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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:
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.
Installation qualification (IQ) testing confirms that the software is installed according to approved specifications and that it meets the prerequisite conditions to function as expected. Operational qualification (OQ) testing verifies that the software consistently works according to the predefined intended use.
Performance qualification (PQ) testing verifies that the software works as expected under simulated real-world conditions that are specific to a customer’s unique configuration and processes.
Learn how Arena’s product-centric quality management system (QMS) connects quality and product development processes helps medical device manufacturers overcome challenges to successfully deliver innovative, safe, and compliant products.
