Once the summary report is signed, the validation project is completed. Since validation reports provide an overview of the entire validation project. When regulatory auditors review validation projects, they begin by reviewing the summary report.
When validation projects use multiple testing systems, some organisations will produce a testing summary report for each test protocol, then summarise the project with a final summary report. Validation reports should reflect the relation business use, and regulatory risk of the system. The reports is often structured to reflect the validation plan that initiated the project.
The collection of documents produced during a validation reports is called validation package. Once the validation project is complete, all validation packages should be stored according to your site document control procedures. However, summary reports should always be approved by the system owner and quality assurance.
Examples Of Validation Reports
- All test cases performed, including whether those test cases passed without issue
- All deviations reported, including how those deviations were resolved
- A statement whether the system met the defined requirements
Benefits Of Validation Reports
Validation reports have been intended mainly for smaller organisations that might lack the most sophisticated tools for providing robust responses to fraud threats or reacting in the event of fraudulent activity. Additionally, it is most useful for institutions with smaller transaction sizes, since they require manual review processes.
Whereas larger institutions will naturally have more comprehensive cyber defences and fraud prevention controls, as well as their own backup reporting systems. Their large transaction volumes mean that a manual review process using validation reports might be less suitable, although smaller branches of larger institutions might find the reports useful.