The data resulting from validation tests, inspections, demonstrations, or evaluations are analyzed against the defined validation criteria. Analysis reports indicate whether the needs were met; in the case of deficiencies, these reports document the degree of success or failure and categorize probable cause 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 may also indicate that bad test results are due to a validation procedure problem or a validation environment problem.