Validation Summary Report

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

For more examples, see our FastVal Validation Summary Report Template.

Frequently Asked Questions about Validation Summary Reports

Q: What is the definition of Validation Plan?
A: The National Institute of Cancer’s validation summary report definition is: A summary of all planned activities, their success or failure, and any deviations from the expected results or plans encountered. A satisfactory resolution should be provided to explain and resolve any deviations encountered. This test summary report may be optional. Results of all testing activities may be summarized in the Validation Summary Report rather than a separate summary for each testing phase. In practice, the validation summary report describes how the activities described in the validation plan were (or were not) accomplished.

Q: Can I see an example of a validation plan?
A: We have a sample validation summary report available for download.

Alternative Document Names and Acronyms

The following terms or abbreviations are sometimes used: Validation Summary Report, Validation Report, Summary Report, Validation Report Summary, Summary Validation Report, VSR, SVR, VR, SR.

Validation Summary Report

Validation Summary Examples

Frequently Asked Questions about Validation Summary Reports

Alternative Document Names and Acronyms

Validation Document Resources