GAMP 5 - Good Automated Manufacturing Practice
Chapter 7: Supplier activities (products, applications, services and the supplier good practices) – GAMP 5 - Good Automated Manufacturing Practice

GAMP 5 - Good Automated Manufacturing Practice 7.11: Commercial Release

What does 7.11 require?

Releasing a system to customers follows a formal process that sets out when a release may go ahead, who is responsible, which records are kept and what is released, whether software, hardware or documentation. Clear policies and acceptance criteria reflect how many known defects remain and how serious they are, and every release, minor releases and patches included, comes with release notes listing what was fixed or changed, what is new, and which problems are known. A commercial release is not the same as release into the GxP environment, which the regulated company carries out; for custom applications the regulated company accepts the system under its own procedures.

Maintained by Gerard BlokdykControl text last updated

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  • 5.8.2 5.8.2 Document known residual anomalies

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Other controls in Chapter 7: Supplier activities (products, applications, services and the supplier good practices) – GAMP 5 - Good Automated Manufacturing Practice

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