Validating Corporate Computer Systems

Good IT Practice for Pharmaceutical Manufacturers

Häftad, Engelska, 2019

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Beskrivning

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.

Produktinformation

Utgivningsdatum:2019-09-23
Mått:178 x 254 x 29 mm
Vikt:938 g
Format:Häftad
Språk:Engelska
Antal sidor:544
Förlag:Taylor & Francis Ltd
ISBN:9780367398569

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Mer om författaren

Guy Wingate

Innehållsförteckning

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.