Enzyme
AcquiredAutomating regulatory approval & compliance for life science companies
About
Enzyme provides online quality management system software and supportive QA/RA consulting, helping life science companies with FDA approval and ongoing compliance. Enzyme staff has over 50 years of medical device industry experience, across several Fortune 500 companies and startups.
Enzyme provides QMS software for life sciences, covering cGMP, QSR, and ISO standards across the product lifecycle. It positions itself as a scalable, integrated QMS designed for medical devices, digital health, and biopharma, with out-of-the-box validation and extensive tool integrations.
Enzyme QMS is a software platform that includes modules for document control, change control, training, design control, risk management, suppliers, audits, complaints, nonconformance, and CAPA. It is 21 CFR Part 11 compliant, validated out-of-the-box, integrates with existing tools, and can generate reports directly from the eQMS. The system supports premarket to postmarket activities and is designed to scale from startup to enterprise, adapting to modern workflows and enabling data import and reporting within its interface.
Who it’s for: Life science companies developing or manufacturing medical devices, digital health products, and biopharmaceuticals that require regulatory quality management systems and lifecycle governance.
- Document control
- Change control
- Training management
- Design control
- Risk management
- Audits management
- CAPA and nonconformance handling
Customers: Endpoint Health, Subtle Medical, DawnLight Technologies
Acquired by Greenlight Guru; customer testimonials; emphasis on scalable, enterprise-ready deployment
Founders · 2
Website over time
How Enzyme’s homepage introduced itself over the years — each line is the page title the web actually saw, linked to that moment’s archived capture.
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