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:

  1. Is 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).


What is software validation testing?

Software Validation content is being added. Stay tuned.

How do you validate a software?

Software Validation content is being added. Stay tuned.

What is the difference between software verification and validation?

Software Validation content is being added. Stay tuned.

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.