Validating pharmaceutical systems: good computer practice in life science manufacturing

Content: Foreword, Guy WingateEditor\'s Introduction, John AndrewsConsiderations for Computerized System Validation in the 21st Century Life Sciences Sector, T. De Claire, P. Coady, and N. StevensAn Inspector\'s Viewpoint, S. ClarkState of the Art Risk Assessment and Management, J. AndrewsValidation Planning and Reporting, C. ClarkAudit Preparation for Suppliers: A Question and Answer Approach, G. WingateDeveloping Good Specifications, M. CherryTraceability of Requirements Throughout the Lifecycle, K. Collyer and J. DickGood Documentation in Practice, M.L. WyrickGood Testing Practice: Part 1, D. StokesEnterprise Resource Planning Services - Aligning Business and Validation Requirements, A. Nobibux, J.C Peters, S. Sharp, and J.E.H. StaffordCalibration in Practice, M.E. FossValidating Legacy Systems, S. SchmittTechnology Transfer Keys, S. Green and P. WarrenQualifying SCADA Systems in Practice Acquisition, O. LopezThe Application of GAMP4 Guidelines to Computer Systems Found in GLP Regulated, P. CoombesThe Validation of a LIMS System - A Case Study, D. Hogg and F. PedeconiCompliance and Validation in Central andEastern Europe (CEE), P. Irving, C. Turner, W. Duncan, and D. ForrestDistribution Management Validation in Practice, B. Gilkes