Alphazyme uses Qualio to produce molecular enzymes at scale for biotech companies
Alphazyme is a biotechnology manufacturer headquartered in Jupiter, Florida that produces custom enzymes used by large-scale biotech companies to read, write and edit DNA molecules.
Alphazyme was founded in 2018 and has grown steadily over the last 18 months as it helps biotech firms accelerate cutting-edge applications in DNA literacy technologies.
To facilitate this growth, Alphazyme implemented Qualio as its electronic quality management system (eQMS) when the company initiated its first R&D experiments.
In 2005, Alphazyme founder Christopher Benoit had founded an earlier life science company called Enzymatics.
After an early customer sent over an 18-page supplier evaluation form and asked for a site visit to further explore their products and processes, Benoit realized the company needed to rapidly implement a robust quality management system.
At the time, electronic QMS systems were rare, unfriendly to users and costly. The Enzymatics team established a paper-based system - a decision that turned into a learning experience.
Seeking to avoid a similar problem in his new venture, the Alphazyme business plan called for a paperless, ISO 13845-compliant quality system architecture from the get-go.
We rued the day we chose paper. Every time we wanted to change a document, we needed five signatures. Papers would get lost on someone’s desk. It was a cumbersome process that slowed us down.
Right after Stephana Petrino was hired as the Vice President of Quality at Alphazyme, she was tasked with finding an eQMS that met these requirements. Because the young company needed to operate with agility, the right system would also need to be flexible.
Petrino examined roughly 15 solutions and had sales discussions with 8 vendors. After thoroughly assessing the options, Alphazyme selected the Qualio product and embarked on a process of building its quality system inside the system - from the ground up.
We needed something that was user-friendly, easy to onboard new team members, and easy to get up and running. Qualio has surpassed our expectations on those metrics.
Alphazyme’s decision to use Qualio as the foundation of its electronic quality system has helped the company accelerate its innovation while empowering them to accelerate their development cycle, work more efficiently and prepare for the future:
1. Accelerated and compliant product development
First and foremost, Alphazyme has been able to bring numerous products and development processes online rapidly, thanks to Qualio.
We barely had a lab when we started using Qualio. Once we set up a process for designing, recording, and reviewing experiments in lab notebooks in Qualio, we were able to move through the development of a number of enzymes in a matter of months.
Using Qualio allowed management to review the work product in real time, mentor our team and build towards ‘design-lock ready’ processes far more quickly than with a paper-based experimental tracking system.
2. Streamlined collaboration
Qualio has enabled Alphazyme to streamline collaboration across the organization. Currently, all categories of team members - from C-level executives to scientists, quality engineers, and more - use Qualio to document, review and approve their work in tandem.
By using Qualio to track all of our experimental records, we can review scientists’ data and advance projects from anywhere.
This has been of particular benefit during the pandemic and has allowed us to maintain fast-paced development while navigating work-from-home and split schedule strategies to keep our staff safe.
Using Qualio enables the Alphazyme team to collaborate more effectively with external clients, too:
Much of our work is directed by individual clients, and experimental records are easily exported via PDF from Qualio lab notebook entries.
We are always two mouse clicks away from sharing important data with clients, which drives project progress and transparency.
3. Boosted productivity
Qualio’s intuitive interface and simple UX has helped the Alphazyme team to work more productively and collaboratively.
3 users in the system have expanded to 15, with steady participant growth planned. Stephana noted the ease for new hires to grasp the system concepts and start navigating Qualio immediately upon hire.
By tying the Alphazyme together within a single source of quality truth, productivity has benefited. All business information, including documents and images, are stored in a centralized paperless repository that keeps the team on track for meeting their timelines and key deliverables.
4. Future-proof processes
For Alphazyme, Qualio is more than just a static software product. It’s a robust and evolving platform they are able to influence with their feedback and suggestions, and the team has welcomed several upgrades and augmentations since they went live.
In this light, Qualio’s customer-centric approach gives Alphazyme, like Qualio's other start-up customers, an eQMS that can grow alongside them.
Looking ahead, the company aims to become certified to ISO 13485:2016 and is also looking to achieve compliance with certain federal regulations for diagnostic and therapeutic products.
5. Customer satisfaction
Qualio has also impressed Alphazyme’s clients and increased the satisfaction and confidence of Alphazyme's customer base.
Recently, a publicly traded company conducted a “light” audit of Alphazyme’s facilities and was impressed by the integral role Qualio played in company operations.
We’ve been able to show certain clients what we’ve accomplished with Qualio, and they were very impressed.
The VP of Quality for a client company said, "If I could build from the bottom up, I’d do it exactly the way you guys did it".
Qualio was a key system feature they would look to incorporate.
