Operational Qualification Definition
The FDA provides guidance applicable to the validation of medical device software or the validation of software that is used to design, develop, or manufacture medical devices. Installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) are the three independent and documented procedures used to validate that software is:
- Installed correctly
- Meets its design requirements and specifications
- Operates the way in which it was designed under load
The OQ tests or qualifies that the solution is working using test data in general. This maps across to the requirements stated in the Functional Specification, and ensures the product or application meets all the predetermined requirements as stated.