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About Enzyme
What is Enzyme?
Enzyme is a cloud-based electronic Quality Management System (eQMS) designed for medical device and life sciences companies. It helps organizations manage quality and regulatory processes from product design and development (premarket) through to postmarket surveillance and compliance.
Who is Enzyme for?
Enzyme is built for quality and regulatory professionals at startups, scale-ups, and complex enterprises in the medtech space. It is also used by clinical teams and executives who need streamlined document control, change control, training, and audit readiness. It is not designed for non-regulated industries or general business process management.
Real use cases
Teams use Enzyme to centralize CAPA management, automate complaint handling, manage supplier quality, and maintain an electronic Trial Master File (eTMF). For example, Diego Rey at Endpoint Health describes the switch from a manual QMS to Enzyme as night and day. Subtle Medical uses Enzyme to streamline post-market compliance and quality processes.
Key features
Enzyme covers document control, design control, risk management, audits, complaints, nonconformance, CAPA, supplier management, training, change control, and eTMF. The system is intuitive, built by QA/regulatory professionals for their peers, and scales from startup to enterprise.
Key features
- Document Control — Centralize version management, approval workflows, and audit trails for all quality documents.
- Design Control — Manage design history files and design changes in compliance with regulatory standards.
- Risk Management — Identify, assess, and mitigate product risks throughout the lifecycle.
- CAPA — Streamline corrective and preventive actions with automated routing and tracking.
- Complaint Handling — Capture, investigate, and report complaints to meet postmarket surveillance requirements.
- Supplier Management — Evaluate and monitor supplier performance and qualifications.
- eTMF — Maintain an electronic Trial Master File for clinical trial documentation.
SaaSpartout Score
7.7
/10
Editorial score from our review methodology — not user ratings.
Enzyme Pricing
Enzyme pricing: Request pricing (custom quote).
Core Plan
Includes document control, training, eSignatures, and integrations. Request pricing.
Premarket Plan
Adds design control, risk management, suppliers, audits, complaints, nonconformance, CAPA, and eTMF. Request pricing.
Postmarket Plan
Same full feature set as Premarket, optimized for ongoing compliance and surveillance. Request pricing.
Schedule a free demo to see if Enzyme fits your needs.
Frequently asked questions
How much does Enzyme cost?
Enzyme does not publicly list exact pricing. Plans are quoted based on company size and needs. You can request a custom quote and schedule a free demo on their website.
Is Enzyme free?
No, Enzyme is a paid eQMS software. There is no free plan, but a free demo is available to evaluate the platform.
What is Enzyme used for?
Enzyme is an electronic Quality Management System (eQMS) for medical device and life sciences companies. It helps manage document control, design control, risk management, CAPA, complaints, audits, supplier quality, and eTMF across premarket and postmarket stages.
Who is Enzyme best for?
Enzyme is best for quality and regulatory professionals in medtech startups and enterprises. It scales from small medical device companies to large, complex organizations needing a configurable, compliant QMS.
What are the top alternatives to Enzyme?
Top alternatives include Greenlight Guru (which acquired Enzyme), Qualio, MasterControl, and Arena QMS. Each offers a different focus on compliance, pricing, and scalability.
Does Enzyme include eTMF functionality?
Yes, Enzyme includes electronic Trial Master File (eTMF) capabilities as part of its Premarket and Postmarket plans, helping manage clinical trial documentation.
