Validation
Asked by Vanessa Lucien:

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?


Answers:
author: Jake {Ketryx}
body: Hi Vanessa,

There are easier ways to do this than add-ons and creating your own documentation. Our product - Ketryx - creates a validated connection to Jira to configure it for ISO 13485 and 62304 compliance.

We validate the solution ourselves and can provide you with the design control documentation so you don't have to do that. We think that self validating Jira is generally a bad idea for product focused organizations because it takes up resources better devoted to product development. I wrote a blog post about that [here](https://www.ketryx.com/blog/the-turtle-problem).

We created Ketryx to help organizations focus on the work that really matters. If you'd like to learn more, check us out [here](https://www.ketryx.com/contact-us).

All the best,

Jake

![Screenshot 2023-04-17 at 18.44.26.png](https://community.atlassian.com/t5/image/serverpage/image-id/252309i3E95A76F0E4FEFFF/image-size/large?v=v2&px=999 "Screenshot 2023-04-17 at 18.44.26.png")


author: EPS Software Engineering AG
body: 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)

comments: author: John Crocker
body: 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?


author: Matteo Gubellini _SoftComply_
body: Hello,

We have recently released a new App for Confluence [Validation App](https://marketplace.atlassian.com/apps/1229288/softcomply-validation-for-confluence?hosting=cloud&tab=overview) .

This App runs a set of tests in the background to ensure that the integrity of Confluence is maintained, and creates an automatic protocol and report.

Matteo


author: Matteo Gubellini _SoftComply_
body: 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


author: Abhijith Chunduru
body: Hi, I am in charge of setting up the QMS workflows and processes at our company. We wish to validate Confluence and JIRA as a QMS solution as per ISO 13485. I have gone through the answers given here. The documents at <https://wiki.comalatech.com/pages/viewpage.action?pageId=36275626> and <https://wiki.comalatech.com/display/CW/Comala+Workflows+FDA+Title+21+CFR+Part+11+Compliance+Statement> are helpful on how Confluence helps in addressing some of the ISO13485 requirements. However, I want to know if there is a document with reasoning on how Confluence addresses all or most of ISO 13485 requirements. Can Atlassian help with this ? Or is there any documentation already available ?

Thanks and Regards,

Abhijith Chunduru

comments: author: Matteo Gubellini _SoftComply_
body: Hello [@Abhijith Chunduru](/t5/user/viewprofilepage/user-id/4094170) , together with Comala we have create a solution on Confluence that addresses all the 21 CFR 11 requirements. We will be happy to show you a demo if you are interested.

Regards

Matteo Gubellini


author: Abhijith Chunduru
body: Sure. How do I register / get-in-touch ?


author: Marion Lepmets _SoftComply_
body: Hi [@Abhijith Chunduru](/t5/user/viewprofilepage/user-id/4094170) ,

You can read more about the MediCompli solution here <https://softcomply.com/medicompli/> (demo form in the bottom of the page) and see a short video of MediCompli here [https://youtu.be/tVosqamiUtU.](https://youtu.be/tVosqamiUtU.?)

Looking forward to talking to you soon.

Kind regards, Marion


author: Shannon S
body: Hello Vanessa,

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

There's currently a feature request for this below:

* [CONFCLOUD-58288](https://jira.atlassian.com/browse/CONFCLOUD-58288) *Document control \& record management as per ISO 13485*

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.

* [Atlassian Marketplace \> ISO 13485 Add-ons](https://marketplace.atlassian.com/search?product=confluence&query=13485)

Let me know if you have any questions about that.

Regards,

Shannon

comments: author: Pascal Werner
body: 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


author: Shannon S
body: 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](https://www.atlassian.com/trust/compliance), 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](https://marketplace.atlassian.com/apps/142/comala-workflows?hosting=server&tab=overview) which is available only for Confluence Server and Data Center.

* [Comala Workflows ISO 13485 Sections 4.2.4 \& 4.2.5 (Control of Documents, Control of Records) Compliance Statement](https://wiki.comalatech.com/pages/viewpage.action?pageId=36275626)

Regards,

Shannon


author: Mike Rink
body: FYI [@Vanessa Lucien](/t5/user/viewprofilepage/user-id/3512236) \& [@Pascal Werner](/t5/user/viewprofilepage/user-id/2786474) 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.


Tags: atlassian-marketplace