What we like
- Jira data flows into design-control records, with Xray test executions, a trace matrix export and a generated Design and Development File, all documented in release notes.
- Documents stay in Google Docs or Microsoft Office, edited inside Enzyme, with controlled PDFs and redlines generated automatically.
- Still maintained after the acquisition: 23 releases between July 2025 and September 2026.
- CAPA, complaints, nonconformances and audits each have an approval workflow, and approvals can require a Part 11 PIN (2020 help center).
- The 2018 terms let customers cancel at any time, with a prorated refund on longer terms.
What to watch
- Greenlight Guru hasn't said publicly whether Enzyme will stay a separate product or still be sold to new customers.
- No public prices, implementation fees are possible, and the SOP library costs extra.
- Data is hosted in the US only, with no public DPA or subprocessor list.
- The help center is now for customers only; the workflow documentation we found is from 2020, for an earlier version.
- No reviews on G2 and only six on Capterra, the latest from May 2025: too few to judge what users think.
About the price: No public prices (Oct 2026). Priced by plan (Core, Premarket, Postmarket) and by number of Full and Lite users; implementation fees possible, SOP library extra. In 2022 the list was $499 or $1,999 a month for up to 25 users, with the plan that includes CAPA on request.
What is Enzyme?
Enzyme is a cloud eQMS from Enzyme Corporation, based in South San Francisco.1 It was founded in 2017 and went through Y Combinator’s Summer 2017 batch.23 It sells to medical device, digital health and biopharma companies.4 Its first customers were device and diagnostics companies, and its product pages are built around design controls, ISO 14971 risk and complaints.567
On 23 July 2025 Greenlight Guru bought the company.89 The product is still maintained. Its public release notes list 23 releases between July 2025 and September 2026, most of them fixes to the Jira integration.10 Neither company has said whether Enzyme will be merged into Greenlight Guru’s platform, or whether it’s still sold to new customers. Greenlight Guru has promised existing customers “continuity” and a clear roadmap.811 The website still takes demo and pricing requests, but apart from an acquisition banner it hasn’t been updated since mid-2025.412
Who Enzyme is for
Enzyme suits teams building software-driven devices whose engineers already work in Jira. Requirements and tests sync into Enzyme’s design controls, so quality gets traceability without engineers re-entering their work.106
Look elsewhere if you:
- Need certainty about the product’s future. Ask Greenlight Guru what its plans for Enzyme are, and how long it will support it, before you sign. Otherwise you may face a second migration within a few years.
- Need EU data hosting. Enzyme says its services are hosted and operated entirely in the United States.1
- Want current public documentation. The help center is now for customers only. The workflow descriptions we found are archived copies from 2020, written for version 1.13
Enzyme pricing
Enzyme doesn’t publish prices (checked 8 October 2026).1415 The price depends on the plan and on how many users of each type you need:14
- Core: document control, training, e-signatures and integrations.
- Premarket: Core plus design control, risk management and suppliers.
- Postmarket: Premarket plus audits, complaints, nonconformance and CAPA.
Full users work in the system. Lite users only view documents and sign off training.14 Discounts depend on the length of the term, how often you pay and when the contract starts.16
On top of the subscription:
- Implementation fees: the terms allow them, payable at signature, but don’t say how much.17
- SOP library: more than 80 SOPs, work instructions and forms, sold as an optional extra.1819
- Consulting: paid separately, by time and materials, project, retainer or embedded staff.20
Enzyme did publish prices until 2022.21 In August 2022 Starter cost $499 a month and Development $1,999 a month, each for 1 to 25 users. Development added design controls, risk, suppliers and the DHF export. Go-to-Market, which added nonconformance, CAPA and audits, was on request. Document templates cost $1,500, $5,000 or $10,000, depending on the set. By April 2023 the prices were gone.22 The plans have been renamed since, so treat the old figures as history, not as a quote.
We found no independent price data we could read, so we can’t estimate what a 10-person team pays today.
The full breakdown is on our Enzyme pricing page.
Features
Product pages exist for each of Enzyme’s modules, but they are marketing pages. Today’s public help center holds mainly release notes, plus one article that lists the record types and which fields need re-approval.1323 In 2020 the how-to articles were public, and the Internet Archive kept about 180 of them. They describe version 1, but the same modules and record types exist today. We based the clause matrix on those articles, the release notes, a 2023 blog post and the narration of the vendor’s demo video.2419
Document control and training
Documents go through draft, review, approval and obsolescence. You edit them in Google Docs or in Microsoft Office.19 Since 2023, Word, Excel and PowerPoint files open in Office for the web inside Enzyme, and saving creates a new revision.24 Enzyme generates controlled PDFs and redlines, and you can set permissions by project, product or folder.25 Change requests route to approvers based on roles and document restrictions.2627 Changing an approved field on any approved record triggers a new approval.23
Training is assigned automatically by role, and quizzes check understanding.19 The training page also lists curricula, a training matrix, and email and Slack reminders.28
Design controls, risk and software
This is Enzyme’s best-documented area. The release notes show:10
- Jira issues pushed into design-control records, filtered by JQL;
- Xray test plans and executions linked to Jira issues;
- products moving through design-review stages;
- a trace matrix export linking user needs to requirements;
- a design history file export, renamed the Design and Development File in February 2026 to match the FDA’s QMSR.
In late 2025 some customers reported that Jira updates intermittently didn’t reach design controls. Enzyme fixed the problem in November 2025 and kept improving the integration into 2026.2910
Risk sits in a Hazard Analysis module with a configurable risk matrix.3023 You record hazards, hazardous situations and harms, with initial and mitigated risk scores. Risk controls are product requirements, so they trace into design controls.317 The DHF export bundles user needs, requirements, outputs, verifications, validations, the trace matrix and a change log.32 We found no IEC 62304 features such as software safety classes or SOUP lists.
CAPA, complaints and other quality events
The archived 2020 help articles describe each workflow:
- Nonconformances can come from audits, complaints, suppliers or inspections. They carry defect codes and a severity and occurrence rating. Interim actions and dispositions must be approved before an NC closes, and an NC is either escalated to a CAPA or you record why not.33
- CAPAs start from an escalated NC and run through four approved phases: investigation planning, investigation results, implementation and verification of effectiveness. Extending a due date needs a justification and approval.34
- Complaints go through triage, a reportability decision and an investigation, then to the required approvers. Editing an approved complaint sends it back to draft.35 A March 2026 release added validation of patient age on complaint forms.36 Complaints can also come in from Zendesk and Salesforce.19
- Audits cover internal, supplier and external audits, with major and minor findings, and are routed for approval.37 Audit planning and checklists appear only on the marketing page.38
- Suppliers have a status, risk, type and rating, and changes to an approved supplier need re-approval.39
We found no FDA MDR or EU vigilance reporting.
What users say
There’s too little to go on. G2 lists Enzyme QMS without any reviews, with Greenlight Guru as the seller.40 Capterra shows 4.7 out of 5 from six reviews, written between April 2023 and May 2025. Four of them are marked as incentivized or invited by the vendor.41 Reviewers praise ease of use and the Jira and Microsoft Office integrations, and three mention a learning curve, tedious configuration or a clunky interface. Two say they chose Enzyme over Greenlight Guru on price.41 Until a site shows at least ten reviews, usability, support and sentiment get our neutral value. We found no first-hand posts on Reddit or in quality forums.
Security, hosting and validation
Enzyme runs on AWS, and each customer gets an isolated virtual private cloud. Data is encrypted in transit and at rest, and single sign-on is available.42 The privacy policy says the services are “hosted and operated entirely in the United States”.1 We found no EU hosting option, public data processing agreement or subprocessor list.
The homepage links to a help article about a SOC 2 Type II report, but the article is for customers only.43 Enzyme calls its software “validated out-of-box” and Part 11 compliant.4 In 2020 its help center described a validation package with every major release, with test evidence and a validation summary.44 For Part 11, admins can require a PIN on every approval, and quality owners get a Part 11 compliance report.45 We found no current description of either.
Buying and contract terms
- Trial: no free trial. The homepage has a four-minute recorded demo, and you can book a live one.419
- Contract: the public terms date from May 2018 and leave the term to a separate subscription agreement. They allow monthly, annual, two-year and three-year terms. Contracts renew automatically for a month or a year unless you give notice 30 days before the end.17 On paper you can cancel at any time, with a prorated refund on terms longer than a month, but your agreement can override that.17 Ask whether Greenlight Guru’s own agreement now applies instead.
- Price increases: Enzyme can raise prices at renewal with 30 days’ notice. The terms set no cap.17
- Leaving: when the contract ends, Enzyme returns your data and then erases it. The terms don’t say in what format.17 Individual exports are documented for CAPAs, complaints, audits, design controls, the trace matrix and the design history file, and named for controlled PDFs and the approved supplier list.343537322546 We found no documented export of everything, and no file formats.
- API: webhooks are mentioned in the release notes, but we found no public API documentation.47
- Go-live: Enzyme states no typical time. Onboarding covers three one-hour training sessions.20
- If the vendor is sold or closes: the terms contain no clause on continuity or escrow.17 Enzyme has already changed hands twice.
Company and ownership
- Legal entity. Enzyme Corporation, South San Francisco, California.1 We couldn’t read a state registry entry.
- Founded. 2017, in Y Combinator’s Summer 2017 batch.23
- Funding. In January 2018 it raised a $1.85 million round from venture investors including Refactor Capital, Data Collective, Soma Capital and Rock Health.5
- 2022. Roivant Sciences, a listed biotech company, became majority shareholder, according to a 2023 Olin College article.48 We found no SEC filing that confirms it.
- 2025. Greenlight Guru, which is backed by private-equity firm JMI Equity, acquired Enzyme on 23 July 2025. It was Greenlight Guru’s second acquisition in a few weeks, after Ultralight Labs.8
- Size. Y Combinator lists a team of 32.3 As a private company, Enzyme files no public accounts.
Verdict
Enzyme scores 4.8. Its design controls, fed from Jira and Xray, are well documented and will appeal to software-driven device teams. Before you buy, ask Greenlight Guru what its plans for the product are. Prices aren’t published, hosting is US-only, and the help center that documented its quality workflows is now for customers only.
Enzyme: Privacy policy. Vendor legal page, last updated 15 Mar 2023, checked 8 Oct 2026. ↩︎ ↩︎ ↩︎ ↩︎
Enzyme: About. Vendor website, checked 8 Oct 2026. ↩︎ ↩︎
Y Combinator: Enzyme. Accelerator company profile, checked 8 Oct 2026. ↩︎ ↩︎ ↩︎
Enzyme: homepage. Vendor website, checked 8 Oct 2026. ↩︎ ↩︎ ↩︎ ↩︎
Rock Health: FDA compliance made easy: Welcome, Enzyme!. Investor announcement, published 18 Jan 2018, checked 8 Oct 2026. ↩︎ ↩︎
Enzyme: Design control. Vendor marketing page, checked 8 Oct 2026. ↩︎ ↩︎
Enzyme: Risk management. Vendor marketing page, checked 8 Oct 2026. ↩︎ ↩︎
Greenlight Guru acquires Enzyme. Acquirer press release, 23 Jul 2025, checked 8 Oct 2026. ↩︎ ↩︎ ↩︎
Enzyme: A grateful goodbye and a confident step forward. Vendor blog, 23 Jul 2025, checked 8 Oct 2026. ↩︎
Enzyme Support: Release notes, versions 2.9.2 (15 Jul 2025) to 2.9.24 (11 Sep 2026). Vendor release notes, checked 8 Oct 2026. ↩︎ ↩︎ ↩︎ ↩︎
Greenlight Guru: Welcome Enzyme to the Greenlight Guru family. Acquirer blog, 23 Jul 2025, checked 8 Oct 2026. ↩︎
Enzyme: page sitemap. Vendor website (last-modified dates), checked 8 Oct 2026. ↩︎
Enzyme Support Center. Vendor help center, 27 public articles, checked 8 Oct 2026. ↩︎ ↩︎
Enzyme: Plans. Vendor website, checked 8 Oct 2026. ↩︎ ↩︎ ↩︎
Enzyme: Request pricing. Vendor website, checked 8 Oct 2026. ↩︎
Enzyme: QMS software. Vendor website, checked 8 Oct 2026. ↩︎
Enzyme Corporation: Terms & Conditions. Vendor terms, updated 22 May 2018, checked 8 Oct 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎
Enzyme: Product. Vendor website, checked 8 Oct 2026. ↩︎
Enzyme QMS demo video, embedded on the homepage. Vendor video, narration read from its caption track 8 Oct 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎
Enzyme: Consulting. Vendor website, checked 8 Oct 2026. ↩︎ ↩︎
Enzyme: Pricing (archived). Vendor price list, captured 23 Aug 2022. ↩︎
Enzyme: Plans (archived). Vendor website, captured 20 Apr 2023. ↩︎
Enzyme Support: Fields that don’t require approval. Vendor help center, 5 Jul 2024, checked 8 Oct 2026. ↩︎ ↩︎ ↩︎
Enzyme: New Microsoft Office 365 integration. Vendor blog, 9 Oct 2023, checked 8 Oct 2026. ↩︎ ↩︎
Enzyme: Document control. Vendor marketing page, checked 8 Oct 2026. ↩︎ ↩︎
Enzyme Support: Release 2.9.4. Vendor release notes, 8 Sep 2025, checked 8 Oct 2026. ↩︎
Enzyme Support: Release 2.9.17. Vendor release notes, 24 Mar 2026, checked 8 Oct 2026. ↩︎
Enzyme: Training. Vendor marketing page, checked 8 Oct 2026. ↩︎
Enzyme Support: Release 2.9.9. Vendor release notes, 4 Nov 2025, checked 8 Oct 2026. ↩︎
Enzyme Support: Release 2.9.3. Vendor release notes, 30 Jul 2025, checked 8 Oct 2026. ↩︎
Enzyme Support: Overview of risk management module (archived). Vendor help center, captured 29 Sep 2020. ↩︎
Enzyme Support: How to view and export a product’s design history file (archived). Vendor help center, captured 25 Sep 2020. ↩︎ ↩︎
Enzyme Support: Overview of nonconformance (NC) module (archived). Vendor help center, captured 29 Sep 2020. ↩︎
Enzyme Support: Overview of CAPA module (archived) and How to extend a CAPA phase due date (archived). Vendor help center, captured Sep 2020. ↩︎ ↩︎
Enzyme Support: How to manage complaint records (archived). Vendor help center, captured 29 Sep 2020. ↩︎ ↩︎
Enzyme Support: Release 2.9.16. Vendor release notes, 9 Mar 2026, checked 8 Oct 2026. ↩︎
Enzyme Support: Overview of audits module (archived). Vendor help center, captured 29 Sep 2020. ↩︎ ↩︎
Enzyme: Audits. Vendor marketing page, checked 8 Oct 2026. ↩︎
Enzyme Support: Overview of suppliers module (archived). Vendor help center, captured 28 Sep 2020. ↩︎
G2: Enzyme QMS reviews. Review site, checked 9 Oct 2026. ↩︎
Capterra: Enzyme reviews. Review site, 6 reviews, checked 9 Oct 2026. ↩︎ ↩︎
Enzyme: Security policy. Vendor website, checked 8 Oct 2026. ↩︎
Enzyme Support: Security: SOC 2 Type II. Vendor help center, customer login required, checked 8 Oct 2026. ↩︎
Enzyme Support: How do I validate Enzyme? (archived). Vendor help center, captured 24 Sep 2020. ↩︎
Enzyme Support: How to manage your PIN for Part 11 compliance (archived). Vendor help center, captured 23 Sep 2020. ↩︎
Enzyme: Suppliers. Vendor marketing page, checked 8 Oct 2026. ↩︎
Enzyme Support: Release 2.9.20. Vendor release notes, 11 May 2026, checked 8 Oct 2026. ↩︎
Olin College: Alum’s startup becomes big player in biomedical/software industries. University news article, 29 Mar 2023, checked 8 Oct 2026. ↩︎
Visit the Enzyme website (made by Enzyme Corporation (part of Greenlight Guru))
Notable features
| Built-in document editor | NoDocuments are edited in Google Docs or Microsoft Office for the web |
|---|---|
| Edit in Word or Google Docs | YesGoogle Docs sync, and Word, Excel and PowerPoint editing inside Enzyme |
| SOP templates included | No80+ SOPs and forms are an optional purchase |
| Jira or Git integration | YesJira and Xray sync into design controls; GitHub named on the product page |
| IEC 62304 software features | Not confirmed yetNo IEC 62304 features found |
| Validation package included | YesValidation package with every major release (2020 help center) |
| Public API | Not confirmed yetWebhooks mentioned; no public API documentation |
| Single sign-on (SSO) | YesListed on the security page |
| Supplier portal | Not confirmed yetNone documented |
| Training with quizzes | YesQuiz questions shown in the vendor's demo video |
| FDA MDR or EU vigilance reporting | Not confirmed yetNo FDA MDR or EU vigilance reporting found |
| AI features | YesAI knowledge-base chat and document analysis in beta |
How we scored compliance coverage (17 ISO 13485, FDA and EU MDR requirements)
| Clause | Requirement | Enzyme |
|---|---|---|
| 4.2.4 | Control of documents | |
| 4.2.5 | Control of records | |
| 6.2 | Training and competence | |
| 7.3 | Design and development | |
| 7.3.9 | Change control | |
| 7.4 | Supplier qualification and control | |
| 7.5 | Production records (DMR/DHR) | |
| UDI | UDI management (EU MDR, FDA) | |
| 8.2.2 | Complaint handling | |
| 8.2.3 | Regulatory reporting (FDA MDR, EU vigilance) | |
| MDR 83 | Post-market surveillance | |
| 8.2.4 | Internal audit | |
| 8.3 | Nonconforming product | |
| 8.5.2 | Corrective action (CAPA) | |
| ISO 14971 | Risk management file | |
| IEC 62304 | Software lifecycle | |
| Part 11 | Electronic signatures |