Enzyme

What is Enzyme?

Enzyme is an AI-powered Quality Management System (QMS) platform built specifically for innovators in the medical device, digital health, and biopharmaceutical sectors. It simplifies compliance with critical regulatory standards including cGMP, FDA's QSR, and ISO 13485 by automating quality workflows across the entire product lifecycle. From early-stage design to post-market surveillance, Enzyme centralizes quality operations—offering intelligent tools for document control, risk assessment, audit readiness, and corrective actions—so teams can focus on innovation without compromising compliance.

How to use Enzyme?

Getting started with Enzyme is simple: request a personalized demo to see how the platform aligns with your quality goals. After onboarding, migrate your legacy data effortlessly and connect Enzyme to your existing tech stack through seamless integrations. Navigate intuitive modules tailored to your operational needs—such as training management, change requests, or supplier evaluations—with AI-driven guidance that adapts to your processes. Whether you're managing design inputs or closing out CAPA records, Enzyme supports a scalable, compliant workflow that evolves with your business.

Key Features From Enzyme

Document Control

Change Control

Training Management

Design Control

Risk Management

Supplier Management

Audit Management

Complaint Handling

Nonconformance Tracking

CAPA Workflow Automation

Enzyme's Use Cases

Automating quality documentation and approvals

Maintaining continuous regulatory compliance

Managing end-to-end product development workflows

Improving traceability in change and design history

Scaling training programs across global teams

Conducting efficient internal and external audits

Responding swiftly to customer complaints and deviations

Driving root cause analysis and preventive actions

• Enzyme Support Email & Customer Service Contact & Refund Information

  For assistance, visit the contact us page (https://www.enzyme.com/about/contact-us/)

• Enzyme Company

  Company Name: Enzyme

  Learn more about our mission and team at the about us page (https://www.enzyme.com/about/).

• Enzyme Pricing

  View pricing plans and subscription options at https://www.enzyme.com/plans/

• Enzyme LinkedIn

  Follow us on LinkedIn: https://www.linkedin.com/company/enzymecorp/

FAQ from Enzyme

What is Enzyme?

Enzyme is an AI-enhanced QMS solution designed for medical device, digital health, and biopharma organizations. It streamlines compliance with regulations like cGMP, QSR, and ISO by automating core quality processes such as document control, audits, CAPA, and risk management throughout the product lifecycle.

How to use Enzyme?

Begin with a guided demo to explore Enzyme’s capabilities. Once implemented, import existing data and integrate with your current tools. Utilize key features like training tracking, change control, and nonconformance management within a flexible, user-friendly interface that aligns with your team’s workflows and compliance requirements.