What is Software Validation?

Software Validation 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. Installed correctly
  2. Meets its design requirements and specifications
  3. Operates the way in which it was designed under load

The IQ records the installation of the software, and ensures that the installation follows the correct steps.

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.

The final step of qualifying equipment is PQ. PQ addresses that the software application, under real life conditions, consistently produces products, 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).