Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers, 1st Edition (Hardback) 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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Hardback: 9781574911176
pub: 2000-05-31
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Description

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, G. Moelgaard

Developing an Information System Strategy, C. Reid, N. Harris &B. Ravenscroft

Regulatory Expectations, H. Hambloch

IT Validation Policy, H. Hambloch

GxP Compliance, G. Wingate

Integrating Manufacturing Systems, C. Evans & D. Stokes

Validating Asset Management Systems, C. Reid & T. Richards

Validating Enterprise/Manufacturing Planning Systems, O. Salvage & M. Snelham

Validating Lab Information Management Systems, C. Evans

Validating Electronic Document Management, R. Dean & R. Mitchell

Compliance for IT Infrastructure, P. Wilks

Validating Local & Wide Area Networks, N. Signorile

Maintenance & Support of IT Systems, E. Koelman, K. de Jong & K. Piket

Auditing Suppliers, A. Dillinger, R. Kampfmann & T. Wichmann

Auditing Software Integrators & Hardware Manufacturers, H. Smith

Practical Implications of Electronic Signatures & Records, D. Selby

21st Century Validation, G. Wingate

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology