New GAMP Guide for Laboratory Computerized Systems

Recommendation

23-25 May 2023
Vienna, Austria

Analytical Instrument Qualification
Practical Approaches for USP General Chapter <1058> Compliance in the QC Laboratory

ISPE published the revision of the GAMP Good Practice Guide "Risk-based Approach to GxP Compliant Laboratory Computerized Systems" in October 2012.

This guide is a revision of the first edition and is intended to complement the superordinate GAMP® 5 Guide. Concepts and terminology from GAMP 5® are adopted in this revised guide.

The document gives an overview of the life cycle of laboratory computerized systems from design to decommissioning and describes a flexible approach to categorisation.

By means of three different annexes a difference is made between simple, medium, and complex systems. Further annexes describe, inter alia, the following topics:

• Categories of Software 
• System Description 
• Data Integrity 
• Interfaces to LIMS and ELN 
• Robotics Systems  
• Definition of Electronic Records and Raw Data  
• Safety Management 
• Supplier Documentation and Services

You can purchase the complete Guide (160 pages) directly at the ISPE.