Tag Archive for software

Objective Evidence: How to Document It to FDA’s Satisfaction

Q: Could you tell me what’s considered best practice when it comes to documenting objective evidence? A: First of all, remember that objective evidence is NOT the words “pass/fail”, “true/false”, “as expected”, or “yes/no”. They are conclusions. [pullquote align=”right” cite=”” link=”” color=”” class=””…


FDA’s Expectations for Software Traceability

Q: It’s my understanding that FDA standards and guidelines call for software traceability of the requirements down to the level of the code (modules and functions). However, I believe a lot of companies may not be able to demonstrate requirements traceability down to…