GAMP 5 - Good Automated Manufacturing Practice
Chapter 8: Efficiency improvements – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 8.9: Using Tools and Automation

What does 8.9 require?

Appropriate tools and automation supporting the management of IT processes and infrastructure, the system life cycle, and the specifying, building and testing of software can make work markedly more efficient while raising quality and reducing risk, and their use is encouraged, with the risk-based approach to the tools themselves described in Appendix D9.

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