Validating Corporate Computer Systems

Good IT Practice for Pharmaceutical Manufacturers

Inbunden, Engelska, 2000

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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

Utgivningsdatum2000-05-31
Mått178 x 254 x 34 mm
Vikt1 170 g
FormatInbunden
SpråkEngelska
Antal sidor544
FörlagTaylor & Francis Inc
ISBN9781574911176

Tillhör följande kategorier

Tillverkningsteknik inom Naturvetenskap och teknik
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Medicinsk utrustning och medicinska tekniker inom Medicin
Farmakologi inom Medicin

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.