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Greenlight Guru keeps device design and quality records. Seal runs each unit’s build on the same records.

Seal, the GxP execution system, is your eBR, your QMS and more. Neil, your AI agent, does the paperwork across your systems. You sign. Paradromics cut operator paperwork by 80%. Start with one process beside Greenlight Guru.

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Where Greenlight Guru falls short.

From Greenlight Guru’s own pages and a reviewer on Info-Tech.

  • Implementation
    Priced separately
    Done by
    “a medical device consultant”
    Typically
    2 to 8 weeks
    Seal, a first process
    48 hours

    Configured by a consultant.

    Greenlight Guru prices implementation separately: “hands-on work from a medical device consultant”, typically two to eight weeks. Seal has a first process working for you to evaluate within 48 hours, once the scope is agreed and the inputs received.

    Greenlight Guru, Quality pricing
  • Quality
    Documents, events, suppliers
    Product development
    Requirements, risk
    Clinical evidence
    Trials, PMCF, ePRO
    Device history record
    Not in its menu

    It stops before the device is built.

    Greenlight Guru’s menu lists quality, product development and clinical software, with no device history record. In Seal, each serial’s build is recorded as it is made, on the same records as design controls.

    Greenlight Guru, platform menu
  • An Info-Tech reviewer
    “not as easy as GG markets”
    The same review
    “significant groundwork is still required”

    Not as easy as marketed, a reviewer says.

    A reviewer on Info-Tech wrote that “Customization and effective implementation is not as easy as GG markets”, and that “significant groundwork is still required”. In Seal, Neil configures the first process from your procedure, and your team approves it.

    Info-Tech SoftwareReviews, February 2026
  • Its EDC
    A separate product
    Subscription
    From $9,000 a year
    Study builds
    Priced separately
    Seal
    EDC on the same platform

    Clinical data is a separate product.

    Greenlight Guru’s EDC is a separate product from $9,000 a year, and clinical study builds are priced separately. In Seal, clinical data capture, ePRO and post-market clinical follow-up sit on the same records as the device.

    Greenlight Guru, Quality pricing
  • Search
    Answers from your QMS
    Summaries
    Documents and change orders
    Neil
    Drafts the change

    Its AI summarises. Neil does the paperwork.

    Greenlight Guru AI searches and summarises your QMS records, suggests trace links and drafts change order summaries. Neil prepares the change itself and the paperwork around it, for your team to approve.

    Greenlight Guru, Greenlight Guru AI

See it in Seal.

Real Seal screens with fictional test data: one late transfer, from the batch record to the fix, then Neil’s overnight release review.

  1. 1

    Each value at the step it belongs to.

    Batch B-041’s readings are recorded as the work happens, with its sample and its deviation linked to the record.

    Batch record B-041, post-mix hold and transfer, in Seal: the instruction to transfer within 45 minutes of completing the mix, process readings at 10:12, 10:42 and 11:04 with temperature and pH, and the linked lab sample IPC-041 and investigation DEV-018.
    1. The step’s limitTransfer within 45 minutes of completing the mix.
    2. Recorded as it happensMix complete at 10:12, transfer at 11:04: 52 minutes.
    3. The deviation, linkedDEV-018 sits on the batch record it concerns.
  2. 2

    The deviation starts with its evidence.

    DEV-018 has the batch, its readings and the sample linked, so the investigation starts from the facts.

    Deviation DEV-018, extended post-mix hold, in Seal: the affected batch B-041, the transfer 52 minutes after mixing against a permitted 45, and a table of evidence from the process readings, temperature readings and sample IPC-041.
    1. The batchB-041, the batch the deviation concerns.
    2. What happened52 minutes, against a permitted 45.
    3. The evidenceReadings and the sample, from the same records.
  3. 3

    The fix is a change to the workflow.

    CC-019 makes the record calculate the hold and route anything over 45 minutes. It is verified before release, and the next batch runs the new version.

    Change CC-019, elapsed-time check, in Seal: DEV-018 as the reason, the affected procedure MBR-014, a table of current and proposed workflow behaviour, a verification plan at 44, 45 and 46 minutes and a missing start time, and a release review for authorised people.
    1. From the deviationDEV-018 is the reason for the change.
    2. The workflow itselfThe hold is calculated from both timestamps, and anything over the limit is routed for assessment.
    3. Verified before releaseAt 44, 45 and 46 minutes, and with a start time missing.
  4. 4

    Neil checks every lot. People decide.

    Overnight, Neil checked each lot against its release plan and said what its record leaves out.

    The release board in Seal: 111 lots in release across three sites, $123M waiting, 86 with nothing open, and a table of the lots with findings, each with Neil’s summary, its value and a predicted certification date.
    1. The morning, in two lines111 lots and $123M waiting. 86 need only a decision.
    2. Neil’s summary of each lotWhat is open, and where Neil found it.
    3. A predicted certification dateFrom how long this site’s lots have taken.

What Seal’s customers measured.

Each figure links to the customer’s story.

QualityAcclinate and Skye Biologics

−50%
quality cycle times at Acclinate, from a procedure change to everyone trained.Acclinate
−40%
non-conformances at Skye Biologics, with training checked before execution.Skye Biologics

RecordsMiAlgae and Bioventix

−75%
documentation time at MiAlgae, from the lab to commercial production.MiAlgae
−80%
document admin time at Bioventix, after two decades on paper.Bioventix

Greenlight Guru and Seal, side by side.

Every source is listed under References.

Greenlight GuruSeal
What it isMedical device QMS¹The GxP execution system, with a device QMS built in
Built forMedical devices only¹Devices, diagnostics, drugs, biologics
Data modelThe design history file and its trace matrix²Primitives your team composes: record types, their relationships, steps and checks
AISearches, summarises and suggests links; an MCP server for outside AI tools³⁴Neil, Seal’s AI agent, prepares changes to the process; your team approves them
Company size337 of 435 G2 reviews from teams of 50 or fewer⁵Starts with one process; sites are added as you need them
Configuring itIts own settings, with paid configuration services⁶Your process, prepared from your procedures
Design controlsMulti-level traceability matrix²Trace links made as work is done
RiskISO 14971, linked to design²ISO 14971, linked to evidence
CAPA and complaintsConfigured event processes⁶Linked to the serials affected
Device historyNot in its product menu¹Each unit’s build, as it happens
Clinical dataA separate EDC subscription⁶EDC on the same platform
A design changeChange orders, impacted documents⁷Reaches requirements and units built
Getting startedConsultant-led, two to eight weeks⁶A 48-hour evaluation of one process, once the scope is agreed and the inputs received

Summary

The story
Greenlight Guru is good for medical device design controls and quality records. Jon Speer, a medical device engineer turned consultant, had the idea in 2006,⁸ the company was founded in Indianapolis in 2013,⁹ and in 2015 it sold quality management software exclusively for medical device companies, promising FDA design-control compliance and a traceability matrix created “instantly”.¹⁰ Its model is still the design history file, traced between design inputs, outputs, verifications and risk controls.¹ It says quality teams can reconfigure it “without a developer or a paid services engagement”, yet it quotes implementation separately, with a named consultant who configures it with your team, and sells further services for configuration and automations.⁶ Its AI began in 2021 as Halo, which recommends the items a change order affects, and now searches records, summarises change orders and suggests trace links inside the QMS.¹¹³ If you design devices and others build them, it can work well. Most device makers also build, test and release them, and need that work on the same records.

1What Greenlight Guru offers.

Greenlight Guru says more than 1,000 medical device companies use it to manage quality, product development and clinical evidence.¹ Its quality side covers documents, training, change, CAPAs, audits, nonconformances, suppliers and parts; its product development side links needs, requirements and verification to design controls and ISO 14971 risk.¹² Quality and product development subscriptions start at $12,000 a year, with clinical data capture from $9,000; implementation is quoted separately, typically over two to eight weeks.⁶ In 2025 it bought Ultralight Labs¹² and Enzyme.¹³

2Neil does the paperwork across Greenlight Guru. You sign.

You can keep Greenlight Guru. Seal’s Greenlight Guru connection is set up per project on its REST API, scoped to the design controls, documents, parts, suppliers, quality events and training records your subscription exposes, with separate approval for any write-back.⁴ Once it is connected, Neil, your AI agent, can:

  • compare design-control records with verification evidence and list unresolved links;
  • group complaints and compare them with related CAPAs and the units involved;
  • assemble affected parts, supplier records and quality events to assess a supplier change.

People approve, Neil never releases a change on its own, and Neil is not used in GMP execution.

3Start beside Greenlight Guru.

  1. Choose a change with consequences beyond one document, such as a component revision that reaches verification, risk controls and units already built.
  2. Bring the affected requirements, the configuration and the design and verification evidence. Start with sample material, or arrange an NDA first.
  3. Neil proposes the trace structure and the change workflow, and your engineering and quality teams check them against the device. Once the scope is agreed and the inputs received, Seal prepares the first working process and its validation pack to evaluate within 48 hours. Production timing then depends on scope, interfaces, migration and your release requirements.
  4. Read the design controls and test evidence through its API, and follow the change into manufacturing and the affected units.
  5. Agree which records move and which stay retrievable in Greenlight Guru, and reconcile representative records before you rely on the new workflow.

References

  1. 1Greenlight Guru home page and platform menu, Greenlight Guru. https://www.greenlight.guru/ (read 5 November 2026)
  2. 2Medical Device Design Control Software, Greenlight Guru. https://www.greenlight.guru/design-control-software (read 5 November 2026)
  3. 3Greenlight Guru with AI, Greenlight Guru. https://www.greenlight.guru/greenlight-guru-ai (read 5 November 2026)
  4. 4API and Integrations, Greenlight Guru. https://www.greenlight.guru/api (read 5 November 2026)
  5. 5Greenlight Guru Quality Management System reviews, G2, as archived on 12 October 2026. https://web.archive.org/web/20261012114916/https://www.g2.com/products/greenlight-guru-quality-management-system/reviews (read 5 November 2026)
  6. 6Greenlight Guru Quality (QMS Software) Pricing and Packages, Greenlight Guru. https://www.greenlight.guru/quality-pricing (read 5 November 2026)
  7. 7Medical Device Change Management Software, Greenlight Guru. https://www.greenlight.guru/change-management (read 5 November 2026)
  8. 8About Greenlight Guru, Greenlight Guru. https://www.greenlight.guru/about-us (read 5 November 2026)
  9. 9Greenlight Guru, TechPoint tech directory. https://techpoint.org/tech-directory/greenlight-guru/ (read 5 November 2026)
  10. 10greenlight.guru home page, Greenlight Guru, as archived on 5 February 2015. https://web.archive.org/web/20150205232850/http://greenlight.guru:80/ (read 5 November 2026)
  11. 11Greenlight Guru Launches Halo for Change Management, World’s First AI & ML Recommendation Engine for Medical Device Quality, AiThority, 18 January 2021. https://aithority.com/saas/greenlight-guru-launches-halo-for-change-management-worlds-first-ai-ml-recommendation-engine-for-medical-device-quality/ (read 5 November 2026)
  12. 12Greenlight Guru acquires Ultralight Labs to better serve modern MedTech innovators, Greenlight Guru, 17 June 2025. https://www.greenlight.guru/greenlight-guru-acquires-ultralight-labs (read 5 November 2026)
  13. 13Greenlight Guru Acquires Enzyme to Power Ongoing Innovation and Strengthen Customer Support, Greenlight Guru, 23 July 2025. https://www.greenlight.guru/greenlight-guru-acquires-enzyme (read 5 November 2026)

AQuestions and answers

Is Seal better than Greenlight Guru?

Yes. Greenlight Guru is good for medical device design controls and quality records. Jon Speer, a medical device engineer turned consultant, had the idea in 2006, the company was founded in Indianapolis in 2013, and in 2015 it sold quality management software exclusively for medical device companies, promising FDA design-control compliance and a traceability matrix created “instantly”. Its model is still the design history file, traced between design inputs, outputs, verifications and risk controls. It says quality teams can reconfigure it “without a developer or a paid services engagement”, yet it quotes implementation separately, with a named consultant who configures it with your team, and sells further services for configuration and automations. Its AI began in 2021 as Halo, which recommends the items a change order affects, and now searches records, summarises change orders and suggests trace links inside the QMS. If you design devices and others build them, it can work well. Most device makers also build, test and release them, and need that work on the same records. Seal has no fixed model of one kind of work. It is built from primitives: record types, the relationships between them, and the steps and checks that use them, which your own team composes into your process, with Neil able to prepare each change for approval. So one platform runs process development, the laboratory, manufacturing, batch release and the quality system, and each change becomes a new version, released once its selected tests pass, while earlier runs keep theirs. Moving from paper and legacy systems, Paradromics cut operator paperwork by 80% and engineers’ traveler review time by 90%.

Do we have to replace Greenlight Guru?

No. Seal’s Greenlight Guru connection is set up per project on its REST API, scoped to the objects and operations in your subscription, with separate approval for any write-back. Start with one device and one real change beside it.

Is Seal a medical device QMS?

Yes. Seal covers design controls, ISO 14971 risk management, CAPA, nonconformances, complaints, document control, training, suppliers, audits, EU MDR technical documentation and device history records, for ISO 13485 and the FDA QMSR. Paradromics and Bioventix run their quality systems on Seal.

Does Greenlight Guru keep device history records?

Its product menu lists quality, product development and clinical software, with no device history record or manufacturing execution, so each unit’s build is recorded elsewhere. In Seal, each serial’s build is recorded as it is made, on the same records as design controls and quality events.

How does Greenlight Guru AI differ from Neil?

Greenlight Guru AI searches and summarises its own QMS and clinical records, suggests trace links and drafts change order summaries and training quizzes, for your team to review. Neil assembles what a change reaches across design, quality and manufacturing records, finds unverified requirements and configures workflows from your procedures, for your team to verify and release. Neil is not used in GMP execution.

How long does it take to start with Seal?

Once the scope is agreed and the inputs received, Seal prepares a first working process and its validation pack to evaluate within 48 hours, configured from one of your procedures. Production timing then depends on scope, interfaces, migration and your release requirements.

Start beside Greenlight Guru.

Keep Greenlight Guru. Seal’s Greenlight Guru connection lets Neil work from your design controls and quality records while you start with one device and one real change, so nothing has to move on day one.

Book a demo