1st Edition
Validating Corporate Computer Systems Good IT Practice for Pharmaceutical Manufacturers
Edited By Guy Wingate
Copyright 2000
ISBN 9780367398569
544 Pages
Published
September 23, 2019
by
CRC Press
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$79.95
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USD $63.96
ISBN 9781574911176
544 Pages
Published
May 31, 2000
by
CRC Press
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Original Price
$230.00
Sale Price
USD $184.00
ISBN 9780429134173
544 Pages
Published
May 31, 2000
by
CRC Press
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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.
Paperless & Peopleless Plants. Developing an Information System Strategy. Regulatory Expectations. IT Validation Policy. GxP Compliance. Integrating Manufacturing Systems. Validating Asset Management Systems. Validating Enterprise/Manufacturing Planning Systems. Validating Lab Information Management Systems. Validating Electronic Document Management. Compliance for IT Infrastructure. Validating Local & Wide Area Networks. Maintenance & Support of IT Systems. Auditing Suppliers. Auditing Software Integrators & Hardware Manufacturers. Practical Implications of Electronic Signatures & Records. 21st Century Validation.
Biography
Guy Wingate
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