Meet the only eQMS as
innovative as you

Enzyme eQMS is flexible and scalable, making it easy to use for startups, yet configurable to meet the needs of the most complex enterprise.

Serving teams from 2 to 2,000, Enzyme is the
only eQMS you'll ever need.

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A complete solution for your quality and regulatory needs

Enzyme QMS
Our software includes modules for all stages of the product development life cycle from Design Control to CAPA.
Services
Our in-house experts are here to back you up! We can guide you through the quality challenges and regulatory submission process.

Designed for use across all of life science,
from Device to Digital to Biopharma

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Streamlined QMS

A QMS that includes modules for all stages of the product life cycle from Design Control to CAPA
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Integrates with existing tools

Enzyme QMS integrates with your existing tools, such as JIRA, GitHub and Jenkins with Enzyme
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In-depth Onboarding

We train your entire team and provide you with support when and as it's needed

Trusted by

Maria Chacon-Heszele
Biomeme
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Enzyme has vastly exceeded any of my expectations in helping us get started in setting a compliant QMS.
After cycling through several consultants who did not meet our needs, Enzyme's tools and customer support team struck exactly the right balance to help us navigate the process of learning how to adapt our existing work processes into compliant workflows while maintaining company culture.
I would recommend Enzyme to anyone, especially companies looking to implement (or improve the efficiency of) a quality management system.”
Henry Mancke
Posit Science
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We'd been struggling for months to find a compliance solution that worked for our software medical device before we ran into Enzyme. We evaluated a range of consultants and other software solutions and found Enzyme to be the best fit for us.
I highly recommend Enzyme to any digital health startup that needs to comply with FDA regulations.”
Steve Badelt
Suttons Creek
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A simple, intuitive solution for running a lean team while staying compliant.”
Enhao Gong
Subtle Medical
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As an early-stage healthcare technology company, we need to be both thorough and efficient.  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.

Maria Chacon-Heszele
Biomeme
Quote icon

Enzyme has vastly exceeded any of my expectations in helping us get started in setting a compliant QMS.

After cycling through several consultants who did not meet our needs, Enzyme's tools and customer support team struck exactly the right balance to help us navigate the process of learning how to adapt our existing work processes into compliant workflows while maintaining company culture.

I would recommend Enzyme to anyone, especially companies looking to implement (or improve the efficiency of) a quality management system.

Henry Mancke
Posit Science
Quote icon

We'd been struggling for months to find a compliance solution that worked for our software medical device before we ran into Enzyme. We evaluated a range of consultants and other software solutions and found Enzyme to be the best fit for us.

I highly recommend Enzyme to any digital health startup that needs to comply with FDA regulations.

Trusted by

Maria Chacon-Heszele
Biomeme
Quote icon
Enzyme has vastly exceeded any of my expectations in helping us get started in setting a compliant QMS.
After cycling through several consultants who did not meet our needs, Enzyme's tools and customer support team struck exactly the right balance to help us navigate the process of learning how to adapt our existing work processes into compliant workflows while maintaining company culture.
I would recommend Enzyme to anyone, especially companies looking to implement (or improve the efficiency of) a quality management system.”
Henry Mancke
Posit Science
Quote icon
We'd been struggling for months to find a compliance solution that worked for our software medical device before we ran into Enzyme. We evaluated a range of consultants and other software solutions and found Enzyme to be the best fit for us.
I highly recommend Enzyme to any digital health startup that needs to comply with FDA regulations.”
Steve Badelt
Suttons Creek
Quote icon
A simple, intuitive solution for running a lean team while staying compliant.”
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