Pharmaceutical Computer Systems Validation - 2nd Edition

CRC Press

Pharmaceutical Computer Systems ValidationQuality Assurance, Risk Management and Regulatory Compliance\nAuthor(s): Guy Wingate\nFormat: Hardback\nPublisher: Taylor & Francis Inc, United States\nImprint: CRC Press Inc\nISBN-13: 9781420088946, 978-1420088946\nSynopsis\nThoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revisA