# Dot Compliance vs Greenlight Guru (2026) Source: https://bestqmssoftware.com/compare/dot-compliance-vs-greenlight-guru/ By Tom Muller, updated October 5, 2026 Part of Best QMS Software (https://bestqmssoftware.com/). Method: https://bestqmssoftware.com/how-we-rank/ Verdict: Pick Dot Compliance if you make drug or biologic products as well as devices and want a pre-configured GxP quality system on Salesforce. Pick Greenlight Guru if you're a device-only company that wants linked design controls and risk, software support, and prices and contract terms you can read before the first sales call. ## Dot Compliance - Overall score: 5.9 out of 10 (#13 of 18 systems tested) - Price: on request (No price on the vendor site or Salesforce AppExchange (Sep 2026). A vendor-supplied software-directory listing (SourceForge, 2023–2026) says it starts at $10,000 a year with validation included; users and edition not stated. Implementation services exist; whether they cost extra isn't published.) - Best for: You run a device, pharma or combination-product company and want a pre-configured GxP quality system on Salesforce that goes live in weeks to a few months. - Watch out: Prices, contract terms and data export aren't published, and there's no documented support for software development (IEC 62304) or developer tools. - Maker: Dot Compliance Ltd., https://www.dotcompliance.com - Last checked: October 2026 - Full review: https://bestqmssoftware.com/reviews/dot-compliance/ Scores out of 10: - Compliance coverage: 8.0 (Validation package included; ISO 27001; UDI not found) - Design controls and traceability: 2.5 (Design control module exists, manuals customer-only) - Usability: 8.0. 8.0 / 10 on G2 (85 ratings) - Support and onboarding: 8.0. 8.5 / 10 on G2 (70 ratings) - Community sentiment: 8.0 (4.0/5 on G2 (95 reviews); 4.4/5 on Capterra (94)) - Affordability: 4.0. Not published (Directory listing: from $10k/yr, seats not stated) - Price transparency: 1.0. Contact sales (Never priced on its own site; directory listing only) - Try before you buy: 7.0. Free trial on request (Vendor pre-qualifies first; demo on request) - Contract and lock-in: 4.0. Not published (No documented export; Salesforce APIs) - Time to go live: 7.0. 4 weeks–4 months (Customer case studies; sample SOPs included) - EU data residency: 8.0. Salesforce region of choice (Public subprocessor list; DPA not public) - Budget predictability: 5.0. Terms not public (No published prices or renewal terms to check) ## Greenlight Guru - Overall score: 7.4 out of 10 (#3 of 18 systems tested) - Price: from $12k/yr (Vendor-published entry price for eQMS packages (Sep 2026); users and modules at that price not stated. Implementation is priced separately. Buyers report $21k–55k/yr (Vendr) and about $30k in year one for a 40-person team (2025).) - Best for: You build a medical device, want design controls, ISO 14971 risk and quality events linked in one MedTech-only system, and can budget well above the entry price. - Watch out: Users report the bill growing quickly as the team grows, and implementation is charged on top of the subscription. - Maker: Greenlight Guru, https://www.greenlight.guru - Last checked: October 2026 - Full review: https://bestqmssoftware.com/reviews/greenlight-guru/ Scores out of 10: - Compliance coverage: 8.5 (Validation package each release; no UDI or eMDR features found) - Design controls and traceability: 9.0 (Linked design, risk and tests; Jira and GitHub sync) - Usability: 8.0. 8.6 / 10 on G2 (320 ratings) - Support and onboarding: 8.0. 9.4 / 10 on G2 (308 ratings) - Community sentiment: 8.0 (4.5/5 on G2 (431 reviews); Reddit split) - Affordability: 5.5. from $12k/yr (Buyers report $21–55k a year (Vendr)) - Price transparency: 5.0. Starting price only (Implementation fee not published) - Try before you buy: 5.0. No free trial (Interactive tour and live demo) - Contract and lock-in: 8.0. Annual (Per pricing page; agreement defaults to two years if the order form is silent. Export in standard formats; JSON API) - Time to go live: 9.0. 2–8 weeks (Vendor estimate; SOP templates listed) - EU data residency: 7.0. Germany available (Set per order form; no public QMS DPA) - Budget predictability: 8.0. Uncapped renewal increases (90 days' notice; no price history before 2026) ## Comparison Both are full eQMS products that device companies shortlist against each other; a 2025 post on r/regulatoryaffairs from a MedTech team lists both on its evaluation list.[^dc-reddit-ra] They differ in where they come from. Greenlight Guru builds software only for medical device companies, and its strongest area is design controls and risk.[^gg-pricing][^gg-pd] Dot Compliance runs natively on Salesforce and sells a pre-configured, pre-validated system to pharma, biotech and device makers.[^dc-home] You would run one or the other, not both. ### Who each is built for Dot Compliance fits best where GxP processes such as deviations, batch records and equipment management sit next to device quality.[^dc-home][^dc-qe] Most of its Capterra reviewers work in pharma or biotech.[^dc-capterra] Devices are a clear second market: it has a device complaint module and publishes device case studies, from EyeQue, a 50-person company, to Dandy, with more than 1,500 employees.[^dc-rn52][^dc-eyeque][^dc-dandy] The Salesforce licence is included, so you don't need your own.[^dc-home] Greenlight Guru fits device companies of roughly 10 to 50 people preparing for or recently past a 510(k) or CE mark, and it has no pharma GMP modules.[^gg-pricing] Reddit users with experience of several systems recommend it for single-product or early-stage firms.[^gg-reddit-eqms] Users report it becoming cumbersome with more product lines or manufacturing processes.[^gg-reddit-worth] ### Price and contract terms Greenlight Guru publishes an entry price: eQMS packages start at $12,000 a year, with implementation quoted separately.[^gg-pricing] Vendr reports a median of $43,989 a year, with deals from $20,975 to $54,739.[^gg-vendr] A current customer wrote in March 2026 that "the cost is starting to hurt a bit as the team grows."[^gg-reddit-expensive] Dot Compliance publishes no prices on its site or its Salesforce AppExchange listing.[^dc-home][^dc-appx] The only figure is a software-directory listing (SourceForge) saying it starts at $10,000 a year with validation included, unchanged in snapshots from January 2023 to February 2026.[^dc-sourceforge] It doesn't say how many users or which edition that covers, so treat it as a rough floor. On Capterra, six reviewers praise the value for money, while three say licences are costly, in part because of the Salesforce platform.[^dc-capterra] Dot sells implementation services but doesn't say whether they cost extra.[^dc-services] Contract terms are the bigger gap. Greenlight Guru publishes its agreement. Order forms renew unless either side gives 60 days' notice, fees can rise at each renewal with 90 days' notice and no cap, and you have 90 days after termination to request an export.[^gg-msa] It says quality records export in standard formats without paying for services.[^gg-pricing] Dot Compliance publishes no minimum term, renewal terms or exit process; its public terms cover only use of the website.[^dc-terms] Integrations use Salesforce's APIs.[^dc-complaints] Neither has escrow or a public clause covering what happens to your data if the vendor closes or is sold.[^gg-msa][^dc-terms] With Dot, ask for the term, a renewal cap and the export process in writing. Dot Compliance's free trial is on request and "subject to pre-qualification", though its AppExchange listing still advertises a 14-day trial.[^dc-trial][^dc-appx] Greenlight Guru has no free trial; it has an interactive product tour and recorded demos, and a live demo goes through sales.[^gg-tourpage][^gg-demo] ### Design controls, risk and software Greenlight Guru leads here by a wide margin. Its tour shows a design control matrix linking user needs, inputs, outputs, verifications and validations, a risk matrix of hazards, hazardous situations and harms, and Jira and GitHub references on the cards.[^gg-tour] Trace graphs flag missing links across design, risk and tests.[^gg-pd] For software devices it adds IEC 62304-aligned release management and SBOM scanning.[^gg-ultralight][^gg-samd] Dot Compliance has a Design Control module: it's in the help center, and Omega Diagnostics deployed it.[^dc-help][^dc-omega] But it isn't in the core Xpress process lists, and its manual is for customers only, so we couldn't check how it works.[^dc-xpress2025][^dc-gate] Its product pages describe FMEA with risk priority numbers, hazard traceability matrices, and initial and residual risk.[^dc-risk] We found no documented traceability from requirements to risks to tests, no design history file export, no IEC 62304 features and no Jira or Git integration.[^dc-help][^dc-gate] ### Quality processes Both cover the core device processes. Dot Compliance links CAPAs to the deviation, complaint or audit finding that started them, with root-cause forms such as 5 Whys and fishbone diagrams and built-in effectiveness checks.[^dc-capa] Greenlight Guru has separate workspaces for CAPA, complaints, nonconformance and audits.[^gg-release] Dot Compliance claims more on regulatory reporting, but we couldn't check how it works. Dot's version 5.2 added a device complaint process covering investigations, returns, recalls and regulatory reporting.[^dc-rn52] The vendor says it can generate US MDR and EU MIR forms for electronic submission, and its subprocessor list names an optional FDA eMDR gateway.[^dc-complaints][^dc-subproc] We couldn't read a manual showing that workflow.[^dc-gate] Greenlight Guru's complaint flow includes a decision on whether reporting is needed, which creates a task to prepare the FDA report; we found no eMDR submission.[^gg-complaints] We found no UDI management in either. Dot Compliance also covers GxP areas Greenlight Guru doesn't: deviations, batch records, equipment and clinical modules.[^dc-home][^dc-help] For suppliers, Dot offers qualification, scorecards and supplier corrective action requests, plus a community site for suppliers that needs external licences.[^dc-supplier] Greenlight Guru assigns suppliers risk levels and suggests required documents and audits from a policy matrix.[^gg-supplier] Documents work similarly. Dot Compliance documents are edited in Office 365 or Google Docs with check-in and check-out.[^dc-docs] Greenlight Guru stores documents as files that you co-author in Google Docs or Microsoft Office for the web.[^gg-qms] For training, Dot has exams with passing scores and SCORM courses; Greenlight Guru's AI drafts training quizzes.[^dc-training][^gg-pricing] ### Hosting, security and validation Dot Compliance says it is certified to ISO/IEC 27001, ISO/IEC 27017, ISO 9001 and ISO/IEC 42001; we found no SOC 2 statement.[^dc-home] Greenlight Guru states ISO 27001, ISO 42001, ISO 9001 and SOC 2, without saying whether the SOC 2 report is Type I or Type II.[^gg-pricing][^gg-legal] With Dot Compliance, customer records sit on Salesforce in the region you choose, and PDF and AI services run on AWS in Frankfurt.[^dc-subproc] Queries to its Dottie AI are processed by OpenAI and Google Cloud in the US.[^dc-subproc] Its subprocessor list is public, but we found no public data processing agreement.[^dc-subproc][^dc-privacy] Greenlight Guru's 2022 architecture overview says data stays in one region set in the order form: the US, Germany, Singapore or Australia.[^gg-arch] Its public DPA covers only the clinical product.[^gg-dpa] Both include validation in the subscription. Greenlight Guru ships an IQ protocol and completed OQ and PQ reports with every release.[^gg-pricing] Dot Compliance includes a validation package, but its contents aren't public.[^dc-sf][^dc-home] ### What users say and go-live On G2, Greenlight Guru has 4.5/5 from 431 reviews, with 8.6 for ease of use and 9.4 for support.[^gg-g2] Dot Compliance has 4.0/5 from 95 reviews, with 8.0 and 8.5.[^dc-g2] Both have 4.4/5 on Capterra, from 82 and 94 reviews.[^gg-capterra][^dc-capterra] Most G2 reviews of both were invited by the vendor or incentivized: 88% for Greenlight Guru and 97% for Dot Compliance.[^gg-g2-labels][^dc-g2-labels] Dot Compliance reviewers split on ease of use: more than a dozen call it intuitive, and a similar number report a learning curve, crowded screens or too many clicks.[^dc-capterra] Several say deeper changes need Salesforce-level work.[^dc-capterra] We found no first-hand Dot Compliance reports on Reddit. Greenlight Guru gets more Reddit attention, with first-hand comments split and users reporting costs rising with headcount.[^gg-reddit-eqms][^gg-reddit-cost] Both go live quickly. Greenlight Guru says standard implementations take two to eight weeks and lists SOP templates in the package.[^gg-pricing] Dot Compliance's device case studies range from under 30 days at Dandy and six weeks at Nanox to three to four months at Pi-Cardia, and the system comes with sample SOPs.[^dc-dandy][^dc-nanox][^dc-picardia][^dc-appx] ### Choose Dot Compliance if… - you make drug or biologic products alongside devices and need deviations, batch records or equipment management in the same system; - you want a pre-configured system with sample SOPs and validation included; - you're comfortable on Salesforce and can get prices, term and exit terms in writing before signing. ### Choose Greenlight Guru if… - you make only medical devices, and design controls, ISO 14971 risk and traceability matter most; - you build software or software-driven devices and need IEC 62304-aligned releases and Jira and GitHub links; - you want to read the contract and see an entry price before talking to sales. [^dc-reddit-ra]: [Reddit r/regulatoryaffairs: comment on an eQMS evaluation](https://www.reddit.com/r/regulatoryaffairs/comments/1d5yyj5/compliance_management_platforms_what_are_you_using/n7nskul/). Community post, Aug 2025. [^gg-pricing]: [Greenlight Guru: Quality pricing and packages](https://www.greenlight.guru/quality-pricing). Vendor website, checked 29 Sep 2026. [^gg-pd]: [Greenlight Guru: Product development software](https://www.greenlight.guru/product-development-software). Vendor website, checked 29 Sep 2026. [^dc-home]: [Dot Compliance: homepage and FAQ](https://www.dotcompliance.com/). Vendor website, checked 30 Sep 2026. [^dc-qe]: [Dot Compliance: Quality event management](https://www.dotcompliance.com/solutions/quality-events-management/). Vendor website, checked 30 Sep 2026. [^dc-capterra]: [Capterra: Dot Compliance reviews](https://www.capterra.com/p/192574/Dot-Compliance/reviews/). Review site; rating checked in a browser 30 Sep 2026, review texts (pages 1–4) read with a fetch tool 30 Sep 2026 and again 4 Oct 2026. [^dc-rn52]: [Dot Compliance 5.2 release highlights](https://info.dotcompliance.com/sf-dot-compliance-5.2). Vendor release notes, checked 30 Sep 2026. [^dc-eyeque]: [Case study: EyeQue](https://info.dotcompliance.com/hubfs/Case%20Study%20-%20EyeQue.pdf). Vendor case study, checked 30 Sep 2026. [^dc-dandy]: [Case study: Dandy](https://info.dotcompliance.com/hubfs/Content%20Assets/Dandy%20case%20studypdf.pdf). Vendor case study, checked 30 Sep 2026. [^gg-reddit-eqms]: [r/MedicalDevices: Are all eQMS pretty much the same?](https://www.reddit.com/r/MedicalDevices/comments/1ibdedc/are_all_eqms_pretty_much_the_same_overwhelmed/) and [eQMS recommendations](https://www.reddit.com/r/MedicalDevices/comments/1ne2lv6/eqms_recommendations/). Community discussion, Jan and Sep 2025. [^gg-reddit-worth]: [r/MedicalDevices: Is Greenlight Guru worth using?](https://www.reddit.com/r/MedicalDevices/comments/1k05y0i/is_greenlight_guru_worth_using/). Community discussion, Apr 2025. [^gg-vendr]: [Vendr: Greenlight Guru pricing](https://www.vendr.com/marketplace/greenlight-guru). Price benchmark, checked 29 Sep 2026. [^gg-reddit-expensive]: [r/MedicalDevices: Greenlight Guru is ok but expensive, what eQMS did you switch to?](https://www.reddit.com/r/MedicalDevices/comments/1s8cj89/greenlight_guru_is_ok_but_expensive_what_eqms_did/). Community discussion, Mar–Apr 2026. [^dc-appx]: [Salesforce AppExchange: Dot Compliance QMS listing](https://appexchange.salesforce.com/appxListingDetail?listingId=a0N30000000q6ToEAI). Vendor listing (read through the AppExchange data feed), checked 30 Sep 2026. [^dc-sourceforge]: [SourceForge: Dot Compliance QMS (archived)](https://web.archive.org/web/20260227105400/https://sourceforge.net/software/product/Dot-Compliance/). Software directory with vendor-supplied text, Wayback Machine snapshot 27 Feb 2026. [^dc-services]: [Dot Compliance: Services and support](https://www.dotcompliance.com/services/). Vendor website, checked 30 Sep 2026. [^gg-msa]: [Greenlight Guru: Master subscription agreement](https://www.greenlight.guru/master-subscription-agreement). Vendor legal page, updated 26 Aug 2026, checked 1 Oct 2026. [^dc-terms]: [Dot Compliance: Terms and conditions](https://www.dotcompliance.com/terms-conditions/). Website terms of use, updated 25 Nov 2024, checked 30 Sep 2026. [^dc-complaints]: [Dot Compliance: Complaint management](https://www.dotcompliance.com/solutions/complaint-management/). Vendor website, checked 30 Sep 2026. [^dc-trial]: [Dot Compliance: Free trial](https://info.dotcompliance.com/free-trial). Vendor website, last modified 18 Sep 2026, checked 30 Sep 2026. [^gg-tourpage]: [Greenlight Guru: Quality management software product tour](https://www.greenlight.guru/quality-management-software-product-tour). Vendor website, checked 29 Sep 2026. [^gg-demo]: [Greenlight Guru: Document and change management demo](https://www.greenlight.guru/live-demo/document-change-management-greenlight-guru-quality). Recorded vendor demo (agenda checked), 10 Apr 2024. [^gg-tour]: [Greenlight Guru: Interactive product tour](https://capture.navattic.com/clwik2336000209jseofsekzc). Vendor product tour with screenshots (captured 2024), checked 30 Sep 2026. [^gg-ultralight]: [Greenlight Guru: Ultralight eQMS](https://www.greenlight.guru/ultralight-eqms). Vendor website, checked 29 Sep 2026. [^gg-samd]: [Greenlight Guru: Product development for SiMD/SaMD](https://www.greenlight.guru/productdevelopment-simd-samd). Vendor website, checked 29 Sep 2026. [^dc-help]: [Dot Compliance: Help center](https://www.dotcompliance.com/help-center/). Help-center index (titles only), checked 30 Sep 2026. [^dc-omega]: [Case study: Omega Diagnostics](https://info.dotcompliance.com/hubfs/Content%20Assets/Omega%20case%20study.pdf). Vendor case study, checked 30 Sep 2026. [^dc-xpress2025]: [Dot Compliance: eQMS Xpress (archived)](https://web.archive.org/web/20250125054115/https://www.dotcompliance.com/eqms-xpress/). Vendor website, Wayback Machine snapshot 25 Jan 2025. [^dc-gate]: [Dot Compliance content portal: Design Control manual 5.1](https://content.compliance.life/?name=Express+5/Design+Control+Manual+Guide+5.1.pdf). Customer login required, checked 30 Sep 2026. [^dc-risk]: [Dot Compliance: Risk management](https://www.dotcompliance.com/solutions/risk-management/). Vendor website, checked 30 Sep 2026. [^dc-capa]: [Dot Compliance: CAPA management](https://www.dotcompliance.com/solutions/capa-management/). Vendor website, checked 30 Sep 2026. [^gg-release]: [Greenlight Guru: Introducing adaptable quality processes](https://www.greenlight.guru/blog/introducing-adaptable-quality-processes). Vendor release notes, 26 Jun 2025. [^dc-subproc]: [Dot Compliance: List of sub-processors](https://www.dotcompliance.com/list-of-dot-compliance-sub-processors/). Vendor website, checked 30 Sep 2026. [^gg-complaints]: [Greenlight Guru: Complaint management software](https://www.greenlight.guru/complaint-management-software). Vendor website, checked 29 Sep 2026. [^dc-supplier]: [Dot Compliance: Supplier quality management](https://www.dotcompliance.com/solutions/supplier-quality-management/). Vendor website, checked 30 Sep 2026. [^gg-supplier]: [Greenlight Guru: Supplier management software](https://www.greenlight.guru/supplier-management-software). Vendor website, checked 29 Sep 2026. [^dc-docs]: [Dot Compliance: Document management](https://www.dotcompliance.com/solutions/document-management/). Vendor website, checked 30 Sep 2026. [^gg-qms]: [Greenlight Guru: Medical device QMS software](https://www.greenlight.guru/quality-management-software). Vendor website, checked 29 Sep 2026. [^dc-training]: [Dot Compliance: Training management](https://www.dotcompliance.com/solutions/training-management/). Vendor website, checked 30 Sep 2026. [^gg-legal]: [Greenlight Guru: Legal and trust information](https://www.greenlight.guru/legal-info). Vendor website, checked 29 Sep 2026. [^dc-privacy]: [Dot Compliance: Privacy policy](https://www.dotcompliance.com/privacy-policy/). Vendor website, checked 30 Sep 2026. [^gg-arch]: [Greenlight Guru: System architecture and security practices](https://www.greenlight.guru/system-architecture-and-security-overview). Vendor document, updated 14 Jun 2022. [^gg-dpa]: [Greenlight Guru: Clinical online data processing terms](https://www.greenlight.guru/online-data-processing-terms). Vendor legal page, checked 29 Sep 2026. [^dc-sf]: [Dot Compliance: Salesforce platform FAQ](https://www.dotcompliance.com/salesforce/). Vendor website, checked 30 Sep 2026. [^gg-g2]: [G2: Greenlight Guru Quality Management System reviews](https://www.g2.com/products/greenlight-guru-quality-management-system/reviews). Review site, checked in a browser 29 Sep 2026. [^dc-g2]: [G2: Dot Compliance QMS reviews](https://www.g2.com/products/dot-compliance-qms/reviews). Review site, checked in a browser 30 Sep 2026. [^gg-capterra]: [Capterra: Greenlight Guru reviews](https://www.capterra.com/p/140578/greenlight-guru/reviews/). Review site, checked 29 Sep 2026. [^gg-g2-labels]: [G2: Greenlight Guru reviews, all pages](https://www.g2.com/products/greenlight-guru-quality-management-system/reviews). Review site, read in a browser while logged in, checked 3 Oct 2026. [^dc-g2-labels]: [G2: Dot Compliance reviews, all pages](https://www.g2.com/products/dot-compliance-qms/reviews). Review site, read in a browser while logged in, checked 2 Oct 2026. [^gg-reddit-cost]: [r/MedicalDevices: How much do Greenlight Guru and MasterControl cost?](https://www.reddit.com/r/MedicalDevices/comments/1hshh8l/how_much_do_greenlight_guru_and_mastercontrol_cost/). Community discussion, Jan 2025. [^dc-nanox]: [Case study: Nanox](https://info.dotcompliance.com/hubfs/Content%20Assets/Nanox%20case%20study.pdf). Vendor case study, checked 30 Sep 2026. [^dc-picardia]: [Case study: Pi-Cardia](https://info.dotcompliance.com/hubfs/Content%20Assets/Pi-Cardia%20case%20study.pdf). Vendor case study, checked 30 Sep 2026.