What is Validation Summary Report in Computer System Validation

 

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In Earlier post we understood How to handle Discrepancies during Computer System validation?


Now in this article we are going to understand What is Validation Summary Report in Computer system Validation


Validation Summary Reports provide an overview of the entire validation project. It is summary of all planned activities, their success or failure, and any deviations from the expected results or plans encountered.


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.


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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 purpose of a Validation Summary Report (VSR) is to provide a concise overview of the entire validation effort and the results obtained. Additionally, the approval of the VSR authorizes the release of the system for operational use.


The validation summary report brings together all of the documentation collected throughout the life cycle and presents a recommendation for management approval that the system is validated and should be released for operational use.


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 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.


The report is reviewed and signed by the system owner and Quality. Summary reports should be approved by the System Owner and Quality Assurance.

 

 

Validation Summary Report should address the following elements:

•         Identification of the system subject to validation.

•         An inventory of all the deliverables generated during the validation effort including the document identifier and the approval date.

•         A summary of the results obtained during testing along with a discussion of any non-conformance encountered, their impact, and how they were resolved.

•         Details of any deviations from the Validation Plan and the impact of these occurrences on the validation project.

•         A list of any outstanding issues along with any known system limitations.

•         A statement of acceptance allowing for the release of the system.

 

The validation summary report should include:

1. A description of the validation project, including the project scope

2. All test cases performed, including whether those test cases passed without issue

3. All deviations reported, including how those deviations were resolved

4. A statement whether the system met the defined requirements

 “Trust but Verify “ Ronald Reagan

 

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