Enzyme
Enzyme Corporation is a cloud-based electronic Quality Management System (eQMS) software company serving FDA-regulated medical device, digital health, and biopharma companies. Founded in 2017, it was acquired by Greenlight Guru in July 2025 and now operates as a brand under its acquirer.
- Company typePrivate
- Founded2017
- HeadquartersSan Francisco, United States
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What Enzyme does
Enzyme (Enzyme Corporation) is a cloud-based electronic Quality Management System (eQMS) software company serving FDA-regulated life sciences organizations, specifically medical device, digital health, and biopharma companies. Founded in 2017 by Jared Seehafer and Jacob Graham and headquartered in South San Francisco, Enzyme was acquired by Greenlight Guru in July 2025, after which co-founder and CEO Jared Seehafer departed. The company operates as a brand under Greenlight Guru, a competing medical device eQMS provider with 1,000+ customers.
The company's core product, Enzyme QMS, is a 21 CFR Part 11 compliant SaaS platform, validated out-of-box and hosted on AWS with isolated Virtual Private Cloud environments per customer, TLS 1.2/1.3 encryption, and SSO support. The platform is structured into modules spanning the full product lifecycle — premarket activities (document control, change control, design control, risk management, suppliers, training) and postmarket activities (audits, complaints, nonconformance, CAPA). Enzyme emphasizes integration breadth with 70+ connections including Microsoft Office 365, Jira, GitHub, GitLab, Bitbucket, CircleCI, Jenkins, Salesforce, Slack, Okta, Zendesk, and Google Workspace, positioning the product to fit into existing customer workflows rather than forcing process changes. The company also achieved SOC 2 Type II certification in 2023 under AICPA standards.
Enzyme generates revenue through subscription-based licensing of its QMS software using an enterprise field sales motion with demo-based conversion as the primary engagement mechanism, supplemented by regulatory and quality consulting services. The customer base skews toward early-stage medical device and digital health startups (named logos include Endpoint Health/formerly GeneWEAVE, Subtle Medical, DawnLight Technologies, ClearCam, and Caption Health), with the platform positioned to scale with customers from startup through IPO. Disclosed funding is limited to approximately $1.97 million across a 2017 Y Combinator investment ($120K) and a 2017 seed round ($1.85M from DCVC, Hack VC, Parcel B, Refactor, Rock Health Capital, and Soma Capital), suggesting a capital-efficient or partially bootstrapped operating history prior to the July 2025 acquisition.
Enzyme firmographics
Firmographics- Name
- Enzyme
- Legal name
- Enzyme Corporation
- Website
- https://enzyme.com
- Company type
- Private
- Founded year
- 2017
- Operating status
- Acquired
- Headcount range
- 11–50 employees
- Short description
- Enzyme Corporation is a cloud-based electronic Quality Management System (eQMS) software company serving FDA-regulated medical device, digital health, and biopharma companies. Founded in 2017, it was acquired by Greenlight Guru in July 2025 and now operates as a brand under its acquirer.
- Ownership category
- akta.pro rank
Enzyme industry classification
Industry- NAICS
- Software Publishers (5132)
- SIC
- Services-Prepackaged Software (7372)
- akta.pro primary industry
- Quality, Compliance & Validation Software for Labs (GxP/CSV, eQMS for QC Labs) (HLAGAJAI)
- akta.pro secondary industries
- Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI), Laboratory Quality & GLP/GCLP Compliance (HLAGAKAK), Quality Engineering & Risk Management (ICH Q9/Q10, validation, change control) (HLAGAKAL)
Keywords
Where Enzyme is headquartered
LocationHeadquarters
- HQ city
- San Francisco
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Enzyme business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Personnel, Technology or R&D, Infrastructure, Marketing or Sales, Operations
Revenue model
- QMS Software Subscription: Enzyme generates revenue through subscription-based licensing of their electronic Quality Management System (eQMS) software. The platform is sold as a cloud-based SaaS solution supporting medical device, digital health, and biopharma companies with their quality and regulatory compliance needs.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels4 records
Enzyme product offering
Product offeringCore offering
Enzyme sells a cloud-based electronic Quality Management System (eQMS) software platform, branded as Enzyme QMS, that helps medical device, digital health, and biopharma companies manage FDA-regulated quality processes across the full product lifecycle from premarket to postmarket. The platform covers document control, change control, training, design control, risk management, suppliers, audits, complaints, nonconformance, and CAPA, and is delivered as a subscription-based SaaS product hosted on AWS with 21 CFR Part 11 compliance and 70+ third-party integrations. Enzyme also offers regulatory and quality consulting services to complement the software.
Product overview
Enzyme offers a unified QMS software platform called Enzyme QMS (Electronic Quality Management System) designed for medical device, digital health, and biopharma companies. The platform consists of a core QMS product with integrated modules covering both premarket activities (Document Control, Change Control, Training, Design Control, Risk Management, Suppliers) and postmarket activities (Audits, Complaints, Nonconformance, CAPA). The platform is 21 CFR Part 11 compliant, validated out-of-box, and offers an industry-leading number of integrations. Enzyme also provides complementary consulting services for regulatory strategy and submission support.
Differentiator
Problem solved
Functional benefit
Companies that use Enzyme
Customer profileNamed customers5 records
Segments3 records
Ideal customer profiles2 records
Enzyme technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration15 records
Feature5 records
Enzyme partnerships and signals
Strategic signalPartnerships
One partnership is on record.
- Greenlight GurucoreGreenlight Guru acquired Enzyme to bolster innovation and customer support in the electronic quality management systems space for medical device companies. Greenlight Guru is a provider of electronic QMS for the medical device industry. The acquisition is intended to enhance product development and regulatory compliance, combining Enzyme's modern QMS platform with Greenlight Guru's operational strength and customer base of 1,000+ companies. Enzyme co-founder Jared Seehafer departed as CEO following the acquisition in July 2025.
Scale indicators3 records
Recent moves6 records
Expansion highlights5 records
Enzyme competitors and assessment
Company assessmentDirect peers
- Greenlight Guru: Electronic QMS provider purpose-built for medical device companies; acquired Enzyme in July 2025. Directly comparable on core eQMS functionality, target customer (medical device, digital health), and FDA 21 CFR Part 11 / ISO 13485 positioning.
- MasterControl: Long-standing eQMS suite for life sciences covering document, change, training, CAPA, audit, and validation. Comparable core product and regulated buyer base, with a broader enterprise footprint and longer sales cycles.
- Dot Compliance: eQMS solution focused on life sciences quality and compliance on Salesforce. Comparable on regulated-vertical focus and cloud-native delivery, with overlap in document/change/CAPA workflows.
- ComplianceQuest: Next-generation QMS built natively on the Salesforce platform with life-sciences, medical-device, and manufacturing verticals. Comparable cloud-native QMS positioning and enterprise field-sales GTM.
- SimplerQMS: ISO 13485-compliant eQMS for medical device and life sciences companies of similar size to Enzyme. Directly comparable on customer segment, validation posture, and SaaS-only delivery.
- Qualio: Cloud eQMS for life sciences startups and mid-market companies. Closely comparable on target customer profile (medical device, pharma startups), GxP validation, and SaaS delivery model.
Broad incumbents
- Veeva Systems: Large life-sciences cloud platform with Vault QualityDocs, Vault QMS, and Vault Training. Comparable QMS functionality bundled into a much broader regulated RIM/clinical suite serving enterprise pharma and med-device customers.
- Sparta Systems (TrackWise): TrackWise QMS for life sciences and other regulated industries. Comparable on core QMS workflows and regulated-vertical focus; a much larger installed enterprise base, including pharma and medical device manufacturers.
- ETQ (Hexagon): Enterprise QMS platform within Hexagon's quality and EHS portfolio. Comparable document, change, audit, and CAPA functionality, but positioned at larger enterprise accounts and broader industrial verticals.
Emerging players
- AssurX: Mid-market QMS provider with regulated-industry focus including life sciences. Overlaps with Enzyme on document, change, CAPA, and audit modules for similar-size regulated customers.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat4 records
Key risks5 records
Key highlights6 records
Customer concentration
Enzyme social profiles
Digital presenceEnzyme compliance and trust
Trust signalCompliance2 records
Enzyme financial estimates
Financial estimateRevenue estimate
Valuation estimate
Enzyme leadership team
Management profileNumber of profiles
Profiles2 records
Enzyme funding detail
Funding detailFunding overview
Funding rounds3 records
Investors7 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Enzyme M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Enzyme
What does Enzyme do?
Enzyme sells a cloud-based electronic Quality Management System (eQMS) software platform, branded as Enzyme QMS, that helps medical device, digital health, and biopharma companies manage FDA-regulated quality processes across the full product lifecycle from premarket to postmarket. The platform covers document control, change control, training, design control, risk management, suppliers, audits, complaints, nonconformance, and CAPA, and is delivered as a subscription-based SaaS product hosted on AWS with 21 CFR Part 11 compliance and 70+ third-party integrations. Enzyme also offers regulatory and quality consulting services to complement the software.
Is Enzyme a public or private company?
Enzyme is a private company. It is currently acquired.
When was Enzyme founded?
Enzyme was founded in 2017. It employs 11 to 50 people.
Where is Enzyme based?
Enzyme is headquartered in San Francisco, United States, in the North America region.
How does Enzyme make money?
One revenue line is on record: QMS Software Subscription.
Who are Enzyme's main competitors?
Direct peers on record are Greenlight Guru, MasterControl, Dot Compliance, ComplianceQuest, SimplerQMS and Qualio. Broad incumbents are Veeva Systems, Sparta Systems (TrackWise) and ETQ (Hexagon). AssurX is listed as an emerging player.
Does Enzyme have an API?
No public API is recorded for Enzyme.
What industry is Enzyme in?
Its primary akta.pro industry code is HLAGAJAI, Quality, Compliance & Validation Software for Labs (GxP/CSV, eQMS for QC Labs), with a secondary code of HLAGAKAI, Clinical Quality Assurance (GCP QA, TMF/QMS oversight). Its NAICS code is 5132 and its SIC code is 7372.