New GAMP Guide for Laboratory Computerized Systems
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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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