Analyze results of validation activities.
The data resulting from validation tests, inspections, demonstrations, or evaluations are analyzed against defined validation criteria. Analysis reports indicate whether needs were met. In the case of deficiencies, these reports document the degree of success or failure and categorize probable causes of failure. The collected test, inspection, or review results are compared with established evaluation criteria to determine whether to proceed or to address requirements or design issues in the requirements development or technical solution processes.
Analysis reports or as-run validation documentation can also indicate that bad test results are due to a validation procedure problem or a validation environment problem.
Example Work Products
- Validation deficiency reports
- Validation issues
- Procedure change request
1. Compare actual results to expected results.
2. Based on the established validation criteria, identify products and product components that do not perform suitably in their intended operating environments, or identify problems with methods, criteria, or the environment.
3. Analyze validation data for defects.
4. Record results of the analysis and identify issues.
5. Use validation results to compare actual measurements and performance to the intended use or operational need.
6. Provide information on how defects can be resolved (including validation methods, criteria, and validation environment) and initiate corrective action.