Greenlight Guru QMS: public-source profile

Product: Greenlight Guru eQMS (Greenlight Guru Quality on the pricing page), part of the “Greenlight Guru Platform” of quality management, product development, and electronic data capture. Separate commercial items: product-development subscriptions, Greenlight Guru EDC (from the SMART-TRIAL acquisition), Guru services (Assist, Guidance, professional services), Greenlight Guru Academy, and an optional REST API plus pre-built connectors. Vendor: Soladoc, LLC, doing business as Greenlight Guru (website terms). Press releases are datelined Indianapolis. Category: Medical-device electronic quality management system (eQMS), with a separate design-control / product-development subscription and a separate clinical EDC. Not a pharmaceutical MES, ERP, or equipment-control system. Verification date: 2026-10-03. Scope: Public web sources only.

1. Overview

Greenlight Guru is a device-specific eQMS that pairs ISO 13485 quality processes (document control, CAPA, complaints, supplier quality, audits) with design controls, ISO 14971 risk files, and a clinical EDC, sold to medical-device and SaMD companies from first submission to commercial portfolio. The Indianapolis company is backed by JMI Equity, has grown by acquisition (SMART-TRIAL in 2022, Ultralight Labs and Enzyme in 2025), and reports “1,000+ device companies” as customers (Homepage; Platform).

Greenlight Guru runs on Amazon Web Services as an annual, browser-based subscription; customers cannot self-host. eQMS packages start at $12,000 per year and EDC at $9,000 per year, with implementation quoted separately; Greenlight Guru publishes no full price list (Quality pricing).

The homepage says the platform “lowers audit risk by 3.5x.” The platform FAQ describes quality, product development, and eClinical software for the whole device lifecycle. Sponsors and CROs can buy EDC without the quality system.

What it is not:

Not a pharmaceutical MES, electronic batch record system, or shop-floor controller. Greenlight Guru’s pages describe no batch execution, weigh-and-dispense, or machine protocols.
Not an ERP, PLM, LIMS, or CRM. The API page describes connecting to those systems (API).
Not Greenlight Guru EDC. EDC is a separate product with its own price floor and separately priced study-build. It came from SMART-TRIAL, a Danish company (SMART-TRIAL release).
Not Enzyme or Ultralight Labs. The 24 July 2025 release announces the Enzyme acquisition, a separate life-sciences QMS, one month after Ultralight Labs, and announces no product merge (PR Newswire, 24 Jul 2025).

2. Company and product identity

Point	Fact	Source
Legal name	The website is “owned and operated by Soladoc, LLC d/b/a Greenlight Guru.” Terms updated Wednesday, 17 February 2026. The terms give no street address, state of formation, or officer.	Terms
Location	The 15 June 2021 JMI release, the 2 June 2022 SMART-TRIAL release, and the 24 July 2025 Enzyme release are datelined Indianapolis. The 2022 release says “the Indianapolis-based company.”	JMI, 15 Jun 2021; SMART-TRIAL blog; Enzyme release
Growth investment	15 June 2021: JMI Equity investment, amount and stake undisclosed. CEO quoted: David DeRam. The release cites “over 500 medical device customers” and says Greenlight Guru is the only QMS vendor “named a Leader by G2 for ten consecutive quarters.”	JMI page
EDC acquisition	2 June 2022: SMART-TRIAL, an EDC for medical devices and diagnostics, founded in Denmark in 2013 by Páll Jóhannesson, Jón Ingi Bergsteinsson, and Alex Bondo Andersen, with “over 100 companies” and “20+ employees.” The release says earlier acquisitions included CanvasGT and Vertex Intelligence. No terms disclosed.	SMART-TRIAL blog
Enzyme acquisition	24 July 2025: Enzyme, a life-sciences QMS founded in 2017. Quoted: Greenlight Guru CEO Ed Holmes and Enzyme CEO Jared Seehafer. Second acquisition in recent weeks, after Ultralight Labs “last month.” No price. Greenlight Guru is “backed by JMI Equity.”	PR Newswire, 24 Jul 2025
CEO	David DeRam in the 2021 and 2022 releases; Ed Holmes in the July 2025 release.	JMI page; SMART-TRIAL blog; Enzyme release
Halo	The 2021 JMI release says the company released “Halo, the world’s first and only AI and ML-powered recommendation engine for medical device quality.” The 2026 pages describe AI search, chat, training quizzes, and an MCP server, and do not name Halo.	JMI page; pricing and platform pages

3. Medical-device relevance

Standards alignment. Greenlight Guru says the eQMS is “Aligned to ISO 13485, FDA QMSR, ISO 14971, and IEC 62304” (pricing page). The FAQ says the software includes “Part 11 compliant review and approval workflows” and “fully integrated ISO 14971 Risk Management,” and “facilitates” compliance with 21 CFR Part 820 and ISO 13485:2016 (Quality pricing; FAQ).
“Designed in accordance with” list. The platform page names ISO 13485, ISO 11137, ISO 11607, ISO 42001, ISO 14971, ISO 11135, ISO 17665, ISO 10993, IEC 60601, IEC 62304, and ISTA-3A, several of them device-process standards for sterilization, packaging, biocompatibility, electrical safety, and transit (Platform).
Company certifications. Greenlight Guru says every subscription is “covered by our ISO 42001, ISO 27001, ISO 9001, and SOC 2 certifications,” and that its AI management system is certified to ISO 42001 (pricing page). The platform FAQ repeats ISO 9001, ISO 27001, and SOC 2. Security documentation sits at http://trust.greenlight.guru/ (API page).
21 CFR Part 11. Pricing and platform pages list role-based access, SSO, a Part 11 audit trail, and Part 11 electronic signatures. API-created records land in the same audit trail (API FAQ).
QMSR. Named as an alignment target on the pricing page.
NIH RADx Tech. A Greenlight Guru blog (15 April 2021, updated 25 September 2025) says the company was selected as the QMS for NIH’s RADx Tech program at NIBIB, quotes NIBIB program director Michael B. Wolfson, and says Greenlight Guru worked as a VentureWell subcontractor under contract 75N92020P00171. The $1 billion it cites is the program’s federal funding (RADx blog).

Vendor counts:

Homepage: “1,000+ device companies,” “1,700+ 510(k) clearances & CE marked devices,” “2,000+ ISO 13485 certifications,” “1,200+ clinical trials.” The clearance and certificate counts refer to customers’ devices and quality systems.
Platform page: “1000+ medical device companies,” “1200+ clinical trials,” “50+ countries.”
2021 JMI release: “over 500.” 2025 Enzyme release: “over 1,100,” including NEC Corporation, W.L. Gore, Whoop, Candid Care, and FridaBaby.
FAQ: “more than 500 cities, on 5 different continents.”

4. Capabilities

Capability	Status	What Greenlight Guru says	Source
Document control	Native	Current version in use, approval routing, Part 11 electronic signatures, not via email.	Pricing page
Change control	Native	Review and approval, then automatic retraining when a change is released.	Pricing page
Training management	Native	Assign by role or group; track complete, overdue, and pending.	Pricing page
Supplier management	Native	Qualification, risk-based oversight, approvals, audits, performance over time.	Pricing page
Complaints, CAPA, nonconformance	Native	Configurable processes linked to products, design records, risks, suppliers, changes, and training.	Pricing page
Audit management	Native	Audits, findings, actions, owners, and evidence in one place.	Pricing page
Post-market trends	Native	Recurring complaints and quality events across products and processes, with complaint, CAPA, design, and risk records linked.	Pricing page; FAQ
Design controls	Product-development subscription	Requirements, reviews, verification, validation, and the design and development file; a design-history file traces inputs, outputs, verification, and risk controls.	Pricing page; homepage
Risk management	Product-development subscription	ISO 14971 hazard analysis and FMEA; risk controls linked to requirements and verification.	Pricing page
Quality-design traceability	Native	A quality event links to other events, change orders, releases, or a product’s risk and design controls.	Platform FAQ
Parts, inventory, receiving	Product-development subscription	Part records, bills of material, receiving, incoming inspection, stock.	Pricing page
Software lifecycle evidence	Product-development subscription	Versioned software parts, release records, test results, SBOMs, vulnerability reports.	Pricing page
QMS templates	Content	“Audit-tested templates” for a quality manual, management reviews, project and risk plans, supplier surveys, and quality-event procedures; “80+ audit-tested templates.”	Pricing page; platform page
AI in the eQMS	Native, included	Plain-language search, answers from records, change-order summaries, training quizzes. A person reviews output. “Customer data is not used to train AI models.”	Pricing FAQ
AI on the homepage	Marketing	Brainstorming for design controls and risks, “AI Chat,” global search with source links, training analytics charts.	Homepage
Dashboards	Native	Open quality events, training completion, product-development milestones, clinical study progress.	Platform FAQ
Customer configuration	Native	Workflows, document types, fields, views, versioning, change-order types, quality-event stages, risk matrices, supplier criteria, with per-product-line workflows. Greenlight Guru says quality teams do this without a developer or paid services, with audit trails, approvals, signatures, and links intact.	Pricing FAQ
Electronic data capture	Separate product	Study build, data capture, and amendments without taking capture offline.	Pricing FAQ

5. Architecture and deployment

Greenlight Guru is cloud software on an annual subscription, used in a standard web browser. Customers cannot install it on their own servers (FAQ). It runs on Amazon Web Services with role-based security and encryption, with nothing for the customer to host (pricing FAQ). A system overview covering storage, disaster recovery, and security is available on request (FAQ).

The pricing page lists “Role-based security and SSO” as a platform feature without naming a tier. Greenlight Guru publishes no data-residency region, RPO/RTO, or uptime target.

Validation: each release ships a Part 11 installation-qualification protocol and completed operational and performance qualification reports at no additional cost; the customer completes a short IQ step instead of a new validation project (Quality pricing; FAQ). Integrations the customer builds are the customer’s software to validate under a risk-based CSA approach, while Greenlight Guru “provides the platform, audit trail, and record integrity underneath” (API).

AI: customer data does not train models, a person reviews output, and the AI management system is certified to ISO 42001 (pricing page).

6. Integrations

Kind	What Greenlight Guru documents	Depth
Engineering connectors	Jira and GitHub, on the pricing page (“let engineers work in Jira and GitHub”) and the API page, as no-code links between issues and design controls.	Most pre-built integrations run on a schedule or trigger, not continuous sync (API FAQ).
Office connectors	Microsoft Office for the web and Google Drive: co-editing while Greenlight Guru keeps versioning, approvals, and the audit trail.	Vendor description
REST API	JSON; keys from a developer interface. Actions: export, import, update, event notification. Objects: documents, design controls and DHF records, parts, suppliers, quality events (CAPA, complaints, nonconformances), training, users and roles. “Capabilities vary by solution and endpoint.”	Customer or partner builds and maintains it
ERP, PLM, CRM, BI	API page examples: import parts and export revision status; export events and training to Power BI or Tableau.	Build examples
Identity	Export users, roles, and groups to Okta and Entra ID for access review.	Export
Outside AI assistants	MCP server for approved assistants (ChatGPT, Claude, Copilot, Gemini) to query quality data, separate from in-product AI chat.	Named integration
Customer-built connections	Customer validates them; API writes land in the audit trail.	Responsibility split

7. Pricing and commercial model

eQMS packages start at $12,000 per year; Greenlight Guru publishes no full price list. The pricing page states:

“Greenlight Guru eQMS packages start at $12,000 per year.”
“Greenlight Guru quality management and product development subscriptions start at $12,000 per year. Greenlight Guru EDC subscriptions start at $9,000 per year.”
“Your price depends on the products and capabilities you need.”
Quality implementation and clinical study-build are priced separately, with subscription and services costs given before signature.
Included at no additional cost: validation documentation each release, a dedicated customer success manager, training resources, support, and software updates.
eQMS and product-development subscriptions are annual. EDC has a 12-month minimum or can run for the length of a study.
Export of quality records and clinical data in “standard formats” needs no services purchase.
Customers can buy capabilities in stages. An account manager confirms any price change before it takes effect.

The page does not say what the $12,000 floor covers in users, SSO, API, product development, or environments.

Implementation: most standard eQMS engagements take two to eight weeks. A named medical-device consultant plans, configures, migrates documents, supplies templates, and trains. Out-of-scope work is priced before it starts. Greenlight Guru argues that “free” implementation shifts work onto the customer. The FAQ adds a dedicated industry expert for every customer, no charge for upgrades, and the Part 11 IQ protocol or checklist plus completed OQ and PQ reports at no charge. Guru Assist, Guru Guidance, and professional services have no published rates.

Public money that is not a list price

USAspending and TED searches on 3 Oct 2026 found no award or notice naming Greenlight Guru or Soladoc. The RADx Tech subcontract (NIH contract 75N92020P00171, via VentureWell) is documented only on Greenlight Guru’s blog, with no fee stated.

Questions a buyer should ask

What does the $12,000 year include: quality only or with product development, and how many users, sites, and environments?
Are SSO, the REST API, Jira, GitHub, and the MCP server inside the floor or extra?
Is implementation hourly, fixed, or open-ended, and what does our team do in the two-to-eight-week window?
Which IQ, OQ, and PQ documents ship per release, what is the “short” IQ step, and what remains for our CSA of configuration and API integrations?
Which AWS region, what retention, what export format, and what happens at the end of an annual term?
If clinical work is in scope, is it the $9,000 EDC floor plus a separate study-build quote?
After the Enzyme and Ultralight acquisitions, which product will we log into?
Which Part 11, ISO 13485, QMSR, and ISO 27001 statements are product alignment, and which certificates can we read?

8. Implementation and validation support

Greenlight Guru assigns a named medical-device consultant for planning, configuration, document migration, templates, and training; most standard engagements take two to eight weeks; extra scope is priced before it starts; each release ships a validation pack (Part 11 IQ protocol, completed OQ and PQ) (pricing FAQ).

Validation of customer-built integrations, including Jira mappings and scripts, sits with the customer (API page). The customer also completes an IQ step. Greenlight Guru publishes no GAMP 5 software category or validation protocol.

Services without published rates: Guru Assist (in-app coaching and expedited support), Guru Guidance (scheduled time with a device expert), professional services (configuration, audit prep, design and risk reviews, automations), and clinical study-build (eCRFs, build through user acceptance testing, training of sponsor, site, and CRO). A partner network introduces QA/RA consultants.

9. Customer evidence

Who is named	What the page says	Source type
Daniel Powell, CEO, Spark Biomedical	The software is “expensive on day one, and dirt cheap on day two,” and “a year’s worth of someone’s salary already done.”	Pricing page testimonial
Amanda Feddersen, QA Manager, Monitored Therapeutics Inc.	eQMS, SOP templates, and Guru guidance helped with “all of our audits this year.” The page spells the company “Therapuetics.”	Homepage testimonial
Morris Sherwood, Regulatory Compliance, Zyris	The software “addresses each one” of a quality system’s dependencies.	Homepage testimonial
Clive Seymour, CEO, Canterbury Scientific	“What used to take six weeks, now takes a much shorter time period.”	Homepage testimonial
Dr. Gabriel Georges, Co-Founder and Chief Scientific Officer, Puzzle Medical	Safer devices and a quality culture.	Homepage testimonial
Crystal Womack, Quality Manager, Avenda House	Design-controls module and traceability.	Homepage testimonial
Sally Dillehay, President and Chief Medical Officer, ClintrialSolutions	Solutions fit how the company works.	Platform page testimonial
NEC Corporation, W.L. Gore, Whoop, Candid Care, FridaBaby	“Including” list under “trusted by over 1,100.”	Enzyme release, 24 July 2025
RADx Tech participants	Michael B. Wolfson quoted; participants use the platform. Individual companies not named.	Vendor blog

10. Competitive and third-party context

Enzyme, acquired 24 July 2025, was itself a life-sciences QMS. Greenlight Guru frames the deal as customer continuity and a lifecycle strategy. Ultralight Labs (the month before), CanvasGT, and Vertex Intelligence are named without terms.
JMI Equity’s 2021 release is the investor record. Its G2 “Leader” line is Greenlight Guru’s statement about G2.
No Gartner or Forrester report on Greenlight Guru was retrieved; their reports are paywalled.

11. Changes, renames, and research status

15 April 2021: Greenlight Guru blog names the company as QMS for NIH RADx Tech.
15 June 2021: JMI Equity investment; David DeRam CEO; “over 500” customers; Halo named.
2 June 2022: SMART-TRIAL acquisition (EDC), after CanvasGT and Vertex Intelligence.
2025, one month before Enzyme: Ultralight Labs acquisition.
24 July 2025: Enzyme acquisition; Ed Holmes CEO; “over 1,100” companies.
17 February 2026: website terms updated (Soladoc, LLC d/b/a Greenlight Guru).
2026 pricing page: eQMS and product development from $12,000 per year; EDC from $9,000 per year; implementation extra.

An openFDA device search on 3 Oct 2026 found no record naming Greenlight Guru or Soladoc. Greenlight Guru publishes no data-residency region or RPO/RTO.

12. Source library

Full URL list, discovery method, and file-retention decisions: ../sources/greenlight-guru-sources.md.

Claim-level records: ../evidence/greenlight-guru.evidence.jsonl.

Primary pages:

1. Overview

What it is not:

Not a pharmaceutical MES, electronic batch record system, or shop-floor controller. Greenlight Guru’s pages describe no batch execution, weigh-and-dispense, or machine protocols.
Not an ERP, PLM, LIMS, or CRM. The API page describes connecting to those systems (API).
Not Greenlight Guru EDC. EDC is a separate product with its own price floor and separately priced study-build. It came from SMART-TRIAL, a Danish company (SMART-TRIAL release).
Not Enzyme or Ultralight Labs. The 24 July 2025 release announces the Enzyme acquisition, a separate life-sciences QMS, one month after Ultralight Labs, and announces no product merge (PR Newswire, 24 Jul 2025).

2. Company and product identity

Point	Fact	Source
Legal name	The website is “owned and operated by Soladoc, LLC d/b/a Greenlight Guru.” Terms updated Wednesday, 17 February 2026. The terms give no street address, state of formation, or officer.	Terms
Location	The 15 June 2021 JMI release, the 2 June 2022 SMART-TRIAL release, and the 24 July 2025 Enzyme release are datelined Indianapolis. The 2022 release says “the Indianapolis-based company.”	JMI, 15 Jun 2021; SMART-TRIAL blog; Enzyme release
Growth investment	15 June 2021: JMI Equity investment, amount and stake undisclosed. CEO quoted: David DeRam. The release cites “over 500 medical device customers” and says Greenlight Guru is the only QMS vendor “named a Leader by G2 for ten consecutive quarters.”	JMI page
EDC acquisition	2 June 2022: SMART-TRIAL, an EDC for medical devices and diagnostics, founded in Denmark in 2013 by Páll Jóhannesson, Jón Ingi Bergsteinsson, and Alex Bondo Andersen, with “over 100 companies” and “20+ employees.” The release says earlier acquisitions included CanvasGT and Vertex Intelligence. No terms disclosed.	SMART-TRIAL blog
Enzyme acquisition	24 July 2025: Enzyme, a life-sciences QMS founded in 2017. Quoted: Greenlight Guru CEO Ed Holmes and Enzyme CEO Jared Seehafer. Second acquisition in recent weeks, after Ultralight Labs “last month.” No price. Greenlight Guru is “backed by JMI Equity.”	PR Newswire, 24 Jul 2025
CEO	David DeRam in the 2021 and 2022 releases; Ed Holmes in the July 2025 release.	JMI page; SMART-TRIAL blog; Enzyme release
Halo	The 2021 JMI release says the company released “Halo, the world’s first and only AI and ML-powered recommendation engine for medical device quality.” The 2026 pages describe AI search, chat, training quizzes, and an MCP server, and do not name Halo.	JMI page; pricing and platform pages

3. Medical-device relevance

Standards alignment. Greenlight Guru says the eQMS is “Aligned to ISO 13485, FDA QMSR, ISO 14971, and IEC 62304” (pricing page). The FAQ says the software includes “Part 11 compliant review and approval workflows” and “fully integrated ISO 14971 Risk Management,” and “facilitates” compliance with 21 CFR Part 820 and ISO 13485:2016 (Quality pricing; FAQ).
“Designed in accordance with” list. The platform page names ISO 13485, ISO 11137, ISO 11607, ISO 42001, ISO 14971, ISO 11135, ISO 17665, ISO 10993, IEC 60601, IEC 62304, and ISTA-3A, several of them device-process standards for sterilization, packaging, biocompatibility, electrical safety, and transit (Platform).
Company certifications. Greenlight Guru says every subscription is “covered by our ISO 42001, ISO 27001, ISO 9001, and SOC 2 certifications,” and that its AI management system is certified to ISO 42001 (pricing page). The platform FAQ repeats ISO 9001, ISO 27001, and SOC 2. Security documentation sits at http://trust.greenlight.guru/ (API page).
21 CFR Part 11. Pricing and platform pages list role-based access, SSO, a Part 11 audit trail, and Part 11 electronic signatures. API-created records land in the same audit trail (API FAQ).
QMSR. Named as an alignment target on the pricing page.
NIH RADx Tech. A Greenlight Guru blog (15 April 2021, updated 25 September 2025) says the company was selected as the QMS for NIH’s RADx Tech program at NIBIB, quotes NIBIB program director Michael B. Wolfson, and says Greenlight Guru worked as a VentureWell subcontractor under contract 75N92020P00171. The $1 billion it cites is the program’s federal funding (RADx blog).

Vendor counts:

Homepage: “1,000+ device companies,” “1,700+ 510(k) clearances & CE marked devices,” “2,000+ ISO 13485 certifications,” “1,200+ clinical trials.” The clearance and certificate counts refer to customers’ devices and quality systems.
Platform page: “1000+ medical device companies,” “1200+ clinical trials,” “50+ countries.”
2021 JMI release: “over 500.” 2025 Enzyme release: “over 1,100,” including NEC Corporation, W.L. Gore, Whoop, Candid Care, and FridaBaby.
FAQ: “more than 500 cities, on 5 different continents.”

4. Capabilities

Capability	Status	What Greenlight Guru says	Source
Document control	Native	Current version in use, approval routing, Part 11 electronic signatures, not via email.	Pricing page
Change control	Native	Review and approval, then automatic retraining when a change is released.	Pricing page
Training management	Native	Assign by role or group; track complete, overdue, and pending.	Pricing page
Supplier management	Native	Qualification, risk-based oversight, approvals, audits, performance over time.	Pricing page
Complaints, CAPA, nonconformance	Native	Configurable processes linked to products, design records, risks, suppliers, changes, and training.	Pricing page
Audit management	Native	Audits, findings, actions, owners, and evidence in one place.	Pricing page
Post-market trends	Native	Recurring complaints and quality events across products and processes, with complaint, CAPA, design, and risk records linked.	Pricing page; FAQ
Design controls	Product-development subscription	Requirements, reviews, verification, validation, and the design and development file; a design-history file traces inputs, outputs, verification, and risk controls.	Pricing page; homepage
Risk management	Product-development subscription	ISO 14971 hazard analysis and FMEA; risk controls linked to requirements and verification.	Pricing page
Quality-design traceability	Native	A quality event links to other events, change orders, releases, or a product’s risk and design controls.	Platform FAQ
Parts, inventory, receiving	Product-development subscription	Part records, bills of material, receiving, incoming inspection, stock.	Pricing page
Software lifecycle evidence	Product-development subscription	Versioned software parts, release records, test results, SBOMs, vulnerability reports.	Pricing page
QMS templates	Content	“Audit-tested templates” for a quality manual, management reviews, project and risk plans, supplier surveys, and quality-event procedures; “80+ audit-tested templates.”	Pricing page; platform page
AI in the eQMS	Native, included	Plain-language search, answers from records, change-order summaries, training quizzes. A person reviews output. “Customer data is not used to train AI models.”	Pricing FAQ
AI on the homepage	Marketing	Brainstorming for design controls and risks, “AI Chat,” global search with source links, training analytics charts.	Homepage
Dashboards	Native	Open quality events, training completion, product-development milestones, clinical study progress.	Platform FAQ
Customer configuration	Native	Workflows, document types, fields, views, versioning, change-order types, quality-event stages, risk matrices, supplier criteria, with per-product-line workflows. Greenlight Guru says quality teams do this without a developer or paid services, with audit trails, approvals, signatures, and links intact.	Pricing FAQ
Electronic data capture	Separate product	Study build, data capture, and amendments without taking capture offline.	Pricing FAQ

5. Architecture and deployment

The pricing page lists “Role-based security and SSO” as a platform feature without naming a tier. Greenlight Guru publishes no data-residency region, RPO/RTO, or uptime target.

AI: customer data does not train models, a person reviews output, and the AI management system is certified to ISO 42001 (pricing page).

6. Integrations

Kind	What Greenlight Guru documents	Depth
Engineering connectors	Jira and GitHub, on the pricing page (“let engineers work in Jira and GitHub”) and the API page, as no-code links between issues and design controls.	Most pre-built integrations run on a schedule or trigger, not continuous sync (API FAQ).
Office connectors	Microsoft Office for the web and Google Drive: co-editing while Greenlight Guru keeps versioning, approvals, and the audit trail.	Vendor description
REST API	JSON; keys from a developer interface. Actions: export, import, update, event notification. Objects: documents, design controls and DHF records, parts, suppliers, quality events (CAPA, complaints, nonconformances), training, users and roles. “Capabilities vary by solution and endpoint.”	Customer or partner builds and maintains it
ERP, PLM, CRM, BI	API page examples: import parts and export revision status; export events and training to Power BI or Tableau.	Build examples
Identity	Export users, roles, and groups to Okta and Entra ID for access review.	Export
Outside AI assistants	MCP server for approved assistants (ChatGPT, Claude, Copilot, Gemini) to query quality data, separate from in-product AI chat.	Named integration
Customer-built connections	Customer validates them; API writes land in the audit trail.	Responsibility split

7. Pricing and commercial model

eQMS packages start at $12,000 per year; Greenlight Guru publishes no full price list. The pricing page states:

“Greenlight Guru eQMS packages start at $12,000 per year.”
“Greenlight Guru quality management and product development subscriptions start at $12,000 per year. Greenlight Guru EDC subscriptions start at $9,000 per year.”
“Your price depends on the products and capabilities you need.”
Quality implementation and clinical study-build are priced separately, with subscription and services costs given before signature.
Included at no additional cost: validation documentation each release, a dedicated customer success manager, training resources, support, and software updates.
eQMS and product-development subscriptions are annual. EDC has a 12-month minimum or can run for the length of a study.
Export of quality records and clinical data in “standard formats” needs no services purchase.
Customers can buy capabilities in stages. An account manager confirms any price change before it takes effect.

The page does not say what the $12,000 floor covers in users, SSO, API, product development, or environments.

Public money that is not a list price

Questions a buyer should ask

What does the $12,000 year include: quality only or with product development, and how many users, sites, and environments?
Are SSO, the REST API, Jira, GitHub, and the MCP server inside the floor or extra?
Is implementation hourly, fixed, or open-ended, and what does our team do in the two-to-eight-week window?
Which IQ, OQ, and PQ documents ship per release, what is the “short” IQ step, and what remains for our CSA of configuration and API integrations?
Which AWS region, what retention, what export format, and what happens at the end of an annual term?
If clinical work is in scope, is it the $9,000 EDC floor plus a separate study-build quote?
After the Enzyme and Ultralight acquisitions, which product will we log into?
Which Part 11, ISO 13485, QMSR, and ISO 27001 statements are product alignment, and which certificates can we read?

8. Implementation and validation support

9. Customer evidence

Who is named	What the page says	Source type
Daniel Powell, CEO, Spark Biomedical	The software is “expensive on day one, and dirt cheap on day two,” and “a year’s worth of someone’s salary already done.”	Pricing page testimonial
Amanda Feddersen, QA Manager, Monitored Therapeutics Inc.	eQMS, SOP templates, and Guru guidance helped with “all of our audits this year.” The page spells the company “Therapuetics.”	Homepage testimonial
Morris Sherwood, Regulatory Compliance, Zyris	The software “addresses each one” of a quality system’s dependencies.	Homepage testimonial
Clive Seymour, CEO, Canterbury Scientific	“What used to take six weeks, now takes a much shorter time period.”	Homepage testimonial
Dr. Gabriel Georges, Co-Founder and Chief Scientific Officer, Puzzle Medical	Safer devices and a quality culture.	Homepage testimonial
Crystal Womack, Quality Manager, Avenda House	Design-controls module and traceability.	Homepage testimonial
Sally Dillehay, President and Chief Medical Officer, ClintrialSolutions	Solutions fit how the company works.	Platform page testimonial
NEC Corporation, W.L. Gore, Whoop, Candid Care, FridaBaby	“Including” list under “trusted by over 1,100.”	Enzyme release, 24 July 2025
RADx Tech participants	Michael B. Wolfson quoted; participants use the platform. Individual companies not named.	Vendor blog

10. Competitive and third-party context

Enzyme, acquired 24 July 2025, was itself a life-sciences QMS. Greenlight Guru frames the deal as customer continuity and a lifecycle strategy. Ultralight Labs (the month before), CanvasGT, and Vertex Intelligence are named without terms.
JMI Equity’s 2021 release is the investor record. Its G2 “Leader” line is Greenlight Guru’s statement about G2.
No Gartner or Forrester report on Greenlight Guru was retrieved; their reports are paywalled.

11. Changes, renames, and research status

15 April 2021: Greenlight Guru blog names the company as QMS for NIH RADx Tech.
15 June 2021: JMI Equity investment; David DeRam CEO; “over 500” customers; Halo named.
2 June 2022: SMART-TRIAL acquisition (EDC), after CanvasGT and Vertex Intelligence.
2025, one month before Enzyme: Ultralight Labs acquisition.
24 July 2025: Enzyme acquisition; Ed Holmes CEO; “over 1,100” companies.
17 February 2026: website terms updated (Soladoc, LLC d/b/a Greenlight Guru).
2026 pricing page: eQMS and product development from $12,000 per year; EDC from $9,000 per year; implementation extra.

An openFDA device search on 3 Oct 2026 found no record naming Greenlight Guru or Soladoc. Greenlight Guru publishes no data-residency region or RPO/RTO.

12. Source library

Full URL list, discovery method, and file-retention decisions: ../sources/greenlight-guru-sources.md.

Claim-level records: ../evidence/greenlight-guru.evidence.jsonl.

Primary pages:

Greenlight Guru QMS

1. Overview

2. Company and product identity

3. Medical-device relevance

4. Capabilities

5. Architecture and deployment

6. Integrations

7. Pricing and commercial model

Public money that is not a list price

Questions a buyer should ask

8. Implementation and validation support

9. Customer evidence

10. Competitive and third-party context

11. Changes, renames, and research status

12. Source library

Sources note

Sources: Greenlight Guru QMS

Vendor and company

Greenlight Guru QMS

1. Overview

2. Company and product identity

3. Medical-device relevance

4. Capabilities

5. Architecture and deployment

6. Integrations

7. Pricing and commercial model

Public money that is not a list price

Questions a buyer should ask

8. Implementation and validation support

9. Customer evidence

10. Competitive and third-party context

11. Changes, renames, and research status

12. Source library

Sources note

Sources: Greenlight Guru QMS

Vendor and company