Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation

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 (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority's requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. 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 is correctly achieved.

Orlando López E-records Integrity SME Durham North Carolina USA Orlando Lopez has significant understanding and experience with worldwide regulatory authorities regarding CSV, e-records integrity, and related requirements/guidelines related to Production Manufacturing Systems, IT Systems, Analytics, and Business Intelligence. He has knowledge and experience in the development of governance and SLC deliverables. Wrote and deployed CSV methodology to computer infrastructure J&J worldwide. Several times he had re-engineered the computer validation methodology to regulated companies. Orlando Lopez has experience with direct participation in FDA agency remedial action plans, regulatory inspections, response activities, and consent decree remediation related verifications. He is published in the Encyclopedia of Pharmaceutical Science and Technology, 4th Edition - Chapter 56 Computer Systems Validation (Taylor & Francis Group, LLC) and had written 25+ publications, including 9 computer compliance related books - amazon.com/author/orlandolopez/ Familiar with gap assessment, remediation planning and remediation execution activities.

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

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