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 7.4: Supplier Requirements

What does 7.4 require?

For product development the supplier gathers, defines and elaborates the requirements; the customer supplies them where the work is a service, a configured product or a custom application. Requirements state exactly and unambiguously what the system must do and any constraints on it; they are produced, reviewed and approved under the supplier's linear or iterative method, kept under change control with dependent specifications updated, and written so that each can be tested and traced on its own, since regulated companies wish to rely on supplier testing as far as possible. Where a product is configured or an application custom built, the regulated company describes the business processes to be automated, matched to what the product does where a product is used, and suppliers should manage requirements information with effective software tools.

Maintained by Gerard BlokdykControl text last updated

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This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • 5.2.6 5.2.6 Verify software requirements

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

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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