The decision to move to Qualio was vindicated in weeks.
Not only did Qualio simplify CGX's FDA 510(k) process, it has unlocked the flexibility CGX needed to pivot quickly, helping them improve collaboration with multiple stakeholders across distributed environments.
Qualio also helps Spencer and his team to make regulatory best practice natural and automatic.
Qualio delivered a number of key benefits to CGX, including:
1. Easy onboarding and easy validation
Spencer oversaw a rapid validation process which wrapped up in less than three hours — something he credits to Qualio’s robust documentation.
And since CGX weren't migrating existing documentation into Qualio, onboarding was completed in record time too.
15 members of the CGX now actively use Qualio, including the quality team, engineers, contractors, and the company president.
2. Improved collaboration
CGX uses Qualio as a central hub to store all of their processes, SOPs and step-by-step how-to guides. As a result, all stakeholders — including contractors and consultants working remotely — can hop into Qualio and access information in a couple of clicks.
Qualio has therefore become a trusted, reliable single source of quality that enables CGX to move work forward faster.
3. Scalability and increased output
During the first three years of the company, CGX released 10 products to market. In the 18 months of using Qualio, they’ve released 12 products and revisions.
This 140% boost in product output, driven by sharper digital quality processes in Qualio, has lifted the lid on CGX's expansion plans and made the organization more profitable than ever.