Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers

by Guy Wingate (Editor)

Overview

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.

Product Details

ISBN-13:	9781574911176
Publisher:	Taylor & Francis
Publication date:	05/31/2000
Pages:	544
Product dimensions:	7.00(w) x 10.00(h) x (d)

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.

Editorial Reviews

Incorporating case study material from real-life pharmaceutical industry experiences with corporate computer systems, this volume offers advice on validating these systems from industry professionals around the world. Specific areas covered include the role of IT systems in the modern pharmaceutical plant; how to develop an information strategy; the importance of demonstrating regulatory compliance; how to maintain validated IT systems, such as performing supplier audits for software packages and hardware manufacturers and the implications of the U.S. FDA regulation governing the use of electronic records; and key practices and how they impact validation. Annotation c. Book News, Inc., Portland, OR (booknews.com)

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