From Legacy QMS to Modern, Flexible Solution in Weeks
Faster product cycles
Reduction in quality costs
Streamlined collaboration between quality and engineering teams
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Until we came across Ultralight we had resigned ourselves to the limitations other e-QMS packages provide, which meant most of our engineering documentation happened in siloes. It was clear from our initial interactions with Ultralight that they wanted to do things differently. The flexibility provided by Ultralight’s solution is unprecedented!
Dustin Kasel
Head of Engineering, Brevitest
Introduction
Brevitest is an innovative diagnostics company that was falling behind on quality documentation due to their inflexible electronic quality management system (eQMS) vendor Greenlight Guru.
With Ultralight, Brevitest saw an opportunity to not only move to a more modern, flexible eQMS, but also to bring engineering stakeholders into an integrated platform that worked for all stakeholders. Ultralight automated a complex migration effort into just hours. Now Brevitest has a single source of truth for product and compliance data, and they’ve been able to save dozens of hours each month on documentation work.
A Bit About Brevitest
Brevitest was founded in 2013 and specializes in rapid point-of-care testing technology. Their innovative platform allows for quick and accurate screening of substances like fentanyl, cocaine, and methamphetamine in whole blood, providing results in just 15 minutes. Based in Texas, they are a multidisciplinary team that includes in-house quality experts.
Before Ultralight, Brevitest faced challenges in managing the complex documentation and compliance requirements inherent in medtech which slowed down their ability to innovate and respond to market needs.
Brevitest was stuck using an incumbent eQMS system called Greenlight Guru, which limited their ability to manage quality and product development workflows in an integrated fashion. Two of Brevitest’s main challenges with their existing system:
Their eQMS platform was inflexible, and limited their ability to configure the workflows to their unique needs.
Their engineers were using Excel to manage product requirements and risk assessments, which led to a lot of difficulty in maintaining and managing design history. This is because eQMS systems generally are not designed to handle requirements management activities for engineers.
Why Brevitest
Chose Ultralight
Brevitest chose Ultralight for its all-in-one medtech product and compliance hub, which simplifies the process of building modern medical devices. Ultralight's promise of quick and collaborative product design, risk mitigation, and enhanced traceability was a perfect match for Brevitest’s needs, since their engineers were previously managing these workflows in Excel and Word documents, and then handing them to the Quality team for documentation.
The Migration Obstacle
Brevitest’s main concern was the volume and integrity of a data migration from one system to another. They had thousands of documents and records in various versions, and they were concerned about the time it would take to handle such a migration as well as the lack of traceability of versions across systems.
How Ultralight
Responded
Ultralight created automated tools to streamline the migration of thousands of documents, and enabled Brevitest to maintain their document statuses and version history in Ultralight. Instead of having to manually upload documents, the Brevitest team was able to save over 85 hours of migration efforts and get the peace of mind they needed for data integrity.
Ultralight’s founders personally set up and trained the Brevitest team, with end-to-end onboarding complete in just three weeks!
Since partnering with Ultralight, Brevitest has experienced faster product cycles, a significant reduction in quality costs, and a streamlined collaboration between quality and engineering. The flexibility of Ultralight's system allowed Brevitest to maintain their innovative edge while ensuring full regulatory compliance.
We needed to switch our QMS, but our main concern was the integrity and time commitment of data migration. Ultralight made it seamless by offering automated migration capabilities that saved us hundreds of hours and helped us maintain our document versioning scheme. Even after onboarding, the team has continued to deliver new capabilities at a rapid pace that sets them apart! Overall, we find Ultralight to be user friendly, flexible, and with excellent capabilities that made the switch well worth it.
Edgardo Romero
Director of Quality, Brevitest
