Foreword. Editor's Introduction. Considerations for Computerized System Validation in the 21st Century Life Sciences Sector. An Inspector's Viewpoint. State of the Art Risk Assessment and Management. Validation Planning and Reporting. Audit Preparation for Suppliers: A Question and Answer Approach. Developing Good Specifications. Traceability of Requirements Throughout the Lifecycle. Good Documentation in Practice. Good Testing Practice: Part 1. Enterprise Resource Planning Services - Aligning Business and Validation Requirements. Calibration in Practice. Validating Legacy Systems. Technology Transfer Keys. Qualifying SCADA Systems in Practice Acquisition. The Application of GAMP4 Guidelines to Computer Systems Found in GLP Regulated. The Validation of a LIMS System - A Case Study. Compliance and Validation in Central and
Eastern Europe (CEE). Distribution Management Validation in Practice.

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John Andrews

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