Discussion on FDA Part 11 compliant Confluence setups for medical device documentation

[Tuelle]

I would like to know if anybody has managed to setup an FDA Part11 compliant Confluence system, e.g. for documenting medical devices. We are still working on this issue and I would be interested in sharing and discussing experiences. 

Our requirements are:

1. Traceability of any content change (who changed what and when)
2. Predefined review workflows
3. Ideally automatic generation of meaningful page/document ids
4. Review steps that require finalization with electronic signatures
5. Assurance that approved pages cannot be edited without losing their approval state.

We are using the latest Confluence version and the following plugins:

• Comalatech workflows (for review workflows with electronic signatures)
• ScrollPDF Exporter

This is how we organize our content:

• One space for each product and product version
• One document (e.g. Project Plan or Validation & Verification Plan) per Confluence page
• Each document/page is linked to a  predefined Comalatech Workflow based review process with the states Editing (ends with Author approval), Reviewing (ends with Reviewer approval) and Approval (ends with Approver approval)

Our current challenges/ open issues:

If a document/page has been approved its content should be frozen. This means that as soon as the content is edited the document has to lose its Approved status. But how can the following issues be solved:

• An author can use macros that dynamically generate content when the page is loaded. So the content can change even the page is set to read-only. As a consequence, an approved page might display content that has not been subject of the review process and approval.
• You can refer to content of other pages, e.g. display an image that is an attachment of another page. Therefore, you can change the content of a read-only and approved page by updating the source image attached to the second page.

One idea to approach this problem is to automatically generate a PDF including information about the electronic signatures as soon as the page reaches the approved status. The PDF is static and cannot be changed easily. We would then argue that our employees should refer to the PDF files in their daily work and that Confluence is just used as a content editor. This is how we worked in the past (MS Word for editing document and generating PDFs files, which are printed out, signed by hand, scanned and archived in SVN and folders), but it is obviously not the way you would like to use a Confluence based system.  

Has anybody managed to solve these issues or another idea how to approach this topic?

Best regards

Thorsten     

[James Conway]

Hi Pascal,

I am the Senior Product Manager at Comalatech. Currently we cannot integrate plugins in Confluence Cloud. Workflows Lite offers e-signature in the QMS Workflow and we hope to extend the functionality of this soon.

I hope that helps. If you want to discuss your requirements in more detail you can contact us via https://comalatech.com/support any time.

Kind regards

James

[Pascal Werner]

Hi Thomas,
Thanks for recommending Scroll Documents.
I have a very similar issue as the original poster and just watched the video of Scroll Documents. 
Do you know whether Scroll Documents can be combined with Comala Workflows Lite (working on a Cloud instance)?

Background:
It is about a medical device documentation in confluence, of which parts are auto-generated from Jira. As posted earlier, the easiest (but not very nice) workaround is to export those confluence pages as a PDF. 
When using Comala Workflows and having approved a page with the Jira macro, you can still change the related Jira issues and refresh the Jira macro on the approved confluence page. The Comala Workflows status won't be affected.
Ideally I'd like to freeze the confluence page before it goes into review. And, ideally, the review of the page can be done with a 21 CFR 11 valid electronic signature.

Do you know whether this is possible?

[Carol G]

Hello. We are searching for a firm to implements some new medical device software solutions compliant with a newest law. If you don't mind - read it and let us know what do you think about this choice?

[Anatol Straub]

Comalatech is working on a feature to include the functionality to "freeze" pages in Comala Workflows: If you contact their support they will surely keep you up to date.

I think the first step will be PDF aswell but maybe it will still be easier to handle. The ultimate goal is to have proper versioning for all page content for auditing and every day use like working instructions etc.

Imo this is actually an issue of Confluence as it makes sense to freeze dynamic content in historical versions for almost any use-case I can imagine.

Regards, Anatol

[Deleted user]

Hi Tuelle,

I'm sorry that Scroll Documents isn't currently available for server – we're working on creating the server version, but unfortunately we currently can't provide a concrete estimate of when it will be ready.

If any further questions about Scroll Documents arise, you can always reach out to us at support@k15t.com and we'll be happy to help.

Cheers, Tom.

[Tuelle]

Hi Thomas,

Thanks for the tip. I will definitely have a look at the plugin. Unfortunately, our system is an on-premise installation, so I will wait until the server version is released.

Thanks,

Tuelle    

[Deleted user]

Hi @Tuelle,

Your current method, using Comala Workflows and Scroll PDF Exporter, sounds like a great approach – I actually work for the developers of Scroll PDF Exporter, so it's always interesting to hear about people using our apps in new ways.

However, I did notice that you described storing your approved versions of documents outside of Confluence as a pain point – and I totally understand that. In an ideal world, Confluence would be a place for both authoring documents, and storing them once approved.

I thought I’d let you know that my company, K15t Software, also has an app for managing documents in Confluence that sounds well suited to your use case. The app is called Scroll Documents, and it allows you to define trees of Confluence pages as documents, and then save static versions of these documents within Confluence. You can then view, compare, export (to PDF, using Scroll PDF Exporter), and link to these document versions at any subsequent time. And because in the server version the versioned content is static, this means that the content in dynamic macros will be rendered the moment you save the version, so this won’t change over time.

If you’d like to see the app in action, you can watch the short get started video.

I should also mention that Scroll Documents is currently only available for Confluence Cloud, but we’re currently working on a server version. If you’d like updates and more information about Scroll Documents for Server, please sign up on our website and we’ll keep you in the loop.

If you have any questions, please ask and I’ll be happy to help.

Cheers, Tom.

[Alex Stoeckli]

Hi Thorsten,

I think we run into similar challenges. Please contact me by using my "first.lastname", then add an "at"-symbol and end with "shl-group.com". Sorry for the anti-bot instruction.

Cheers,

Alex