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Home > Services > Computer Validation > Validation Resources > Protocol Test Deviations
Protocol Test Deviations
Testing Protocols test software requirements at different points in the validation process. When the actual results of the test step 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.
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