Enzyme

Enzyme is an electronic Quality Management System (eQMS) platform purpose-built for life sciences companies, including medical device, digital health, biopharma, drug, and biologic organizations. Founded in 2017 by industry veterans Jared Seehafer and Jacob Graham and headquartered in South San Francisco, Enzyme was created to solve the real-world frustrations of fragmented QMS workflows and the difficulty of generating FDA-ready documentation. The platform is 21 CFR Part 11 compliant, validated out-of-the-box, and designed to scale alongside a company from startup through IPO — supporting the full product development lifecycle from premarket to postmarket. Enzyme has since been acquired by Greenlight Guru.

Enzyme eQMS is built to be flexible and configurable, adapting to a team's existing way of working rather than forcing process changes. It integrates with an industry-leading number of third-party tools — including Microsoft Office 365 — so teams can import existing data and generate reports directly from the platform. The system was designed by quality and regulatory professionals for quality and regulatory professionals, with an emphasis on intuitive usability, modern workflows, and continuous product evolution.

Core QMS Modules

• Document Control — Manage, version, and approve quality documents in a centralized, audit-ready system
• Design Control — Track and manage design history files and product development documentation
• Change Control — Streamline the review and approval of changes across the organization
• Training — Assign, track, and document employee training activities
• Risk Management — Identify, assess, and mitigate product and process risks
• Suppliers — Manage supplier qualification and ongoing oversight
• Audits — Plan, execute, and document internal and external audits
• Complaints — Capture and manage post-market customer complaints
• Nonconformance — Record and resolve nonconforming products and processes
• CAPA — Drive corrective and preventive actions through to resolution

Compliance and Standards Coverage

• Covers key components of cGMP, the Quality System Regulation (QSR), and ISO standards
• 21 CFR Part 11 compliant for electronic records and signatures
• Validated out-of-the-box, reducing the burden of IQ/OQ/PQ for customers
• Enzyme's own quality policy is maintained in accordance with ISO 9001:2015
• Supports FDA-ready documentation generation, enabling faster and more efficient regulatory submissions

Platform Capabilities and Design Philosophy

• Designed to unify multiple disparate software tools into a single, streamlined QMS workflow
• Supports the entire product lifecycle — from early-stage development through commercialization and post-market compliance
• Scalable architecture suitable for early-stage startups as well as complex enterprise organizations
• Industry-leading number of third-party integrations, including Microsoft Office 365, allowing teams to continue using familiar tools
• Enables direct report generation from within the eQMS platform
• Remote-first team with a shared mission to help companies foster a culture of quality through modern software and expert guidance

Customers and Testimonials

• ClearCam — Praised Enzyme's user-friendly system, rapid document loading, seamless transition from paper, and audit-ready organization
• Endpoint Health (formerly GeneWEAVE) — Chief Scientific Officer described the transformation as "night and day" compared to operating without Enzyme
• Subtle Medical — CEO highlighted Enzyme's role in streamlining quality processes and post-market compliance, noting outstanding professionalism and service
• DawnLight Technologies — VP of Clinical, QA, and RA credited the care and thoughtfulness of the Enzyme team in designing and implementing the eQMS

Consulting and Additional Services

• Enzyme offers quality and regulatory consulting services alongside its software platform
• Consulting expertise spans quality management, regulatory affairs, and software development life cycle (SDLC)
• Customer success support is available to assist with onboarding, historical document migration, and ongoing questions
• Multiple pricing plans available to accommodate organizations at different stages of growth

Enzyme eQMS represents a modern, integrated approach to quality management for life sciences companies — combining deep regulatory expertise, broad compliance coverage, and a highly configurable platform to help organizations innovate faster while maintaining the highest standards of quality. Following its acquisition by Greenlight Guru, Enzyme continues to serve the life sciences community as part of a broader quality management ecosystem.