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Validating application design against specifications

A good tool provides guard rails to ensure that the important things are always done.It gives your team flexibility to produce ad hoc views and reports to better use (and explore) the data you’ve captured.

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Being able to link anomalies directly to a requirement improves communication between testers and developers. Generating anomalies directly from a test protocol failure means that more detail about the issue is captured.If you develop products — medical devices, particularly — then you’ve heard the terms design validation and design verification (also called V&V).Here we’ll explain what the two activities are, the difference between them, plus share tips for getting the most out of your efforts.Says Megan, “Early development of test methods can shed light on technology issues before they become major obstacles.” Early test development can also provide test tools.These can then be used to speed the product development process as well as provide test evidence during formal testing.This can be accomplished in a variety of ways, including written specifications, electrical or mechanical drawings, component purchasing specifications, or other methods.

Design verification provides evidence (test results) that the design outputs (actual product) meet the design inputs (product requirements and design specifications).

Planning for verification occurs throughout the project life cycle.

You’ll develop the test plan, which captures critical milestones.

Depending on the item being verified, a test case or test suite would be run, or an inspection or analysis done to provide the required evidence.

When collected together in a V&V Report, the combination of verification and validation test results, along with traceability back to user needs, product requirements, and design specifications, provides part of the evidence the FDA requires when submitting a medical device for clearance.

Using the same terms eliminates confusion for team members (not just new members — veterans, too).