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

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

  1. 379 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

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

About this book

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

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Information

Publisher
CRC Press
Year
2015
Print ISBN
9781482243628
eBook ISBN
9781482243635
Edition
1
Topic
Business
Subtopic
Operations
Index
Business

Table of contents

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

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