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Moving Your CAPA Management to Jira Cloud: 4 Lessons Learned by a Global Digital Health Company (Case Study)

This article was written by Rina Nir from RadBee

For companies in heavily regulated spaces like life sciences, Corrective and Preventive Actions (CAPAs) and Nonconformities (NCs) Management push the company for ever-better quality. A Jira cloud-based quality management (eQMS) solution provides loads of benefits, from better documentation and audit outcomes to increased user adoption worldwide and greater overall quality.

The choice to implement quality processes in Jira isn’t obvious. After all, there are specialized eQMS systems that are marketed and sold for this purpose. But in my experience, innovative companies look for ways to make internal and external (i.e., regulatory bodies) compliance simple, fast, and reliable.

This is why Babylon Health, a fast-growing global digital health company, came to my company, Radbee, for help migrating their server-based CAPA and NC system to Jira Cloud.

Throughout the process, we learned several valuable lessons that apply to any company considering moving a core business process to the Jira Cloud.

Let’s dive in.

Lesson #1: Do It for the Right Reasons

While using Jira for software development is a no-brainer, using it to manage business systems like NCs and CAPAs isn’t as prevalent.

In Babylon’s case, their software division already uses Jira. So, the order came down from the top to use Jira Cloud to streamline processes — a sensible call for several reasons:

  • It reduced the cost of ownership.
  • It eliminated the friction caused by introducing another system.
  • It lessened new users’ learning curve.
  • It provided easier access to global teams through the main Jira dashboards.
  • All other processes that are running in Jira are better integrated.

Does this mean using Jira for CAPA/NC Management was a slam-dunk?

Not totally. There were some hurdles to overcome. For example, Jira isn’t validated out-of-the-box, so validation required specific effort and know-how. Also, the project owner, Quality Manager & CAPA Manager Daksha Singham, had never worked with Jira before, so there was a potential learning curve.

Still, it was the right choice. And as long as you understand why you chose Jira in the first place, you’ll be motivated to overcome any challenges.

Lesson #2: Know Who Owns the Process

Whoever’s in charge of the project implementation owns the process. For Babylon, even though the technical work was wholly outsourced to us, Daksha was the point person throughout development to define the specifications, evaluate the process, and deliver feedback.

This ownership of both the outsourcing budget and result is vital to the project’s success. Furthermore, it ensures that the most authentic input and guidance are provided to the technical team. In other words, Daksha’s hands-on, first-hand experience made it possible to customize the system to Babylon’s specific needs.

Bottom line: Work carried out “at arm’s length” by someone who does not “live the process every day.” It won’t deliver the same outstanding results that can be achieved when the process owner is fully engaged with the Jira implementation project and committed to the time and effort involved.

Lesson 3: Make Space to Iterate

Time is always of the essence, and the good news is that the actual configuration work in Jira is usually pretty speedy — most processes can be set up in a day or two.

But the project itself? That takes longer. It took us a few months to roll out the first implementation, and then we iterated several times based on feedback from users.

Here are the main things that take time — not because Jira isn’t lightweight and flexible, but because it is.

  • Outlining an abstract process idea into Jira terms (i.e., workflow steps, fields, etc.)
  • Discussing and deciding upon all the minor points (i.e., field names, workflow steps, conditions, automation)
  • Rolling out the first iteration to a small team to smooth any rough edges before a wider launch

Also, from the “good things take time” files, the people who use the CAPA/NC system first become your evangelists. They’ll spread the word, and like Babylon, you’ll see continuous increases in users over time.

Lesson 4: Engineer the Process

One of the best things about using proven cloud-based software like Jira is that the platform itself is powerful straight out of the box. So, when it comes to engineering efforts, you can focus on process over product.

Here are the key considerations that widely apply to fast-moving, heavily regulated businesses:

  • Optimize for the “sunny scenario”: Many processes have a “happy route” — simple, straightforward, lightweight — which impacts 80% (or more) of the cases. For example, for Babylon, many NCs don’t require a full-blown, complex CAPA process. So, when we designed the process in Jira, we created a clear distinction for those “happy cases” and focused on making this route as easy as possible.
  • Create dedicated fields for necessary data: For any data item with regulatory compliance or another essential aspect, we created specific field names to clarify what the user should include. For example, instead of labeling a field “description,” we instead had fields marked, “What happened?” and “Why is this a nonconformity?”
  • Control points: Having control steps where the QA team can review and provide feedback mid-processing is vital, particularly for companies that regularly face audits. In Babylon’s case, that meant that the learning curve was expedited, as team members who processed issues got feedback almost immediately.
  • Automation: Jira allows for massive automation, but there is a trade-off. Because of scripts, it can be expensive to implement and maintain. We did a cost-benefit analysis to be sure any automation was worth it. Additionally, we used ScriptRunner, as Babylon already had it in use and available on their platform.

Using Jira Cloud for business systems, like CAPAs and NCs, can be a powerful way to increase quality, ace audits, and cut waste. The trick is to plan strategically and be flexible along the way.

Please be sure to check out the Babylon Health Case Study for more inspiration and details about how the international digital healthcare company not only up-leveled their CAPA/NC process but are also using Jira Cloud to improve other business systems, including a new complaints management system.