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Enzyme

Empowering life science companies to innovate better and faster.

San Francisco (CA), US
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Overview

Enzyme is a company dedicated to providing quality management system (QMS) software for life science companies, including medical device, digital health, and biopharma sectors. Our mission is to empower life science companies to innovate better and faster by offering a QMS that is 21 CFR Part 11 compliant, validated out-of-box, and integrates with existing tools.

  • Document control
  • Change control
  • Training
  • Design control
  • Risk management
  • Suppliers
  • Audits
  • Complaints
  • Nonconformance
  • CAPA

Enzyme's eQMS is designed to be flexible and scalable, making it suitable for startups and complex enterprises alike. It supports the full product lifecycle, from premarket to postmarket, and is continuously evolving to meet the needs of its users.