Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies

Guy Wingate, Anthony J. Trill, Ludwig Huber, R.D. McDowall, John Andrews, Peter Bosshard, Mark Cherry, Chris Clark, Tony De Claire, Christopher Evans, Joan Mary Evans, Adrian Kavanagh, Louise Killa, Barbara Mullendore, Arthur D. Perez, Chris Reid, Owen Salvage, Nicola Signorile, Rob Stephenson, Ulrich Caspar, Peter Coady, Roger Dean, Robert Fretz, Stephen Giles, Peter Owen, Anthony Richards, Ron Savage

ISBN 10: 0849318718 / ISBN 13: 9780849318719

Published by CRC Press 2003-12-18, 2003

About this Item

Seller Inventory # 6666-TNFPD-9780849318719

Bibliographic Details

• Title: Computer Systems Validation: Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies
• Publisher: CRC Press 2003-12-18
• Publication Date: 2003
• Language: English
• ISBN 10: 0849318718
• ISBN 13: 9780849318719
• Binding: Hardcover
• Condition: New

About this title

Synopsis

Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-risk public safety projects or the production and control of life-saving medicines or devices, it is necessary to ensure that it is reliable, quality assured, and validated. The most comprehensive guide on computer validation currently available, containing more than 200 illustrations and more than 100 tables, Computer Systems Validation helps you see the big picture. The author reviews regulations and their development, organization responsibilities, validation life cycle based on GAMP4 Guide, strategic approaches to validation, electronic records and signatures, handling regulatory inspections, metrics, and opportunities for performance improvement. He presents practical examples and checklists throughout the book and explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. Covering methods that help you avoid duplicating effort among departments and business functions, the book demonstrates how you can use your investment in technology to improve business efficiency and gain the competitive edge.

About the Author

Guy Wingate