FDA Approval or Clearance

Not to be mean Tanya, but that answer had absolutely nothing to do with the question. However to your defense the question had absolutely nothing to do with TestComplete.



As far as I know, FDA (Food and Drug Administration) approval has nothing to do with the test tool used, but rather with what tests are done on the software itself. The software itself has to undergo stringent development cycle as described here:



http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm

The company I work for has recently completed a Commercial Off The Shelf validation package for TestComplete 8.70 for use in FDA Part 11 compliance software... so... yes... it's possible to use TestComplete for this purpose.

Robert, does your company do formal validation on the automated tests themselves?

We JUST finished the COTS so we're still working on figuring out how to build it in to our SOP's.  We've scoped automation usage for regression testing so it will most likely be used in Formal Testing Validation when there is a need to regress existing functionality.



So, as of right now, the answer is no... but within the next month or so, I hope to be able to answer yes.

Are there any communities that you know of for discussing FDA validation topics? Thanks!

I haven`t searched extensively, but if I had to guess I would say no. These validations are rather specialized, and firms offering them are usually pretty expensive, and there are tons of legal ramifications to doing the actual final approbation, it`s not something that is typically done in-house.

Yah, I hear you.

Hi,



Has anybody validated TestComplete for "21 Code of Federal Regulations (CFR) §820.30".



And would it be possible to get a copy of the report for use for the FDA?



Thanx... :-)