Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers

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Guy Wingate

Validating Corporate Computer Systems

Good IT Practice for Pharmaceutical Manufacturers

Guy Wingate

$126

Paperback

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English

CRC Press
23 September 2019

Pharmaceutical technology; Computer science

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.

Edited by: Guy Wingate
Imprint: CRC Press
Country of Publication: United Kingdom
Dimensions: Height: 254mm, Width: 178mm,
Weight: 2.070kg
ISBN: 9780367398569
ISBN 10: 0367398567
Pages: 544
Publication Date: 23 September 2019
Audience: College/higher education , Professional and scholarly , Primary , Undergraduate
Format: Paperback
Publisher's Status: Active

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.

Guy Wingate