#28 in Privacy & ComplianceUpdated 2026-08

Enzyme

by Enzyme · eQMS for medical device, digital health and biopharma companies

19.1 — BenchRank score out of 100

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Overview

Enzyme is an electronic quality management system for life sciences companies. It covers document control, change control, training, design control, risk management, suppliers, audits, complaints, nonconformance and CAPA, with eSignatures and integrations that let teams import data from tools they already use. Enzyme states the system is 21 CFR Part 11 compliant and validated out of the box.

Best for: Medical device, digital health and biopharma teams needing a validated, Part 11 compliant eQMS
Pricing: No prices are shown; Enzyme says packages depend on the plan chosen (Core, Premarket or Postmarket) and the number of Full and Lite users, and asks buyers to request pricing.

Strengths and trade-offs

Strengths

21 CFR Part 11 compliant and validated out of the box
Covers premarket and postmarket quality processes in one system
Integrates with existing tools, including Microsoft Office 365
Lite user type for staff who only view and sign off training

Trade-offs

Enzyme has been acquired by Greenlight Guru; product future unclear
No prices published; you have to request a quote
Capabilities split across Core, Premarket and Postmarket plans
Aimed at life sciences only; not a general-purpose quality tool

Pricing

Published plans from Enzyme’s own pricing page, in USD. Usage charges and add-ons may apply on top.

Enzyme pricing tiers, monthly rates in USD
Plan	Monthly	Includes
Core	Contact sales	Document control Change control Training
Premarket	Contact sales	Design control Risk management Suppliers
Postmarket	Contact sales	Audits Complaints Nonconformance CAPA

How this score is made up

Each dimension is scored out of 100 and combined into the headline score using fixed weights.

MCP support: 0 out of 100
Documentation: 0 out of 100
Agent friendliness: 80 out of 100
Changelog: 0 out of 100
Marketing site structure: 40 out of 100
Operational trust: 0 out of 100

Measured, but not part of the score

Useful to know, but not a mark for or against the product — so these do not affect the ranking.

Openness: 60 out of 100
Maintenance: 65 out of 100

This doesn’t look right — report a problem with Enzyme’s score

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