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 enterprises. Serving teams from 2 to 2000, Enzyme is the only eQMS you’ll ever need.
An eQMS empowering innovation
across the life sciences
Enzyme's quality management system serves medical device, digital health, and biopharma companies
Flexible
Enzyme QMS adapts to your workflow, not the other way around.
Scalable
Enzyme QMS supports the full product lifecycle, premarket to postmarket.
Easy to use
With Enzyme’s quality management system, you’ll onboard in weeks, not months.
Efficient
Enzyme QMS offers an industry-leading number of integrations.
Out-of-the-box QMS solution
Enzyme's quality management system covers the key components of cGMP, the QSR, and ISO standards, and all stages of the product development lifecycle.
Nonconformance
Work your way with Enzyme QMS
Designed for modern workflows, Enzyme's quality management system integrates with your existing tools so you can easily import your data. You can also generate reports directly from our eQMS.
Get started with
Enzyme's document library
Enzyme offers a complete set of 80+ SOPs, work instructions, quality manuals, and forms specific to your product type, from small molecule to digital therapeutic, for your quality management system.
Quality and regulatory experts at the ready
Our in-house support team, each with 10+ years of experience, is here to help.
Whether it’s setting up your first quality management system and developing your design history file or acting on your behalf with FDA, Health Canada, EMA, and notified bodies, we can assist with any quality or regulatory challenge. Our team has dealt with hundreds of audits and handled dozens of regulatory submissions from 510(k)s to NDAs.
Trusted by
Electronic Quality Management System
Enzyme eQMS is flexible and scalable, making it easy to use for startups, yet configurable to meet the needs of the most complex enterprise
