Enzyme QMS

Enzyme QMS is a comprehensive quality management software platform built specifically for medical device, digital health, and biopharma companies. If navigating cGMP, QSR, ISO standards, and FDA submissions feels overwhelming, Enzyme QMS is the system that grows with you — from startup to IPO. It covers every stage of the product development lifecycle, from Design Control to CAPA, and is 21 CFR Part 11 compliant, validated right out of the box. With an industry-leading number of integrations, in-house expert guidance through quality challenges and regulatory submissions, Enzyme QMS adapts to your way of working — whether you're premarket, postmarket, or anywhere in between.