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    Content date: · Editorial responsibility: Dimitris Mitsios · No individual check logged· AI use
    Pre-validated eQMS vs medical-device eQMS · Guide revised September 2026

    Dot Compliance vs Greenlight Guru: Scope, limits and demo questions

    Side-by-side comparison

    Dot Compliance and Greenlight Guru: pricing, evaluation starting point, scope, what to verify and offline scope. Select a row label to show its full text.
    AttributeDot ComplianceGreenlight Guru
    No amount on record; request quote
    Published amount; check product and plan
    Quality Management
    Validate user roles, sites and scale against your proposed deployment.
    Confirm hosting, support languages and contractual coverage for your region.
    See the linked profile's capability evidence
    See the linked profile's unresolved questions
    Not yet classified

    Where the two scopes differ

    Both records describe electronic signatures with an audit trail and a vendor validation package for regulated manufacturers, so the first difference is what each product is built around. The Dot Compliance record describes a pre-built eQMS running natively on Salesforce, with eleven process applications running from document control through equipment to electronic batch records, a layer of AI agents called Dottie, and a vendor-delivered configuration described as pre-validated, where changes by the customer need their own assessment. The Greenlight Guru record describes a medical-device platform in three product areas: Quality (the eQMS), Product Development and Clinical data capture. Design controls, risk files, parts and bills of materials and software-release evidence sit in product development; clinical data capture is a separate product that can be bought without quality.

    The industries differ. Dot Compliance's site lists pharma, biotech, device and cosmetics offerings and cites 21 CFR Parts 210, 211 and 820 alongside ISO 13485 and ISO 14971; the record treats that list as target markets, not certification. Greenlight Guru's record is explicitly medtech, and its pricing page states alignment to ISO 13485, FDA QMSR, ISO 14971 and IEC 62304, again as vendor wording. The Greenlight Guru record does not describe batch records, and the Dot Compliance record does not describe design controls, so a pharma team and a device team would test different first paths.

    Commercial evidence is uneven. Dot Compliance shows no subscription amount and no pricing page, offers a free trial only after pre-qualification, and asks that a quote separate applications, users, Dottie agents and implementation. Greenlight Guru states yearly starting amounts in dollars for Quality plus Product Development and for Clinical data capture, with no ISO currency shown, and prices implementation and study-build services apart; a self-service trial was not verified. On validation, Dot Compliance says every customer receives a full validation documentation package in the subscription, while Greenlight Guru says updated documentation accompanies each release and the customer completes a short installation-qualification step. In both records the buyer still owns the intended-use assessment, the configuration and the integrations. The Dot Compliance record adds that changes to delivered workflows need the customer's own assessment, and its pages say the platform runs on Salesforce, so releases may come from two parties.

    Dot Compliance: status on record

    • Trial: Trial or demo on request.
    • Offline: Not yet classified.
    • Pricing: No amount on record; request quote.
    • Profile record checked 10 October 2026.

    Greenlight Guru: status on record

    • Trial: Trial or demo on request.
    • Offline: Not yet classified.
    • Pricing: Published amount; check product and plan.
    • Profile record checked 14 October 2026.

    When each is the safer first demo

    Start with Dot Compliance when

    Start with Dot Compliance when the quality unit wants delivered process coverage quickly and the open questions sit in production and complaints: a distributor complaint should become a prioritised investigation and CAPA with a readable signature trail and, if batch records are in scope, a production exception should reach quality. Begin by mapping your change-control and complaint procedures against the delivered workflows and listing each gap, because the record says every later change needs your own assessment against the vendor's validation package. Also ask who assesses each Salesforce release.

    Start with Greenlight Guru when

    Start with Greenlight Guru when the company is developing the device and the weak handoff runs from engineering into quality: a post-market complaint should reach a risk update, a design change, verification evidence and retraining. Confirm in the first session which of Quality, Product Development and Clinical the quote contains and which currency the starting amounts use. If engineers work in Jira or GitHub, test a failed transfer in the first week instead of the last.

    A two-week evaluation plan

    Ask Dot Compliance

    • Which Salesforce organisation and edition does the subscription run in, who administers releases, and what regression evidence comes with each?
    • What does the validation package contain, how is it refreshed, and which changes to delivered workflows fall outside it?
    • Which applications, users, Dottie agents and implementation services are separate quote lines, and what does trial pre-qualification require?

    Ask Greenlight Guru

    • Which of the Quality, Product Development and Clinical areas does the quote cover, which currency and user count do the starting amounts assume, and which services are priced apart?
    • Which validation documents arrive with each release, what does the installation-qualification step involve, and what remains ours?
    • Which AI functions are licensed, how are answers sourced and retained, and who approves an AI draft before it becomes a record?

    Week 1, same script for both on synthetic data: log a complaint, let the product route it, open an investigation and corrective action, approve it with an electronic signature and read back the recorded signature meaning, then open the audit trail and check that each signature points at the version it approved. Revise a controlled document and look at the training assignment. Dot Compliance's trial is subject to pre-qualification and Greenlight Guru's record describes a demonstration by request, so settle the environment, its dates and its enabled modules first.

    Week 2 follows each product's reach. For Dot Compliance, change one step of a delivered workflow, ask which validation documents cover the change and, if electronic batch records are quoted, show the manufacturing interface with field mapping and failure handling. For Greenlight Guru, alter one design input, trace it into risk controls and verification evidence, route the release and export the history, then test an AI-drafted summary with a named reviewer. Finish by reading every quote line against what each session needed.

    Worked evaluation scenarios

    These scenarios are hypothetical. They show how to turn the record facts into a demo test and what outcome would change a choice; they are not case studies or customer results.

    Hypothetical: a contract manufacturer wants a batch exception to reach quality

    A contract manufacturer of tablets wants an exception raised during batch execution to appear in the quality system with its batch reference. The Dot Compliance record describes electronic batch records that link work instructions, procedures, forms and test results to the batch record and refers to eQMS-to-MES integration, while naming no systems. The Greenlight Guru record describes complaints, nonconformances and CAPA linked to products, suppliers and changes, and does not describe batch records. Ask each vendor to show the path from a production exception to a nonconformance in the quoted applications with the batch identifier intact. If the path needs a customer-built interface, or the production record sits in a third system, price the interface and name its owner before the demo is scored.

    Hypothetical: a device start-up changes a design input after a complaint

    A device start-up receives a complaint that suggests a design input was wrong. The Greenlight Guru record describes design controls linking user needs, inputs, outputs, verification and design reviews, and risk controls linked to verification evidence, with traceability exports. The Dot Compliance record describes complaint intake that can trigger a CAPA, and does not describe design controls. In each demo, log the complaint, open the investigation and a change, then ask to see which risk, test and document records the change touches. If design history has to live in a separate engineering tool, test how a finding from the quality system reaches it, and who maintains that link after each release.

    Hypothetical: an AI pilot on deviation summaries

    A quality head wants to pilot AI on deviation summaries and draft responses, with every output reviewed by a named person. The Dot Compliance record describes ready-made research, review and document-to-protocol agents and agents the customer defines by duties and boundaries, which the vendor says pause for expert approval before a critical step moves on. The Greenlight Guru record describes search, grounded answers, summaries and quiz drafts framed as suggestions for human review, with licensing, models and retention to be confirmed. Feed each tool a deviation containing one outdated source and one ambiguous instruction. Check whether answers cite sources, whether the outdated one is flagged, who approves before anything becomes a record, and what is logged. If an output can enter a controlled record without a named approver, restrict the pilot.

    What the records do not establish

    Dot Compliance

    • A subscription amount: no pricing page was found on the dates checked.
    • Offline or mobile synchronisation; the record describes browser access through Salesforce.
    • A delivered MES, LIMS or ERP interface: the pages describe those links in general terms without naming systems.
    • Which Dottie actions on a quality record need a named human approver; the record asks the buyer to define that boundary before enabling it.

    Greenlight Guru

    • Which currency the published starting amounts use, and what a realistic configuration costs.
    • A self-service free trial.
    • Disconnected work in the quality, development or clinical products; exports are not offline editing.
    • Whether clinical data capture, with its study limits and add-ons, is part of an eQMS subscription.

    Neither product

    • That either product makes a company, device, batch or submission compliant: both records leave procedures, intended-use validation and regulatory conclusions with the customer.
    • How long implementation takes, what it costs in total or how users rate it; no customer-review sample sits behind either record.
    • Current certificates: the certification lists are vendor statements and no certificate or report was reviewed.

    Written from the profile records and the decision guide above, not from a hands-on test. Where a record is silent, the page says so instead of filling the gap.

    Evaluate Dot Compliance

    • Identify the exact product, application and licence.
    • Review the profile's demonstration questions.
    • Run the same task and record unresolved questions.
    See Dot Compliance profile

    Evaluate Greenlight Guru

    • Identify the exact product, application and licence.
    • Review the profile's demonstration questions.
    • Run the same task and record unresolved questions.
    See Greenlight Guru profile

    Dot Compliance vs Greenlight Guru | FAQ

    Which product is cheaper?
    Comparable total cost has not been established. Request the same applications, users, sites, configuration, migration, integrations and support period from both vendors. Published entry pricing is subject to the plan conditions shown in each profile.
    How should I compare offline capability?
    Use the exact proposed mobile application and plan. Download required data, disconnect, create a record with a photo, reconnect and inspect synchronization. Record which preparation and tasks require connectivity.
    How should I decide between these products?
    Set acceptance criteria for your actual workflow. Complete the same demo, record observed results separately from vendor statements and resolve remaining questions in a scoped pilot. The linked profiles show the sources and review status for each product.

    Vendor sources and next steps

    Dot Compliance13 sources, profile checked 10 October 2026
    Greenlight Guru19 sources, profile checked 14 October 2026
    Record the same demo tasks in the scorecard →

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