
Automating regulatory approval & compliance for life science companies
screenshot pendingEnzyme is a quality management system (QMS) software designed specifically for life science companies, including those in the medical device, digital health, and biopharma sectors. The software is compliant with 21 CFR Part 11 and is validated out-of-the-box, making it a reliable choice for organizations that must adhere to stringent regulatory standards. Enzyme QMS supports the entire product development lifecycle, from premarket to postmarket, and is adaptable to the unique workflows of various organizations, ensuring that it meets the needs of both startups and more complex enterprises.