Customer
Vyaire Medical
Compliance and traceability are critical to medical device development companies like Vyaire Medical.
Vyaire is a global company focused exclusively on supporting breathing through every stage of life. With a 70-year history of pioneering breathing technology, the integrated solutions offered by their Ventilation and Respiratory Diagnostics (RDx) businesses help enable, enhance, and extend lives.
As described in their core values, Vyaire acts with integrity and a commitment to compliance in everything they do. Their ethical business practices and commitment to product quality are why Vyaire is trusted by respiratory specialists around the world. And it’s why Vyaire trusts Perforce Helix ALM to manage requirements, testing, and any issues that arise – and to ensure continuous traceability.
With Helix ALM, Vyaire was able to
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Seamlessly migrate from an overly customized legacy tool. | SVG
Easily configure workflows to suit their specific processes. | SVG
Gain comprehensive traceability to demonstrate compliance. |
Using Legacy Tools Is Limiting
Vyaire turned to Helix ALM after using their previous system for nearly two decades. Over the years, their implementation of the tool had become so customized, it was no longer possible to update to a newer version. So, they were stuck using a legacy version, unable to benefit from new functionality, features, or bug fixes. It’s a situation many organizations in highly regulated industries can relate to, since such tools must be re-validated any time they are updated.
The team knew that eventually the legacy version would no longer be supported by the vendor of their previous system and they would be forced to update. Yet, as they learned more about the cost of the update, the amount of resources it would take, and the downtime required, it became clear that updating was not a viable option. It was time to look elsewhere.
Luckily, the team was aware of an alternative: Helix ALM. They analyzed the feasibility of migrating to the Helix ALM solution and determined that they would make the switch.
Migrating to Helix ALM Was Swift and Seamless
Thomas Markert manages the Research and Development Verification team for Vyaire Respiratory Diagnostics (RDx). This team is responsible for the planning, performing, and documentation of the verification phase for both RDx hardware and software development projects.
It’s a tough job, and one that requires continuous, unbroken traceability across the entire development lifecycle.
So, Thomas was understandably a bit nervous about the migration to Helix ALM. “My biggest nightmare was that our older data would not be accessible or usable after the migration,” he admits.
He need not have worried. Vyaire was able to migrate to Helix ALM seamlessly without losing any traceability or access to old projects or data.
“The whole process of bringing everything from our old database into Helix ALM went so smoothly,” Thomas explains. “And we can still create a traceability matrix that references the old data if we need to. That, for me, is the biggest benefit.”
Helix ALM Boosts Ease of Use and Configurability
When the Vyaire team started using Helix ALM, they were impressed with the usability and ease of configuration.
“You don’t need to install anything. You don’t need a VPN. With the web client, you can easily work from anywhere,” says Judith Engelen, Senior Engineer, Software Quality.
They soon realized that seemingly small UX/UI details in Helix ALM have a measurable impact on their day-to-day work.
“The attachment ‘drag and drop’ functionality speeds up our test run process, which saves time and helps the team work more efficiently,” Thomas explains. “It’s a simple thing, but it adds up,” notes Judith.
The team is also pleased with how easy it is to configure workflows in Helix ALM, compared to their old tool.
“The interface is more user-friendly, so it’s easier to configure the tool to suit our specific needs and processes,” Judith says. “Users can make adjustments without having any coding knowledge.”
Helix ALM Offers Unparalleled, End-to-End Traceability
Thomas’s team now uses Helix ALM to manage all requirements, test cases, and issues. Then, at the end of the verification phase, they’re able to use Helix ALM to create the traceability matrix and documentation necessary to fulfill regulatory compliance needs, demonstrate that all requirements have been met, and prepare for audits.
According to the team, Helix ALM offered more thorough traceability than their previous solution through key features:
- More ways to link requirements, test cases, and other items to show the relationships and dependencies between various development artifacts.
- Automatic traceability matrix generation, resulting in an immutable single source of truth.
- Built-in traceability reports to compare historical data with baselines.
Ensure the Highest Level of Quality and Safety
Helix ALM helps companies like Vyaire achieve the traceability they need to demonstrate compliance with extensive medical device regulations and to develop the safest, highest quality products possible.
See for yourself how Helix ALM can help your organization automate traceability, streamline complex development, and accelerate compliance — so you can get your product to market quickly without compromising quality or safety.
Try it free for 30 days.