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.

Comparing how we did QMS at GeneWEAVE without Enzyme and how we do things now is night and day.
Diego Rey, Chief Scientific OfficerEndpoint Health
The team at Enzyme has helped us streamline our quality process and post-market compliance, including our QMS process. Their level of professionalism and service has been outstanding.
Enhao Gong, CEOSubtle Medical
The care and thought the Enzyme team has put into designing and implementing the eQMS has made our lives one thousand times easier.
Judy Brimacombe, VP Clinical, QA, RADawnLight Technologies