What is Performance Qualification (PQ)?

Performance 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:

  1. Is installed correctly
  2. Meets its design requirements and specifications
  3. Operates the way in which it was designed under load

After IQ and OQ, the final step of qualifying equipment is PQ. PQ addresses that the software application, under real-life conditions, consistently produces products that, which meet all predetermined requirements. The PQ is the final test before production, testing that the solution works fully in the live environment using live data, and should be based back on a workflow model from your user requirements specification (URS).

What is Performance Qualification


What is the difference between operational qualification and performance qualification?

Operational qualification (OQ) confirms that the software is operating according to its predefined intended use, whereas performance qualification (PQ) confirms that software performs as expected under simulated real-world conditions.

What is the purpose of a performance qualification?

PQ testing verifies that end users are able to run their unique processes on the software.

The Cost

Delivering new products to market is challenging. And it is difficult to see the cost impact of one or more mistakes.

Try our calculator to estimate the impact on your business. Input your business details, select a challenge, and see the real-world cost impact as validated by our customers.