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QMS
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
Training
Complaints
Audits
Suppliers
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
Customize Standard Operating Procedures (SOPs)
Enzyme integrates with your existing SOPs or we create new ones for you
Our team can also guide you on implementing SOPs
Our team can customize the SOPs to your product - 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
