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Dot Compliance sells a ready-made eQMS. Seal is configured around your process.

Seal, the GxP execution system, is your eBR, your QMS and more. Neil, your AI agent, does the paperwork across your systems. You sign. Skye Biologics cut non-⁠conformances by 40%. Start with one process beside Dot Compliance.

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Where Dot Compliance falls short.

From Dot Compliance’s own pages and its founder.

  • Its eQMS
    “pre-built and pre-validated”
    Whose workflows
    Its own, “out of the box”
    Seal
    Configured from your procedure

    You start from its process.

    Dot Compliance sells its eQMS “pre-built and pre-validated”, with industry best practices and key workflows out of the box. In Seal, Neil configures the first process from your procedure, and your team approves it.

    Dot Compliance, home page
  • A lab result
    Attached to the record
    Beside it
    Photographs, data logs
    Seal
    Recorded where the test runs

    Lab results arrive as attachments.

    In Dot Compliance, users attach evidence such as photographs, lab results or data logs to a deviation or nonconformance. In Seal, the investigation opens from the result, with the sample, method and batch already linked.

    Dot Compliance, Quality Event Management
  • Dot Compliance, live
    Weeks
    Seal, a first process
    48 hours

    Weeks to go live.

    Dot Compliance’s founder says it shortens implementation “from many months to weeks”. Seal has a first process working for you to evaluate within 48 hours, once the scope is agreed and the inputs received.

    Globes, May 2024
  • Research Agent
    Researches records
    Review Agent
    Reviews content, detects gaps
    Neil
    Drafts the change

    Its agents work on the records. Neil drafts the change.

    Dot Compliance says that instead of configuring software features, “you are hiring digital personas”: agents that research records and review content. Neil prepares the change itself and the paperwork around it, for your team to approve.

    Dot Compliance, Dottie 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

Dot Compliance and Seal, side by side.

Every source is listed under References.

Dot ComplianceSeal
What it isReady-to-deploy eQMS on Salesforce, from 2015¹²The GxP execution system, with a complete QMS built in
Built forPharma, biotech, devices, cosmetics¹Devices, diagnostics, drugs, biologics
Data modelPre-built quality modules on Salesforce³⁴Primitives your team composes: record types, their relationships, steps and checks
AIDottie: agents that research, review and pause for approval⁵Neil, Seal’s AI agent, prepares changes to the process; your team approves them
Whose processIts pre-built best-practice workflows³Yours, configured from your procedures
Batch recordsA module that connects to LIMS and ERP⁶On the same records as lab and quality
LaboratoryNo LIMS on its product list¹LIMS on the same records
Laboratory resultsEvidence attached to an event⁷Recorded where the test runs
A deviation or nonconformanceA quality event, linked to CAPAs⁷Opened from the step or result it concerns
Getting startedPre-configured modules³A 48-hour evaluation of one process, once the scope is agreed and the inputs received

Summary

The story
Dot Compliance is good for a ready-made eQMS. Its founder started it in 2015 after advising a medical equipment company whose QMS implementation took a year and a half and several million,⁸² and it still sells off-the-shelf, pre-configured best-practice processes, built natively on Salesforce.²⁴ That is quick to start, because you begin from its pre-built processes rather than yours.³ Its product list names no LIMS, and laboratory results reach a quality event as attachments.¹⁷ Its AI, Dottie, dates from 2023 and is now sold as agents that research records, review content and pause for expert approval.⁹⁵ If your processes match its best practices, it can work well. Most teams improve their processes every month, and need the quality system to change with them, on the same records as the work.

1What Dot Compliance offers.

Dot Compliance sells an eQMS to pharmaceutical, biotechnology, medical device and cosmetics companies, running natively on Salesforce without a separate Salesforce licence.¹ Founded in 2015, it comes with pre-built modules configured with industry best practice,²³ covering document, training, change, complaint, quality event, CAPA, supplier quality, audit, equipment and risk management, along with an electronic batch record module.¹⁶ Its professional services team supports customers from inception through deployment.¹⁰

Its AI, Dottie, was on the market by 2023.⁹ Dot Compliance now calls it an “Agentic AI workforce”: research and review agents, and custom personas you define, which work across internal records and “pause for expert approval before critical steps move forward”.⁵

2Running Seal alongside Dot Compliance.

Teams move to Seal one process at a time. Dot Compliance can keep documents, training and supplier records while OOS investigations run in Seal. Seal has no dedicated Dot Compliance connector; systems not on Seal’s integrations list connect through Seal’s REST API and Scripts, and Seal reviews their interfaces with you.

The API lets another system read and write Seal records under credentials, transfer direction and failure handling agreed in advance. Scripts, written in versioned Python, can check data, update several records or call an external service when an event occurs or on a schedule; each is changed and tested before it is published. If your environment gives API access to its records, Seal’s Salesforce connection can also reference selected Salesforce records, including queryable custom objects; that connection only reads.

Begin by reading, and qualify the connection with the checks in the regulatory guide: source identifiers, field mappings, missing, late and duplicate records, and reconciliation against the source. Any write-back to Dot Compliance is a separate decision with its own actions and review.

3Moving from Dot Compliance to Seal.

Start with one process whose evidence lives in the laboratory.

  1. Pick a process such as a release test with repeated OOS or invalid results.
  2. Bring the procedure, one representative investigation and the records it touches: the result, its raw data, the method version and the batch. Start with sample material, or arrange an NDA before sharing your own.
  3. Neil proposes the workflow from the procedure, including the Phase I checklist, the retest plan and its approval, and the impact scope. Once the scope is agreed and the inputs received, Seal prepares the first working process and its validation pack to evaluate within 48 hours. The pack includes source traceability, recorded test results and configuration history; production release follows your intended-use assessment and quality controls.
  4. Exercise the hard paths before release: a clear calculation error, a passing retest after an OOS result, and an attempt to close the investigation while the batch decision is open.
  5. Extend to the next process, and agree which records move and which stay retrievable in Dot Compliance. Relationships, attachments, versions and available audit context are preserved within that scope, and representative records are reconciled before you rely on the new workflow.

Retention obligations continue for the records that remain in Dot Compliance. The LIMS and QMS blueprints describe the laboratory and quality workflows in more detail.

References

  1. 1Dot Compliance home page, Dot Compliance. https://www.dotcompliance.com/ (read 5 November 2026)
  2. 2Dot Compliance raises $17.5 million in Series B extension to promote AI-driven compliance, Meir Orbach, Calcalist (Ctech), 16 April 2024. https://www.calcalistech.com/ctechnews/article/h1nd8k2x0 (read 5 November 2026)
  3. 3eQMS, Dot Compliance. https://www.dotcompliance.com/eqms/ (read 5 November 2026)
  4. 4Leverage the power of Salesforce, Dot Compliance. https://www.dotcompliance.com/salesforce/ (read 5 November 2026)
  5. 5Dottie AI, Dot Compliance. https://www.dotcompliance.com/ai/ (read 5 November 2026)
  6. 6Electronic Batch Record, Dot Compliance. https://www.dotcompliance.com/solutions/ebr/ (read 5 November 2026)
  7. 7Quality Event Management, Dot Compliance. https://www.dotcompliance.com/solutions/quality-events-management/ (read 5 November 2026)
  8. 8AI that speeds up decision making in biomed, Gali Weinreb, Globes, 1 May 2024. https://en.globes.co.il/en/article-ai-that-speeds-up-decision-making-in-biomed-1001477562 (read 5 November 2026)
  9. 9Say Hello to Dottie, Axendia, 1 September 2023. https://axendia.com/blog/2023/09/01/say-hello-to-dottie-combining-quality-compliance-and-production-optimization-with-ai/ (read 5 November 2026)
  10. 10Services and Support, Dot Compliance. https://www.dotcompliance.com/services/ (read 5 November 2026)

AQuestions and answers

Is Seal better than Dot Compliance?

Yes. Dot Compliance is good for a ready-made eQMS. Its founder started it in 2015 after advising a medical equipment company whose QMS implementation took a year and a half and several million, and it still sells off-the-shelf, pre-configured best-practice processes, built natively on Salesforce. That is quick to start, because you begin from its pre-built processes rather than yours. Its product list names no LIMS, and laboratory results reach a quality event as attachments. Its AI, Dottie, dates from 2023 and is now sold as agents that research records, review content and pause for expert approval. If your processes match its best practices, it can work well. Most teams improve their processes every month, and need the quality system to change with them, on the same records as the work. 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, Skye Biologics cut non-conformances by 40%, with training checked before execution.

Is Seal an alternative to Dot Compliance?

Yes. Seal covers the quality processes Dot Compliance does, including documents, training, deviations, CAPA, change control, complaints, audits and suppliers, configured from your procedures rather than a preset, and adds what it does not run: the laboratory. An investigation in Seal opens from the result, sample and batch it concerns, and each change to the process carries its own test evidence.

Is Seal a LIMS as well as a QMS?

Yes. Samples, methods, instruments and results are recorded in Seal as the test runs, on the same records as deviations, CAPAs, batch records and equipment. An out-of-specification result opens its investigation with the raw data, method version and batch history already linked.

Can Seal work alongside Dot Compliance?

Yes. Seal has no dedicated Dot Compliance connector, but Seal’s REST API and Scripts can connect it, starting with read access. Dot Compliance can keep documents and training while the first laboratory or quality process runs in Seal.

How do Dottie and Neil differ?

Dot Compliance describes Dottie as an agentic AI for quality work: research and review agents, and personas you define, which work across records and pause for expert approval. Neil prepares changes to the process itself, with their tests, for your approval, across laboratory, manufacturing and quality records in Seal. In line with the EU’s draft GMP Annex 22 on AI, Neil is not used in GMP execution. It helps set up configuration, which your team verifies and releases under change control.

Does Dot Compliance run the laboratory?

Dot Compliance is designed for quality management, and its product list names no LIMS: laboratory results reach a quality event as supporting evidence attached to the record. In Seal, samples, methods, instruments and results are recorded as the test runs, on the same records as deviations, CAPAs, batch records and equipment.

How long does it take to start with Seal?

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

Start beside Dot Compliance.

Start with one laboratory or quality process, such as OOS investigations, so nothing has to move on day one. Seal’s REST API and Scripts connect Dot Compliance, starting with read access.

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