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Full Product Details

Author:   Orlando Lopez
Publisher:   Taylor & Francis Ltd
Imprint:   CRC Press
Weight:   0.810kg
ISBN:  

9781138041189

ISBN 10:   1138041181
Pages:   326
Publication Date:   02 October 2018
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print  
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Table of Contents

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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Author Information

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.

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