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ValGenesis manages the validation lifecycle. 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 ValGenesis VLMS.

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Where ValGenesis VLMS falls short.

From ValGenesis’s own pages and announcements.

  • Its showcase, live
    97 days
    Seal, a first process
    48 hours

    Months to go live.

    ValGenesis cites its complete suite at MilliporeSigma’s Carlsbad site: 97 days from kick-off to go-live. Seal has a first process working for you to evaluate within 48 hours, once the scope is agreed and the inputs received.

    ValGenesis, Software Delivery
  • Assessing your needs
    ValGenesis’s team
    Configuration
    ValGenesis’s team
    Validation work
    ValGenesis’s team
    Seal
    Neil, then your approval

    Configured by its delivery team.

    ValGenesis says its team shoulders the assessment of your needs, configuration and validation work, on a five-step schedule. In Seal, Neil configures the first process from your procedure, and your team approves it.

    ValGenesis, Software Delivery
  • 2005
    Paperless validation
    2025
    Smart GxP, two suites
    LIMS, MES, QMS
    Through integration

    A validation system, extended.

    ValGenesis won a 2005 award as the first paperless system for executing and approving validation. Its Smart GxP suites integrate with LIMS, MES, ERP and QMS. In Seal, the lab, the batch and quality are one set of records.

    ValGenesis, June 2025
  • VAL
    Authors validation content
    Also
    Compares what changed
    Neil
    Drafts the change

    Its AI writes the protocol. Neil drafts the change.

    ValGenesis says VAL authors, examines, analyses, traces, compares and summarises validation content. Neil prepares the change itself and the paperwork around it, for your team to approve.

    ValGenesis, AI-native GxP validation

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

ValGenesis VLMS and Seal, side by side.

Every source is listed under References.

ValGenesis VLMSSeal
What it isValidation lifecycle software¹The GxP execution system: your eBR, your QMS and more
Data modelProtocols and a requirements trace matrix²Primitives your team composes: record types, their relationships, steps and checks
AIVAL drafts protocols and reviews evidence³Neil, Seal’s AI agent, prepares changes to the process; your team approves them
ScopeValidation, cleaning, logbooks, CMC risk, CPV⁴Process development, the lab, manufacturing, batch release and quality
EvidenceExecuted protocols, automated trace matrices⁵Test results tied to the version in use
A changeImpact found from the trace matrix²Checks run on the proposed change first
Lab and qualityIntegrates with LIMS, MES and QMS⁴LIMS, MES and QMS on one platform
ImplementationIts delivery team configures and validates⁶Neil prepares it; your team approves
Getting started97 days to go-live in its own showcase⁶A 48-hour evaluation of one process, once the scope is agreed and the inputs received

Summary

The story
ValGenesis VLMS is good for validation lifecycle management. ValGenesis says it was founded in 2005 and created the first fully digital validation lifecycle management system;¹ that year the PDA gave it its New Innovative Technology Award as the first paperless system for executing and approving validation.⁴ Its model is still the protocol, with a dynamic requirements trace matrix linking specifications and tests.² ValGenesis says customers configure templates, workflows and entities themselves, without customisation,² yet its delivery team shoulders the needs assessment, configuration and validation work, and its own showcase took 97 days from kick-off to go-live.⁶ Its AI agent, VAL, first announced in March 2025 as an assistant, generates protocols, compares evidence and assesses change inside the validation suite.⁷³ If validation is a periodic project run apart from the work, it can work well. That is rare, and rarer now that systems change with every release.

1What ValGenesis VLMS offers.

ValGenesis, Inc., of Santa Clara, California, says that since its founding in 2005 its one mission has been “to bring digital order to the world of validation in life sciences”.¹ Since June 2025 it has sold its applications together as Smart GxP, in two suites.⁴ The Validation Lifecycle Suite holds iVal, which centralises planning, test authoring, execution and oversight for CQV, CSV and CSA;⁵ iClean, for cleaning validation; and iOps, which replaces paper logbooks for equipment, cleanrooms and processes with digital forms.⁴⁸ The Process Lifecycle Suite holds iCMC, for Quality by Design risk assessment in CMC process development, and iCPV, for continued process verification on data from LIMS, MES and SAP.⁴⁹ ValGenesis says the suite is highly configurable, with customers configuring templates, forms, workflows and entities themselves, and modular, so it can be implemented in phases.² It says 30 or more of the top 50 global life sciences companies use ValGenesis.¹

2Running Seal alongside ValGenesis.

You can start without replacing ValGenesis: it keeps existing qualification packages while the first process runs in Seal. Seal has no dedicated ValGenesis connector. Where a system is not on Seal’s integrations list, Seal’s REST API and Scripts can connect it: the API reads and writes records from another system, and Scripts are versioned Python that can call an external service after an event or on a schedule, changed, tested and published like other Seal records. ValGenesis describes Smart GxP as integrating with LIMS, MES, ERP and QMS on its side.⁴

Agree the records, the direction of transfer, the credentials and the failure handling before implementation. Start with read access, and treat any write to ValGenesis as a separate decision with its own review gates and audit evidence. Qualify the connection by defining identifiers and mappings, testing missing and duplicate records, and reconciling against the source, as the regulatory guide describes.

3Moving from ValGenesis VLMS to Seal.

Start with one process where the validated state has to hold at the moment of use.

  1. Choose one shared equipment train across a changeover, with at least three products, a justified worst case and a failed result, or one release-test limit you need to change.
  2. Bring the matrix and limit inputs, the procedure and recent results. Start with sample records, or arrange an NDA before sharing confidential ones.
  3. Neil proposes the configuration and prepares the verification cases, and your team checks them against how the work runs. 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. Exercise the difficult cases before relying on it: a failed swab result, an exceeded hold, a changed PDE and the release decision that follows.
  5. Use existing ValGenesis protocols as source material. Imported evidence keeps its original version and context, and the packages that stay in ValGenesis remain retrievable for their retention period.

The validation blueprint sets out the approach in detail.

References

  1. 1About ValGenesis, the Leader in Validation Digitalization, ValGenesis. https://www.valgenesis.com/about (read 5 November 2026)
  2. 2Validation Lifecycle Suite, ValGenesis. https://www.valgenesis.com/smart-gxp/validation-lifecycle-suite (read 5 November 2026)
  3. 3AI-Native GxP Validation for Faster Product Readiness, ValGenesis. https://www.valgenesis.com/smart-gxp/ai-native-gxp-validation (read 5 November 2026)
  4. 4ValGenesis Launches Smart GxP™ as First AI-Enabled Platform to Unify Validation and Process Development, ValGenesis, 4 June 2025. https://www.valgenesis.com/news/valgenesis-launches-smart-gxp-as-first-ai-enabled-platform-to-unify-validation-and-process-development (read 5 November 2026)
  5. 5ValGenesis iVal™, ValGenesis. https://www.valgenesis.com/application/ival (read 5 November 2026)
  6. 6Software Delivery, ValGenesis. https://www.valgenesis.com/customer-experience/delivery (read 5 November 2026)
  7. 7ValGenesis to Unveil AI-Enabled Digital Validation at INTERPHEX 2025, ValGenesis, 27 March 2025. https://www.valgenesis.com/news/valgenesis-to-unveil-ai-enabled-digital-validation-at-interphex-2025 (read 5 November 2026)
  8. 8ValGenesis iOps™, ValGenesis. https://www.valgenesis.com/application/iops (read 5 November 2026)
  9. 9ValGenesis iCPV™, ValGenesis. https://www.valgenesis.com/application/icpv (read 5 November 2026)

AQuestions and answers

Is Seal better than ValGenesis VLMS?

Yes. ValGenesis VLMS is good for validation lifecycle management. ValGenesis says it was founded in 2005 and created the first fully digital validation lifecycle management system; that year the PDA gave it its New Innovative Technology Award as the first paperless system for executing and approving validation. Its model is still the protocol, with a dynamic requirements trace matrix linking specifications and tests. ValGenesis says customers configure templates, workflows and entities themselves, without customisation, yet its delivery team shoulders the needs assessment, configuration and validation work, and its own showcase took 97 days from kick-off to go-live. Its AI agent, VAL, first announced in March 2025 as an assistant, generates protocols, compares evidence and assesses change inside the validation suite. If validation is a periodic project run apart from the work, 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 ValGenesis VLMS?

Yes. ValGenesis is designed for validation lifecycle management. Seal covers qualification, cleaning validation, process and method validation and computer system assurance, and also runs the lab, manufacturing and quality work they apply to. The clean, calibrated and qualified state is checked by the step that uses the equipment, and each configuration change is verified against the candidate before 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.

Does ValGenesis run the lab or manufacturing work?

ValGenesis sells applications for validation, cleaning validation, operational logbooks, process risk assessment in development and continued process verification, and integrates them with the LIMS, MES, ERP and QMS where batches are made and tested. In Seal, process development, the laboratory, manufacturing, batch release and quality run on the same platform as validation, so the clean, calibrated and qualified state is checked by the step that uses the equipment.

How does ValGenesis’s AI compare with Neil?

ValGenesis announced VAL, now its AI agent, in March 2025 and a next generation in April 2026. ValGenesis says VAL authors validation content, examines it for issues, analyses execution evidence, maintains traceability, compares changes and summarises, within its Validation Lifecycle Suite. Neil prepares changes to the process itself, Seal’s configuration, with the verification cases your team checks and approves under change control. Neil is not used in GMP execution.

How does Seal handle cleaning validation?

In Seal, the limit calculation, the executed clean, the hold times and the swab results are linked records, and the production step checks the equipment’s clean state before use. A change to a toxicological input, the procedure or a surface area identifies the calculations, studies and scheduled campaigns it affects.

Can Seal work alongside ValGenesis?

Yes. Seal has no dedicated ValGenesis connector, but its REST API and Scripts can connect a system that is not on its integrations list. Teams start one process in Seal with read access while ValGenesis keeps existing packages, and treat any write to ValGenesis as a separate decision with its own controls.

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 ValGenesis VLMS.

Start with one process, such as one shared equipment train or one release-test limit. Existing ValGenesis 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.

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