Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement. Compliance is a state of being in accordance with established guidelines or specifications.
This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems are correctly achieved.
Data Integrity SME
Durham North Carolina USA
Orlando has worldwide pharmaceutical experience with relevant work in computer systems regulatory requirements including US, EMA, Australian, Japanese, WHO, PIC/S, and ICH regulations and guidance's.
Experience with direct participation in FDA agency remedial action plans, regulatory inspections, response activities, and consent decree remediation related verifications.
He is a member of the data integrity (DI) Working Group (IVT), DI in Manufacturing System Track (PDA) and the Institute of Validation Technology Editorial Advisory Board.
He is published in the Encyclopedia of Pharmaceutical Science and Technology, 4th Edition - Chapter 56 Computer Systems Validation (Taylor & Francis Group, LLC).
2. What Is a Computer Systems Validation (CSV)?
3. CGMP Regulatory Requirements for Production
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
18. Remediation Projects
19. Production CSV Program Organization
20. Integratation 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: References
Appendix V: References Papers - E-Records Integrity
Appendix VI: Case Study Cloud-Based SCADA
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