A shiny new digital quality platform twinned with expert help

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Californian start-up ViQi emerged from UC Santa Barbara and develops cloud-based image analysis software powered by AI and machine learning.

Their technology is used by life science organizations to accelerate drug discovery by modelling treatment and cell behavior, and has even been applied by the Bureau of Ocean Energy Management to perform oil spill risk modelling.

The company's continued evolution into the life science sector, and their software's use as a medical device data system (MDDS) for preclinical work, prompted the ViQi team to begin planning a quality and regulatory pathway for the future.

Co-founder and CTO Dmitry Fedorov wanted to set a solid, proactive quality baseline for the organization in line with their digital, cloud-based 'mindset'.

It was important for the business to embrace modern eQMS technology early, before 'progressively more difficult' regulatory demands started to slow company growth.

Critically, the organization had no internal quality expertise. Any quality software vendor they found would need to offer a highly supportive and collaborative relationship.

Dmitry and Project Manager Hallie Greene began to search for the perfect eQMS platform and the close QA/RA support they needed.

A call with Sumatha Kondabolu on the Qualio+ team 'sealed the deal' by offering friendly, proactive and expert help to guide ViQi to their quality milestones.

Going into September 2022, the ViQi team had the ambitious goal of getting the fundamentals of a quality management system in place and getting registered with the FDA by December.

They became Qualio customers at the end of the month and let themselves be guided by Qualio's expert onboarding team.

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:

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.