Overview

Validating Pharmaceutical Systems is a highly readable text that offers a pragmatic approach to the validation of automated/computerized systems, which is an essential step in maintaining compliance with global regulatory authorities, such as the FDA. It examines the different levels of automated systems used throughout the drug development, manufacture, and delivery life cycle using the GAMP-4 life cycle approach to their validation. Rich with case studies and real-life examples, it also supplies the reader with true applications of GAMP 4 to different areas of regulations, such as good laboratory practice, good clinical practice, good manufacturing practice, and good data practice.

Full Product Details

Author:   John Andrews
Publisher:   Taylor & Francis Inc
Imprint:   CRC Press Inc
Dimensions:   Width: 15.60cm , Height: 3.60cm , Length: 23.40cm
Weight:   0.929kg
ISBN:  

9780849323249

ISBN 10:   084932324
Pages:   572
Publication Date:   03 August 2005
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print  
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Table of Contents

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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