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Kneat Gx makes validation paperless. Seal runs the process, and tests changes to it.

Seal, the GxP execution system, is your eBR, your QMS and more. Neil, your AI agent, does the paperwork across your systems. You sign. Bioventix cut document admin time by 80%. Start with one process beside Kneat Gx.

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Where Kneat Gx falls short.

From Kneat’s own pages.

  • From purchase
    Kneat’s consultants
    New sites
    Expert support
    Seal, a first process
    48 hours

    Configured with consultants.

    Kneat’s consultants are with you from the moment you buy, and new sites come with expert support. Seal has a first process working for you to evaluate within 48 hours, once the scope is agreed and the inputs received.

    Kneat, Implementation & Scalability
  • Power User, level 1
    8 hours, live
    Power User, level 2
    16 hours, live
    Super User
    Kneat partners only
    Seal
    Neil, then your approval

    No code, after a course.

    Kneat Academy certifies Power Users in templates and workflows in an 8-hour live course, offers a 16-hour second level, and keeps Super User for partners. In Seal, Neil configures the first process from your procedure, and your team approves it.

    Kneat, Kneat Academy
  • Kneat Gx
    The validation lifecycle
    QMS, ERP
    Through open APIs
    Seal
    One set of records

    Validation, kept beside the work.

    Kneat Gx manages the validation lifecycle and connects to QMS, LMS and ERP systems through open integration APIs. In Seal, validation runs where the work runs, as each change is prepared.

    Kneat, August 2026
  • Kneat AI
    Drafts test cases, protocols
    Also
    Runs QA checks
    Neil
    Drafts the change

    Its AI writes the protocol. Neil drafts the change.

    Kneat AI helps build requirements, test cases and protocols from approved content, and runs automated QA checks. Neil prepares the change itself and the paperwork around it, for your team to approve.

    Kneat, August 2026

See it in Seal.

Real Seal screens with fictional test data: validating a LIMS update, from its requirements to a failed test and what is still missing.

  1. 1

    Requirements, by risk.

    Each requirement for a LIMS update carries its risk and the tests that cover it on the version under test.

    Requirements in Seal: six requirements for a LIMS, from a complete audit trail to backup and restore, each with its risk and the tests that pass on version 4.3.0.
    1. Requirements as recordsEach one published, with its own version.
    2. Risk on every requirementHigh, medium or low.
    3. Coverage, by versionWhich tests pass on 4.3.0.
  2. 2

    A failed step, with its evidence.

    The user acceptance run records what should happen, what did, and the screenshot that shows it.

    Step 3 of user acceptance run UAT-01 on version 4.3.0 in Seal: the expected out-of-specification banner, the actual result accepted without a flag, the step marked Fail, and the screenshot of the LIMS result entry attached as evidence.
    1. What should happenAn out-of-specification banner, and the result flagged.
    2. What did7.46 shown as 7.5 and accepted, with no flag.
    3. The evidence, attachedThe screenshot from the run, kept with the step.
  3. 3

    What is still missing, in one place.

    The change to the LIMS shows the required check that failed and the sign-offs still to come.

    Completion checks in Seal for change CC-003 to SampleTrack LIMS 4.3.1: two sign-offs remaining on the change and two on run UAT-01, and the required check that approved test cases pass marked Failed because the run on 4.3.1 is not finished.
    1. Sign-offs, countedTwo remaining on the change and two on the test run.
    2. A required check, failedApproved test cases must pass; the run on 4.3.1 isn’t finished.

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

Kneat Gx and Seal, side by side.

Every source is listed under References.

Kneat GxSeal
What it isPaperless validation platform¹The GxP execution system: your eBR, your QMS and more
Built forMulti-site enterprise validation teams²Starts with one process; sites are added as you need them
Data modelValidation documents and entities, traced in an RTM³⁴Primitives your team composes: record types, their relationships, steps and checks
AIKneat AI drafts and reviews validation documents²⁴Neil, Seal’s AI agent, prepares changes to the process; your team approves them
ScopeValidation, plus batch records and eLogbooks⁵⁶Process development, the lab, manufacturing, batch release and quality
EvidenceExecuted protocols and a live RTM²Test results tied to the version in use
A changeLinked IQ and OQ update with the URS⁵Checks run on the proposed change first
IQ, OQ and PQTemplates and document packs³Evidence mapped to them where needed
Other softwareCSV and CSA protocols³Your tests run on each supplier release
Lab and qualityConnect your QMS, LMS and ERP²LIMS and QMS on the same platform
Configuring it“Without code”, with certified Power Users for templates and workflows¹⁷Neil prepares it from your procedures; your team approves
Getting startedKneat consultants or certified partners⁸²A 48-hour evaluation of one process, once the scope is agreed and the inputs received

Summary

The story
Kneat Gx is good for paperless validation. Three engineers from the pharmaceutical sector founded Kneat in Limerick in 2007 to replace paper validation, and wrote 900,000 lines of code over eight years before its first customer delivery.²⁹ It began with the validation document: templates for every document, linked by a traceability matrix of requirements, risks and tests,³ and it now also offers a data-centric approach in the same workspace.⁵ Even its batch records are sold as a way to “digitalize and manage any validation process”.⁶ Kneat says workflows are configured without code,¹ yet its Academy certifies Power Users in document templates, document packs and approval workflows in live courses, and keeps its highest certification for partners.⁷ Kneat AI, introduced in 2025, drafts and reviews validation documents and answers regulatory questions.¹⁰⁴ If validation is a project run once on a system that rarely changes, it can work well. That is rare, and rarer now that systems change with every release.

1What Kneat Gx offers.

Kneat sells Kneat Gx as paperless GxP validation software.¹ Kneat says it covers process, cleaning, CSV and CSA, commissioning and qualification, equipment, analytical instrument, utility and facility, cold chain and method validation, with electronic logbooks and document and drawing management, in a single configurable system,⁵ and it sells batch records on the same platform.⁶ Its working parts are templates, document packs and entities: pre-approved IQ, OQ and PQ templates generate document packs, and a requirements traceability matrix links requirements, risks and tests and updates as changes are saved.³² Kneat says teams configure workflows without code, in a document-centric or a data-centric way.¹

Kneat AI, introduced in 2025, adds a content review assistant, natural-language process analysis, a user-support chatbot and translation.¹⁰ Kneat Gx 26R2, in 2026, added a chatbot over FDA, EMA, ICH, ISO and GAMP sources and an agent that writes summary-report sections from approved test documents.⁴ Alongside the software, Kneat sells implementation, process mapping, training and certification, data migration, custom integrations and managed services, and more than 50 certified partners sell the same.²

2Running Seal alongside Kneat Gx.

You can start without replacing Kneat. Seal has no dedicated Kneat connector. Where a system is not on Seal’s integrations list, Seal’s REST API and Scripts can connect it.

Seal’s API reads and writes records from another system; agree the records, direction of transfer, credentials and failure handling first. Scripts are versioned Python in Seal that can call an external service after an event or on a schedule, and they are changed, tested and published like other Seal records. Kneat Gx offers open integration APIs on its side.²

Start with read access, and treat any write to Kneat as a separate decision with defined actions, review gates and audit evidence. Qualify the connection by defining identifiers and field mappings, testing missing, delayed and duplicate records, and reconciling transferred records against the source. The scope also names which system holds each record: Kneat can keep existing qualification packages while the first process runs in Seal.

3Moving from Kneat Gx to Seal.

Start with one change, not a migration of the validation library.

  1. Choose one configuration change you need to make on a process that will run in Seal, such as a release-test limit or a review step, with its requirement and current test evidence.
  2. Bring that material, starting with sample records or under an NDA for confidential ones. Existing Kneat protocols can serve as source material for the configured plan.
  3. Neil prepares the impact assessment, the verification cases and the review package, and your team inspects them against how the work should run. In the 48-hour evaluation, once the scope is agreed and the inputs received, Seal turns one process into a working workflow with a validation pack to inspect. Production timing then depends on scope, interfaces, migration and your release requirements.
  4. Test the complete cycle before relying on it: a boundary value, a missing reading, an invalid unit, a failed case and its retest, a lapsed equipment prerequisite, and the release decision that follows.
  5. Keep imported evidence with its original version and context. Importing it does not establish that it covers the current use, and retention obligations continue for the packages that stay in Kneat.

For a supplier system, start with its next release: its requirements, the tests you already run and the supplier’s release notes.

The validation blueprint, computer system assurance blueprint and commissioning and qualification blueprint describe the approach in detail.

References

  1. 1Kneat Gx, the leading paperless GxP validation software, Kneat. https://kneat.com/solution/ (read 5 November 2026)
  2. 2Official Information About Kneat Solutions, Kneat, updated 28 August 2026. https://kneat.com/llm-info/ (read 5 November 2026)
  3. 3Computer system validation (CSV) software, Kneat. https://kneat.com/application/computer-system-validation/ (read 5 November 2026)
  4. 4Kneat Gx 26R2, Kneat, last updated 27 July 2026. https://kneat.com/article/kneat-gx-26r2/ (read 5 November 2026)
  5. 5Validation lifecycle management, Kneat. https://kneat.com/application/validation-lifecycle-management/ (read 5 November 2026)
  6. 6Batch records, Kneat. https://kneat.com/application/electronic-batch-records/ (read 5 November 2026)
  7. 7Kneat Academy, Kneat. https://kneat.com/academy/ (read 5 November 2026)
  8. 8Implementation & Scalability, Kneat. https://kneat.com/implementation/ (read 5 November 2026)
  9. 9About us, Kneat. https://kneat.com/about-us/ (read 5 November 2026)
  10. 10Kneat Releases 2025 Annual Shareholder Letter Highlighting Resilience, Opportunities Presented by Artificial Intelligence, Kneat (GlobeNewswire, reproduced by ResearchPool), 25 February 2026. https://app.researchpool.com/provider/globenewswire/kneatcom-inc-ksi-kneat-releases-2025-annual-shareholder-letter-highlighting-resilience-Mz538uhP3Y (read 5 November 2026)

AQuestions and answers

Is Seal better than Kneat Gx?

Yes. Kneat Gx is good for paperless validation. Three engineers from the pharmaceutical sector founded Kneat in Limerick in 2007 to replace paper validation, and wrote 900,000 lines of code over eight years before its first customer delivery. It began with the validation document: templates for every document, linked by a traceability matrix of requirements, risks and tests, and it now also offers a data-centric approach in the same workspace. Even its batch records are sold as a way to “digitalize and manage any validation process”. Kneat says workflows are configured without code, yet its Academy certifies Power Users in document templates, document packs and approval workflows in live courses, and keeps its highest certification for partners. Kneat AI, introduced in 2025, drafts and reviews validation documents and answers regulatory questions. If validation is a project run once on a system that rarely changes, it can work well. That is rare, and rarer now that systems change with every release. 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, Bioventix cut document admin time by 80%, and a customer audit commented positively on its electronic signatures and audit trails.

Is Seal an alternative to Kneat Gx?

Yes. Kneat Gx is designed for paperless validation, with batch records and eLogbooks on the same platform. Seal covers commissioning and qualification, cleaning, process, method and computer system validation, and also runs the process development, laboratory, manufacturing, batch release and quality work being validated. Fitness for intended use is shown from the work, and each configuration change is verified against the candidate before release. Seal also validates other software, such as a supplier’s LIMS, release by release.

Does Seal support IQ, OQ and PQ?

Yes. Where your validation plan or EU GMP Annex 15 calls for those stages, Seal’s evidence maps onto them: installation checks against the asset as installed, operational cases at limits and worst case, and performance runs linked to their batches. The evidence stays with the equipment and its configuration after release.

Can Seal validate software other than Seal?

Yes. A supplier system gets its intended use, requirements and test cases in Seal, and each release is a change control. Automated test cases call the system’s API from a Seal Script; manual test cases are run step by step with screenshots. The release cannot be signed until its tests pass. Each failed step raises a warning that must be answered, and failures are recorded as a deviation before Quality signs.

How do Kneat Gx and Seal handle a change to a validated process?

Kneat says that when a URS is updated in Kneat Gx, linked IQ and OQ entities update automatically, and repeat tests can be re-executed. In Seal, the change carries its impact assessment and selected checks, which run against the candidate version; publication requires current passing results, and earlier results keep the version they tested.

Is Kneat Gx a QMS or a LIMS?

Kneat Gx is designed for paperless validation, and its use cases add document management, batch records and eLogbooks; none of them is a LIMS. Kneat describes it as digital validation software that connects to QMS, LMS and ERP systems through open APIs. In Seal, the LIMS and QMS run on the same platform as validation, so fitness for intended use is shown from the work itself.

How does Kneat’s AI compare with Neil?

Kneat AI, introduced in 2025, works on validation content inside Kneat Gx. Kneat says it drafts requirements, test cases and protocols from approved content, reviews documents, answers questions in natural language, and, from release 26R2, writes summary-report sections from approved test documents. Neil prepares changes to the process itself, the configuration of Seal, with the impact assessment and verification cases, for your team to check, run and release under change control. Neil is not used in GMP execution.

Can we bring our Kneat protocols into Seal?

Yes, as source material for the configured plan. Imported evidence keeps its original version and context, and importing it does not establish that it covers the current use. Agree which packages stay retrievable in Kneat for their retention period.

How long does it take to start with Seal?

In the 48-hour evaluation, once the scope is agreed and the inputs received, Seal turns one process into a working workflow with a validation pack to inspect, configured from your own procedure. Production timing then depends on scope, interfaces, migration and your release requirements.

Start beside Kneat Gx.

Start with one change on one process. Existing Kneat protocols serve as source material, and Seal’s REST API and Scripts can read what else it needs, so nothing has to move on day one.

Book a demo