Intertech Engineering Associates, Inc.

Medical Device Validation Series. Part 2 of 4

Part 2, Validation: More Than Testing

This is part two of a four-part series on medical device validation practices.

A common misperception is that validation of software is synonymous with the testing of software. This is not at all accurate.

Federal regulation requires software validation, not software testing. Validation, by the FDA’s definition, is the “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.”

Certainly, testing activity may be a component of validation, but note that the definition above does not use the word “test” at all. In fact, the definition mentions specifications and requirements specifically, assuming they exist and therefore creates a de facto linkage between validation and requirements.

The GPSV describes at length the definitions of, and differences between, software validation and software verification. Only a few of the related activities would be considered test activities. Similarly, verification activities, though narrower in scope, involve reviews, evaluations, and testing activities.

Keep in mind that all verification and test activities are validation activities, with other activities making up the remainder. Some testing is considered a verification activity, but there are verification activities that are not testing activities, and there is also testing that is not verification testing. Stay mindful that validation is not the same as testing.,

From: Vogel, David A., Ph.D. “Validating Medical Device Software Includes and Goes Beyond Testing.” Medical Product Outsourcing Mar. 2006: .

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