Does the procedure define the “verification & validation” of the software:
- Defining the Verification and Validation process.
- Including the test procedure or test description and that results shall be documented, reviewed and retained.
- Provide objective evidence that the software performs its required function.
- Trace software to requirements.
- Require that someone acting in an acknowledged product integrity role must perform the inspection review and approval of software. That software used to verify quantitative values (e.g., CMM, etc.) requires an independent method of validation (i.e., layout inspection, fixture check or comparison with another CMM program previously verified by an independent method) and correlation of the two sets of results.
- Acceptable correlation requires the difference to be within 10% of the tolerance for each characteristic. Differences greater than 10% but not exceeding 25% may be acceptable with documented justification.
Differences greater than 25% are not acceptable.