Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers
Author:   Guy Wingate
Publisher:   Taylor & Francis Ltd
ISBN:  

9780367398569


Pages:   544
Publication Date:   23 September 2019
Format:   Paperback
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

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Validating Corporate Computer Systems: Good IT Practice for Pharmaceutical Manufacturers


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.

Full Product Details

Author:   Guy Wingate
Publisher:   Taylor & Francis Ltd
Imprint:   CRC Press
Weight:   0.938kg
ISBN:  

9780367398569


ISBN 10:   0367398567
Pages:   544
Publication Date:   23 September 2019
Audience:   College/higher education ,  Professional and scholarly ,  Tertiary & Higher Education ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Active
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

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.

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Author Information

Guy Wingate

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Latest Reading Guide

NOV RG 20252

 

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