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I wish to validate Confluence as a QMS Solution currently used for document control of procedures and records as per ISO 13485. Do you have documentation on its validation?

3 answers

Hi Vanessa,

We have a customer, which is using Confluence for the engineering of pharmaceutical manufacturing plants. They use Comala workflows in combination with our Page Tree Creator. The Page Tree Creator gives you the ability to put templates under the control of Comala workflows and support the instanced page (created from this templates) with the version, author, name, etc. of the template. Of course you put the instanced pages again under control of Comala workflows.

Regards,
Stephan (CEO of EPS Software Engineering AG, the vendor of the Page Tree Creator)

Since Forms are controlled documents and the filled in form is a record, does confluence have editible forms that the user can not alter the controlled original form?

Hello Vanessa and everyone else,

We have recently launched a service to provide a fully 21 CFR 11 compliant turnkey solution based on Atlassian tools. Check this if you are interested.

https://softcomply.com/medicompli/

We can also help you set it up yourself in your own server instance if you prefer.

Matteo

0 votes

Hello Vanessa,

Welcome to Atlassian Community! It's nice to have you.

There's currently a feature request for this below:

In addition, there appears to be an add-on for Confluence Server that could help with that. It is not available for Cloud, so please be aware of that if you are on Cloud.

Let me know if you have any questions about that.

Regards,

Shannon

Hello Shannon, 

Thank you for the response!
You can use confluence for ISO 13485 compliance already now. I think what Vanessa is asking for is support on the validation that you are required to perform. By providing test cases or at least guidelines it would be easier and less work for companies to use confluence for ISO 13485 compliance.

If that is something you work on at Atlassian, I'd be interested in hearing about it. I'd also be happy to give feedback or guidance if helpful.

Best, Pascal

Pascal,

Thank you for your follow-up. This is not something that Atlassian can assist with, unfortunately. I'm personally not familiar with ISO 13485 compliance, so I am not aware of what validation would be required for you to perform.

We do have a page on Compliance within our products, but ISO 13485 is not mentioned here. 

Further reading states that it would be required to use an add-on to meet the requirements. Such as Comala Workflows which is available only for Confluence Server and Data Center.

Regards,

Shannon

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FYI @Vanessa Lucien & @Pascal Werner we did co-write a blog about ISO 13485 compliance and Confluence. You can view it here: https://comalatech.com/the-challenges-and-best-practices-of-developing-software-for-medical-devices/

Happy to help if you have further questions. 

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