Validation of tool as a part of QMS

[Akila S R]

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. 

[Matteo Gubellini [SoftComply]]

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