living brain Takes QMS Compliance to the Cloud with Help from Comalatech
Posted November 8, 2021 in Case Studies
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living brain develops solutions for neuro-rehabilitation that allow patients to re-train themselves on the activities of daily living in immersive virtual reality. To establish their quality management system (QMS) and meet compliance standards for medical devices, they use Confluence Cloud with add-ons Comala Document Management and Comala Publishing.
Virtual Reality Tools for Neuro-Rehabilitation
For co-founder Julian Specht, the vision for better rehabilitation tools came from personal experience. Faced with the prospect of brain surgery, Julian discovered both the risks of impairment and cognitive decline, and the limited treatments available from traditional computer programs and pen-and-paper exercises. While his surgery was successful, Julian and fellow psychology student Barbara Stegmann were inspired to create new neuro-rehabilitation tools using the latest technology.
Their first treatment, teora mind, is a virtual reality application which allows patients to train in every day activities. The goal is to improve cognitive functioning. With VR, patients can immerse themselves in a realistic environment and interact with it, while making the training accessible anytime and anywhere. The training has three locales, a kitchen, garden, and beach hut, allowing users to practise activities of daily living like making coffee, gardening and selling ice cream. Gamification elements encourage the patient and keep the activities from getting too repetitive. Today living brain has successfully published the results of their first clinical trial with stroke patients and healthy older adults, with a second trial ongoing.
Building a QMS for Medical Documents in Confluence
As a medical device manufacturer, living brain required a compliant QMS for their documentation. While their team started out using Word and paper documents, they quickly outgrew that system. “It became clear we had to do something, the old system with paper was not enough,” says Till Ikemann, Head of Development. “We wanted something centralized, accessible and easy.” This lead them to adopt Confluence Cloud, a remote-friendly team workspace that allows users to collaborate on documents in real-time, and provides a single, accessible source of truth.
living brain’s Confluence instance is divided between working spaces, for developing and reviewing content like product documentation, and published spaces which act as storage for the finalized versions. Documents are developed collaboratively by three active contributors, reviewed, and then published, so that the rest of the team can view the final, approved version. To manage this approval process and meet compliance standards, they use two Confluence add-ons, Comala Document Management and Comala Publishing.
Adding Approvals and Publishing Processes
As part of their compliant QMS, living brain needed the ability to elicit and record approvals from specific team members. To add this functionality to Confluence, they use Comala Document Management and Comala Publishing. Document Management is an app which adds customizable approval workflows to Confluence, while Comala Publishing lets users easily copy content from one space to another. “With Comala Document Management, it’s very easy to show when an approval has happened, or if a page has been rejected,” Till explains.
living brain’s team built a custom workflow to help manage their document approval process and meet compliance needs. “The workflow builder is really great,” Till says, “especially to pinpoint the people who need to review a document.”
In this workflow, the document starts out in the “IN WORK” state where it is written and developed. Once the document is ready it can be reviewed and approved by a manually assigned team member, transitioning into the IN REVIEW state. Here it undergoes a second manually assigned review, before passing into the “APPROVED FOR CONTENT” state. In this state the approval is assigned to a specific team member as part of the workflow itself. Finally, if approved again, the page goes to the FORMALLY APPROVED state. At this point, Comala Publishing automatically copies the page to the published space. There it can be viewed in its finalized version by the rest of the team. If the document is rejected or updated at any point in the process, it will return to the original IN WORK state for another round of reviews.
With this custom workflow living brain has added a multi-stage review process to their documentation, and separated their draft and approved content.
“It’s a very nice tool for publishing because we don’t have to do everything manually,” says Barbara.
“I know and even more important, the whole team knows, once the document is approved, it will be automatically published. This enables us to meet the high requirements of a QMS for medical devices,” adds Julian.
Comala Document Management also keeps a record of all workflow activity, including the user, time and date of approvals, and living brain’s team has used the app’s workflow diagram to quickly take screenshots of their process to share with auditors.
To learn more about living brain and their medical device for neuro-rehabilitation teora mind, visit their website. You can try Comala Document Management and Comala Publishing for free for 30 days from the Atlassian Marketplace.