GAMP Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition) PDF

The ISPE GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems is intended as a supplement to ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems. This Guide provides an overview of the life cycle of laboratory computerized systems, from concept to retirement. It has been updated to align with the concepts and terminology of GAMP® 5 and regulatory and industry developments which focus attention on patient safety, product quality, and data integrity.

This revision:

• Describes a flexible categorization approach consistent with GAMP® 5, based on risks associated with the use of the system to support the relevant business process
• Applies the GAMP® 5 specification and verification approach to laboratory computerized systems
• Emphasizes the importance of leveraging supplier documentation and knowledge to avoid unnecessaryduplication of efforts

This Guide provides direction for identifying, securing, and managing critical electronic records involved in regulated business decisions, consistent with recent regulatory guidance.

This Guide has been designed so that it may be used in conjunction with GAMP® 5 and other ISPE publications, such as the ISPE Baseline® Guides.