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Moving a CAPAs management system to Jira Cloud for global compliance & continuous improvements

How RadBee empowered Babylon Health, a leading international digital health company, by seamlessly moving their Jira-driven CAPA Management System to the Atlassian Cloud, improving global user adoption, audit outcomes, documentation, and overall quality.

 

When I came to Babylon, I had the unique opportunity to design a Nonconformities and CAPAs management system. It was an amazing trip, and I couldn’t have asked for a better partner than Radbee. We literally designed and developed the system from scratch.

Daksha Singham

Quality Manager & CAPA Manager
Daksha Singham
Babylon Healthcare logo

Highlights

Challenges

  • Company-wide initiative to move existing Jira server-based processes to the Atlassian Cloud.
  • Massive undertaking streamlining quality and improvements for a fast-growing user base: Babylon has more than 2000 employees globally and is serving millions of people worldwide  .
  • CAPA Manager, although a seasoned Quality professional, was new to Jira.
  • Existing CAPA Management system was server based and we were looking for a cloud based system that would allow access to a much larger internal audience
  • System validation and documentation had the potential to cause crucial delays in system implementation.
  • Risk of noncompliance and failed audits if “every dot” isn’t documented.

Solution

  • Designed and implemented a bespoke Jira Cloud-based Nonconformities (NCs) and CAPAs management system.
  • Migrated existing Jira processes from Jira Server to Jira Cloud.
  • Optimized the process, so it’s lighter and more intuitive for Babylon’s team to use.
  • Validation documentation kept up-to-date as the system evolved; no “documentation debt” was created.
  • Seamlessly transferred to full virtual collaboration for ongoing project maintenance and improvements in March 2020 — just when COVID-19 hit.
  • Short feedback loop: Requests arising from real-world usage are turned around quickly.

Results

  • Completed full Jira-system design and cloud migration within four months.
  • Aced multiple audits and impressed auditors with the system’s comprehensive nature.
  • Rolled out the system globally, with a high rate of adoption and user satisfaction.
  • Thanks to the success of the NC and CAPA system, the work continues on a new complaints management system.
Babylon team at work

Challenges

Spearhead the CAPA Management System’s move from server-based Jira to the Atlassian Cloud to meet a company mandate and improve quality and compliance worldwide.

Veteran CAPA Manager Daksha Singham was hired and given the remit to improve Babylon Health’s CAPA management processes, ensure successful audits, and foster a culture of continual improvement.

When she arrived, the limitations of the existing CAPA management system for this rapidly expanding global startup were immediately highlighted to her. 

“We did have a system on the server, but it was a low-tier license, which meant we were restricted on the numbers that could have access to the system,” Daksha explains.

Beyond that, the nonconformities (NC) system was nonexistent. The importance of this gap wasn’t lost on Daksha.

“The NC management system comes under the ISO 13485 clause on Measurement, Analysis and Improvement, and it’s integral to not just that standard, but all of our standards and regulations that Babylon Health states we adhere to ,” she notes.

With a background in large pharma and medical devices companies, Daksha was thrilled to have the unique, rare opportunity to design a custom NC/CAPA system from scratch. She had just two parameters she had to adhere to: move operations to the Atlassian Cloud and gain standard and regulatory compliance of the system and process.

For Daksha, this presented a challenge:

“Jira was new to me; I had never used it before,” she admits.

The other primary area of concern for Daksha was the need to document and validate the system.

“We have a very specific software validation process… and so we have particular documentation with requirements that we need to agree on, test, report, approve, and align to the procedure document. We then bring it all together in a Validation Report, which links to the different artifacts. Finally, we have to sign off the Validation Report at the end of it. The system can’t go live until all that documentation is in place and approved.”

 

All valid challenges but none of them are insurmountable. While ambitious, a four-month window from conception through build to implementation was achievable with the help of the right expert.

Solutions

Design, migrate, and expand the process for a seamless transition to the Atlassian Cloud.

Daksha connected immediately with Rina Nir, Radbee’s CEO, who had set up Babylon’s original CAPA process on a Jira server. 

With Rina’s support, Daksha was pleased to find that not only is the software exceptionally user-friendly, but it also supports compliance.

“I liked the fact that any changes, even as simple as a dot, is traceable. There’s a comprehensive history log — matching regulations and requirements, that’s very important,” she emphasizes.

Plus, Daksha had loftier goals for the system’s global users beyond compliance. 

“I wanted them to use it to raise issues. And, you know, issues don’t necessarily mean a negative thing. You can raise an issue just to improve your internal process,” she says.

Working closely with Radbee, Daksha pulled from her years of experience working for international life sciences companies to create the blueprint for a comprehensive CAPA and NC system. With an ambitious vision, she wasn’t shy about asking Radbee for precisely what she needed.

“With Rina, I could request anything. Rina would never say ‘no.’ It was always, “Oh, yes, of course. Let me show you what we can do,” Daksha enthuses.

The resulting process is called Non-Conformance and CAPA management. Driven by self-inquiry and continuous improvement, the system allows users to raise nonconformities. While most issues are resolved at this level, a minority is escalated to significant nonconformity (SNC) and ultimately CAPA (corrective and preventive action). 

This differential approach means that every issue processed gets precisely the level of attention and effort it requires.

“The design made the whole process much more streamlined and seamless,” Daksha notes.  

System validation documentation also was no obstacle with Radbee as a partner, much to Daksha’s delight. 

“It was a brilliant, two-way communication with Radbee and me working in a shared drive and on Confluence. When Rina made updates, I would get notifications. So it was all in real-time,” she recalls.

After running several iterations until Daksha was fully satisfied, the system was successfully launched on March 14, 2020. With her sights set on continuous improvement, she found once again that no bar she set was too high for Radbee.

“We have already upgraded the system a few times… we carried on working as we did initially. There was no break in the service at all and no delay,” Daksha recounts.

Results

Consistent compliance, continual improvements, and a system that Babylon’s users worldwide embrace — and depend upon.

With Radbee’s help, Daksha’s primary mission to ensure that the company’s product is safe and appropriate for end-users has been met. This is no small feat, as regulatory compliance is a top concern for a fast-paced, high-growth company like Babylon.

“We’ve been audited and have passed multiple times since we’ve set the system up. The system has impressed a lot of the auditors with its comprehensive nature,” Daksha notes.

This is a point of pride for her that has profound implications beyond getting a regulatory stamp.

“I am a lead auditor, and when I see somebody take an improvement process that seriously and is that widely used, then it makes me feel confident that the company wants to do better in an authentic way,” she says.

The other significant benefit to Daksha is how Jira Cloud, as configured by Radbee, supports continuous improvements. 

“I found the platform easily updatable from when it was set up to when we’ve gone through audits. As a user, I find it very straightforward; I’ve used many other systems. I have yet to find any disadvantages.”

The feeling is shared company-wide, as Daksha is pleased to see evidence that the system is well-constructed to meet the needs of a wide variety of users beyond those in the regulatory and quality areas. From Information Security to Product Engineering and the Babylon developers, the system supports iteration and positive change across the board.

“A CAPA system should not be used as a stick to beat people. At many companies, that’s traditionally the feeling. Here at Babylon, that’s not the case. The user base is increasing, and not because of any negative reasons. It’s used as a way of improving a process that already works.”

With a smile, Daksha adds:

“Rina is truly an asset. I have been in huge global companies and worked with a lot of quality systems people. Radbee delivers a fantastic combination, having somebody very tuned into what the customer wants and able to deliver exactly what the customer needs.”

Moving your quality systems to the cloud should be painless, safe, and seamless.

Find out how we can help you create a cloud-based electronic quality management system that cuts waste, optimizes opportunities, ensures compliance, and empowers you to serve your users better.