Content: 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, W. Duncan, and D. Forrest Distribution Management Validation in Practice, B. Gilkes