Software (SaMD) mobile application verification testing: objective evidence

#1
Hello - I'm working on performing verification testing for medical device software applications. There's a debate on what qualifies as objective evidence that the software complies with the design/specs/requirements. In the past I've used screenshots as objective evidence. However, some believe that attestations of the test result (e.g. basically a signoff that the test passes and the expected result is met) can be used as objective evidence. The concern with screenshots is that it's incredibly time consuming and inefficient, so we're wondering if auditors value screenshots or if they are actually required.

Does anybody have experience performing software application validation testing and methods of collecting objective evidence?
Thanks.
 
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yodon

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#3
The goal behind objective evidence should be to allow a reviewer (with sufficient knowledge) to draw the same conclusion made by the tester. Anything less than that is less than ideal... which, frankly, is a lot of what I've seen. :)

Kind of a side note here: one thing I've seen with screenshots is that people tend to verify the implementation rather than the requirements. See a button, take a screenshot (but is that really the requirement)? My experience has been that if you (re)focus on the requirements the number of screenshots is reduced (and you can use attestation along the way to get there; e.g., click the button).

It's been my experience, most times in (regulatory) reviews, that the reviewers tend to "weigh" the results (is the paper stack high enough). I kind of get that since such results would be quite tedious to go through (exacerbated if they have to jump to separate screenshots).

The bottom line is "who knows" what a reviewer/auditor will care about. Strive for ideal but balance with practicality. But don't let practicality completely win. :)
 
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