How to Document Validation Testing to FDA’s Satisfaction

Q: Regarding the documentation of validation testing, if “pass” is not sufficient as objective testing evidence, would FDA prefer video of the testing, or would screen shots of a large portion of the test cases be sufficient?

A: FDA doesn’t really have a preference for how you document the data from validation testing.

The best rule of thumb to apply is this: Can someone other than the tester (such as a supervisor, quality approver, or even an FDA investigator) look at BOTH the expected and the actual recorded results and reach his/her own conclusion about whether they match?

FDA generally will not accept someone’s subjective determination (such as “pass”, “check mark”, “OK”, “as expected”, etc.) as proof of anything. The fact that it may be “allowed” under a test plan doesn’t make it acceptable.

Actual results must be documented in a way that provides clear and objective evidence of the test outcome.

Furthermore, it sends a strong signal that an organization may not understand good software and systems engineering practice or FDA’s expectations. This is why actual results MUST be documented in a way that provides clear and objective evidence of the test outcome.

It’s also critically important to make sure your chosen approach is logical. For example, if you use a screen shot to show that an indicator changed from red to green, you need to ensure the screen shot is printed in color — a black and white screen shot obviously is useless, since it doesn’t adequately demonstrate what occurred.

Gordon B. Richman, EduQuest VP of Strategic Compliance Consulting (20 years as a senior executive for global pharmaceutical and medical device companies and attorney for major D.C. law firms). For further information on FDA expectations for validation testing, attend EduQuest’s FDA Auditing of Computerized Systems and Part 11/Annex 11 Compliance training class.


Leave a Reply

Your email address will not be published. Required fields are marked *