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.”
Quality Manager & CAPA ManagerQuality Manager & CAPA Manager
- 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.
- 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.
- 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.
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.
For Daksha, this presented a challenge:
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.”
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.
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.
This differential approach means that every issue processed gets precisely the level of attention and effort it requires.
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.
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.
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.”
“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.