راهنمای پیوست ۱۱ اتحادیه اروپا در انطباق اعتبارسنجی کامپیوتری با الزامات GMP سازمان بهداشت جهانی ۲۰۱۵
EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP 2015

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