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Enzyme QMS Software

Enzyme's QMS is built by industry veterans frustrated by existing QMS solutions. We designed it for all life science companies, paying particular attention to the challenges building FDA-regulated software.

Out-of-the-Box Solution

Enzyme’s QMS includes modules that cover the key components of 21 CFR 820 and ISO 13485
Design Control
Document Control
Nonconformance (NC)
Corrective and Preventive Action (CAPA)

Integrates with your existing tools

Our QMS is designed for use in a modern, agile software development process
Imports existing data into Enzyme so you don’t have to repeat the work
Generate reports directly from Enzyme which can be used for submission

Quality System Template Library

Enzyme offers a complete set of SOPs, Work Instructions, Quality Manuals and forms
Enzyme Consulting, LLC. can support you in customization and implementation your Quality System
The templates support innovative products - whether its traditional, SaMD or hybrid of the two

Onboard your team swiftly

Enzyme offers a comprehensive onboarding process
We train you on the modules you need first
After your onboarding, Enzyme’s team is available for follow up calls and to answer your questions
Start with Enzyme today
info@enzyme.com or