Validating Corporate Computer Systems

Good IT Practice for Pharmaceutical Manufacturers

By: Guy Wingate (Editor)

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Paperback | 23 September 2019 | Edition Number 1

At a Glance

Paperback
546 Pages

Dimensions(cm)
25.4 x 17.78 x 2.79

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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.

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