Tennessee-based Helix Biotech, founded in May 2022, develops and manufactures lipid nanoparticles, liposomes and hybrid nanoparticles for customers, as well as producing manufacturing tools like extrusion and injection systems.
Robust quality and GMP processes are vital to support the company's work from R&D to manufacturing.
As a biotech manufacturer, compliance with 21 CFR Part 210/211 is crucial, as well as ICH Q10 and 21 CFR Part 11 compliance.
Founder and President Graham Taylor began his career in quality as an associate quality engineer in 2007. Having spent over 15 years in the medical device and pharmaceutical worlds, he recognised the importance of an optimized QMS as he set up Helix.
At a previous role, Graham battled the time and effort demands of a paper-based quality system, which included constant circulation, completion and filing of paper documents.
It was an easy decision to go digital.
Before, we had one full-time person just dealing with the document shuffle.
We'd call it the 'document dance': moving things around, getting them signed, putting them in their files.
With Helix as a blank slate, Graham wanted to sidestep the effort of paper and build an efficient, easy-to-run quality system from the company's first days.
Graham compared multiple eQMS vendors like MasterControl and Greenlight Guru, and found it 'easy' to home in on Qualio as the most valuable and sensibly priced option on the market.
Graham was also swayed by Qualio's 'straightforward' and 'easy-to-use' interface, particularly in relation to other, less intuitive systems he'd used in the past like TrackWise.
Qualio's easy to learn for people to use of all job types.
It's a refreshing take on electronic quality management.
Graham decided to become a Qualio customer and went live with the system in October 2022.
The infancy of Helix Biotech meant Graham faced a double task of scaling the company and building a quality management system from scratch.
Starting with Qualio, and leveraging extra guidance and support from the Qualio+ team, made that task rapid and simple.
The 'document dance' was eliminated and a modern, digital quality system built in its place in a 'matter of weeks'.
All Helix employees, from quality to manufacturing, all log into Qualio day-to-day, and the system offers an easy onboarding pathway for new employees as the company begins to expand.
With a lean, agile and fully paperless quality system as their cornerstone, Helix are now poised to open their first GMP manufacturing facility in April 2023 - with even bigger plans (and facilities!) lined up for the future.