Performance Qualification

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.

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

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.

Performance Qualification Examples

For example, a performance qualification might demonstrate:

• That a system can handle multiple users without significant system lag
• That when the system contains large quantities of data, queries are returned in a certain (short) period of time
• That concurrent independent work-flows do not affect each other
• That a laboratory test correctly identifies a known material
• That a process was completed within defined system requirements

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, Operational/Performance Qualification, Performance Qualification, IOPQ, IOQ, IQ, IQ/OQ/PQ.