A common mistake is skipping the DS or configuration spec. In automated systems, untested configuration—such as a mis-set alarm limit or an incorrect formula—is the leading cause of validation failures. This phase must also address data migration, security roles, and backup procedures.
How does a failure affect patient safety or product quality? Probability: How likely is the failure to occur? Detectability: If it fails, will we know?
How will the system meet those requirements?
Validation is not complete until a is approved. This report consolidates all test results, deviations, and risk assessments, concluding whether the system is fit for its intended use. Once signed, the system is released for live operation.