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When will 21 CFR 11 and ISO 13485 be addressed?

Wyatt Davis

Does Atlassian plan on being compliant to these regulations/standards in their cloud offerings?

I posted in the Regulations & Compliance: General Discussion thread but didn't receive any answer. In fact I'm not seeing much activity in this group or the general Compliance forum (other than a few spam posts). Am I in the right place?

Comments

Fili

Hello Wyatt,

There is work in progress to evaluate if a combination of Release Tracks capability, with 3rd party services (we are currently collaborating with SoftComply) could satisfy these regulations. There is no final determination yet, we can update you once we have made further progress cc: @Matt Tse

Wyatt Davis

Thanks for the reply. I do agree that Release Tracks may be enough to satisfy the validation requirements for FDA and I don't see any other issues regarding the digital signature requirements when using a third party for workflow/document management with Confluence.

Any ideas on how you plan to comply with Section 11.1 (e)?

(e) Computer systems (including hardware and software), controls, and attendant documentation maintained under this part shall be readily available for, and subject to, FDA inspection.

Also Section 11.30 specifically "additional measures such as document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality."?

Wyatt Davis

PS - A quick review of the ISO standard suggests that Confluence Cloud can probably be used for documents as is - the standard appears to be less stringent.

Fili

Thank you @Wyatt Davis ,

We do have at rest and in transit encryption, not sure if this is what you meant: https://www.atlassian.com/trust/security/security-practices#encryption-of-data