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).

FAQs

What is software validation testing?

Validation testing is the process of determining whether the developed software meets the requirements of the client or user. The logic or different scenarios for the business requirements as well as key software functionality must be thoroughly tested.

*Source: https://www.softwaretestinghelp.com

How do you validate a software?

Validating software entails capturing proof that a software system fulfills the required standards and quality attributes, has been correctly installed, and will perform as intended. You must validate how you intend to utilize your software to create regulated products and/or perform relevant business procedures during this phase. The goal is to not only show that the software will do what you want it to do, but also to identify and mitigate issues that could negatively impact the manufacture of regulated products.

*Source: https://www.datacor.com

What is the difference between software verification and validation?

Specifications play a major role in the distinction between the two terms. Validation is the process of ensuring that the product specifications accurately reflect the needs of the customer, whereas verification is the process of ensuring that the program meets the required specifications.

*Source: https://www.arbourgroup.com

The Cost
of
Mistakes

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

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