Enzyme QMS Software for Medical Devices, Digital Health, & Biopharma
Our cloud-based QMS software adapts to your workflows, scales as you scale, and allows you to keep using the tools you love with an industry-leading number of integrations.
Built for the life sciences industry,
by industry veterans
Enzyme QMS software helps you stay compliant globally while giving you the freedom to innovate. Our modules cover the key components of cGMP, the QSR, and ISO standards, and all stages of the product development lifecycle.
21 CFR Part 11 compliant
Draft, review, approve, revise, and obsolete documentation with automatic, digitized change control and record-keeping using e-signatures.
Innovative infrastructure
The core of our cloud QMS is document control, training, and approvals — the hub of every key quality activity.
Integrations galore
Keep using the tools you love like Jira, GitHub, Google Drive, and so much more.
Customizable to you
Our quality management system software adapts to your workflow, not the other way around.
QMS software for small business to large enterprise
Enzyme has everything you need, premarket to postmarket, startup to IPO, with 3 plans and 12 modules.
Time-saving features
From automatically generated redlines to our easy-to-use foldering system to our training matrix, discover the difference with Enzyme.
ISO quality management software
Our eQMS software meets requirements for ISO 9001 QMS software and as an ISO 13485 quality management system for medical devices.
Competitive QMS software pricing
Discounts are available based on length of term, payment frequency, and contract start date.
Electronic Quality Management System
Enzyme eQMS is flexible and scalable, making it easy to use for startups, yet configurable to meet the needs of the most complex enterprise
