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GAMP5

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**GAMP5**

What is GAMP5?

GAMP 5 (Good Automated Manufacturing Practice) is a guideline for computer system validation (CSV) in the pharmaceutical and other regulated industries. It provides a risk-based approach to validating automated systems to ensure they are fit for their intended purpose and comply with regulations. It covers the entire lifecycle of an automated system, from planning and specification to operation and decommissioning, and promotes a common understanding of computer system validation among manufacturers and regulators.

Which organizations are mentioning GAMP5?

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