Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers, 1st Edition (Paperback) book cover

Validating Corporate Computer Systems

Good IT Practice for Pharmaceutical Manufacturers, 1st Edition

Edited by Guy Wingate

CRC Press

544 pages

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Paperback: 9780367398569
pub: 2019-09-23
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Hardback: 9781574911176
pub: 2000-05-31
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pub: 2000-05-31
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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.

Table of Contents

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.

About the Editor

Guy Wingate

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology
SCIENCE / Chemistry / General