Paige.ai, a global leader in AI-based pathology diagnostic software, uses Jira and Confluence for their Quality Management System (QMS). RadBee Ltd. has helped this fast-growing startup create a QMS that supports their Software as a Medical Device products (SaMD) — including a custom extension for Confluence that alleviated a critical bottleneck from the release process and ensured compliance.
VP of Regulatory Affairs & Quality at Paige
- The company’s Software as a Medical Device (SaMD) products are updated frequently, and the manual documentation process — particularly creating Medical Device Records (MDR) index table— was painfully tedious work.
- Risk of release delays due to the documentation not being ready on time.
- Elevated risk of errors and nonconformities because of the manual process.
- Risk of non-compliance and failed audits if each release doesn’t have a complete, accurate regulatory dossier.
- Team members were bogged down by the documentation process with no time to take on high-value tasks.
- No existing programmable Confluence extension or Atlassian Marketplace app to make the creation of index tables easier.
- Radbee designed a tailor-made Confluence extension called “Powertags,” making creating MDR for new releases effortless and foolproof.
- Powertags provide a robust MDR Index for the regulatory dossier, ensuring compliance over time.
- Easy release process that is aligned with the Paige release flow.
- Passed audits by the FDA and other regulatory organizations with flying colors.
- The Paige team has time to do high-value work, like improvement projects.
- Increased the product and engineering teams’ speed by eliminating the need to duplicate Confluence pages.
- Removed bottlenecks and paved the way for other optimized efficiencies with new features to further improve the quality system.
- A QMS that fits a medical device Agile development process.
- A close working relationship with Radbee means continuous improvements are fast and easy to implement, even during Paige’s off-hours.
Develop a QMS in Confluence that automates, streamlines, and speeds the medical device release process and alleviates the manual burden on the team.
When veteran quality and regulatory expert Emre Gültürk joined the Paige team in 2020, he inherited a project to overhaul the QMS for the innovative medical device startup. From his lengthy experience, Emre had a clear perspective on what makes a quality system tick.
When Emre joined the team, MDR index creation was manual. As a compliance expert, the first challenge Emre identified was the sheer frequency of new releases.
In Emre’s eyes, the bottom line was to get his team out from under work that wasn’t moving their main business forward quickly with an eye on both compliance and higher-value outputs.
Develop a custom Confluence extension that automates the MDR index creation process as much as possible to eliminate errors and ensure robust, traceable documentation that passes audits while supporting continuous improvement.
With these goals in mind, Emre and his team developed clear guidelines for Radbee to create a custom-built Confluence extension to fix the problem.
Leveraging the power of the Atlassian API, Radbee set to work on designing a solution called “Powertags.” Each page gets new tags: one tag to identify the product version and a second to associate it with the category of the document in the MDR table. This is the only step that the page author must do “manually.” These tags are linked to a specific version of that page and are maintained even when the page has newer versions.
Then, when a release is ready, a new MDR Index page is created using a blueprint template. The index table is completed automatically from all the Powertagged pages.
An almost fully automated system of MDR index tables that aces audits and enables Paige’s team to focus on more high-value work — plus ongoing projects with Radbee to continue iterating and improving the quality system.
With Radbee’s help, the new MDR index has ensured a faster, easier path to iron-clad compliance.
Find out how we can help you automate and otherwise make your QMS system more efficient to keep your medical device releases flowing, so your team can focus on high-value work for happier customers and a healthier bottom line.