Headquartered in South San Francisco, Enzyme was founded in 2017 by industry veterans frustrated by existing QMS solutions. Leveraging our deep experience in regulated software development, we’ve applied the best practices in software system integration to designing a product for all life science companies, including drug, biologic, device, and digital.
After years of working in the biotech and medical device industries, co-founders Jared Seehafer and Jacob Graham were exhausted by the challenges of day-to-day Quality Management Systems (QMS) and submission generation activities.
On average, Jacob found himself using 5 different software tools for day-to-day tasks, which created inefficiencies and delays. As a regulatory consultant, Jared found that many companies wasted immense resources while preparing submissions due to difficulty locating and extracting data that was already within their QMS.
These experiences inspired Jared and Jacob to create a unifying QMS tool that simplified and streamlined numerous workflows and generated FDA-ready documentation at the click of a button. The result? Enzyme eQMS.
Enzyme and its employees are committed to satisfying the applicable requirements per ISO 9001:2015 (Quality management systems – Requirements) as they pertain to providing customers with a software platform that consistently facilitates the design, production, and commercialization of life science products.
Enzyme actively pursues continuous improvement of its own quality management system to: