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Confluence Cloud was their knowledge hub. So it was practical to move the Standard Operating Procedure (SOPs) and other controlled documents to Confluence Cloud too. The question was, how would authors and reviewers sign the SOPs in Confluence? Of course, there was always the option to export the pages from Confluence, route the exported file with DocuSign, and then file it somewhere.

Jason did not like this option one bit. It is effort-intensive and leaves a long follow-up tail. He was looking for a quick way to document sign-offs in Confluence.

If you are like Jason, look no further. Here, we provide the full recipe for the quickest way to a controlled documents setup in Confluence. Moreover, It’s a setup that meets the requirements of FDA 21 CFR part 11.

Processing and signing controlled pages in Confluence

Before taking you behind the scenes, let’s see how we will process controlled documents on Confluence Cloud once we have configured everything. It’s better to know the endgame before swamping you with the technical details under the hood.

First, we will organize our QMS pages in a QMS space. This space will be the home for our Quality Manual, SOPs, work instructions, audit reports, and all the rest. Everyone in the team can view the pages here, but very few can edit.

We also have a drafting Space. Whenever a page needs an update, we copy it to the drafting space, and we update it there. We exchange feedback and iterate through several revisions until we arrive at a good version. It’s now time to sign it, so it becomes the official version. The signees are the owner of the document, another person who is knowledgeable enough to review the page, the relevant department head, and a member of our QA team.

Once everybody signs, QA will move the page from the drafting space to the QMS space. At the same time, they will also archive the previous version. They do it by moving the old version of the page from the QMS space to the QMS Archive space. The archive space is only accessible for the QA team, so there is never a danger of using an outdated document.

We adapted our controlled documents SOP to reflect how we leverage Confluence Cloud.

Configuration recipe

As promised, this configuration is straightforward to set up. It requires a single Atlassian Marketplace App. The App we’ll need is Document control for Confluence Cloud. For the rest, we’ll use Confluence out-of-the-box capabilities.

Here are the configuration steps:

  1. First, create three spaces: A QMS space, a drafting space, an archive space.
  2. Set space permissions:
    • The QMS space: Everyone in the team needs VIEW access. Only the QA team needs access to add and edit pages.
    • Drafting space: Everyone can have both VIEW and EDIT permissions. As it’s a drafting space, there is no problem giving everyone access to edit. Once a page is ready for signature, updating it will be restricted. The Document Control App controls this.
    • Archiving space: Only QA team members have VIEW and EDIT access.
  3. Configure a space-level header in the drafting space. When people view pages in the drafting space, the banner highlights that these pages are not official and should not serve as a reference.
    • Configure the header here: Space settings → Look and feel → Header
    • Put this wiki snippet inside the ‘Header’ area:
h2.{color:red} DRAFTING SPACE {color}

4. Page properties: We’ll use Confluences’ page properties macro to designate each page with a unique identifier and other metadata like official version, change order reference, and owner.

    • Define the list of metadata you need for each page, and create an example page with a page property macro.
    • It is convenient to put a page properties report on the home page of each space. You’ll now have an instant documents index table.

5. Title conventions: agree on title conventions. You’ll need to have the official version of the page in the page title. Like this, you’ll avoid having two pages with the same title in the archiving space (where many versions of the same page will accumulate over time). Like so “Nonconformities Management SOP v1.2.”

6. Install the Document control for Confluence Cloud App and configure it. These are the most important settings:

    • If you need to be FDA CFR 21 part 11 compliance, tick the box for electronic signature.
    • Adjust the list of signature meanings to your needs
    • Use the automation around page restriction to avoid unwarranted edits of pages in the signature process.

7. Page template: In the Drafting space, create a template for your official pages. It includes placeholders for the various sections (Scope, List of references, etc.) and also these two elements:

      • Page properties table.
      • Document Control macro: This macro is part of the Document Control App. It shows the information pertained to the signatures given.

Document Control macro

The rundown

So here you are, Confluence is ready. Go ahead and create your first official document. Create a page in the Drafting space, using the template for official pages. Complete the page properties macro with the document identifier and other details. Complete the content and give a proper title, like so: “How to process controlled pages in Confluence v1.0”.
Invite others to give feedback, and refine until the page is ready. Then assign people to sign it off. Once all signees have signed, move the page to its new location in the official Space.

That’s it. No juggling, no loose ends. It’s time to share this process with everyone. Soon your Confluence Cloud will have dozens of marvelously processed new controlled documents.

Confluence is now both your knowledge hub and your QMS platform. A single Atlassian Marketplace App and a few hours of configuration work were all it took.

Your Quality Documents are now part of the beating heart of your team. You love it, and you know that the auditors will love it too.