COTS Validation
Rarely do I ask questions so you know this one is a doozy... I've been using TestComplete for almost 10 years now in various kinds of tests and such so I don't have any real problems with the a...
Forum Discussion
robert Martin [TeamAQA]
However, if anyone has any particular insights of things to test, things to look at, areas to cover, etc., for this kind of validation, I'd love to hear from you. Essentially:
When I've done COTS validation for FDA projects, I've focused on the the features of the products that we've used in our testing. This is covered in the Special Considerations section of 21 CFR Part 11 (section 6.1.3 specifically).
@Sergei Sokolov
We want to visibly expand with the TestComplete offering into the regulated industries in the next year or so, thus working with you on this project will be extremely valuable to us as well.
After this effort has been completed, is it intended that the end result (self executing test suite, supporting documentation, etc...) would be available to other customers?
However, if anyone has any particular insights of things to test, things to look at, areas to cover, etc., for this kind of validation, I'd love to hear from you. Essentially:
When I've done COTS validation for FDA projects, I've focused on the the features of the products that we've used in our testing. This is covered in the Special Considerations section of 21 CFR Part 11 (section 6.1.3 specifically).
@Sergei Sokolov
We want to visibly expand with the TestComplete offering into the regulated industries in the next year or so, thus working with you on this project will be extremely valuable to us as well.
After this effort has been completed, is it intended that the end result (self executing test suite, supporting documentation, etc...) would be available to other customers?