Hi everyone!
Hope you're doing well.
Please let me know how to proceed to perform validation for confluence tool (test protocols) as a part of software Validation process as it is one of the requisites of ISO 13485 and 21 CFR.
Hi Akila,
This is not an easy question. You can start with the FDA guidance on software validation, which covers both products and tools. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation
As a company, we can provide this type of service, if you are interested.
Regards
Matteo
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