Enzyme

Discover how Enzyme eQMS transformed quality management for leading life science companies.

RecommendedEnzyme eQMS offers a robust, industry-specific quality management system with strong compliance features and integrations, ideal for regulated life science companies, though pricing is not publicly disclosed.

Enzyme eQMS is a cloud-based quality management system software designed for medical devices, digital health, and biopharma companies. It adapts to your workflows, scales with your company, and integrates with existing tools, covering key components of cGMP, QSR, and ISO standards across all product development lifecycle stages.

Visit Enzyme

Visit Enzyme

Key Features:

21 CFR Part 11 compliant e-signatures
Document control, training, and approvals
Integrations with popular development and collaboration tools
Customizable workflows for various company needs
Modules for premarket (Design Control, Risk Management) and postmarket (Audits, CAPA)

Pros

Life science startups needing a scalable QMS
Medical device companies requiring ISO 13485 compliance
Biopharma companies streamlining post-market compliance

Cons

Enzyme has been acquired by Greenlight Guru, which may impact future product direction.
Pricing is not transparent and requires a direct request.
The platform is highly specialized for the life sciences, limiting its applicability elsewhere.

Pricing

paidFree tier

Starting at:unverified

Free tier:unverified

Price verified on the live site 2026-07-12 · pricing page

Categories:

Healthcare & Medical Legal & Compliance Business & Enterprise

Tags:

eQMS quality management medical devices biopharma compliance ISO 13485 21 CFR Part 11

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Quick Decision

Try if: You are a life science company (medical device, digital health, biopharma) looking for a comprehensive, compliant, and highly integrated eQMS solution.

Skip if: You are not in the life sciences industry or require a QMS with transparent, upfront pricing without needing to contact sales.

Not for: Companies outside the life sciences industry; Individuals seeking a free or low-cost QMS solution

Trust Signals

Team Size
medium

Compliance

21 CFR Part 11ISO 9001ISO 13485SOC 2 Type II

Notable Customers

ClearCamEndpoint HealthSubtle MedicalDawnLight Technologies

Tech Details

Platforms

web

Integrations

JiraGitHubGoogle Drive

Open Source

Support

Channels

contact form

Company

Name
Enzyme

Enzyme provides an electronic Quality Management System (eQMS) software specifically designed for the life sciences industry, including medical devices, digital health, and biopharma. The company has been acquired by Greenlight Guru.

FAQ

What is Enzyme eQMS?

Enzyme eQMS is a cloud-based Electronic Quality Management System software tailored for the life sciences industry, helping companies manage quality processes and maintain compliance with regulations like 21 CFR Part 11, ISO 9001, and ISO 13485.

What are the different plans offered by Enzyme eQMS?

Enzyme offers three main plans: CORE (Document control, Training, eSignatures, Integrations), PREMARKET (CORE + Design control, Risk management, Suppliers), and POSTMARKET (PREMARKET + Audits, Complaints, Nonconformance, CAPA).

How does Enzyme eQMS handle pricing?

Enzyme's pricing is flexible and based on the chosen plan (Core, Premarket, Postmarket) and the number and types of users (Full or Lite). Specific pricing details require a direct request, but discounts are available for longer terms, payment frequency, and contract start dates.

Use Cases

Life science startups needing a scalable QMS
Medical device companies requiring ISO 13485 compliance
Biopharma companies streamlining post-market compliance