目次

Preface 1. Introduction 2. What Is a Computer Systems Validation (CSV)? 3. CGMP Regulatory Requirements for Production Computer Systems 4. Maxims in CSV 5. General CSV Principles 6. System Life Cycle 7. SLC Documentation 8. Management of the Computer System Requirements 9. Risk Based Validation 10. CSV Plans and Schedules 11. Project Management, SLC, Production CSV, ITIL 12. Computer Systems Operational Life 13. Suppliers and Service Providers 14. Trustworthy Computer Systems 15. Control of Data and Records 16. Technologies Supporting Integrity of E-Records 17. Infrastructure Qualification Overview 18. Remediation Projects 19. Production CSV Program Organization 20. Integration Between Computer System and E-Records Life Cycles 21. Digital Date and Time Stamps 22. New Technologies and Critical Processes 23. All Together Appendix I: Glossary of Terms Appendix II: Abbreviations and/or Acronyms Appendix III: Regulatory Cross Match Appendix IV: Additional Readings Appendix V: References Papers—E-Records Integrity Appendix VI: Case Study—Cloud-Based SCADA Index