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Building a QMS on Jira and Confluence makes sense, especially if your team already uses this platform.

You may find it complicated and grueling to do it solo, so you are looking for a specialist to guide you and do some of the heavy lifting. To illustrate how we could make it more doable for you, let’s take this abstract idea into a real-world context with the story of a QA manager, Jean. Her three-step journey is typical.

Step 1: Deciding It’s Time for a Change
Surviving an Audit

Jean heaved a sigh of relief. No major findings and only three minor issues. After two days of a grueling audit, her medical devices company had managed to shake off the disaster that was their previous audit.

Still, being off one hook didn’t solve her daily pain and the stress that kept her up at night. The toll on herself and the business was immense and unsustainable, as, in the last few months, the quality efforts had eclipsed all other activities. Everyone was fed up.

Now that the situation was under control, there was only one way to keep it that way: it was clear the company had to move their QMS on Jira and Confluence. CAPAs and complaints, controlled documents, and all other processes must become part of the routine. The cost of compliance without a system was brutally evident.

The good news is that Jean has researched her options and has a clear understanding of what it takes: she will need a group of process champions who will inform about the business context and needs so that the configuration will fit. Moreover, thanks to the intensive work preparing for the audit over the previous few months, Jean knows a good candidate in each department.

All Jean needs now is someone who can transform those needs into a working platform. And she has an idea of who can help: Andy from DevOps. He is responsible for the ongoing administration of Jira and Confluence so he should be the perfect candidate.

Step 2: Considering Internal Options
Identifying Needs, Resources, Constraints, and Risks

Before her conversation with Andy, Jean gets clear on the top three requirements:

  • Knowledgeable about configuring Atlassian products
  • Understands regulations and compliance needs
  • Able to map between regulations and Atlassian: for example, creating a CSV (Computers System Validation) plan

Unfortunately, one hour with Andy is all Jean needs to determine he’s not the best person to create their QMS on Jira and Confluence. Although he has done some basic Jira configuration work in the past, his current focus is managing the company’s Active Directory and a collection of other tools people were using. This is a far cry from systems configuration.

Additionally, as Andy explains to Jean, Jira and Confluence configuration is a whole world in itself. To make it work, he will need time and space —that means being released from some of his other duties to have enough time to learn the tool and do the work. The regulatory language Jean uses worries Andy, like “electronic signatures” and “validation.” He isn’t sure what that means in terms of technology —it sounds like an expert’s territory to Andy.

Moreover, some process needs don’t seem to exist in Jira. Andy knows there’s a large Atlassian marketplace, but he’s only ever downloaded apps that people have specifically requested. Choosing the right app requires trial and error and might even need special development, which all points back to time —again, something he doesn’t have. Nor does he have any other resources internally to call upon. The developers always have so much product work on their plates.

As Andy explains all of this to Jean, she realizes the risks of using Andy are too high. Suppose he doesn’t get the system right out of the gates. In that case, it will waste valuable time. More importantly, it might result in a compromised configuration that makes things harder for her team — and Jean doesn’t want to be the cause (and target) of an ever-suffering team.

After talking to Andy, Jean realizes the designer of their QMS on Jira and Confluence must be someone who understands Design Controls, CFR 21 part 11 and knows how to build a validation file. It’s got to be someone who has done this before.

Step 3: Hiring a Consultant

Jean takes a minute to reflect on how she and the company have arrived at this place. Four years ago, the team was much smaller, and their device was not yet certified. If they had worked on the QMS project back then, it could’ve easily been an internal project for a couple of reasons:

  • They were not under immediate audit pressure.
  • Their quality processes were far simpler —back then, Andy might have been the perfect candidate to set up their initial QMS on Jira and Confluence.

Today, their device is on the market. The team is busy with a heavy workload evolving and growing their offerings. The cost of messing up their QA is so significant that Jean knows it’s time to bring in an Atlassian Solution Partner familiar with the regulatory context.

And that’s how Jean ended up hiring us. And from the most crucial standpoints — time, budget, compliance — she is working optimally. Our collaboration is simple:

  • Jean tells us how she needs her process to work.
  • She invites her process champions to share their needs and concerns as well.
  • We quickly configure a staging system and let Jean and her team try it out.
  • They provide feedback, and we refine the configuration.
  • We validate the system and create a long-term validation strategy.
  • The system is ready, we train the team on how to squeeze every drop of functionality out of the platform, and we are done!

It doesn’t take long to get Jean’s QMS on Jira and Confluence and the collaboration flow creates a momentum of enthusiasm and engagement. Jean is reassured that preparing for the next audit will be a snap.

For more insight into how consultants like Radbee helps life sciences companies thrive (and QA managers sleep peacefully at night!), check out our case studies or just talk to us!