GMP News: 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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