Features:

• Covers computer system validation from all perspectives: GLP, GCP, GMP, and GDP
• Concludes each chapter with summaries of do's and don'ts written by international experts working in current computerized systems validation
• Provides coverage of manufacturing execution systems and laboratory information systems
• Includes a glossary that defines all technical terms as well as an abbreviation guide
• Contains invaluable suggestions on life cycle management, electronic records and signatures, risk management, and regulatory inspections

Validating Pharmaceutical Systems offers a step-by-step review of topics such as planning, design, auditing, risk management, and specification. The in-depth, by example coverage demystifies the challenges of manufacturing execution systems(MES), laboratory information management systems(LIMS), and network qualification.

Contents

• 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
• Distribution Management Validation in Practice

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