The ViQi team received both a brand new, fully digital quality management system and expert quality and regulatory guidance from Sumatha to help them build and populate it, from document and SOP creation to managing workflows and development lifecycles.
This targeted Qualio+ support allowed ViQi to save $20,000 in planned consultancy costs.
Onboarding completed right on time in December 2022. ViQi could register with the FDA with an operational QMS in place for the first time.
For Hallie and Dmitry, the combined impact of Qualio's software and Qualio+ support hasn't been a question of accelerating their quality journey, but the difference between possibility and impossibility:
I can tell you right now, it wouldn't have happened. I think that's pretty clear.
I don't think we would've been able to pull it off if we didn't have a partner that could provide us guidance and templates.
There's just no way. It's not even a time saving. It's a go-no go situation.
The new system has helped ViQi prove their quality credentials to new customers, too, with their new eQMS a 'powerful talking point' in sales conversations.
With both quality system and know-how in place, ViQi are perfectly poised to expand further into the life science sector and execute their future plans of developing Class II SaMD products.
And they're only scratching the surface of their Qualio usage - with design controls the next area of the system to be utilized.