Confluence Cloud & Comala Document Management System Compliance

[amit.kakkar]

Hi, We are using Confluence Cloud and Comala Document Management System for our QMS.

I would like to ask if Confluence Cloud and Comala Document System are ISO 13485:2016 & FDA CFR Part 11compliant?

Where can I get more information about it?

Thanks.

[Matteo Gubellini _SoftComply_]

Hello Amit,

We recommend our customers Comala Document Management + Comala Publishing. This is more or less the best you can get on Confluence Cloud.

13485 is not a problem, the real challenge is 21 CFR 11. There are some small gaps in the Cloud products, such as the fact that they keep on getting updated without your control.

All in all, we have dozens of customers using it for 21 CFR 11 compliance and we haven't heard any issue with it so far.

Matteo