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. The validation summary report should include:

• A description of the validation project
• All test cases performed, including if those test cases passed without issue
• All deviations reported, including how those deviations were resolved

Summary reports should be approved by the System Owner and Quality Assurance.

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 rules.

Additional Resources

Validation Document Resources

• Validation Plans
• User Requirement Specification
• Functional Requirements
• Design Specification
• Testing Protocols
• Installation Qualification
• Operational Qualification.
• Performance Qualification
• Traceability Matrix
• Risk Assessment
• Testing Deviations
• Summary Report
• Change Control for Validated Systems

• Compliance Validation
• Computer System Validation
• Process, Design and Equipment Validation
• Cleaning Validation
• Frequently Asked Questions about Validation
• Training courses on the validation process, including summary reports and computer validation