Operational Qualifications are a collection of test cases used to verify the proper functioning of a System. The operational qualification tests requirements defined in the Functional Requirements. Operational Qualifications are usually performed before the system is released for use.
For example, the operational qualification might test:
- That each screen accepts the appropriate data
- That an item can be moved through an entire workflow
- That system security has been properly implemented
- That all technological controls for compliance with 21 CFR 11 are functioning as expected
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Each step of the qualification should include an instruction, an expected result and the actual result. Any discrepancy between the expected result and the actual result should be tracked as a deviation. Deviations should be resolved before validation is complete.
Depending on your needs and the complexity of the system, Operation Qualifications can be combined with Installation Qualifications or Performance Qualification.
Operational Qualifications should be approved before protocol execution. A copy of the unexecuted protocol should be kept in the validation package. The unexecuted protocol should be approved by the System Owner and Quality Assurance. The executed protocol should be signed by the tester and reviewed by the system owner and Quality.
Frequently Asked Questions
Q: Can I see an example of a operational qualification?
A: We have an sample installation/operational qualification for an Excel spreadsheet available for download.
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Acronyms
Installation/Operational/Performance Qualification, Installation/Operational Qualification, Operational/Performance Operational Qualification, IOPQ, IOQ, OPQ, OQ
Additional Resources
Validation Document Resources
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