Lopez EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

Erscheinungsjahr 2015
ISBN: 978-1-4822-4363-5
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 379 Seiten

This book provides practical information to enable compliance with computer system validation requirements, while highlighting and integrating the Annex 11 guidelines into the computer validation program. The ideas presented in the book are based the author’s experience in the US Department of Defense and regulated industries in various computer systems development, maintenance, and quality functions. A practical approach is presented to increase efficiency and to ensure that software development and maintenance is achieved correctly.

Zielgruppe

Healthcare practitioners involved in the quality assurance of computer systems performing functions regulated by the Good Manufacturing Principles. Regulated users under the regulations of PIC/S, EU, Canada, Australia, ASEAN, and the Unites States; academic libraries and consultants.

Autoren/Hrsg.

Lopez, Orlando

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Mathematik | Informatik EDV | Informatik Technische Informatik Computersicherheit

Inhaltsverzeichnis

Introduction. History of Annex 11. Annex 11 Principles. Risk Management. Personnel. Suppliers and Service Providers. Validation. Data. Accuracy Checks. Data Storage. Printouts. Audit Trails. Change and Configuration Management. Periodic Evaluation. Security. Incident Management. Electronic Signature. Batch Release. Business Continuity. Archiving. Annex 11 and 21 CFR Part 11: Comparisons for International Compliance.