1st Edition
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.
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
Biography
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.
