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.

For more examples, see our operational qualification template.

For an example of protocol execution, see our FastVal Electronic Protocol Execution.

Frequently Asked Questions

Q: What is the definition of Operational Qualification?
A: The FDA definition of operational qualification is: Establishing confidence that process equipment and sub-systems are capable of consistently operating within stated limits and tolerances. In practice, the operational qualification is the executed test protocol documenting that a system meets the defined functional requirements, or that the system does what it’s supposed to do.

Q: Can I see an example of an operational qualification?
A: We have a sample installation/operational qualification for an Excel spreadsheet available for download.

Q: Can I execute operational qualification test 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 perform operational validation with non-compliant software like MS Word and MS Excel.

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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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.

Operational Qualification