Hello All,
This question may have been asked before but I couldn't find appropriate answer.If any Commercial off the shelf application is being used in a FDA regulated industry, can we leverage the testing performed by the vendor? If not why do we need to do additional testing at the site if the vendor has already tested the software functionality?
This question may have been asked before but I couldn't find appropriate answer.If any Commercial off the shelf application is being used in a FDA regulated industry, can we leverage the testing performed by the vendor? If not why do we need to do additional testing at the site if the vendor has already tested the software functionality?