Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation

 
 
CRC Press
  • 1. Auflage
  • |
  • erscheint ca. am 23. August 2018
 
  • Buch
  • |
  • Hardcover
  • |
  • 256 Seiten
978-1-138-04118-9 (ISBN)
 
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.
  • Englisch
  • London
  • |
  • Großbritannien
Taylor & Francis Ltd
  • Für Beruf und Forschung
  • Höhe: 254 mm
  • |
  • Breite: 178 mm
978-1-138-04118-9 (9781138041189)
1138041181 (1138041181)
Orlando López

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).
Preface; Chapter 1: Production CSV Overview; Chapter 2: Regulatory Requirements for Production Computer Systems; Chapter 3: Production Computer Systems Lifecycle (SLC) and Validation Management Cycle; Chapter 4: Production CSV Program Organization; Chapter 5: Project Management and Production Computers Validation; Chapter 6: Risk Management and the Extent of Production CSV; Chapter 7: CSV Plans; Chapter 8: SLC Documentation; Chapter 9: Qualifications; Chapter 10: Production Computer Systems Procedural Controls; Chapter 11: The Integrity of Electronic Records; Chapter 12: Suppliers and Service Providers; Chapter13: Remediation Projects; Chapter 14: Electronic Signatures; Chapter 15: Technologies Supporting Integrity of Electronic Records; Chapter 16: Trustworthy Computer Systems; Chapter 17: Key Operational Controls; Chapter 18: Summary; Appendix 1: Glossary of Terms; Appendix 2: Abbreviations and Acronyms; Appendix 3: Regulatory Cross Match; Appendix 4: References

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