EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

This book provides practical information to enable compliance with computer system validation requirements, while highlighting and integrating the Annex 11 guidelines into the computer validation program. The ideas presented in the book are based the author’s experience in the US Department of Defense and regulated industries in various computer systems development, maintenance, and quality functions. A practical approach is presented to increase efficiency and to ensure that software development and maintenance is achieved correctly.

Table of Contents

Chapter 1: Introduction
Chapter 2: SLC, Computer Validation, and Annex 11
Chapter 3: Annex 11 Principles
Chapter 4: Risk Management
Chapter 5: Personnel
Chapter 6: Suppliers and Service Providers
Chapter 7: Validation
Chapter 8: Data
Chapter 9: Accuracy Checks
Chapter 10: Data Storage
Chapter 11: Printouts
Chapter 12: Audit Trails—Ensuring Data Integrity
Chapter 13: Change and Configuration Management
Chapter 14: Periodic Evaluation : Independent Review to Ensure Continued Validation of Computerized Systems
Chapter 15: Security
Chapter 16: Incident Management
Chapter 17: Electronic Signatures : Electronic Signing Requirements
Chapter 18: Batch Certification and Release
Chapter 19: Business Continuity
Chapter 20: Archiving
Chapter 21: SLC Documentation
Chapter 22: Relevant Procedural Controls
Chapter 23: Maintaining the Validated State in Computer Systems
Chapter 24: Annex 11 and the Cloud
Chapter 25: EU GMP Chapter 4–Documentation and Annex 11
Chapter 26: Annex 11 and Electronic Records Integrity
Chapter 27: Annex 11 and 21 CFR Part 11 : Comparisons for International Compliance
Appendix A: EMA Annex 11, Rev 1992
Appendix B: EMA Annex 11, Rev 2011
Appendix C: Glossary of Terms
Appendix D: Abbreviations and Acronyms
Appendix E:Comparison between EU Annex 11 and US FDA–211, 820, 11; Other Guidelines and Regulations
Appendix F: Case Study SCADA and Annex 11