Validating pharmaceutical systems: good computer practice in life science manufacturing

by Andrews, John

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Title Statements

Full title :Validating pharmaceutical systems : good computer practice in life science manufacturing / edited by John Andrews.

Edition Statements

Publication Date:2006.

Publication Statements

Publisher(s):Sue Horwood Pub, Taylor & Francis/CRC Press
Place of Publication:Boca Raton
Language:eng
Publication Date:2006.

The Physical Object

Description:1 online resource (xix, 549 pages) : : illustrations

Edition Identifiers

ISBN:0203500431, 9780203500439, 9780849323249, 084932324X
oclc:ocm62704513
LC Classification:RS122.2
Dewey Decimal:615/.19/00285

Foreword, Guy Wingate; Editor's Introduction, John Andrews; Considerations for Computerized System Validation in the 21st Century Life Sciences Sector, T. De Claire, P. Coady, and N. Stevens; An Inspector's Viewpoint, S. Clark; State of the Art Risk Assessment and Management, J. Andrews; Validation Planning and Reporting, C. Clark; Audit Preparation for Suppliers: A Question and Answer Approach, G. Wingate; Developing Good Specifications, M. Cherry; Traceability of Requirements Throughout the Lifecycle, K. Collyer and J. Dick; Good Documentation in Practice, M.L. Wyrick; Good Testing Practice: Part 1, D. Stokes; Enterprise Resource Planning Services -- Aligning Business and Validation Requirements, A. Nobibux, J.C Peters, S. Sharp, and J.E.H. Stafford; Calibration in Practice, M.E. Foss; Validating Legacy Systems, S. Schmitt; Technology Transfer Keys, S. Green and P. Warren; Qualifying SCADA Systems in Practice Acquisition, O. Lopez; The Application of GAMP4 Guidelines to Computer Systems Found in GLP Regulated, P. Coombes; The Validation of a LIMS System -- A Case Study, D. Hogg and F. Pedeconi; Compliance and Validation in Central and; Eastern Europe (CEE), P. Irving, C. Turner,…

Subjects

Drug Industry -- organization & adminis… Electronic Data Processing -- methods Industrie pharmaceutique -- Informatique MEDICAL -- Drug Guides MEDICAL -- Nursing MEDICAL -- Pharmacology MEDICAL -- Pharmacy Pharmaceutical industry -- Data process… Pharmaceutical technology -- Data proce… Techniques pharmaceutiques -- Informati… Technology, Pharmaceutical -- methods