specified requirements or to identify differences between expected and actual results.|\n|quality management system (iso)|validation establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.|\n|risk|virus generic term for all the various types of malicious code that has been designed to breach a companys security requirements.|\n|risk analysis|acronyms aid - analogue/digital asqc - american society for quality control cds - chromatography data system cfr - code of federal regulations db - database dq - design qualification ds - design specification ecg - electrocardiogram fda - food and drug administration fs - functional specification gc - gas chromatography gcp - good clinical practices gdp - good distribution practice glp - good laboratory practice gmp - good manufacturing practice|\n|risk management|systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, and controlling risk.|\n|security (ieee)|the protection of computer hardware and software from accidental or malicious access, use, modification, destruction, or disclosure. security also pertains to personnel, data, communications, and the physical protection of computer installations.|\n|severity|measure of the possible consequences of a hazard.|", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "a9eb59a7-aa00-4796-8f4f-c3cffc376f31": {"__data__": {"id_": "a9eb59a7-aa00-4796-8f4f-c3cffc376f31", "embedding": null, "metadata": {"page_label": "46", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Abbreviations and Acronyms Reference Guide", "questions_this_excerpt_can_answer": "1. What does the abbreviation \"gxp\" encompass in the context of regulatory bodies' interests within the pharmaceutical industry, as defined in the ISPE Validation of Laboratory Computerized Systems 2005 guide?\n\n2. In the ISPE Validation of Laboratory Computerized Systems 2005 guide, how is \"hplc\" defined, and what does it stand for in the realm of laboratory technologies?\n\n3. According to the ISPE Validation of Laboratory Computerized Systems 2005 guide, what are the abbreviations and their corresponding full forms for the three stages of qualification mentioned in the document?", "prev_section_summary": "The section discusses the validation and risk management of laboratory computerized systems, as outlined in the ISPE guide. Key topics include periodic reviews, supplier qualifications, quality control standards, risk analysis, risk management, security measures, and acronyms related to quality control and regulatory standards in laboratory environments. The section provides definitions and explanations for terms such as periodic review, quality assurance/control, risk analysis, and security. It also lists acronyms such as ASQC, FDA, GMP, and GDP, along with their meanings in the context of laboratory computerized systems.", "excerpt_keywords": "ISPE, Validation, Laboratory, Computerized Systems, Abbreviations"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## appendix 4\n\n|gpg|good practice guide|\n|---|---|\n|gxp|aggregation of gcp, gmp, glp, gdp - often used for everything of interest for the regulatory bodies.|\n|hplc|high performance liquid chromatography|\n|id|identification|\n|iq|installation qualification|\n|ieee|institute of electrical and electronics engineers|\n|it|information technology|\n|lan|local area network|\n|lims|lab information management system|\n|min|minute|\n|ml|milliliter|\n|ms|mass spectrometers|\n|nir|near infrared|\n|nmr|nuclear magnetic resonance|\n|pcr|polymerase chain reaction|\n|oq|operational qualification|\n|pq|performance qualification|\n|qa|quality assurance|\n|rad|rapid application development|\n|rfi|request for information|\n|rs|requirements specification|\n|sdlc|system development life cycle|\n|silc|system implementation life cycle|\n|sla|service level agreement|", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "61607e2e-6313-4bc3-861b-aeb8f64d460f": {"__data__": {"id_": "61607e2e-6313-4bc3-861b-aeb8f64d460f", "embedding": null, "metadata": {"page_label": "47", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "\"Blank Canvas: A Collection of Diverse Entities\"", "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 are the key guidelines for validating laboratory computerized systems as outlined in the ISPE's 2005 publication?**\n   - This question seeks detailed information contained within the \"ISPE Validation of Laboratory Computerized Systems 2005\" document, which is likely to provide specific methodologies, principles, and case studies relevant to the validation of laboratory computerized systems as of 2005, a topic that may not be extensively covered in more general sources.\n\n2. **How has the approach to the validation of laboratory computerized systems evolved from 2005 to 2024, as evidenced by the creation and modification dates of the document?**\n   - Given the document's creation and last modification dates in 2024, this question probes into the updates or changes made to the original 2005 guidelines, reflecting on the evolution of practices, standards, and technological advancements in laboratory computerized system validation over nearly two decades.\n\n3. **What unique insights or case studies does the document titled \"Blank Canvas: A Collection of Diverse Entities\" provide regarding the practical application of ISPE's 2005 guidelines in laboratory settings?**\n   - This question focuses on the document's content, specifically looking for unique insights, case studies, or practical applications of the 2005 guidelines within the context of laboratory computerized systems validation. It assumes that the document, given its title, might compile a variety of perspectives or examples illustrating the guidelines' application in diverse settings or scenarios not commonly found in other sources.\n\nThese questions are designed to extract unique, detailed information from the document that would be difficult to find in other resources, leveraging the specific context provided about the document's focus, publication date, and content nature.", "prev_section_summary": "The section provides an Abbreviations and Acronyms Reference Guide from the ISPE Validation of Laboratory Computerized Systems 2005 document. It includes definitions for abbreviations such as gxp, hplc, id, iq, ieee, it, lan, lims, min, ml, ms, nir, nmr, pcr, oq, pq, qa, rad, rfi, rs, sdlc, silc, and sla. These abbreviations cover various aspects of laboratory technologies, qualifications, and regulatory bodies' interests within the pharmaceutical industry.", "excerpt_keywords": "ISPE, Validation, Laboratory, Computerized Systems, Guidelines"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\nno_content_here", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "bab1f3a0-1456-4851-b17d-1978dc86898a": {"__data__": {"id_": "bab1f3a0-1456-4851-b17d-1978dc86898a", "embedding": null, "metadata": {"page_label": "48", "file_name": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf", "file_type": "application/pdf", "file_size": 4617012, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Regulatory Guidelines for Validation and Compliance in Automated Systems: Ensuring Quality and Regulatory Compliance in Automated Systems", "questions_this_excerpt_can_answer": "1. What are the specific guidelines and standards referenced in the ISPE Validation of Laboratory Computerized Systems 2005 document for ensuring compliance and validation of automated systems in a laboratory setting?\n\n2. How does the ISPE Validation of Laboratory Computerized Systems 2005 document incorporate risk management principles in the validation of automated systems, particularly in relation to electronic records and signatures?\n\n3. Can you detail the international and regulatory frameworks, including FDA and PIC/S guidance, that the ISPE Validation of Laboratory Computerized Systems 2005 document aligns with for the validation of computerized systems in regulated \"GxP\" environments?", "prev_section_summary": "The section provides information about the ISPE's 2005 publication on the validation of laboratory computerized systems. It outlines key guidelines for validating these systems, discusses the evolution of validation approaches from 2005 to 2024, and hints at unique insights and case studies within the document titled \"Blank Canvas: A Collection of Diverse Entities.\" The section aims to extract specific and detailed information from the document that may not be readily available in other sources.", "excerpt_keywords": "ISPE, Validation, Laboratory Computerized Systems, Automated Systems, Regulatory Compliance"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[16] ISPE Validation of Laboratory Computerized Systems 2005.pdf\n## appendix 5\n\nreferences\n1. gamp 4, gamp guide for validation of automated systems, ispe (publishers), 2001.\n2. gamp good practice guide: a risk-based approach to compliant electronic records and signatures, ispe (publishers), 2005.\n3. guidance for industry part 11, electronic records; electronic signatures - scope and application (fda, sept 2003) (available at http://www.fda.gov/cder/guidance/5667fnl.pdf).\n4. iso 14971:2000 medical devices application of risk management to medical devices. the official web site for pe iso may be visited at http://www.iso.org.\n5. pic/s guidance on good practices for computerised systems in regulated \"gxp\" environments (pi 011-2) (available at www.picscheme.org).\n6. general principles of software validation; final guidance for industry and fda staff, (us food and drug administration, center for devices and radiological healp, january 2002) (available at http://www.fda.gov/cdrh/comp/guidance/938.html).\n7. guidance for industry part 11, electronic records; electronic signatures - scope and application (fda, sept 2003) (available at http://www.fda.gov/cder/guidance/5667fnl.pdf).\n8. japan mhlw \"guideline on control of computerized systems in drug manufacturing\" (bop in japanese and in english), notification no. 11 of compliance division of pharmaceutical affairs bureau, 21 february 1992.\n9. 31(1) pharmacopeial previews: <1058> analytical instrument qualification, pharmacopeial forum, volume 31(1), jan-feb 2005, pp. 233-243.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "e5b1f2e6-4915-44a5-911e-08c035b9aec0": {"__data__": {"id_": "e5b1f2e6-4915-44a5-911e-08c035b9aec0", "embedding": null, "metadata": {"page_label": "1", "file_name": "[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "file_type": "application/pdf", "file_size": 296295, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation of Computerised Systems in the General European OMCL Network (GEON) by the European Directorate for Quality of Medicines & Healthcare", "questions_this_excerpt_can_answer": "1. What is the legislative basis for the \"Validation of Computerised Systems in the General European OMCL Network (GEON)\" guideline as outlined by the European Directorate for Quality of Medicines & Healthcare?\n\n2. Can you detail the evolution or changes in the titles or references of the document related to the validation of computerised systems within the GEON from its first adoption to the latest revision in 2018?\n\n3. Who is the custodian responsible for the elaboration of the document titled \"Validation of Computerised Systems\" and its annexes, specifically focusing on the validation of complex computerised systems within the context of the OMCL network and the EDQM of the Council of Europe?", "excerpt_keywords": "Keywords: European Directorate, OMCL Network, Validation, Complex Computerised Systems, EDQM"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf\n## european directorate for the quality of medicines & healthcare\n\n## general european omcl network (geon)\n\n## quality management document\n\npa/ph/omcl (08) 88 r5\n\n|full document title|validation of computerised systems|\n|---|---|\n|and reference|annex 2 - validation of complex computerised systems|\n|document type|guideline|\n|legislative basis|-|\n|date of first adoption|may 2009|\n|date of original entry into force|july 2009|\n|date of entry into force of revised document|august 2018|\n|previous titles/other references / last valid version|validation of computerised systems|\n| |annex 2: validation of databases (db), laboratory information management systems (lims) and electronic laboratory notebooks (eln)|\n| |pa/ph/omcl (08) 88 r|\n|custodian|the present document was elaborated by the omcl network / edqm of the council of europe|\n|concerned network|geon|", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "d09a0fcf-8040-4491-ae81-e18556e69cdd": {"__data__": {"id_": "d09a0fcf-8040-4491-ae81-e18556e69cdd", "embedding": null, "metadata": {"page_label": "2", "file_name": "[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "file_type": "application/pdf", "file_size": 296295, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation of Complex Computerised Systems: User Requirements Specifications (URS) Document", "questions_this_excerpt_can_answer": "1. What specific criteria are recommended for inclusion in the User Requirements Specification (URS) for the validation of complex computerised systems according to the OMCL network guideline's annex 2?\n   \n2. How does the OMCL network guideline's annex 2 differentiate between mandatory requirements, recommendations, and non-binding possibilities in the context of validating complex computerised systems?\n\n3. What procedures are outlined in the OMCL network guideline's annex 2 for updating the User Requirements Specification (URS) document to ensure traceability and version control of changes in the validation process of complex computerised systems?", "prev_section_summary": "The section discusses the validation of computerised systems within the General European OMCL Network (GEON) by the European Directorate for Quality of Medicines & Healthcare. Key topics include the legislative basis for the guideline, the evolution of the document titles and references from its first adoption in 2009 to the latest revision in 2018, and the custodian responsible for the document's elaboration. Entities mentioned include the European Directorate for the Quality of Medicines & Healthcare, GEON, and the OMCL network/EDQM of the Council of Europe.", "excerpt_keywords": "Validation, Complex Computerised Systems, User Requirements Specification, OMCL Network Guideline, Traceability"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf\n## annex 2 of the omcl network guideline \"validation of computerised systems\"\n\n## validation of complex computerised systems\n\nnote: mandatory requirements in this guideline and its annexes are defined using the terms \"shall\" or \"must\". the use of \"should\" indicates a recommendation. for these parts of the text other appropriately justified approaches are acceptable. the term \"can\" indicates a possibility or an example with non-binding character.\n\n### 1. introduction\n\nthis is the 2nd annex of the core document \"validation of computerised systems\", and it should be used in combination with the latter when planning, performing and documenting the validation steps of complex computerised systems. excel spreadsheet validation is described in the 1st annex of the core document and not subjected here.\n\n### 2. user requirements specifications (urs)\n\nthe selection and purchase of new software and the associated computer and laboratory equipment should follow a conscious decision-making process based on the requirements for the intended use of the computerised system. a user requirements specification (urs) should describe the functional and technical requirements of the computerised system, as defined by the omcl, in terms of both software and hardware. it should also cover the aspects of information security and data integrity.\n\nsome of the items that can be included are:\n\na) description of pe software used (e.g. excel, access, oracle), including version;\nb) requirements on hardware components and operating system;\nc) description of functions;\nd) description of pe attributes of data;\ne) terminology (e.g. important especially for pe consistent description of input masks/fields);\nf) database design, including masks and fields as well as a map of pe data relationships;\ng) specifications of macros, formulas and control commands;\nh) specifications of pe data inputs (e.g. format, decimal places, units);\ni) specification of pe mandatory fields for data;\nj) specifications of pe protection of masks, working sheets or pe whole application;\nk) planning of pe data migration, if applicable;\nl) specifications for traceability of data entry and changes (audit trail) of interfaces to oper system components, if applicable.\n\nthe urs shall be released by a responsible person. changes to the requirements are possible but the changes should be traceable and the urs document should be version controlled or an equivalent system established in order to ensure traceability. new or changed requirements should be communicated to all persons involved.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "165767df-333e-48dc-9240-3ca266c1219d": {"__data__": {"id_": "165767df-333e-48dc-9240-3ca266c1219d", "embedding": null, "metadata": {"page_label": "3", "file_name": "[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "file_type": "application/pdf", "file_size": 296295, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Software Qualification and Testing in IT Environment: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What specific steps and documentation are recommended for ensuring the correct installation of a complex computerised system within an IT environment, as outlined in the \"Software Qualification and Testing in IT Environment: A Comprehensive Guide\"?\n\n2. How does the guide suggest verifying the proper functioning of software during the Operational Qualification (OQ) phase, especially in scenarios where known raw data sets are not available for comparison?\n\n3. What risk-based approach does the document recommend for repeating the Operational Qualification (OQ) process in the context of software and hardware updates or major changes within the IT environment of a complex computerised system?", "prev_section_summary": "The section discusses the validation of complex computerised systems according to the OMCL network guideline's annex 2. It outlines the criteria recommended for inclusion in the User Requirements Specification (URS), differentiates between mandatory requirements, recommendations, and non-binding possibilities, and provides procedures for updating the URS document to ensure traceability and version control. Key topics include the introduction to the annex, user requirements specifications, and the importance of describing functional and technical requirements, information security, and data integrity in the URS. Key entities mentioned are the responsible person releasing the URS, the need for traceability of changes, and communication of new or changed requirements to all involved parties.", "excerpt_keywords": "Software Qualification, Testing, IT Environment, Operational Qualification, Risk-based Approach"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf\n### installation qualification (iq)\n\nthe correct installation of the system in the it environment with defined hardware and operating software shall be documented and tested. detailed installation procedures should be available and carried out by well-trained personnel only.\n\nchecklists with predefined installation steps and acceptance criteria can ensure the correct installation of the system and the traceable qualification of the installation.\n\nin most cases, the computerised system is connected to a computer network with interfaces to other software (other applications) and hardware (computer equipment or laboratory equipment). it must be ensured that the system is correctly integrated and that all components are operative.\n\nthe iq typically includes:\n\n- a) a check of the required system resources both of the server and client, when applicable (e.g. supported operating system, database engine, performance of the processor, free space on the hard disk, memory, access rights for installations);\n- b) documentation of the components of the system (as a minimum, a description of the components and version of the relevant components with date of implementation);\n- c) list of users or user groups with access to the application, including type of access;\n- d) integration test and/or communication test for the interfaces to other systems/equipment.\n\noften the installation is supported by the supplier and the internal it unit.\n\n### operational qualification (oq)\n\nthe proper functioning of the software shall be checked by testing the key functions, e.g. calibration and quantification (internal standards, external standards), peak identification, and calculation of system suitability parameters.\n\nideally, a raw data set can be used for which the results are known. these raw data sets are often provided by the supplier of the software, are processed by the software and the results are then compared to the expected values.\n\nif no such data sets are available, example raw data sets can be acquired by running typical samples.\n\nthe results of the processed raw data sets should be verified by recalculating the key parameters (e.g. calibration curves from peak areas of standards) using standard (e.g., spreadsheet) software.\n\nraw data from the testing of functions affecting the measurement result and its associated measurement uncertainty (input and output data, screenshots) shall be documented within the qualification report.\n\noperational qualification should be repeated in a risk-based approach after installation of new software modules, new software versions, new service packs, patch updates, or after major changes in the software structure of the computer (e.g. new anti-virus software). a similar approach should be taken for every change in hardware platform or system upgrades.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}, "1debcfb7-f11f-4a67-bb33-fcf93d0cbafc": {"__data__": {"id_": "1debcfb7-f11f-4a67-bb33-fcf93d0cbafc", "embedding": null, "metadata": {"page_label": "4", "file_name": "[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf", "file_type": "application/pdf", "file_size": 296295, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Computerised System Performance Qualification, Release for Use, and Archiving Documentation", "questions_this_excerpt_can_answer": "1. What specific types of tests are recommended during the Performance Qualification (PQ) phase to ensure a computerised system meets its intended purpose according to the document \"Computerised System Performance Qualification, Release for Use, and Archiving Documentation\"?\n\n2. How should deviations from expected results during the Performance Qualification (PQ) of a computerised system be handled, as outlined in the document titled \"Computerised System Performance Qualification, Release for Use, and Archiving Documentation\"?\n\n3. What are the requirements for archiving documentation related to the specification and qualification of complex computerised systems, as specified in the document \"Computerised System Performance Qualification, Release for Use, and Archiving Documentation\"?", "prev_section_summary": "This section discusses the Installation Qualification (IQ) and Operational Qualification (OQ) processes for complex computerised systems within an IT environment. Key topics include the importance of documenting and testing the correct installation of the system, integration with other software and hardware components, and verification of system resources. The OQ phase involves testing key functions of the software, using known raw data sets for comparison when available, and documenting testing results. The section also emphasizes the need for a risk-based approach to repeating OQ after software or hardware updates, ensuring the proper functioning of the system in changing IT environments.", "excerpt_keywords": "Computerised System, Performance Qualification, Release for Use, Archiving, Validation, Documentation"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[27] PA-PH-OMCL (08) 88 R5 Annex 2 Validation of Complex Computerised Systems.pdf\n##### performance qualification (pq)\n\nthe aim of the performance qualification is to demonstrate that a computerised system is suitable for its intended purpose in the users own environment as defined in the urs. the user requirements shall be tested in the pq phase to cover the overall business use of the system in the daily routine.\n\nthe pq typically includes:\n\n- tests of functions (e.g. with a data set to ensure each feature of the application is tested);\n- negative or limit test (e.g. input of values outside the specified range);\n- test of alarm displays, if applicable (e.g. display of an oos result);\n- unauthorised input of data and access to the application;\n- tests of aberrant data (e.g. input of data in the wrong data format);\n- backup system and restore test;\n- verification of data migration, if applicable;\n- conformity with requirements of data protection, if applicable;\n- black box test as acceptance testing of the whole system.\n\neach test scenario should be traceable to the urs being tested and should describe the expected results, the acceptance criteria and the observed results. each deviation from the expected results and acceptance criteria must be discussed in the test report. a deviation can either lead to a change in the system and the test being run again or be accepted and documented with an update of the corresponding urs. raw data from the testing (input and output data, screenshots) shall be documented within the qualification report.\n\n##### release for use\n\na summary of all the test findings shall be presented in a validation report, including any deviation and the corrective actions taken. when all deviations are resolved or accepted, a formal release of the system is issued.\n\n##### archiving\n\nall documentation related to specification and qualification of complex computerised systems must be retained as long as the application is in use, plus a defined retention period covering all applicable archiving obligations. this obligation can be covered by a contract with the software provider.", "start_char_idx": null, "end_char_idx": null, "text_template": "{metadata_str}\n\n{content}", "metadata_template": "{key}: {value}", "metadata_seperator": "\n", "class_name": "TextNode"}, "__type__": "1"}}, "docstore/metadata": {"d0e27440-0a14-41f9-b91e-d4b0f66baf57": {"doc_hash": "4f5e6a1c2fd05884a1d7e8415622c9de0ca3c2d5b39a073b23fee0a59db8a7db"}, "51b62fb0-f240-4795-8d1d-9acdbd21cb98": {"doc_hash": 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