Operational Qualification

The Operational Qualification Protocol is a collection of test cases used to verify the proper functioning of a system. The operational qualification test requirements are defined in the Functional Requirements Specification. Operational Qualification is usually performed before the system is released for use.

Depending on your needs and the complexity of the system, Operation Qualification can be combined with Installation Qualification 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.

Operational Qualification Examples

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

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.``

Alternative Names and Acronyms

The following terms or abbreviations are sometimes used: Installation/Operational/Performance Qualification, Installation/Operational Qualification, Operational/Performance Operational Qualification, IOPQ, IOQ, OPQ, OQ.