Validation Summary Reports provide an overview of the entire validation project. Once the summary report is signed, the validation project is considered to be complete. When regulatory auditors review validation projects, they typically begin by reviewing the summary report.
When validation projects use multiple testing systems, some organizations will produce a testing summary report for each test protocol, then summarize the project with a final Summary Report.
The amount of detail in the reports should reflect the relative complexity, business use, and regulatory risk of the system. The report is often structured to mirror the validation plan that initiated the project.
The report is reviewed and signed by the system owner and Quality.
The collection of documents produced during a validation project is called a Validation Package. Once the validation project is complete, all validation packages should be stored according to your site document control procedures. Summary reports should be approved by the System Owner and Quality Assurance.
Validation Summary Examples
The validation summary report should include:
- A description of the validation project, including the project scope
- 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
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