Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers - Softcover

Softcover

ISBN 10: 0367398567 ISBN 13: 9780367398569

Publisher: CRC Press, 2019

Synopsis

One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical information and advice on good IT practice and validation principles. Written by experts, it includes case studies on EDMSs, EAM systems, LIMSs, and MRP II systems.

About this title

About the Author

Guy Wingate

From the Back Cover

Written by experts, this book provides authoritative information and practical advice on validating corporate computer systems. It covers good IT practice and validation principles and presents case studies on EDMSs, EAM systems, LIMSs, and MRP II systems. Topics include the increasing role of IT systems within the modern pharmaceutical manufacturing plant and the move toward paperless manufacturing, how to develop an information strategy, the importance of demonstrating regulatory compliance, how to maintain validated systems, conduct supplier audits for software packages, hardware manufacturers, and software integrators, the practical implications of 21 CFR 11, and more.

Edition details

• Publisher: CRC Press
• Publication date: 2019
• Language: English
• ISBN 10: 0367398567
• ISBN 13: 9780367398569
• Binding: Paperback
• Edition number: 1
• Number of pages: 544
• Editor: Wingate Guy