{"docstore/data": {"4865902c-e3eb-42e0-b65f-affccc6443ae": {"__data__": {"id_": "4865902c-e3eb-42e0-b65f-affccc6443ae", "embedding": null, "metadata": {"page_label": "1", "file_name": "[28] INVIMA Resoluci\u00f3n_3619 - GLP- 2013 5 Equipos procesadores de datos.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/Colombia/[28] INVIMA Resoluci\u00f3n_3619 - GLP- 2013 5 Equipos procesadores de datos.pdf", "file_type": "application/pdf", "file_size": 270770, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29", "document_title": "Requisitos para la gesti\u00f3n de calidad, equipos procesadores de datos y personal en laboratorios farmac\u00e9uticos.", "questions_this_excerpt_can_answer": "1. What specific guidelines does the document provide for ensuring the integrity and confidentiality of data collected, processed, recorded, reported, stored, or retrieved by computer systems, automated equipment, or calibration equipment in pharmaceutical laboratories?\n\n2. According to the document, what are the detailed recommendations for the validation of computerized systems in pharmaceutical manufacturing, as referenced in the appendix of the WHO expert committee report?\n\n3. How does the document outline the responsibilities of technical management in ensuring the competence of personnel operating specific equipment, instruments, or devices, and performing tests and/or calibrations, validations, or verifications in pharmaceutical laboratories?", "excerpt_keywords": "Quality management, Data processing equipment, Pharmaceutical laboratories, Validation, Personnel competence"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[28] INVIMA Resoluci\u00f3n_3619 - GLP- 2013 5 Equipos procesadores de datos.pdf\n#### 4.4. los registros de gestion de calidad deben incluir informes de auditorias internas (y externas, si fueran realizadas) y revisiones de la gestion asi como los registros de todas las quejas y sus investigaciones, incluyendo posibles acciones preventivas y correctivas.\n\n#### 5. equipos procesadores de datos\n\n5.1. recomendaciones detalladas son provistas en el apendice 5 del anexo 4 del cuadragesimo informe del comite de expertos de la oms en especificaciones para preparaciones farmaceuticas: guias suplementarias en buenas practicas de fabricacion: validacion. validacion de sistemas computarizados (12).\n\n5.2. para computadoras, equipos automatizados o de calibracion, y para la recoleccion, procesamiento, registro, informe, almacenamiento o recuperacion de datos de analisis y/o calibracion, el laboratorio debe asegurar que:\n\n- a) el programa informatico desarrollado por el usuario este documentado con suficiente detalle y apropiadamente validado o verificado para demostrar que es adecuado para el uso;\n- b) se establezcan e implementen procedimientos para proteger la integridad de los datos. tales procedimientos deben incluir, pero no se limitan a medidas para asegurar la integridad y confidencialidad del ingreso o recoleccion de datos y el almacenamiento, transmision y procesamiento de los datos. en particular, los datos electronicos deben estar protegidos contra el acceso no autorizado y debe mantenerse evidencia de cualquier enmienda;\n- c) las computadoras y equipos automaticos esten mantenidos para que funcionen correctamente y esten provistos con las condiciones operativas y ambientales necesarias para asegurar la integridad de los datos de ensayo y calibracion;\n- d) se establezcan e implementen los procedimientos para realizar, documentar y controlar los cambios de informacion almacenados en los sistemas computarizados; y\n- e) se realice una copia de seguridad de los datos electronicos a intervalos regulares apropiados, de acuerdo a un procedimiento documentado. los datos copiados deben ser recuperables y almacenados de manera de evitar la perdida de datos.\n\nnota: para pautas adicionales en la validacion de equipos procesadores de datos, referirse a los documentos publicados por la sociedad internacional de ingenieria farmaceutica (13,14), la administracion de alimentos y medicamentos de los estados unidos (15), la comision europea (16) y la red de laboratorios oficiales de control de medicamentos del consejo de europa (17).\n\n#### 6. personal\n\n6.1. el laboratorio debe tener suficiente personal con la educacion, capacitacion, conocimiento tecnico y experiencia necesaria para sus funciones asignadas.\n\n6.2. la gerencia tecnica debe asegurar la competencia de todas las personas que operan equipos especificos, instrumentos u otros dispositivos, y que realizan ensayos y/o calibraciones, validaciones o verificaciones. sus obligaciones incluyen tanto la evaluacion de resultados como la firma de los informes de analisis y certificados de analisis (ver parte tres, secciones 18.7-18.11 y 19).\n\ndisposiciones analizadas por avance juridico casa editorial ltda.(c)pagina 27 de 58", "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"}, "9c56d074-d765-4c0a-8c20-6432648a8f4d": {"__data__": {"id_": "9c56d074-d765-4c0a-8c20-6432648a8f4d", "embedding": null, "metadata": {"page_label": "1", "file_name": "[23] EMA Annex 11 Computerised Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[23] EMA Annex 11 Computerised Systems.pdf", "file_type": "application/pdf", "file_size": 22461, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29", "document_title": "Guidelines for Computerised Systems in Good Manufacturing Practice for Medicinal Products in the European Union: Ensuring Compliance and Quality Assurance", "questions_this_excerpt_can_answer": "1. What is the legal basis for publishing the detailed guidelines found in Annex 11 of the \"Guidelines for Computerised Systems in Good Manufacturing Practice for Medicinal Products in the European Union\"?\n   \n2. What prompted the revision of Annex 11 in the \"Guidelines for Computerised Systems in Good Manufacturing Practice for Medicinal Products in the European Union\"?\n\n3. By what date did the revised Annex 11 of the \"Guidelines for Computerised Systems in Good Manufacturing Practice for Medicinal Products in the European Union\" come into operation?", "excerpt_keywords": "European Commission, Good Manufacturing Practice, Medicinal Products, Computerised Systems, Directive 2001/83/EC"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[23] EMA Annex 11 Computerised Systems.pdf\n## european commission\n\n## health and consumers directorate-general\n\n## public health and risk assessment\n\n## pharmaceuticals brussels\n\neudralex sanco/c8/am/sl/ares(2010)1064599\n\n## the rules governing medicinal products in the european union\n\n## volume 4\n\n## good manufacturing practice\n\n## medicinal products for human and veterinary use\n\n## annex 11: computerised systems\n\nlegal basis for publishing the detailed guidelines: article 47 of directive 2001/83/ec on\nthe community code relating to medicinal products for human use and article 51 of directive\n2001/82/ec on the community code relating to veterinary medicinal products. this document\nprovides guidance for the interpretation of the principles and guidelines of good\nmanufacturing practice (gmp) for medicinal products as laid down in directive 2003/94/ec\nfor medicinal products for human use and directive 91/412/eec for veterinary use.\n\nstatus of the document: revision 1\n\nreasons for changes: the annex has been revised in response to the increased use of\ncomputerised systems and the increased complexity of these systems. consequential\namendments are also proposed for chapter 4 of the gmp guide.\n\ndeadline for coming into operation: 30 june 2011", "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"}, "2611e357-48e7-44d7-9173-43b81777aa5e": {"__data__": {"id_": "2611e357-48e7-44d7-9173-43b81777aa5e", "embedding": null, "metadata": {"page_label": "2", "file_name": "[23] EMA Annex 11 Computerised Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[23] EMA Annex 11 Computerised Systems.pdf", "file_type": "application/pdf", "file_size": 22461, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29", "document_title": "Guidelines for Computerised System Validation and Risk Management in GMP Regulated Activities", "questions_this_excerpt_can_answer": "1. What principles guide the application of risk management throughout the lifecycle of computerised systems in GMP regulated activities according to the EMA Annex 11 guidelines?\n   \n2. How does the EMA Annex 11 address the involvement and responsibilities of third parties, such as suppliers and service providers, in the context of computerised systems used in GMP regulated activities?\n\n3. What criteria and considerations are outlined in the EMA Annex 11 for the validation process of computerised systems within GMP regulated environments, particularly in relation to the project phase documentation and reports?", "prev_section_summary": "The section discusses the guidelines for computerised systems in Good Manufacturing Practice for Medicinal Products in the European Union, specifically focusing on Annex 11. The legal basis for publishing these guidelines is provided, citing directives related to medicinal products for human and veterinary use. The document is in revision 1 due to the increased use and complexity of computerised systems, with consequential amendments proposed for the GMP guide. The deadline for the revised Annex 11 to come into operation is 30 June 2011. Key entities mentioned include the European Commission, the Health and Consumers Directorate-General, and the Pharmaceuticals Brussels division.", "excerpt_keywords": "EMA Annex 11, Computerised Systems, Risk Management, GMP Regulated Activities, Validation"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[23] EMA Annex 11 Computerised Systems.pdf\n## commission europeenne, b-1049 bruxelles / europese commissie, b-1049 brussel - belgium\n\nprinciple telephone: (32-2) 299 11 11\n\nthis annex applies to all forms of computerised systems used as part of a gmp regulated activities. a computerised system is a set of software and hardware components which together fulfill certain functionalities. the application should be validated; it infrastructure should be qualified. where a computerised system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance. there should be no increase in the overall risk of the process.\n\n### general\n\n1. risk management\nrisk management should be applied throughout the lifecycle of the computerised system taking into account patient safety, data integrity and product quality. as part of a risk management system, decisions on the extent of validation and data integrity controls should be based on a justified and documented risk assessment of the computerised system.\n2. personnel\nthere should be close cooperation between all relevant personnel such as process owner, system owner, qualified persons and it. all personnel should have appropriate qualifications, level of access and defined responsibilities to carry out their assigned duties.\n3. suppliers and service providers\n1. when third parties (e.g. suppliers, service providers) are used e.g. to provide, install, configure, integrate, validate, maintain (e.g. via remote access), modify or retain a computerised system or related service or for data processing, formal agreements must exist between the manufacturer and any third parties, and these agreements should include clear statements of the responsibilities of the third party. it-departments should be considered analogous.\n2. the competence and reliability of a supplier are key factors when selecting a product or service provider. the need for an audit should be based on a risk assessment.\n3. documentation supplied with commercial off-the-shelf products should be reviewed by regulated users to check that user requirements are fulfilled.\n4. quality system and audit information relating to suppliers or developers of software and implemented systems should be made available to inspectors on request.\n\n### project phase\n\n1. validation\nthe validation documentation and reports should cover the relevant steps of the life cycle. manufacturers should be able to justify their standards, protocols, acceptance criteria, procedures and records based on their risk assessment.", "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"}, "88f29c14-e4ef-4b65-ae5f-b057fe58317d": {"__data__": {"id_": "88f29c14-e4ef-4b65-ae5f-b057fe58317d", "embedding": null, "metadata": {"page_label": "3", "file_name": "[23] EMA Annex 11 Computerised Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[23] EMA Annex 11 Computerised Systems.pdf", "file_type": "application/pdf", "file_size": 22461, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29", "document_title": "Best Practices for Computerized System Validation and Data Management", "questions_this_excerpt_can_answer": "1. What specific elements should validation documentation for computerized systems in a GMP environment include, particularly regarding change control and deviations observed during the validation process?\n\n2. How does the document recommend ensuring the integrity and accuracy of data when transferring it to another format or system, especially in the context of validation checks to prevent alteration in value and/or meaning?\n\n3. What are the recommended practices for securing stored data in computerized systems, including measures for data security, back-ups, and ensuring data accessibility, readability, and accuracy throughout the retention period?", "prev_section_summary": "The section discusses the principles of risk management in computerised systems used in GMP regulated activities according to EMA Annex 11 guidelines. It emphasizes the importance of validation, qualification of IT infrastructure, and ensuring no decrease in product quality or increase in process risk when transitioning from manual to computerised systems. The section also addresses the involvement and responsibilities of third parties, such as suppliers and service providers, in the context of computerised systems. It highlights the need for formal agreements, supplier competence, and documentation review. Additionally, the section outlines criteria for the validation process during the project phase, emphasizing the importance of justification based on risk assessment and the availability of quality system and audit information for inspectors.", "excerpt_keywords": "Computerized Systems, Validation Documentation, Data Integrity, Data Management, GMP Environment"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[23] EMA Annex 11 Computerised Systems.pdf\n#### validation documentation\n\nvalidation documentation should include change control records (if applicable) and reports on any deviations observed during the validation process.\n\n#### listing of relevant systems\n\nan up to date listing of all relevant systems and their gmp functionality (inventory) should be available. for critical systems, an up to date system description detailing the physical and logical arrangements, data flows and interfaces with other systems or processes, any hardware and software pre-requisites, and security measures should be available.\n\n#### user requirements specifications\n\nuser requirements specifications should describe the required functions of the computerized system and be based on documented risk assessment and gmp impact. user requirements should be traceable throughout the life-cycle.\n\n#### quality management system\n\nthe regulated user should take all reasonable steps to ensure that the system has been developed in accordance with an appropriate quality management system. the supplier should be assessed appropriately.\n\n#### validation of bespoke systems\n\nfor the validation of bespoke or customized computerized systems, there should be a process in place that ensures the formal assessment and reporting of quality and performance measures for all the life-cycle stages of the system.\n\n#### test methods and scenarios\n\nevidence of appropriate test methods and test scenarios should be demonstrated. particularly, system (process) parameter limits, data limits, and error handling should be considered. automated testing tools and test environments should have documented assessments for their adequacy.\n\n#### data validation\n\nif data are transferred to another data format or system, validation should include checks that data are not altered in value and/or meaning during this migration process.\n\n### operational phase\n\n#### data exchange\n\ncomputerized systems exchanging data electronically with other systems should include appropriate built-in checks for the correct and secure entry and processing of data to minimize risks.\n\n#### accuracy checks\n\nfor critical data entered manually, there should be an additional check on the accuracy of the data. this check may be done by a second operator or by validated electronic means. the criticality and potential consequences of erroneous or incorrectly entered data to a system should be covered by risk management.\n\n#### data storage\n\n7.1 data security: data should be secured by both physical and electronic means against damage. stored data should be checked for accessibility, readability, and accuracy. access to data should be ensured throughout the retention period.\n\n7.2 data back-ups: regular back-ups of all relevant data should be done. integrity and accuracy of back-up data and the ability to restore the data should be checked during validation and monitored periodically.", "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"}, "51df4e6d-658e-4a38-8217-01937b7c0499": {"__data__": {"id_": "51df4e6d-658e-4a38-8217-01937b7c0499", "embedding": null, "metadata": {"page_label": "4", "file_name": "[23] EMA Annex 11 Computerised Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[23] EMA Annex 11 Computerised Systems.pdf", "file_type": "application/pdf", "file_size": 22461, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29", "document_title": "\"Ensuring Compliance and Security in Computerised Systems\"", "questions_this_excerpt_can_answer": "1. What considerations should be made when implementing an audit trail for GMP-relevant changes in computerised systems according to the EMA Annex 11 guidelines?\n\n2. How does the EMA Annex 11 document suggest handling the security of computerised systems to ensure only authorised access, and what methods are recommended for preventing unauthorised entry?\n\n3. What are the specific expectations outlined in the EMA Annex 11 document regarding the use and characteristics of electronic signatures in the context of compliance and security within computerised systems?", "prev_section_summary": "The section discusses the importance of validation documentation for computerized systems in a GMP environment, including elements such as change control records and reports on deviations. It emphasizes the need for an up-to-date listing of relevant systems, user requirements specifications based on risk assessment, and the validation of bespoke systems. The section also covers test methods and scenarios, data validation during data transfer, data exchange with other systems, accuracy checks for manually entered data, and data storage practices including data security, back-ups, and ensuring data accessibility, readability, and accuracy throughout the retention period.", "excerpt_keywords": "EMA Annex 11, Computerised Systems, Compliance, Security, Audit Trail"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[23] EMA Annex 11 Computerised Systems.pdf\n## 8. printouts\n\n8.1 it should be possible to obtain clear printed copies of electronically stored data.\n\n8.2 for records supporting batch release it should be possible to generate printouts indicating if any of the data has been changed since the original entry.\n\n## 9. audit trails\n\nconsideration should be given, based on a risk assessment, to building into the system the creation of a record of all gmp-relevant changes and deletions (a system generated \"audit trail\"). for change or deletion of gmp-relevant data the reason should be documented. audit trails need to be available and convertible to a generally intelligible form and regularly reviewed.\n\n## 10. change and configuration management\n\nany changes to a computerised system including system configurations should only be made in a controlled manner in accordance with a defined procedure.\n\n## 11. periodic evaluation\n\ncomputerised systems should be periodically evaluated to confirm that they remain in a valid state and are compliant with gmp. such evaluations should include, where appropriate, the current range of functionality, deviation records, incidents, problems, upgrade history, performance, reliability, security and validation status reports.\n\n## 12. security\n\n12.1 physical and/or logical controls should be in place to restrict access to computerised system to authorised persons. suitable methods of preventing unauthorised entry to the system may include the use of keys, pass cards, personal codes with passwords, biometrics, restricted access to computer equipment and data storage areas.\n\n12.2 the extent of security controls depends on the criticality of the computerised system.\n\n12.3 creation, change, and cancellation of access authorisations should be recorded.\n\n12.4 management systems for data and for documents should be designed to record the identity of operators entering, changing, confirming or deleting data including date and time.\n\n## 13. incident management\n\nall incidents, not only system failures and data errors, should be reported and assessed. the root cause of a critical incident should be identified and should form the basis of corrective and preventive actions.\n\n## 14. electronic signature\n\nelectronic records may be signed electronically. electronic signatures are expected to:\n\na. have the same impact as hand-written signatures within the boundaries of the company,\n\nb. be permanently linked to their respective record,\n\nc. include the time and date that they were applied.", "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"}, "5fe796f0-3943-42e1-8ae6-24986e98f68c": {"__data__": {"id_": "5fe796f0-3943-42e1-8ae6-24986e98f68c", "embedding": null, "metadata": {"page_label": "5", "file_name": "[23] EMA Annex 11 Computerised Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[23] EMA Annex 11 Computerised Systems.pdf", "file_type": "application/pdf", "file_size": 22461, "creation_date": "2024-04-07", "last_modified_date": "2024-03-29", "document_title": "Computerised System Management and Compliance Guidelines", "questions_this_excerpt_can_answer": "1. What specific measures should be taken to ensure the integrity and accessibility of archived data when significant changes are made to a computerised system, according to the EMA Annex 11 guidelines?\n\n2. How does the EMA Annex 11 define the responsibilities of a \"system owner\" in the context of computerised system management and compliance within pharmaceutical manufacturing?\n\n3. What are the EMA Annex 11 guidelines' requirements for the certification and release of pharmaceutical batches using a computerised system, particularly regarding the use of electronic signatures?", "prev_section_summary": "The section covers important topics related to compliance and security in computerised systems, including printouts, audit trails, change and configuration management, periodic evaluation, security controls, incident management, and electronic signatures. Key entities mentioned include the need for clear printed copies of electronically stored data, the importance of audit trails for tracking GMP-relevant changes, the controlled management of system changes, the periodic evaluation of system validity and compliance, security controls to restrict access to authorised personnel, incident reporting and assessment, and the requirements for electronic signatures to have the same impact as handwritten signatures.", "excerpt_keywords": "Computerised system, Compliance guidelines, Pharmaceutical manufacturing, Electronic signatures, Data integrity"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[23] EMA Annex 11 Computerised Systems.pdf\n## batch release\n\nwhen a computerised system is used for recording certification and batch release, the system should allow only qualified persons to certify the release of the batches and it should clearly identify and record the person releasing or certifying the batches. this should be performed using an electronic signature.\n\n## business continuity\n\nfor the availability of computerised systems supporting critical processes, provisions should be made to ensure continuity of support for those processes in the event of a system breakdown (e.g. a manual or alternative system). the time required to bring the alternative arrangements into use should be based on risk and appropriate for a particular system and the business process it supports. these arrangements should be adequately documented and tested.\n\n## archiving\n\ndata may be archived. this data should be checked for accessibility, readability and integrity. if relevant changes are to be made to the system (e.g. computer equipment or programs), then the ability to retrieve the data should be ensured and tested.\n\n## glossary\n\n|application:|software installed on a defined platform/hardware providing specific functionality|\n|---|---|\n|bespoke/customized computerised system:|a computerised system individually designed to suit a specific business process|\n|commercial of the shelf software:|software commercially available, whose fitness for use is demonstrated by a broad spectrum of users.|\n|it infrastructure:|the hardware and software such as networking software and operation systems, which makes it possible for the application to function.|\n|life cycle:|all phases in the life of the system from initial requirements until retirement including design, specification, programming, testing, installation, operation, and maintenance.|\n|process owner:|the person responsible for the business process.|\n|system owner:|the person responsible for the availability, and maintenance of a computerised system and for the security of the data residing on that system.|\n|third party:|parties not directly managed by the holder of the manufacturing and/or import authorisation.|", "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"}, "3b51ceb5-d60b-4a17-8e08-8def1e3ae81f": {"__data__": {"id_": "3b51ceb5-d60b-4a17-8e08-8def1e3ae81f", "embedding": null, "metadata": {"page_label": "1", "file_name": "[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf", "file_type": "application/pdf", "file_size": 955603, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation of Computerised Systems in the European Directorate for the Quality of Medicines & Healthcare and General European OMCL Network (GEON): A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What is the legislative basis for the guideline titled \"Validation of Computerised Systems\" specifically related to the validation of Excel spreadsheets as outlined in the document from the European Directorate for the Quality of Medicines & Healthcare and the General European OMCL Network (GEON)?\n\n2. How has the title or reference of the guideline concerning the validation of computerised systems, particularly Excel spreadsheets, evolved over time according to the document provided by the European Directorate for the Quality of Medicines & Healthcare and the General European OMCL Network (GEON)?\n\n3. Who is the custodian responsible for the elaboration of the document titled \"Validation of Computerised Systems\" with a focus on Annex 1 - Validation of Excel Spreadsheets, and under which organisation's umbrella does this custodian operate as indicated in the provided context?", "excerpt_keywords": "Validation, Computerised Systems, Excel Spreadsheets, European Directorate, Quality Management"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.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) 87 r6\n\n|full document title|validation of computerised systems|\n|---|---|\n|and reference|annex 1 - validation of excel spreadsheets|\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 annex 1: validation of computerised calculation systems: example of validation of in-house software pa/ph/omcl (08) 87 2r|\n|custodian|the present document was elaborated by the omcl network / organisation 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"}, "46fed1e5-288b-4e72-aee4-3a3ea5db184f": {"__data__": {"id_": "46fed1e5-288b-4e72-aee4-3a3ea5db184f", "embedding": null, "metadata": {"page_label": "2", "file_name": "[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf", "file_type": "application/pdf", "file_size": 955603, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Best Practices for Validating and Securing Excel Spreadsheets", "questions_this_excerpt_can_answer": "1. What specific steps should be taken to ensure the security and integrity of validated Excel spreadsheets used for processing laboratory data, according to the OMCL network guideline annex on validation of computerised systems?\n\n2. How does the OMCL network guideline differentiate between mandatory requirements, recommendations, and possibilities or examples in the context of validating Excel spreadsheets?\n\n3. What are the documented procedures for the installation and maintenance of validated Excel spreadsheets to prevent unauthorized modifications, as outlined in the OMCL network guideline annex on validation of computerised systems?", "prev_section_summary": "The section discusses the validation of computerised systems, specifically focusing on Excel spreadsheets, as outlined in a document from the European Directorate for the Quality of Medicines & Healthcare and the General European OMCL Network (GEON). It provides information on the legislative basis, evolution of the guideline title, and the custodian responsible for the document. Key entities mentioned include the European Directorate for the Quality of Medicines & Healthcare, General European OMCL Network (GEON), and the custodian organization EDQM of the Council of Europe.", "excerpt_keywords": "Validation, Excel Spreadsheets, Security, Laboratory Data, OMCL Network"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf\n## annex 1 of the omcl network guideline\n\"validation of computerised systems\"\nvalidation of excel spreadsheets\n\nnote: mandatory requirements in this guideline and its annexes are defined using the terms\n\"shall\" or \"must\". the use of \"should\" indicates a recommendation. for these parts of the text\nother appropriately justified approaches are acceptable. the term \"can\" indicates a possibility or\nan example with non-binding character.\n\n### 1. introduction\n\nthis is the 1st annex of the core document \"validation of computerised systems\", and it should be\nused in combination with the latter when planning, performing and documenting the validation\nprocess of excel(r) spreadsheets used for the processing of laboratory data.\nthis annex presents an example of excel spreadsheet validation, which should be used in\ncombination with the general requirements and recommendations given in the core document.\n\n### 2. installation and security\n\nto guarantee that only the latest validated version of the spreadsheet is being used and to maintain\nthe validated state of the spreadsheet, all validated excel spreadsheets should be stored with read-only access rights for the end users (e.g., on a protected network share). only responsible persons\nshould have write access to the network share.\nend users should have no right to modify a validated spreadsheet, add a non-validated spreadsheet\nto the share, or save data on the share. end users should only have the right to fill in the (permitted)\ncells and to print the data or save a copy to a data repository if needed.\ninstallation shall be documented, e.g. in the validation file, in a system log book or on a qa form.\nthe name of the spreadsheet, unique identification, localization, and the person responsible for the\nspreadsheet shall be documented. the records shall also include verification, regular verification\nand other issues such as updates or any problem encountered. verification is completed after\ninstallation and recorded.\n\n### 3. good practices\n\nwhen setting up a new spreadsheet, following the good practices below will reduce the risk of\naccidental modifications of the template and erroneous data input:\n- all calculating cells shall be locked (format cells > protection > locked) in order to protect\ncells containing calculations against unintended modification, except those used for data\ninput.", "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"}, "50965ba4-9a99-49da-acd2-c245a4b9bd44": {"__data__": {"id_": "50965ba4-9a99-49da-acd2-c245a4b9bd44", "embedding": null, "metadata": {"page_label": "3", "file_name": "[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf", "file_type": "application/pdf", "file_size": 955603, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Excel Data Input and Validation Settings Guide", "questions_this_excerpt_can_answer": "1. How can Excel spreadsheets be configured to ensure data input cells are easily identifiable and protected from the introduction of aberrant values, according to the guidelines provided in the \"Excel Data Input and Validation Settings Guide\" from the document \"[29] PA-PH-OMCL (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf\"?\n\n2. What specific steps are recommended in the \"Excel Data Input and Validation Settings Guide\" for applying data validation rules to prevent incorrect data entry, and how can these settings be communicated to the end user through input and error alert messages?\n\n3. In the context of validating Excel spreadsheets for pharmaceutical development, as outlined in the document \"[29] PA-PH-OMCL (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf\", what are the detailed procedures for locking cells and hiding formulas to secure the worksheet, and how does this process contribute to the overall data integrity and compliance with regulatory standards?", "prev_section_summary": "This section discusses the validation of Excel spreadsheets according to the OMCL network guideline on the validation of computerised systems. It covers topics such as mandatory requirements, recommendations, and examples for ensuring the security and integrity of validated Excel spreadsheets used for processing laboratory data. The section emphasizes the importance of installation and security measures, such as storing validated spreadsheets with read-only access rights, documenting installation procedures, and implementing good practices to prevent accidental modifications and errors in data input. Overall, the section provides guidance on how to validate and secure Excel spreadsheets effectively in a laboratory setting.", "excerpt_keywords": "Excel, validation, data input, data integrity, pharmaceutical development"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf\n|content|page number|\n|---|---|\n|format cell:| |\n|number| |\n|alignment| |\n|font| |\n|border| |\n|locked| |\n|hidden| |\n|locking cells hiding formulas has no effect until you protect the worksheet (review tab changes group protect sheet button)| |\n|cells used for data input can be identified by a specific colour.| |\n|data validation rules (data tab > data validation) can be applied to data input cells to prevent the introduction of aberrant values. input messages and error alert messages can be used to inform the end user of the expected data type and acceptable range.| |\n|data validation| |\n|settings| |\n|input message| |\n|error alert| |\n|validation criteria| |\n|allow:| |\n|decimal| |\n|ignore blank| |\n|data:| |\n|between| |\n|minimum:| |\n|maximum:| |\n|apply these changes to all other cells with the same settings| |\n|clear all| |\n|cancel| |", "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"}, "99a8a15d-d23a-4b30-9615-5f714615d2fa": {"__data__": {"id_": "99a8a15d-d23a-4b30-9615-5f714615d2fa", "embedding": null, "metadata": {"page_label": "4", "file_name": "[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf", "file_type": "application/pdf", "file_size": 955603, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Data Validation and Documentation Best Practices in MS Excel", "questions_this_excerpt_can_answer": "1. How does the document recommend handling data validation errors related to numeric values outside a specified range in Excel spreadsheets, specifically when the value is not between 0 and 10?\n   \n2. What specific Excel features does the document suggest for highlighting out-of-specification results in cells that present calculation outputs, and what are the recommended formatting options for these cells?\n\n3. According to the document, what information should be recorded or displayed to ensure proper documentation and traceability of data entries in Excel spreadsheets used for pharmaceutical development?", "prev_section_summary": "The section discusses how Excel spreadsheets can be configured to ensure data input cells are easily identifiable and protected from aberrant values. It outlines specific steps recommended in the \"Excel Data Input and Validation Settings Guide\" for applying data validation rules to prevent incorrect data entry, and how these settings can be communicated to the end user through input and error alert messages. The section also covers detailed procedures for locking cells and hiding formulas to secure the worksheet, contributing to overall data integrity and compliance with regulatory standards. Key topics include formatting cells, applying data validation rules, input and error alert messages, validation criteria, and protecting the worksheet. Key entities mentioned are data input cells, data validation rules, input messages, error alert messages, and locking cells.", "excerpt_keywords": "Excel, data validation, documentation, pharmaceutical development, data integrity"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf\n## data validation\n\n|settings|input message|error alert|\n|---|---|---|\n|show error alert after invalid data entered|when user enters invalid data, show this error alert:| |\n|style:| | |\n|warning|out of range| |\n| |error message:| |\n|cannot enter numeric value|between and 10| |\n|clear all| |cancel|\n\n- cells used for presenting the results of the calculations (output) can be identified by a specific colour. when the results are tested against acceptance criteria it is recommended using conditional formatting (home tab > conditional formatting) to highlight out-of-specifications results.\n\ngreater than\nformat cells pat are greater than:\nwip light red fill wip dark red text\ncancel\n\n- the name of the operator responsible for data entry, and the date and time of data entry should be recorded in dedicated input cells or the spreadsheet is printed, signed and dated after calculation.\n\n- file path, spreadsheet filename and ms excel(r) version number can be displayed within the print area of the spreadsheet. the excel functions =cell(\"filename\") and =info(\"release\") can be used to display the path, filename, active sheet and the version number of ms excel(r) in use.", "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"}, "25808d54-1dd0-4a91-9e63-1cfa45511a98": {"__data__": {"id_": "25808d54-1dd0-4a91-9e63-1cfa45511a98", "embedding": null, "metadata": {"page_label": "5", "file_name": "[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf", "file_type": "application/pdf", "file_size": 955603, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "\"Securing Vaccine Titration Spreadsheet: Password Protection and Workbook Security Measures\"", "questions_this_excerpt_can_answer": "1. What specific steps are recommended for protecting cells containing calculations in an Excel spreadsheet used for vaccine titration calculations, according to the document \"[29] PA-PH-OMCL (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf\"?\n\n2. How does the document suggest handling the password for both sheet protection and workbook structure protection in Excel spreadsheets used for pharmaceutical calculations, and what is the recommended practice for documenting this password?\n\n3. Can you describe the example provided in the document for calculating vaccine titration, including the type of data required and how the calibration curve and its formula are utilized in the process?", "prev_section_summary": "The section discusses data validation best practices in MS Excel, including handling errors related to numeric values outside a specified range, highlighting out-of-specification results using conditional formatting, and ensuring proper documentation and traceability of data entries. Key topics include setting error alerts for invalid data, identifying output cells with specific colors, recording operator information and entry timestamps, and displaying file path and Excel version information within the spreadsheet.", "excerpt_keywords": "Excel, Spreadsheet, Validation, Vaccine, Titration"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf\n## cell \"filename\"\n\n|path:|u:lprofessionalldesktop [excel template xlsxlsheetl|\n|---|---|\n|version:|=info(\"release\")|\n|excel version:|140|\n\npassword protection is recommended for all cells containing calculations (review tab > protect sheet), with only the default options checked. the same password can be used for all sheets and can be documented in the validation file. the sheet protection password should not be communicated to the end users.\n\nafter protecting each sheet, the workbook structure should also be password protected (review tab > protect workbook). the same password can be used as the one for sheet protection.\n\nan example of a spreadsheet used to calculate a vaccine titration is shown on the image below. from results obtained for a reference product (height measured at 4 concentrations), a calibration curve and its formula are provided. both of them are needed to calculate the concentrations corresponding to the height measured for the tested vaccine.", "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"}, "c960cdeb-4e3b-4383-b10e-18db73a1be89": {"__data__": {"id_": "c960cdeb-4e3b-4383-b10e-18db73a1be89", "embedding": null, "metadata": {"page_label": "6", "file_name": "[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf", "file_type": "application/pdf", "file_size": 955603, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation of ## Operator Software Version 1.0 Spreadsheet for Vaccine Dosage Calculation and Concentration Analysis", "questions_this_excerpt_can_answer": "1. What specific mathematical formula is used in the \"Validation of ## Operator Software Version 1.0 Spreadsheet for Vaccine Dosage Calculation and Concentration Analysis\" to calculate dosage and concentration, and how is it represented in the document?\n\n2. In the validation process of Excel spreadsheets for vaccine dosage calculation and concentration analysis as outlined in the document, what are the specific requirements and steps for documenting the spreadsheet, including handling of VBA macros and matrix formulas?\n\n3. How does the document specify the handling of data input and cell modification within the Excel spreadsheet used for vaccine dosage calculation and concentration analysis, particularly in relation to grey cells and the calibration range?", "prev_section_summary": "The section discusses the importance of password protection for cells containing calculations in Excel spreadsheets used for vaccine titration. It recommends using the same password for sheet protection and workbook structure protection, documenting the password in the validation file, and not sharing the sheet protection password with end users. An example of a spreadsheet for calculating vaccine titration is provided, including the calibration curve and formula needed for the calculations.", "excerpt_keywords": "Validation, Excel Spreadsheets, Vaccine Dosage, Concentration Analysis, VBA Macros"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf\n## operator software name version 1.0 form:\n\n|date|y=0.335x +6.5|\n|---|---|\n|dosage|y=0.335x + 6.5rz = 0.947|\n|29.00|dosage|0.947|\n| |28.00|\n|conc (hgm)|hmm)|\n|65.00|28.00|\n|55.00| |\n|45.00|20.50|\n|35.00|18.50|\n|65.00|28.uu|\n|55.00|24.50|\n|45.00|21.00|\n|35.00|18.50|\n|r2= 0.95|0.97|\n|valid|calculated|calculated concentration|\n|batch number|height mm|concentration (pgml)|(ug/dose)|cv %|\n|8.00|3433|1716|\n|1750| |1642|\n|1900|13|18.66|\n|mean|18.17|34.83|17.41|6.55|valid|\n|25.00| |27.81|\n|2700| |3060|\n|2700|61.49|30.60|\n|mean|26.33|59.20|29.60|5.82|malid|\n|technician| |scientist|\n|software| |\n\nin the image, grey cells are filled with numerical data from experimentation and are the only ones that can be changed by the operator. all other cells are locked. no more than one cell from the calibration range can be empty; all cells for vaccines must be filled to guarantee proper use.\n\n## validation stages\n\n### 4.1. documentation of the spreadsheet\n\nthere should be a general description of the spreadsheet explaining its purpose, general layout, input types and data validation rules if required (some spreadsheet might be self-explaining). this description can be documented in the spreadsheet itself (e.g. in a dedicated sheet), in a sop or in the validation file.\n\nnext to the general description, a full print-out of the spreadsheet where all formulas are shown (formulas tab > show formulas) should be kept in the validation file.\n\nwhen vba macros are used, the vba code should also be printed and kept in the validation file.\n\nif matrix-formulas (array-formulas) are used, this must be indicated. an individual printout of each matrix formula is necessary.\n\n1visual basic for applications", "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"}, "8d7962ee-44dd-4167-b6f3-4ef2bf0e8916": {"__data__": {"id_": "8d7962ee-44dd-4167-b6f3-4ef2bf0e8916", "embedding": null, "metadata": {"page_label": "7", "file_name": "[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf", "file_type": "application/pdf", "file_size": 955603, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation and Documentation Requirements for Spreadsheet Calculations", "questions_this_excerpt_can_answer": "1. What specific documentation requirements are outlined for validating new versions of Excel spreadsheets used in pharmaceutical calculations, according to the document titled \"Validation and Documentation Requirements for Spreadsheet Calculations\"?\n\n2. How does the document \"Validation and Documentation Requirements for Spreadsheet Calculations\" suggest verifying the accuracy of calculations performed by self-developed Excel spreadsheets in a pharmaceutical setting?\n\n3. What example formulas and validation data entries are provided in the document \"Validation and Documentation Requirements for Spreadsheet Calculations\" to illustrate how spreadsheet calculations should be documented for validation purposes?", "prev_section_summary": "This section discusses the validation of an Excel spreadsheet used for vaccine dosage calculation and concentration analysis. It includes details on the mathematical formula used for calculations, handling of data input and cell modification, requirements for documenting the spreadsheet, and the validation stages. The section emphasizes the importance of documenting the spreadsheet, including descriptions of its purpose, layout, and validation rules, as well as the need to keep printouts of formulas, VBA macros, and matrix formulas. Grey cells in the spreadsheet contain experimental data and can be modified by the operator, while other cells are locked. Proper filling of cells is necessary for accurate vaccine dosage calculations.", "excerpt_keywords": "Validation, Documentation, Excel Spreadsheets, Pharmaceutical, Calculations"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf\nc40 {frequency(b5;b14,d38,d40)}\n\n=frequency(b5:b14,d38:d40)\n\n=frequency(b5:b14,d38,d40)\n\n=frequency(b5:b14,d38,d40)\n\nall print-outs shall clearly identify the spreadsheet name or identification and version number. when a new version of the spreadsheet is being validated, a summary of the changes since the previous version should be given. the version of microsoft excel used for the creation and validation of the spreadsheet should be traceable (either by the documentation of the spreadsheet or by the change log of the it department), and any known incompatibilities with older or newer versions should be documented. the documentation of the spreadsheet can be considered as the urs. in order to properly document the spreadsheet, formulas shall be printed and entered into the validation document (see example below).\n\n|operator|software name & version 1.0|date|conc (ug/ml)|h (mm)|\n|---|---|---|---|---|\n|=if(b19<0.85,\"not valid\",\"valid\")|batch number|height|calculated concentration (ug/ml)|(b2+b25+b26)|\n|mean =(b28+b29+b30)|i829-ordonneedrg| | | |\n|technician|software name version|30004/2009| | |\n\n4.2. validation of the calculations of the spreadsheet\n\nall calculations are to be verified with a system completely independent from the self-developed spreadsheet. one validation method is to compare the results obtained by the spreadsheet with results obtained by commercial software or with a calculator, using the same dataset as input. another validation method is to compare the results obtained by the spreadsheet with published reference data (e.g. physicochemical data of substances).", "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"}, "06a6db1e-e6a0-481c-9373-dc660640b869": {"__data__": {"id_": "06a6db1e-e6a0-481c-9373-dc660640b869", "embedding": null, "metadata": {"page_label": "8", "file_name": "[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf", "file_type": "application/pdf", "file_size": 955603, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation of Excel Calculations using Commercial Software and Published Data: A Comprehensive Analysis", "questions_this_excerpt_can_answer": "1. How does the document address the issue of Excel version compatibility in the context of spreadsheet validation, and what specific actions are recommended for ensuring validation across different versions of Excel?\n   \n2. What methodology does the document suggest for validating Excel calculations, particularly in terms of comparing Excel results with those from commercial software or published data, and how is the coefficient of correlation and calibration curve coefficients utilized in this process?\n\n3. Based on the regression analysis example provided in the document, how is the statistical significance of the relationship between the dependent and independent variables determined, and what specific statistical measures are used to assess the fit and predictive accuracy of the model?", "prev_section_summary": "The section discusses the validation and documentation requirements for Excel spreadsheets used in pharmaceutical calculations. Key topics include documenting spreadsheet changes, identifying spreadsheet versions, tracing Excel version used, documenting incompatibilities, and printing and entering formulas for validation. The section also emphasizes the need to verify calculations with independent systems and methods such as comparing results with commercial software, calculators, or published reference data. Key entities mentioned include spreadsheet name, version number, Microsoft Excel version, formulas, operators, software names, batch numbers, technicians, and validation methods.", "excerpt_keywords": "Excel, Validation, Commercial Software, Regression Analysis, Statistical Significance"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf\n#### if the spreadsheet will be used on computers running different versions of excel it is required to perform the validation of the functionality using each of those different versions as some newer excel functions are not retro-compatible with older versions of excel.\n\n#### validation of the calculations by using commercial software or published data\n\na dataset as close to real values as possible must be chosen. excel calculations are compared to the results given by commercial software or by published data, which are considered as validated (see example in the image below). the commercial software provides the coefficient of correlation, r2 and the coefficients of the calibration curve.\n\n|regression analysis|linear model: b%|\n|---|---|\n|dependent variable:|coic standard|\n|independent variable:|estimate error|\n|parameter|significant error|\n|intercept|6389|\n|slope|335|\n|analysis|variance|\n|source|square mean square f-ratio value|\n|model|112.225 112.225 107.31 0ooo|\n|residual|.75 04583|\n|total (corr|116.|\n|correlation coefficient|0.973163|\n|r-squared|7046 percent|\n|standard error|02266|\n\nthe table shows the fitting linear model describing the relationship between coic. the equation of the fitted model is 4 = 6.5 335 coic. since the p-value in the anova table is less than 0.05, there is statistically significant relationship between coic and the confidence level.\n\nthe r-squared statistic indicates that the model fitted explains 94.70468% of the variability. the correlation coefficient of 0.973163 indicates a relatively strong relationship between the variables. the standard error of the estimate shows the standard deviation of the residuals 0.2266. this value can be used to construct prediction limits for new observations by selecting the forecast option from the excel data tab.\n\nif no discrepancy occurs, the validation of this part of the calculation is considered as fulfilled. if a discrepancy is observed, a check and revision of the formulas must be performed (and the whole validation re-performed).", "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"}, "728ae6a3-5f6d-4dba-be2d-9d4e12ec3ca1": {"__data__": {"id_": "728ae6a3-5f6d-4dba-be2d-9d4e12ec3ca1", "embedding": null, "metadata": {"page_label": "9", "file_name": "[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf", "file_type": "application/pdf", "file_size": 955603, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation and Comparison of Calculations Using a Calculator and Spreadsheet", "questions_this_excerpt_can_answer": "1. What specific method is recommended for validating calculations derived from Excel spreadsheets in a pharmaceutical context, as outlined in the document \"Validation of Excel Spreadsheets\"?\n   \n2. How does the document \"Validation of Excel Spreadsheets\" suggest handling discrepancies between manual calculations and spreadsheet results in the context of pharmaceutical validation processes?\n\n3. What are the specific steps and documentation recommended for using a PC calculator as part of the validation process for Excel spreadsheet calculations in pharmaceutical environments, according to the \"Validation of Excel Spreadsheets\" document?", "prev_section_summary": "The section discusses the validation of Excel calculations, particularly in the context of compatibility across different versions of Excel. It emphasizes the importance of comparing Excel results with those from commercial software or published data to ensure accuracy. The methodology involves selecting a dataset close to real values, analyzing regression models, and utilizing statistical measures such as coefficient of correlation, r-squared, and standard error. The section provides an example of regression analysis and highlights the significance of the relationship between variables. It also mentions the need for revising formulas in case of discrepancies during validation.", "excerpt_keywords": "Validation, Excel Spreadsheets, Pharmaceutical, Calculations, Comparison"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf\n## 4.2.2. validation of the calculations with a calculator (manual calculation)\n\nusing the printed formulas from the spreadsheet, all concentrations are calculated using a calculator (see next image) and compared with the results given by the spreadsheet.\n\n|operator|xx|software name version 1.0|form|\n|---|---|---|---|\n|date|03/06/2003|40.00|dosage|\n|h(mm)|38.00| | |\n|conc (pg/ml)|36.00| | |\n|65.00|210|34.00|hhe (omma&l)|\n|55.00|210|32.00|fno|\n|45.00|20.5|130.00|setewaxe|\n|35.00|als|28.08| |\n|65.00|1&.0|24.00| |\n|55.00|24 $|22.00| |\n|45.00|1lo|20.00| |\n|35.00|4s|30.00|45.00 50.00 55.00 60.00 65.00 70.00|\n| | | |concentration pg/ml|\n\nr? = calculated concentration h-6,$ + 0,335 * lnc\n\n|batch number|height mm|concentration (hg/ml)|(ug/dose)|cv %|\n|---|---|---|---|---|\n|a8|333| | | |\n|4s|324|alz| | |\n|mean|4s|mean : 34.| |6.ss val:4|\n|2 $|55.22|23| | |\n|27| |30.06| | |\n|14|3aj572|30.62|582|vakd|\n|mean|40.33|mean = 1160| | |\n\ntechnician: 03/06/2009\n\nscientist: software name version 1.0\n\nas an alternative, the pc calculator can be used and documented in screen shots, as in the image below.\n\nacnual staxdard umcke [ ima ml eee\n\n|70967660545348|747102|61.616|\n|---|---|---|\n|89.827|740|57161|\n\nif no discrepancy occurs, the validation of this part of the calculation is considered fulfilled. if a discrepancy is observed, both the revision of the formulas and the manual calculations should be repeated (and the whole validation re-performed).", "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"}, "60231c92-ab4e-45a9-8298-8653957a1c17": {"__data__": {"id_": "60231c92-ab4e-45a9-8298-8653957a1c17", "embedding": null, "metadata": {"page_label": "10", "file_name": "[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf", "file_type": "application/pdf", "file_size": 955603, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "\"Ensuring Accuracy and Security in Spreadsheet Operations: Validation and Regular Verification of Protections and Calculations\"", "questions_this_excerpt_can_answer": "1. What specific steps are outlined for validating the protections of Excel spreadsheets used in pharmaceutical operations, according to the document titled \"Ensuring Accuracy and Security in Spreadsheet Operations: Validation and Regular Verification of Protections and Calculations\"?\n\n2. How does the document recommend handling the validation of Excel spreadsheet calculations in scenarios involving out-of-specification (OOS) results, missing data, or nonsensical data within the pharmaceutical industry?\n\n3. What procedure does the document suggest for the regular verification of Excel spreadsheets to maintain their validated state after any changes in software or hardware configurations within pharmaceutical operations?", "prev_section_summary": "This section discusses the validation of calculations derived from Excel spreadsheets in a pharmaceutical context. It outlines the method of validating calculations with a calculator by comparing manually calculated concentrations with spreadsheet results. The document suggests documenting the manual calculations using a PC calculator and screen shots. Discrepancies between manual calculations and spreadsheet results should be addressed by revising formulas and repeating the validation process. Key entities mentioned include operators, software version, dates, concentrations, batch numbers, technicians, and scientists.", "excerpt_keywords": "Excel spreadsheets, validation, pharmaceutical operations, calculations, data integrity"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[29] PA-PH-OMCL  (08) 87 R6 Annex 1 Validation of Excel Spreadsheets.pdf\nmoreover, calculations in paragraph 4.2.1 and 4.2.2 should be re-performed with other datasets including exceptional situations, for example: oos results, missing data, or nonsense data. calculations should also be validated under these conditions, as applicable (data not shown).\n\n4.2.3. validation of the protections\n\nthe following points shall be verified and documented:\n\n- access rights to the spreadsheet (e.g. on the network share) are correct: the file cannot be modified or deleted by users.\n- the different sheets within the spreadsheet are properly protected: only input cells can be edited, all other cells are locked.\n- a password (if applicable) is needed to remove sheet protection and workbook protection.\n\nat this stage, the spreadsheet is considered as validated and its status is issued and filed.\n\n5. regular verification of the spreadsheet\n\nregularly, in a risk-based approach an omcl should define an appropriate frequency of regular verification of an existing spreadsheet. after every change performed in the soft- or hardware configuration, the spreadsheet should be verified to ensure that its validated state is maintained. a known dataset is used and the results are compared to the standard one. in order to help the operator, verification instructions containing the information required should be available. each verification is registered, with the following information: date of operation, intervention (i.e. verification), comments, and operators signature. results from the verification should be kept in the validation file or system documentation.", "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"}, "50bd9d5d-d7a4-402f-a9df-5ae4ef8d6e85": {"__data__": {"id_": "50bd9d5d-d7a4-402f-a9df-5ae4ef8d6e85", "embedding": null, "metadata": {"page_label": "1", "file_name": "[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf", "file_type": "application/pdf", "file_size": 431019, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation of Computerised Systems in the European Directorate for the Quality of Medicines & Healthcare: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What is the legislative basis for the \"Validation of Computerised Systems\" guideline as provided by the European Directorate for the Quality of Medicines & Healthcare, and how does it relate to the General European OMCL Network (GEON)?\n\n2. Can you detail the history and revisions of the \"Validation of Computerised Systems\" guideline, including its original adoption, entry into force, and the entry into force of its revised document, as outlined by the European Directorate for the Quality of Medicines & Healthcare?\n\n3. Who is the custodian responsible for the elaboration of the \"Validation of Computerised Systems - Core Document,\" and what is the role of the Organisation EDQM of the Council of Europe in the context of this guideline?", "excerpt_keywords": "European Directorate, Quality of Medicines, Healthcare, Validation, Computerised Systems"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf\n## european directorate for the quality of medicines & healthcare\n\n## general european omcl network (geon)\n\nquality management document\npa/ph/omcl (08) 69 r7\n\n### validation of computerised systems\n\n### core document\n\n|full document title|validation of computerised systems - core document|\n|---|---|\n|and reference|pa/ph/omcl (08) 69 r7|\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|pa/ph/omcl (08) 69 3r|\n|custodian|the present document was elaborated by the omcl network / organisation 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"}, "9bb0e330-3592-443c-80b9-dfebdb103684": {"__data__": {"id_": "9bb0e330-3592-443c-80b9-dfebdb103684", "embedding": null, "metadata": {"page_label": "2", "file_name": "[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf", "file_type": "application/pdf", "file_size": 431019, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Guidelines for Validation of Computerised Systems in Official Medicines Control Laboratories: Ensuring Compliance and Data Integrity", "questions_this_excerpt_can_answer": "1. What specific terminology does the guideline use to differentiate between mandatory requirements, recommendations, and non-binding examples in the validation of computerised systems within Official Medicines Control Laboratories (OMCLs)?\n\n2. How does the guideline propose to handle the validation of computerised systems of varying complexity within OMCLs, and what categorization does it introduce for these systems?\n\n3. According to the document, on what basis should the extent of validation activities for computerised systems in OMCLs be defined, and how does this relate to the dependency of test results' correctness and traceability on these systems?", "prev_section_summary": "The section discusses the \"Validation of Computerised Systems\" guideline provided by the European Directorate for the Quality of Medicines & Healthcare, specifically focusing on the legislative basis, history, and revisions of the document. Key entities mentioned include the General European OMCL Network (GEON), the Organisation EDQM of the Council of Europe as the custodian responsible for the guideline, and the dates of adoption and entry into force of the original and revised documents. The section provides a comprehensive overview of the core document and its importance in ensuring the quality management of computerised systems in the pharmaceutical industry.", "excerpt_keywords": "Validation, Computerised Systems, Official Medicines Control Laboratories, Data Integrity, ISO/IEC 17025"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf\n# validation of computerised systems\n\n## core document\n\nnote: mandatory requirements in this guideline and its annexes are defined using the terms\n<<shall>> or <<must>>. the use of <<should>> indicates a recommendation. for these parts of the text\nother appropriately justified approaches are acceptable. the term <<can>> indicates a possibility or\nan example with non-binding character.\n\n## 1. scope\n\nthis guideline defines basic principles for the validation of computerised systems used within\nofficial medicines control laboratories (omcls) and having an impact on the quality of results,\ndocument control, and data storage [1]. the purpose of this validation is to guarantee confidence in\nthe laboratory data captured, processed, reported, or stored by computerised systems. a validated\nsystem ensures accurate results and reduces any risks to data integrity.\n\nthis document applies to all types of computerised systems used in omcls. however, depending\non their complexity, the extent of testing and documentation will differ. computerised systems can\nbe categorized into three types: exempted, simple, and complex (see table i in section 3). this\ndocument describes a scalable validation approach for simple and complex computerised systems.\n\n## 2. introduction\n\nthis guideline outlines general validation principles for computerised systems of omcls in\naccordance with iso/iec 17025. it defines general minimum requirements for the validation of\ndifferent types of computerised systems and additionally gives recommendations for the practical\nimplementation and practical examples specific for omcls.\n\nthe extent of validation activities should be defined based on risk assessment, considering the\ndependency of the correctness and traceability of test results of the omcl on the computerised\nsystems.\n\ndue to the great variety of computerised systems available, it is not possible to state in a single\ndocument all the specific validation elements that are applicable.\n\nthis guideline is intended for use by omcls working under quality management systems based\non the iso/iec 17025 standard, which use computerised systems for a part or the totality of the\nprocesses related to the quality control of medicines.\n\nin order to simplify the guideline, the present core document contains a general introduction and\ngeneral requirements for different types of computerised systems. this core document is\nsupplemented with system-related annexes containing additional requirements and/or practical\nexamples of validation documentation, which are to be used in combination with the general\nrequirements given here.\n\nthis document should be considered as a guide to omcls for planning, performing, and\ndocumenting the validation of their computerised systems. it is left to the professional judgment\nand background experience of each omcl to decide on the most relevant procedures to be\nundertaken in order to give evidence that their computerised systems are working properly and are\nappropriate for their intended use.", "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"}, "6d877aa0-717f-4328-b7e6-e30a55988d25": {"__data__": {"id_": "6d877aa0-717f-4328-b7e6-e30a55988d25", "embedding": null, "metadata": {"page_label": "3", "file_name": "[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf", "file_type": "application/pdf", "file_size": 431019, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Comprehensive Guide to Computerized System Validation and Qualification Processes", "questions_this_excerpt_can_answer": "1. What distinguishes a \"commercial (off-the-shelf, configurable) computerised system\" from an \"in-house developed (custom-made or bespoke) computerised system\" according to the guidelines provided in the \"Comprehensive Guide to Computerized System Validation and Qualification Processes\"?\n\n2. How does the document define the process and criteria for \"black-box validation\" in the context of computerized system validation, and how does it differ from traditional validation methods?\n\n3. What are the specific roles and definitions of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) or User Acceptance Testing (UAT) in the validation process of computerized systems as outlined in the \"Comprehensive Guide to Computerized System Validation and Qualification Processes\"?", "prev_section_summary": "This section discusses the guidelines for the validation of computerised systems in Official Medicines Control Laboratories (OMCLs). Key topics include the scope of the validation, categorization of computerised systems into exempted, simple, and complex types, the importance of validation for ensuring accurate results and data integrity, general validation principles in accordance with ISO/IEC 17025, the need for risk assessment in determining the extent of validation activities, and the use of this guideline by OMCLs under quality management systems. Entities mentioned include computerised systems, OMCLs, ISO/IEC 17025 standard, validation documentation, and the professional judgment of OMCLs in planning and performing validation activities.", "excerpt_keywords": "Computerized System Validation, Qualification Processes, OMCLs, ISO/IEC 17025, Black Box Validation"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf\n### definitions\n\nfollowing definitions should be used in order speak the same language in omcls documents. some of these terms are also used in environments subjected to good manufacturing practice requirements (gmp). it is stressed that gmp requirements do not apply to omcls, though for practical reasons the commonly used terms are also used in this document.\n\n|computer system|a system containing one or more computers and associated software.|\n|---|---|\n|computerised system|a broad range of systems including, but not limited to, automated laboratory equipment, laboratory information management, and document management systems. the computerised system consists of the hardware, software, and network components, together with the controlled functions and associated documentation.|\n|commercial (off-the-shelf, configurable) computerised system|software defined by a market-driven need, commercially available, and whose fitness for use has been demonstrated by a broad spectrum of commercial users; also known as cots.|\n|in-house developed (custom-made or bespoke) computerised system|a system produced for a customer, specifically to order, to meet a defined set of user requirements set out in a user requirement specification.|\n|user requirement specifications (urs)|describes what the system should do. the user requirements contain scientific, business, legal, regulatory, safety, performance and quality aspects of the future system. the user requirements serve as the basis for the performance qualification (pq).|\n|black box|a black box in this guideline is a system whose inner working is unknown.|\n|computerized system validation plan|the validation plan shall be an approved document, which describes the validation activities and responsibilities. the validation plan specifies the computerized system subjected to validation and compiles the validation activities to be performed and the validation targets/criteria to be fulfilled. the validation plan shall be prepared and approved prior to conducting the test.|\n|dq (design qualification)|documented verification that the proposed design of facilities, systems, and equipment is suitable for the intended purpose.|\n|iq (installation qualification)|documented verification that a system is installed according to written and pre-approved specifications.|\n|oq (operational qualification)|documented verification that a system operates according to written and pre-approved specifications throughout specified operating ranges at the customer.|\n|pq (performance qualification) or user acceptance testing (uat)|documented verification that a system is capable of performing the activities of the processes it is required to perform, according to written and pre-approved specifications, within the scope of the business process and operating environment.|\n|black-box validation|validation based on the fact that, for a given computerised system, its source code or design is unknown to the user. validation is performed from the computerised system or computer system users point of view.|\n|black-box test|periodic check of a computer, computerised system or computerised system based on the black-box validation approach. black box testing examines the functionality of a system without peering its inner structure or workings.|", "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"}, "b52182b5-44f0-4c07-af38-0c23882a34f1": {"__data__": {"id_": "b52182b5-44f0-4c07-af38-0c23882a34f1", "embedding": null, "metadata": {"page_label": "4", "file_name": "[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf", "file_type": "application/pdf", "file_size": 431019, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "\"Comprehensive Guidelines for Inventory Management and Validation of Computerised Systems\"", "questions_this_excerpt_can_answer": "1. What specific actions are recommended for computerised systems that lack a calibration function according to the \"Comprehensive Guidelines for Inventory Management and Validation of Computerised Systems\"?\n\n2. How does the document classify and recommend handling software with a \"small part of software\" in terms of validation, calibration, and function control tests?\n\n3. What are the minimum requirements for the inventory of computerised systems as outlined in the \"Comprehensive Guidelines for Inventory Management and Validation of Computerised Systems\"?", "prev_section_summary": "The section provides definitions related to computerized systems and validation processes. Key topics include distinguishing between commercial and in-house developed computerized systems, user requirement specifications, black-box validation, and the roles of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) or User Acceptance Testing (UAT) in the validation process. The section emphasizes the importance of using consistent terminology in documents and outlines the criteria for validating computerized systems.", "excerpt_keywords": "Inventory Management, Validation, Computerised Systems, Calibration, Software Classification"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf\n|definition|examples|action|\n|---|---|---|\n|no calibration function|calculator, microscope, photo or video camera, standard office pc, microwave, etc.|none|\n|exempted|operating system (e.g. windows, linux, unix), network software, security software (virus check, firewall), office application software (word, excel), database software (e.g. oracle, sql, access), etc.| |\n|small part of software|ph meter, oxidisers, incubator, titration processor, colorimeter, thermo hygrograph/hygrometer, balance, particle sizer, uv/vis spectrometer, liquid scintillation counter, tlc analyser, aas, micro plate counter, image analyser, polarimeter, combistats, etc.|simplified validation - calibration - function control test|\n|restricted customisation|lims (laboratory information management system), erp (enterprise resource planning), edms (electronic document management system), eln (electronic laboratory notebooks), user-developed excel spreadsheet, user-developed access application, automated sample processing systems, liquid chromatograph (lc, hplc), gas chromatograph (gc) including auto sampler and detection systems (uv, vis, ir, ms, nmr, radioactivity or fluorescence monitor, etc.), biological analyser, ecg, etc.|validation|\n|extended amount of functionality|operating systems, office applications, databases and framework packages such as windows, excel, oracle, sas do not have to be validated by the omcl. however, user applications written within or by means of these packages, such as sas procedures, oracle applications, and excel spreadsheets (including complex calculations and macros) shall be validated.| |\n\ngeneral requirements for computerised systems\n\na) inventory\n\nan inventory or equivalent listing of all computerised systems shall be available. the following minimum information shall be included in the computerised systems inventory:\n\n- identification & version\n- purpose\n- validation status\n- physical or storage (drive and files path) location of the computerised system and related documentation\n- responsible or contact person\n\nfor equipment software, this information can be recorded in the equipment logbook. in the case of local installation (workstation), each individual copy of the software installed on several computers needs its own unique identification (e.g. license).", "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"}, "c9933559-d98d-4ad3-bedd-5b230a64b55c": {"__data__": {"id_": "c9933559-d98d-4ad3-bedd-5b230a64b55c", "embedding": null, "metadata": {"page_label": "5", "file_name": "[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf", "file_type": "application/pdf", "file_size": 431019, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Computerised System Validation and Validation Plan: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What are the key components and activities included in a validation plan for computerised systems within the pharmaceutical industry, as outlined in the \"Computerised System Validation and Validation Plan: A Comprehensive Guide\"?\n\n2. How does the document suggest incorporating supplier validation activities and documents into the OMCLs validation file, and under what conditions can the validation effort in OMCLs be reduced to the performance qualification (PQ) phase?\n\n3. What specific methods are recommended for conducting black-box validation of computerised systems to ensure they meet user needs and intended uses, according to the guidelines provided in the document?", "prev_section_summary": "The section discusses the classification and handling of computerised systems based on their functionality and software components. It outlines specific actions recommended for systems without a calibration function, software with a small part of software, and those with extended functionality. The document emphasizes the importance of maintaining an inventory of computerised systems, including identification, purpose, validation status, location, and responsible contact person. It also mentions the requirements for recording software information in equipment logbooks and unique identification for individual software copies.", "excerpt_keywords": "Computerised system validation, Validation plan, Supplier validation, Performance qualification, Black-box validation"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf\n## b) validation\n\nprior to routine use, the computerised system shall be validated. the purpose of validation is to confirm that the computerised system specifications conform to the user needs and intended uses by examination and provision of objective evidence and that the particular requirements can be consistently fulfilled. the extent of validation will depend on the complexity and intended use of the computerised system being validated. the validation effort can be scaled and adapted to the type of system justified by documented risk assessment. the categories mentioned in this guideline (see table i in section 3) can be used in omcls for risk assessment.\n\nurs, validation plans, test and release can also be performed on a rolling basis, if an iterative process (agile software development) is used. use of the supplier activities validation documents and results of tests performed by the supplier of the software can be incorporated into the omcls validation file and does not need to be repeated again by the omcl. the supplier must be subject to supplier evaluation (e.g. by a questionnaire or an audit). validation documents shall verify the computerized system performance, confirming that the system is performing correctly and to standard specifications. using a suppliers validation documents, validation in the omcls can be reduced to the performance qualification (pq) phase and ongoing controls indicating the system is working properly.\n\nvalidation plan\n\nto ensure the correct implementation of a validation, a plan is needed. the validation plan describes all activities such as review of the urs, review of the development plan (design), test strategy, verification of the data migration (if applicable), review of the validation documents and the acceptance testing of the whole system. the plan includes the date, the responsible person and the acceptance criteria for each review or test, or at least a reference to these tests. the validation plan is to be authorised by a responsible person before starting the validation. the test cases and descriptions can be described later, if an iterative process is used.\n\nblack-box validation is an approach to establish by adequate testing that the computerised system meets user needs and intended use, and can involve:\n\n- checking correctness of calculations and formulas and/or analytical results for dedicated and/or samples, references and calibrators;\n- manual calculation of computerised system calculation data (see annex 1); and/or\n- using a second, independent computerised system tool to review correctness of calculations and/or analytical results;", "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"}, "687dabcd-fba8-4dd8-aa2d-b6cc3dd94a67": {"__data__": {"id_": "687dabcd-fba8-4dd8-aa2d-b6cc3dd94a67", "embedding": null, "metadata": {"page_label": "6", "file_name": "[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf", "file_type": "application/pdf", "file_size": 431019, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Validation of Computerised Systems in the OMCL Environment: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What specific steps are recommended for validating simple computerised systems in the OMCL environment, particularly for systems with no or limited customization?\n   \n2. How does the document suggest OMCLs should validate the functionality and accuracy of the CombiStats application, including the verification process after downloading from the EDQM website?\n\n3. What is the outlined process for validating complex computerised systems according to the document, including the initial steps and the documentation required to confirm the system's suitability for its intended use?", "prev_section_summary": "The section discusses the validation of computerised systems in the pharmaceutical industry, emphasizing the importance of confirming that system specifications align with user needs and intended uses. It mentions the scalability of validation efforts based on system complexity and intended use, as well as the incorporation of supplier validation activities and documents into the validation process. The section also highlights the need for a validation plan outlining activities such as review of user requirements, test strategies, and acceptance testing. Additionally, it introduces the concept of black-box validation to ensure that computerised systems meet user needs through various testing methods.", "excerpt_keywords": "Validation, Computerised Systems, OMCL Environment, CombiStats, Documentation"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf\nand/or\n\n(4) documentation of simulations of invalid or oos data input and flagging/mistake signals. for the validation of a computerised system that does not belong to the omcl (e.g. a computerised system from the agency/authority), a simplified validation (e.g.: a function control test) can be performed by the omcl, taking into consideration the specific functionalities for the omcl, to check compliance with the iso 17025 requirements and the omcl guidelines. if there is an interface between computerised systems, for example, exchange of information between an analytical system and lims, validation of the interface should be considered.\n\ni. validation of simple systems validation of simple computerised systems, e.g. systems with no or limited customisation, will usually rely on instrument calibration and/or a system function test, depending on the type of system. for analytical instruments where the raw data cannot be modified by the user (e.g. stand-alone balance, ph meter) instrument calibration is considered as sufficient to demonstrate the system is fit for purpose. for off-the-shelf applications, commercial or supplied by a public agency/authority, a function test shall be performed by the user in order to demonstrate that the application performs properly in the omcl environment. an example of this approach is given below for combistats. the appropriateness and correctness of the calculations performed by combistats is pre-checked and demonstrated by the provider (mainly by the comparison with data published in the book by d.j. finney [7], a standard reference for statistics in bioassays) so that the computerised system can be considered as fit for purpose (i.e., it fulfils the user requirements). however, an omcl shall verify that combistats works properly in its hardware configuration, once downloaded from the edqm website. this can be done by comparing the output of the same example reported both in the user manual (in .pdf format, that will be the \"reference\") and in the \"example\" directory (in .epa format) automatically downloaded in each user pc hard disk. the conclusion regarding the validation status based on this comparison shall be documented. combistats templates and data sheets shall be protected from accidental mistakes and editing. four different levels of protection are available (each one with or without the use of a password). the user manual can be used by the omcl for further details, and to choose the strategy, depending on the internal policy and decision.\n\nii. validation of complex systems validation of complex computerised systems begins with the definition of the user requirements specification (urs), which will serve as a basis for the validation requirements. a validation plan is needed, based on risk assessment, describing the different validation activities planned for the system, and the responsibilities of the different persons involved in the validation process. then test protocols for iq, oq and pq shall be prepared taking into consideration the user requirements and the acceptance criteria. test protocols or checklists provided by the supplier can be used for iq and oq, when available. the process is finalised after the issuing of the various test reports and a final validation report with the statement that the computerised system is suitable for the intended use. if", "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"}, "5807dfb5-9407-472b-8015-50cd7141b07d": {"__data__": {"id_": "5807dfb5-9407-472b-8015-50cd7141b07d", "embedding": null, "metadata": {"page_label": "7", "file_name": "[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf", "file_type": "application/pdf", "file_size": 431019, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Ensuring Adequate Functioning and Security of Computerised Systems in Analytical Procedures: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What specific examples are provided in the document for the validation of complex computerised systems in analytical procedures?\n   \n2. How does the document recommend handling automatic system updates to minimize disruption and ensure the continued validated status of computerised systems in analytical settings?\n\n3. What strategies does the document suggest for ensuring the security of computerised systems against unauthorized access and data alteration in analytical environments?", "prev_section_summary": "The section discusses the validation of computerised systems in the OMCL environment, including recommendations for validating simple and complex systems. Key topics include steps for validating simple systems, such as instrument calibration and function tests, as well as the validation process for complex systems, starting with user requirements specification and risk assessment. The document also outlines the validation of the CombiStats application and the importance of verifying interfaces between computerised systems. Key entities mentioned include instrument calibration, function tests, user requirements specification, risk assessment, test protocols, and validation reports.", "excerpt_keywords": "Validation, Computerised Systems, Analytical Procedures, Security, Risk Assessment"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf\ndeviations are identified during validation, they must be addressed and the impact on the adequate functioning of the system shall be evaluated.\n\nin the case of a computerised system for analytical procedures such as an assay, the software is an integrated part of the test procedure. the respective sop should include or make reference to the sample, the reference standard, reagent preparations, use of apparatus and its computerised system as a unit, generation of calibration curve by means of a computerised system tool, use of calculation formulas, etc.\n\nexamples of validation of complex systems are given for excel spreadsheets (see annex 1) and lims/eln/erp/cds (see annex 2).\n\nc) logging of issues\n\na record of the issues identified by the users and the actions taken should be kept.\n\nd) change control\n\nin the event of changes in the computerised system, including version updates, these should ideally be done first in a test environment after which the validation status needs to be re-established. if a revalidation is needed, it should be conducted not just for validation of the individual change, but also to determine the extent and impact of that change on the entire computerised system.\n\nthe extent of the revalidation will depend on assessment of the change(s), which shall be documented. one possible approach could be the use of logbooks as it is done for equipment, and/or using a documented change control procedure.\n\nautomatic system updates should ideally be controlled by it or a system administrator and installed at pre-defined dates to minimise both disruption and unexpected behaviour of the system. it can be necessary to check the operation of the computerised system following any system updates.\n\ne) periodic review\n\nthe omcl should endorse a policy to check the computerised system periodically, to avoid any error and guarantee the maintained validated status of the system. the frequency of the reviews should be defined on a risk-based approach.\n\ncomputerised systems shall be covered by the internal audit strategy.\n\nf) security and environmental conditions\n\ncomputerised systems must be protected against any intrusion that could change the data and affect the final results.\n\nserver rooms should have restricted access and have the conditions necessary to ensure the correct functioning of equipment (control of temperature, firefighting measures, uninterruptible power supply - ups, etc.).\n\nsystems should be accessed only by authorised personnel, using personalised accounts and password or equivalent identification method. the use of shared and generic accounts should be avoided to ensure that actions documented in computerised systems can be attributed to a unique individual. where personal accounts are not available or feasible, combinations of paper and electronic records should be used to trace actions to the personnel responsible.", "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"}, "a0725ad4-dbbe-46cb-b348-eb24e82dc5b4": {"__data__": {"id_": "a0725ad4-dbbe-46cb-b348-eb24e82dc5b4", "embedding": null, "metadata": {"page_label": "8", "file_name": "[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf", "file_type": "application/pdf", "file_size": 431019, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Comprehensive Guide to Computerised System Security and Data Integrity Management", "questions_this_excerpt_can_answer": "1. What specific measures are recommended for managing administrative rights within a computerised system to ensure system security and data integrity, according to the document titled \"Comprehensive Guide to Computerised System Security and Data Integrity Management\"?\n\n2. How does the document \"Comprehensive Guide to Computerised System Security and Data Integrity Management\" suggest handling the installation and maintenance of hardware components in computerised systems to meet technical and functional requirements?\n\n3. What protocols does the \"Comprehensive Guide to Computerised System Security and Data Integrity Management\" outline for ensuring traceability and integrity of data through audit trails, electronic signatures, and backup processes in computerised systems?", "prev_section_summary": "The section discusses the validation of computerised systems in analytical procedures, emphasizing the importance of addressing deviations and evaluating their impact on system functioning. It provides examples of validation for complex systems like Excel spreadsheets and LIMS/ELN/ERP/CDS. The document recommends logging issues, implementing change control procedures for system updates, conducting periodic reviews, and ensuring security measures to protect against unauthorized access and data alteration. It highlights the need for restricted access to server rooms, personalized accounts for system access, and the use of audit strategies to maintain the validated status of computerised systems.", "excerpt_keywords": "Computerised systems, System security, Data integrity, Audit trails, Electronic signatures"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf\nonly the responsible person(s) or designated it personnel should have administrative rights to implement any computerised system updates and/or installations, change critical system settings (e.g. audit trail, time/date) and manage permissions for other users. all routine tasks, such as for analysis, should be based on a user account and password which does not have administrative rights.\n\nadministrative rights should be documented and only be granted to personnel with system maintenance roles (e.g. it) that are fully independent of the personnel responsible for the content of the records (e.g. laboratory analysts, laboratory management). where these independent security role assignments are not feasible, other control strategies should be used to reduce data integrity risks.\n\ncomputers should be locked after use and the users should not be allowed to change date and time settings.\n\nthe hardware used must fulfil the technical requirements so that the work to be completed can be carried out. such requirements include e.g. minimum system requirements indicated by the manufacturer of the equipment. these requirements should be predefined in accordance with the intended use.\n\nthe hardware components must be installed by skilled personnel (e.g. staff from the information technology (it) unit, a technician from the manufacturer of the equipment, or other trained personnel), and must be checked for their functionality and compared with the requirements. computerised systems that are part of test equipment must be labelled unambiguously and records must be kept on relevant hardware configuration, installation and changes. these records can be entered in the logbook/equipment record of the test equipment.\n\naudit trail\n\nthe computerised system should keep a record of any critical actions that occur, for example who has accessed it and when, any deletion or change of data, etc. if a computerised system does not automatically record an audit trail, an alternative record shall be kept by the omcl. users shall not be allowed to amend or switch off the audit trails or alternative means of providing traceability of user actions. the need for the implementation of appropriate audit trail functionality should be considered for all new computerised systems. where an existing computerised system lacks computer-generated audit trails, personnel shall use alternative means such as procedurally controlled use of logbooks, change control, record version control or other combinations of paper and electronic records to meet the requirement for traceability to document the what, who, when and why of an action.\n\nelectronic signatures\n\nif electronic signatures are used, a statement about the equivalence of the electronic signature to the handwritten signature or similar legal statement must be available.\n\nbackup\n\ntraceability must be ensured from raw data to test results. if all or part of the traceability of parameters relevant for the quality of the results is available only in electronic form, a backup process must be implemented to allow for recovery of the system following any failure which", "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"}, "ecbe8ea0-be22-453a-8f48-981ecd5f46ef": {"__data__": {"id_": "ecbe8ea0-be22-453a-8f48-981ecd5f46ef", "embedding": null, "metadata": {"page_label": "9", "file_name": "[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf", "file_type": "application/pdf", "file_size": 431019, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Computerised System Documentation and Validation: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What types of documentation are required for all computerised systems regardless of their complexity, as outlined in the \"Computerised System Documentation and Validation: A Comprehensive Guide\"?\n\n2. How does the documentation requirement differ between simple and complex computerised systems according to the guide provided in the document \"[30] PA-PH-OMCL (08) 69 R7 Validation of Computerised Systems.pdf\"?\n\n3. What specific documentation is only mandated for complex computerised systems, indicating a higher level of scrutiny and validation, as per the comprehensive guide on computerised system documentation and validation?", "prev_section_summary": "The section discusses the management of administrative rights within computerized systems to ensure system security and data integrity. It emphasizes the importance of granting administrative rights only to designated personnel, locking computers after use, and ensuring hardware components meet technical requirements. The document also outlines protocols for maintaining audit trails, electronic signatures, and backup processes to ensure traceability and integrity of data. Key entities mentioned include responsible personnel, IT personnel, laboratory analysts, hardware components, audit trails, electronic signatures, and backup processes.", "excerpt_keywords": "Computerised systems, Documentation, Validation, Complex systems, Audit trails"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf\n## documentation\n\n|information/documentation that shall be available|exempted|simple|complex|\n|---|---|---|---|\n|inventory list, name, version and unique identification of the computerised system|x|x|x|\n|original files (cd-rom...) or storage location to install the computerised system, and computerised system to manage the computer environment| |x|x|\n|date at which the computerised system was put into operation| |x|x|\n|responsible person in charge of the computerised system| |x|x|\n|manufacturers name, licence number and serial number or other unique identification, where applicable| |x|x|\n|conditions under which the computerised system runs, where applicable (hardware, operating system, ...)| |x|x|\n|manufacturers validation certificate, if available| |x|x|\n|manufacturers instructions, if available, or reference to their location| |x|x|\n|documentation on validation of configurations/modifications performed by the user that can impact the results| | |x|\n|name of the person who developed and validated the computerised system, and the date of validation| | |x|\n|source code (if available)| | |(x)|\n|operating instruction (sop)|x|x|x|\n|documentation on computerised system periodic review and results of audits| | |x|\n|documentation on computerised system validation| | |x|", "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"}, "3595b473-9b95-48f4-9ad3-4980b6194eb5": {"__data__": {"id_": "3595b473-9b95-48f4-9ad3-4980b6194eb5", "embedding": null, "metadata": {"page_label": "10", "file_name": "[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf", "file_path": "/content/drive/MyDrive/Desarrollo Pharma.IA/PharmaWise Engineer/PharmaWise CSV & Data Integrity/raw_data/[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf", "file_type": "application/pdf", "file_size": 431019, "creation_date": "2024-04-07", "last_modified_date": "2024-04-05", "document_title": "Regulatory Guidelines and Best Practices for Computerized Systems Validation in GxP Environments: A Comprehensive Guide", "questions_this_excerpt_can_answer": "1. What specific international standards and guidelines are referenced in the document for the validation of computerized systems in GxP environments?\n2. As of the document's last update, what are the two specific annexes included that detail the validation processes for different types of computerized systems within pharmaceutical environments?\n3. What historical statistical method publication is cited in the document as a reference for the validation of computerized systems, including the edition and publication year?", "prev_section_summary": "The section discusses the documentation requirements for computerised systems, distinguishing between simple and complex systems. Key topics include the types of documentation needed for all systems, such as inventory lists and system operation dates, as well as additional documentation mandated for complex systems, such as validation certificates and source code. Entities mentioned include responsible persons, manufacturers, and developers of the computerised systems. The section emphasizes the importance of thorough documentation for validation and compliance purposes.", "excerpt_keywords": "Regulatory guidelines, Computerized systems validation, GxP environments, International standards, Annexes"}, "excluded_embed_metadata_keys": [], "excluded_llm_metadata_keys": [], "relationships": {}, "text": "[30] PA-PH-OMCL  (08) 69 R7 Validation of Computerised Systems.pdf\nreferences and further reading\n[1] en iso/iec 17025.\n[2] good practices for computerized systems in regulated \"gxp\" environments. pharmaceutical inspection convention/pharmaceutical inspections co-operation scheme (pic/s).\n[3] eu guidelines to good manufacturing practice (gmp). annex 11. computerized systems.\n[4] oecd series on principles of good laboratory practices and compliance monitoring. number 17. the application of pe principles of glp to computerized systems. environment monograph no. 13 (2016).\n[5] u.s. food and drug agency (fda) general principles of computerized system validation; fda glossary of computerized system and computerized system development terminology.\n[6] agit - validation of computerised systems, v 2.0 (2007).\n[7] d. j. finney - \"statistical mepod in biological assay\", 3rd edition, griffin, london (1978).\n[8] who trs 996 annex 5 - guidance on good data and record management practices (2016).\n\nlist of annexes\nthe latest version applies:\n- annex 1: validation of excel spreadsheets - pa/ph/omcl (08) 87;\n- annex 2: validation of complex computerised systems - pa/ph/omcl (08) 88.", "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": {"4865902c-e3eb-42e0-b65f-affccc6443ae": {"doc_hash": "43ce9f2dabcc4178c70cacab88ce2d130a66131a1494ce8e1818df2eaa5381fe"}, "9c56d074-d765-4c0a-8c20-6432648a8f4d": {"doc_hash": "87cd2d2887501c8ddadd07d1110a9331f8651f92068ed0d382bd8a135b8a66c9"}, "2611e357-48e7-44d7-9173-43b81777aa5e": {"doc_hash": "da60c6cb32fda08c01fb486859603396e4f805a9fba86cdca0b9f201f647da76"}, "88f29c14-e4ef-4b65-ae5f-b057fe58317d": {"doc_hash": "f8e576fdc604638149f09826c22137260e5f39e0b273d71e3ea23e49bc612388"}, "51df4e6d-658e-4a38-8217-01937b7c0499": {"doc_hash": "a4d68c782a80509c3320f918c14a12411ba2486770d99b737cb08d3d213c0d82"}, "5fe796f0-3943-42e1-8ae6-24986e98f68c": {"doc_hash": "65662e04316c2de04891b24540d9243041ad68d3ab3235321f8e181424d93614"}, "e5b1f2e6-4915-44a5-911e-08c035b9aec0": {"doc_hash": "7e92c9ba8bb7655449edb6c560d08b4de8060734e1daa25166a60dba5527b5a2"}, "d09a0fcf-8040-4491-ae81-e18556e69cdd": {"doc_hash": "246ec3d4862bc5c85ffe4b629fb7f5d04c1837f768a1a27869542405e29d5f83"}, "165767df-333e-48dc-9240-3ca266c1219d": {"doc_hash": "451546ae38b5822705ee827fc3b6afae5bd39da009de993943b226fe650ca7f9"}, "1debcfb7-f11f-4a67-bb33-fcf93d0cbafc": {"doc_hash": "7efd01f96d0f787d7468640800dfdd9259eafd779f13af82c3d27c6be497aab6"}, "3b51ceb5-d60b-4a17-8e08-8def1e3ae81f": {"doc_hash": "b09ab343895e605fec242e453e3c5a6c8cd5ef102b267e2e5df66d56904020da"}, "46fed1e5-288b-4e72-aee4-3a3ea5db184f": {"doc_hash": "ccf8a9f43e7d78d96c8cd53f124ac63c760e9f49a88f6c5c5dd78a3edba728cf"}, "50965ba4-9a99-49da-acd2-c245a4b9bd44": {"doc_hash": "8a9b6781b81ff2255957e319e9f6dc017d7ce0af96e5efebca9950970756186e"}, "99a8a15d-d23a-4b30-9615-5f714615d2fa": {"doc_hash": "3c3099149c513e8819468d20f77c285073c5e61cd7a8560071052d8664227589"}, "25808d54-1dd0-4a91-9e63-1cfa45511a98": {"doc_hash": "36c47be636784ec33ecc2487487a190634a61a96679fd3a6695b99ad7447de41"}, "c960cdeb-4e3b-4383-b10e-18db73a1be89": {"doc_hash": "7bf1cc592bb9ec7287f2a434c31bc9a6529d1093065a1b2c9812c62b6b614afe"}, "8d7962ee-44dd-4167-b6f3-4ef2bf0e8916": {"doc_hash": "782a22fe83b4f9ed4070e7d1e7d380262843917266ed79385bb276a4f5b15580"}, "06a6db1e-e6a0-481c-9373-dc660640b869": {"doc_hash": "484ea88e4fad695448c6a1261b8d0aa1657ff679da4c32f4d7aad6ded2166a8c"}, "728ae6a3-5f6d-4dba-be2d-9d4e12ec3ca1": {"doc_hash": "294a218d03e4107c9678559f76efb11c6e983701fbcf6535f3ffd952a8c745b5"}, "60231c92-ab4e-45a9-8298-8653957a1c17": {"doc_hash": "cea81f4b62d2241c717ad08eb53a30b774f8ddc65c4d6ac9e73931c509e8f4e8"}, "50bd9d5d-d7a4-402f-a9df-5ae4ef8d6e85": {"doc_hash": "5536c3edfc773fbe3c2c0bd6ee2085834444b4c90310ea09574978b84fadc409"}, "9bb0e330-3592-443c-80b9-dfebdb103684": {"doc_hash": "cc1ad7154e7e739a00d2312a31961db5a981374abb5d3abcd1b48466a5a9e203"}, "6d877aa0-717f-4328-b7e6-e30a55988d25": {"doc_hash": "7c9fa8a3a3a70183de3dc67a5df248b62dbd40fb16cd47069c7bfc284b976b06"}, "b52182b5-44f0-4c07-af38-0c23882a34f1": {"doc_hash": "77548b890fdc7bd213f9c03550d873f4de275838801d5a6cfbd598d6149a0058"}, "c9933559-d98d-4ad3-bedd-5b230a64b55c": {"doc_hash": "ab0e335830598d210b3b0d13eb0ebbb2089d4223986829c5f9359ac36532fa73"}, "687dabcd-fba8-4dd8-aa2d-b6cc3dd94a67": {"doc_hash": "2f4567121ec52f0aca7994cef000be5769d1d6b7e80ed18eef41df4ca7f6e16f"}, "5807dfb5-9407-472b-8015-50cd7141b07d": {"doc_hash": "fd0e143a067740953c67e5d94e26f46473990f76c0f2892ca4e2a44c10704c14"}, "a0725ad4-dbbe-46cb-b348-eb24e82dc5b4": {"doc_hash": "411ed5200025b277c186aa1582565722cbb7fa2c1d941468960bb6238c29b2cb"}, "ecbe8ea0-be22-453a-8f48-981ecd5f46ef": {"doc_hash": "e98a477eb5b321a5bce6f4c87051f179058fea32f40878a468538ba9e7680a3a"}, "3595b473-9b95-48f4-9ad3-4980b6194eb5": {"doc_hash": "0cf19a4827d373a56f112d922ca3bdb9caa953b4d37fedb9012ce25d86966155"}}}