Enzyme QMS is 21 CFR Part 11 compliant, validated out-of-box, and offers an industry-leading number of integrations so you can keep using the tools you love. Designed to scale as you scale, Enzyme supports the full product lifecycle, making it the only QMS you’ll ever need.
- Complete: Enzyme QMS has everything you need, premarket to postmarket, startup to IPO.
- Versatile: Enzyme adapts to your way of working, not the other way around.
- Proactive: Our QMS software is continuously evolving to better meet your needs.
- Intuitive: Designed by quality & regulatory professionals, for quality & regulatory professionals.
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.