Enzyme

What is Enzyme?

Enzyme is a Quality Management System (QMS) tool that Jared Seehafer and Jacob Graham created to tackle the tough challenges in the biotech and medical device sectors. Their goal? To make workflows smoother, tasks simpler, and generating FDA-ready documentation a breeze. Enzyme’s eQMS is built to help companies really boost their quality culture. They do this with modern software and expert advice, offering flexibility for remote work, great productivity perks, and support for things like 401k contributions and team-building events. Enzyme is all about getting better continuously and hitting quality goals, so you get a QMS solution that’s easy to use, efficient, and ready for audits.

Who created Enzyme?

Jared Seehafer and Jacob Graham are the co-founders behind Enzyme. They both spent time working in the biotech and medical device industries, and they saw firsthand how difficult existing Quality Management Systems (QMS) could be. Tired of all the delays and inefficiencies, they decided to build Enzyme eQMS to simplify workflows and make generating documentation much easier. They started Enzyme in 2017 in South San Francisco, focusing on modern software for life science companies and offering a remote-first work environment with top-notch integrations to boost productivity.

What is Enzyme used for?

• It helps customers quickly and efficiently set up an eQMS.
• It shortens the time it takes for customer workflows to complete.
• It provides a solid structure for setting and achieving quality goals.
• It streamlines quality processes and helps with post-market compliance.
• It makes workflows simpler and more efficient.
• It helps you generate FDA-ready documentation without the hassle.
• It supports your product throughout its entire lifecycle.
• It can adapt to different ways of working.
• It’s always being updated to better meet what users need.
• It was designed by quality and regulatory pros, for quality and regulatory pros.
• Enzyme eQMS makes it easy for customers to get an eQMS up and running fast.
• It cuts down the cycle time for customer workflows.
• It gives all employees a clear framework for setting and meeting quality objectives.
• It streamlines quality processes and post-market compliance.
• It helps with the design and implementation of the eQMS.
• It’s compliant with 21 CFR Part 11.
• It comes validated right out of the box.
• It supports the full product lifecycle.
• It adapts to how you work.
• It’s constantly evolving to better serve user needs.
• Quick and efficient eQMS implementation.
• Reduced cycle time for customer workflows.
• A framework for setting and meeting quality objectives.
• Streamlined quality processes.
• Management of post-market compliance.
• Support from pre-market through post-market.
• Scales as your company grows.
• Support for the entire product lifecycle.
• 21 CFR Part 11 compliance.
• Integrates with a wide range of tools.

Who is Enzyme for?

• People working in biotech
• 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?

To get the most out of Enzyme, here’s a simple guide:

1. Understand its purpose: Think of Enzyme as your eQMS tool, designed to simplify quality management in fields like biotech and medical devices.
2. It’s user-friendly: Enzyme offers a system that’s easy to navigate, with quick document loading, making it a smooth switch from paper-based systems.
3. Get help from the support team: The Enzyme support team is there to help you move your old documents and answer any questions, ensuring the transition is seamless.
4. Stay compliant and connected: Enzyme meets 21 CFR Part 11 standards and offers tons of integrations, so you can keep using the tools you already love.
5. It grows with you: Enzyme is built to scale as your business expands, supporting your product all the way from premarket to postmarket.
6. Our Quality Promise: Everyone at Enzyme is dedicated to giving you a software platform that meets ISO 9001:2015 standards, focusing on constant improvement and making sure you’re happy.
7. Built by experts: Enzyme was founded by people who really know the industry. They wanted to simplify QMS and submissions by creating one unified tool.
8. Remote work and perks: Enzyme supports remote work and offers benefits like productivity boosts, 401k plans, paid time off, and team-building events.

By following these steps, you’ll be able to use Enzyme effectively for your quality management and compliance needs.

These guidelines should help you make the most of what Enzyme offers for efficient quality management.