EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP
- 4h 51m
- Orlando López
- CRC Press
- 2015
- Examines the implementation of computer systems compliance program based on EU Annex 11
- Includes examples from laboratory, clinical, and manufacturing computer systems
- Discusses electronic record integrity associated with stored information
- Compares the Annex 11 with key worldwide computer systems regulations and guidelines, including U.S. Food and Drug Administration, Canada, Australia TGA, PIC/S, and China FDA
Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.
The purpose of Annex 11 is to provide the EMA healthcare industry with consistent criteria for effective implementation, control, and use of computer systems. EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP supplies practical information to facilitate compliance with computer system GMP requirements, while highlighting and integrating the Annex 11 guidelines into the computer compliance program.
The ideas presented in this book are based on the author’s 25 years of experience with computer validation in the healthcare industry with various computer systems development, maintenance, and quality functions. The book details a practical approach to increase efficiency and to ensure that software development and maintenance are achieved correctly.
Examining the implementation of the computer systems validation entirely based on EU Annex 11, the book includes examples from laboratory, clinical, and manufacturing computer systems. It also discusses electronic record integrity associated with stored information.
About the Author
Orlando López is the SME for the GAMP Data Integrity SIG. He has 25 years of experience in worldwide pharmaceutical experience with relevant work in computer systems regulatory requirements including US, EU, Australian, Japanese, WHO, PIC/S, and ICH regulations and guidance. His special interest is the GMP compliance issues applicable to computer systems.
He has experience with direct participation in FDA agency remedial action plans, regulatory inspections, response activities, and consent decree remediation-related verifications. He is the author of two other books: 21 CFR Part 11—A Complete Guide to International Compliance, Taylor & Francis/CRC Press, 2004, and Computer Infrastructure Qualification for FDA Regulated Industries, Davis Healthcare International Publishing, 2006.
In this Book
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Introduction
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SLC, Computer Validation, and Annex 11
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Annex 11 Principles
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Risk Management
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Personnel
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Suppliers and Service Providers
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Validation
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Data
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Accuracy Checks
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Data Storage
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Printouts
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Audit Trails—Ensuring Data Integrity
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Change and Configuration Management
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Periodic Evaluation—Independent Review to Ensure Continued Validation of Computerized Systems
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Security
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Incident Management
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Electronic Signatures—Electronic Signing Requirements
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Batch Certification and Release
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Business Continuity
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Archiving
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SLC Documentation
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Relevant Procedural Controls
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Maintaining the Validated State in Computer Systems
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Annex 11 and the Cloud
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EU GMP Chapter 4-Documentation and Annex 11
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Annex 11 and Electronic Records Integrity
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Annex 11 and 21 CFR Part 11 Comparisons for International Compliance
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