Heather noted a 'night and day' difference after implementing Qualio.
Core quality tasks like digital document signatures, review processes and training can now be done at a fraction of the previous time and effort, while engagement with the quality system has skyrocketed.
No-one used our old system. Everyone uses Qualio.
The UX is intuitive and everyone's used to logging in and checking their Dashboard.
Everyone's comfortable using it.
Night and day is the only way to describe it!
Heather and her team now access a complete cloud-based eQMS within Qualio, spanning:
Documents, including technical documents, the company's Design History File and more
Quality event management, including CAPAs, feedback and complaints
To support the groundswell of activity surrounding EvoEndo's upcoming market launch, Qualio is also being used to ensure marketing materials are reviewed and approved by the EvoEndo regulatory and compliance team before going live.
As CEO, Heather has now been able to step away from day-to-day quality management as the business grows, comfortable and able to 'sleep better at night' now that her quality team has an intuitive system behind them.
I can review and sign off on documents on my phone as I travel. I can complete training or take a look at an SOP.
It's really easy and it's allowed us to grow our business.
With a connected cloud-based quality system, the company has been free to grow and pass through Series A funding without compromising on compliance.
New team members can be onboarded and trained quickly, and quality information can be shared and accessed at the touch of a button from a single source of truth.
And crucially, EvoEndo has been able to demonstrate its quality and compliance credentials to the FDA, who cleared the company's 510(k) submission in February 2022.
With Series B funding on the horizon and the company's first market launch arriving this year, Heather believes Qualio will only deliver more value as customer activity, shipping documentation and purchasing controls are added into the company's day-to-day operations.
Qualio gives everyone a roadmap in this time when we're having to move very quickly.
Having that structure for everyone to work within is going to be essential for us to really succeed this year in getting onto the market and staying compliant.
I have only good things to say about Qualio.