Transcript
Supplier evidence can add value
Supplier testing can support a C S A strategy when it is relevant, credible, and current. Review what version, function, configuration, environment, data, and acceptance criteria were covered. A summary stating that thousands of tests passed is weak evidence unless you can connect it to the customer’s validation question.
Identify what the supplier did not test
Supplier regression may support unchanged standard functionality, but it may not cover local routing rules, identity mappings, interfaces, migrated records, custom reports, or the customer’s operating procedure. Security certifications describe management controls; they do not prove that a configured GxP workflow is fit for use.
Leverage, supplement, or reject
Record which supplier evidence is accepted, its limitations, and the additional customer evidence needed. Use targeted local tests for material gaps. If the supplier evidence cannot be reviewed or trusted, do not pretend it reduces uncertainty. Evidence leverage is a reasoned decision, not an automatic waiver of testing.