DESIGN CONTROLTake the document wrangling out of design control

Manage your design data granularly, so you can manage design history and traceability with ease. With Enzyme eQMS, you can focus on your data, not your documents.

Designed to easily set up and maintain traceability

Granular control of design elements enables traceability that is set up at a click of a button, and exported out to external stakeholders just as easily
One-click access to a live traceability view, showing trace relationships and allowing you to pinpoint missing traces to outputs, tests, and risks
Use traceability to inform phase gates in your product design process

Use your QMS as a true system-of-record by integrating other tools

Enzyme sits at the center of your tech stack, enabling your eQMS to be a true system of record by connecting systems like Jira, GitHub, Google Drive, and Slack.
Break down your data silos and stop the copy/paste, import/export dance caused by unconnected systems.
Allow your engineers to work in the systems they know and love while seamlessly taking credit for work completed with Part 11 compliant records.

Generate your design history file with ease

One click generates a design history file export, customized based on your input
Utilize your own templates to generate records specific to your product and use case
Demonstrate GxP compliance with objective evidence and Part 11 compliant eSignatures

Explore other Enzyme eQMS modules

Change control

Centralize change management throughout your QMS

Document control

Intuitive document management that doesn’t lock you in


Ensure your training records are audit-ready 24/7
Wondering which QMS is right for you?
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