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Scott replied to the topic Regression Verification and Validation in the forum The Design History File 7 years, 11 months ago
In agreement that acceptance criteria needs to be re-evaluated. Before that, a deviation should be opened to address the failure of a validation and why the deviation occurred and how it will be addressed. I would re-evaluate what additional testing or changes need to be done, whether its a regression test or opening up tolerance and specifications. From there, I would review if the acceptance criteria needs to be changed due to the added test or changes in tolerances and specs. Lastly, you have to ensure to rerun the entire validation protocol that failed to ensure it passes with the intended results.