What is It?
Enzyme QMS is a cloud-based, AI-enhanced Quality Management System (QMS) specifically designed for life sciences companies including medical device manufacturers, biotech firms, and digital health startups. It streamlines compliance with FDA, ISO 13485, and other regulatory requirements by digitizing quality processes like document control, design controls, training, and CAPA. Enzyme is built with automation and scalability in mind, enabling faster product development and audit readiness from day one.
Key Features
FDA & ISO 13485 Compliance: Pre-validated workflows aligned with regulatory standards.
Design Controls: Link design inputs/outputs, verification, and validation to product development in real time.
AI-Powered Document Control: Automated versioning, review cycles, and approval tracking.
Training Management: Assign, track, and audit employee training records for compliance.
Change Management: Fully traceable change control with risk assessment tools.
CAPA & NCR Automation: Manage corrective/preventive actions and non-conformances efficiently.
Audit-Ready Exports: Instantly generate export packages ready for FDA or ISO audits.
Integrated Risk Management: Map and manage risks across the product lifecycle.
API & Integrations: Connects with Jira, GitHub, Google Drive, and more for smoother workflows.
Medical Device Companies
Biotech Startups
Digital Health & SaMD Developers
Regulatory Affairs Teams
Quality Assurance (QA) Teams
R&D and Product Teams
Compliance Officers
Clinical Operations Teams
Pharmaceutical Innovators
Streamlining QMS setup for FDA/ISO audits
Managing design controls and traceability for medical devices.
Digitizing employee training and document approvals
Running CAPA and risk assessments during product development
Accelerating time-to-market for regulated life sciences products
1
Book a Demo: Visit enzyme.com to schedule a personalized product walkthrough.
2
Onboard Your Team: Enzyme helps with setup, data migration, and role assignments.
3
Customize Workflows: Configure templates for SOPs, DHFs, CAPA, training, and risk based on your company’s structure.
4
Upload Documents: Use AI document management to start controlling and versioning files.
5
Assign Training: Create training modules and track employee compliance.
6
Design Products: Use design control modules to manage requirements, outputs, verification, and validation.
7
Manage Risk & CAPA: Link issues with design elements and initiate CAPA plans with traceability.
8
Prepare for Audit: Export a full documentation package with one click for FDA/ISO compliance.
Enzyme QMS uses custom pricing based on company size, modules required, and regulatory needs:
Startup Plan: Tailored for early-stage medtech/biotech firms. Pricing on request.
Growth Plan: Mid-sized teams with multi-product support.
Enterprise Plan: Full QMS capabilities, integrations, and enterprise-grade security.
Demo: Available upon request via enzyme.com.
Comparision with Competitors
Vs. Greenlight Guru: Enzyme is more customizable and developer-friendly; Greenlight is more out-of-the-box.
Vs. Qualio: Enzyme supports more complex workflows and integrations.
Vs. MasterControl: Enzyme is more agile and startup-friendly; MasterControl is heavyweight.
Vs. Veeva: Veeva is built for large pharma; Enzyme excels in speed and cost-efficiency.
Vs. Dot Compliance: Both are life sciences-focused; Enzyme offers more modern UX and APIs.
Designed specifically for life sciences
Pre-built compliance workflows
AI-powered document automation
Scalable from startup to enterprise
Developer & integration friendly
No public pricing
Requires onboarding for full setup
Currently focused on FDA/ISO, not broader industries
May be too feature-rich for very early-stage startups
Enzyme QMS is a future-forward quality management platform tailored for the fast-paced, heavily regulated life sciences sector. Its AI-enhanced workflows, audit-ready design, and collaborative features make it a top choice for medtech and biotech companies looking to scale quickly without compliance headaches. If you're launching a regulated product and need a modern QMS to match, Enzyme is an excellent partner on your path to approval.
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