Enzyme

What is Enzyme?

Enzyme is a Quality Management System (QMS) tool created to address the challenges of the biotech and medical device sectors. Its eQMS is designed to simplify workflows, speed up tasks, and make generating FDA-ready documentation easier, helping companies strengthen their quality culture through modern software and expert guidance.

Who created Enzyme?

Enzyme was co-founded by Jared Seehafer and Jacob Graham, both of whom worked in the biotech and medical device industries. Having experienced firsthand how slow and inefficient existing QMS platforms could be, they built Enzyme eQMS to simplify workflows and documentation. The company started in 2017 in South San Francisco, focuses on modern software for life science companies, and operates with a remote-first work environment.

What is Enzyme used for?

• Quick and efficient eQMS implementation and setup
• Reduced cycle time for customer workflows
• A clear framework for setting and meeting quality objectives across the whole team
• Streamlined quality processes and post-market compliance management
• Generation of FDA-ready documentation
• Support for the entire product lifecycle, from pre-market through post-market
• Compliance with 21 CFR Part 11, validated out of the box
• Flexibility to adapt to different ways of working, and scalability as a company grows
• Integration with a wide range of tools
• Ongoing updates driven by user needs, designed by quality and regulatory professionals

Who is Enzyme for?

• Biotech professionals
• Medical device professionals
• Regulatory consultants
• Quality engineers
• Chief Scientific Officers
• CEOs
• VPs of Clinical Operations
• Software Development Life Cycle consultants
• DevOps engineers
• Senior software engineers

How to use Enzyme?

1. Understand its purpose: Enzyme is an eQMS tool designed to simplify quality management in fields like biotech and medical devices.
2. Take advantage of its usability: The system is easy to navigate, with quick document loading, making it a smooth transition from paper-based systems.
3. Use the support team: Enzyme’s support team helps migrate old documents and answers questions during onboarding, ensuring a seamless transition.