When the actual results of a test step in a Test Protocol do not match the expected results, this is called a Deviation. Deviation reports should include:

• Description - How the actual results differ from the expected results
• Root Cause - What caused the deviation
• Corrective Action - What changes were made to the testing protocol or the system to correct the deviation

Deviations should be reviewed and the solution approved by the System Owner and Quality Assurance. Deviations do not necessarily need to be separate documents, but a system should be in place to ensure that all deviations are addressed before a validation project is resolved.

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 software testing and computer validation