New GAMP Guide for Laboratory Computerized Systems

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.

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