FDA validation of TeamCity?

I'm working for a medical company where we must have FDA approval of our products. In this connection we have been told that all tools used to create the product must also be validated according to FDA 21 CFR part 11. As we use TeamCity for our CI, this validation should include TeamCity.

The question then is whether TeamCity has been validated according to FDA 21 CDR part 11?

If there are any other companies out there in a similar situation, what have you done?

/Tonny

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Hi Tonny,

TeamCity was not validated according to FDA and we do not have plans do perform validation in the nearest future. If you can formulate the FDA 21 CFR requirements and questions we are open to provide all needed information and answers.
There were no companies that asked us about validation. However we received some related questions about TeamCity audit and logs related to FDA's compliance.

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Hi Alina / JB team,

 

We, at Planet Innovation, are also interested in this topic and I was wondering if you have done any work on this since 2015?

 

- Hami

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Hi Hami,

 

I'm afraid not, we have not pursued FDA validation at all. If there is something you are particularly interested in, please let us know the details via the Submit a request button above. While we can't promise specific action we might be able to address some concerns, or consider future paths to validation.

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