Performance Qualifications are a collection of test cases used to verify that a system performs as expected under simulated real-world conditions. The performance qualification tests requirements defined in the User Requirements Specification (or possibly the Functional Requirements Specification). Sometimes the performance qualification is performed by power users as the system is being released.
Performance 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.
For example, a performance qualification might demonstrate:
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.
For more examples, see our performance qualification template.
For an example of protocol execution, see our FastVal Electronic Protocol Execution.
Q: What is the definition of Performance Qualification?
A: The FDA definition of performance qualification is: Establishing confidence through appropriate testing that the finished product or process produced by a specified process meets all release requirements for functionality and safety and that procedures are effective and reproducible. In practice, the performance qualification is the executed test protocol documenting that a system meets the defined requirements to function in the production environment.
Q: Can I execute performance qualification or combined qualification testing cases using MS Word or MS Excel?
A: When electronic systems are used to perform regulated processes (like the verification of validation test protocols), they need to be compliant with 21 CFR 11. MS Word and MS Excel do not, in their out-of-the-box state, have the necessary technological controls, like individual user passwords or audit trails, required to be compliant with electronic records requirements such as 21 CFR 11 or Annex 11. Ofni Systems recommends that organizations do not do performance validation with non-compliant software like MS Word.
Q: How does Ofni Systems document validation testing?
A: At Ofni Systems, we use FastVal to execute test protocols electronically. This allows us to execute protocols to ensure requirement traceability and to generate the actual requirement traceability document. Other organizations might use Excel spreadsheets to keep a table of requirements, despite this being extremely difficult to maintain manually.
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The following terms or abbreviations are sometimes used: Installation/Operational/Performance Qualification, Operational/Performance Qualification, Performance Qualification, IOPQ, IOQ, IQ, IQ/OQ/PQ.