Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers (Paperback) (ISBN-13: 9780367398569)

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.

Author: Guy Wingate
ISBN-10: 0367398567
ISBN-13: 9780367398569
Publisher: CRC Press
Language: English
Published: 09/23/2019
Pages: 544
Format: Paperback
Weight: 2.73lbs
Size: 9.90h x 7.00w x 1.20d