Qualification and validation reports (2)
The results should meet the acceptance criteria
Deviations and out-of-limit results should be investigated. If these are accepted, this should be justified. Where necessary further studies should be performed
Responsible departments and QA to approve completed report, including the conclusion
10.3 The results should be evaluated, analysed and compared against the pre-determined acceptance criteria. The results should meet the acceptance criteria; deviations and out-of-limit results should be investigated. If these deviations are accepted, this should be justified. Where necessary further studies should be performed.
10.4 The departments responsible for the qualification and validation work should approve the completed report.
10.5 The conclusion of the report should state whether or not the outcome of the qualification and/or validation was considered successful.
10.6 The quality assurance department should approve the report after the final review. The criteria for approval should be in accordance with the company’s quality assurance system.
10.7 Any deviations found during the validation process should be acted upon and documented as such. Corrective actions may be required.