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AssurX tracks corrective actions. Seal runs the work they come from.

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 AssurX.

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Where AssurX falls short.

From AssurX’s own pages and its services brochure.

  • Once purchased
    A Professional Services expert
    Before configuration
    A blueprint, peer-reviewed
    Pre-configured solutions
    “will likely require some level of modification”
    Seal
    Neil, then your approval

    Configured by a services team.

    Once you buy AssurX, you are assigned a Professional Services expert, and a blueprint details how the system will be built. In Seal, Neil configures the first process from your procedure, and your team approves it.

    AssurX, Professional Services brochure
  • Batch records
    Through MES or ERP
    Laboratory results
    Through LIMS
    Seal
    One set of records

    The batch is in another system.

    AssurX reaches manufacturing and laboratory records through integrations with ERP, PLM, MES and LIMS. In Seal, the lab, the batch and quality are one set of records.

    AssurX, Integration Services, May 2026
  • 1998
    Architected
    2000, CATSWeb
    Corrective action tracking
    Since
    “built on that foundation”

    A corrective action tracker, extended.

    AssurX launched CATSWeb in 2000 as a Corrective Action Tracking System, and says it has “built on that foundation ever since”. In Seal, your team composes record types, their relationships, steps and checks.

    AssurX, About AssurX, May 2026
  • Izzy, version 1.0
    Answers how-to questions
    Trained on
    AssurX’s own guides
    Neil
    Drafts the change

    Its AI reads the manual. Neil does the paperwork.

    AssurX’s AI, Izzy, was at version 1.0 in January 2026, trained on its user guides, configuration guides and troubleshooting content. Neil prepares the change itself and the paperwork around it, for your team to approve.

    AssurX, January 2026

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

AssurX and Seal, side by side.

Every source is listed under References.

AssurXSeal
What it isQuality and compliance software, launched in 2000¹The GxP execution system, with a complete QMS built in
Built forLife sciences, manufacturing, energy, government¹Devices, diagnostics, drugs, biologics
Data modelThe quality record, in configured forms and workflows²Primitives your team composes: record types, their relationships, steps and checks
AIIzzy, at version 1.0, trained on its guides; IMDRF coding³⁴Neil, Seal’s AI agent, prepares changes to the process; your team approves them
Who configures itAssurX expert to a blueprint, or your administrators after its courses⁵⁶Your team, with Neil able to prepare each change
A complaintIntake, review, tasks and sub-tasks⁷A record for each open question
The batch behind itThrough ERP, MES or LIMS links⁸On the same platform, linked
Laboratory and batch recordsIntegrated from other systems⁸LIMS, ELN and batch records in Seal
Getting startedPre-configured, then modified with services⁵A 48-hour evaluation of one process, once the scope is agreed and the inputs received

Summary

The story
AssurX is good for corrective action tracking across regulated industries. It began in 1993, and launched CATSWeb in 2000 as a corrective action tracking system,⁹¹ and it sells today to industries from devices and pharmaceuticals to aerospace, government and energy.¹ AssurX says “No other system is easier to deploy, configure, and modify”,² yet its brochure assigns each customer a Professional Services expert, blueprints the build and says its pre-configured solutions “will likely require some level of modification”.⁵ Manufacturing, laboratory and product records stay in other systems, reached through integrations.⁸ Its AI tool, Izzy, was at version 1.0 in January 2026, trained on its own user and configuration guides,³ and in 2024 it described AI that generates IMDRF codes.⁴ If quality is a function of its own, joined to other systems by interfaces, it can work well. Most teams need the deviation, the batch and the test on the same records.

1What AssurX offers.

AssurX, once Intuitive Data Solutions, says it architected its product in 1998 and launched it as CATSWeb in March 2000, promoted as a Corrective Action Tracking System, and that it now sells a full enterprise QMS and compliance system.¹ Its customers run “From medical device, pharma, biotech, food and cosmetics to electronics, aerospace, government, energy & utilities and general manufacturing”.¹ It offers pre-configured workflows from day one,¹⁰ in the cloud or on-premise,² and professional services for implementation, validation, integration, go-live and process documentation.¹¹

2Running Seal alongside AssurX.

Teams usually move to Seal one process at a time. There is no dedicated AssurX connector on Seal’s integrations list; the route is Seal’s REST API and Scripts, and Seal can review AssurX’s web services and open API with you.² Another system can write to Seal through its API under agreed credentials, direction and failure handling, or a Script, versioned Python in Seal, can call the other system’s API after an event or on a schedule. Scripts are tested and published through a change.

Decide first which system owns each record and how status crosses the boundary. A manufacturing or laboratory process can run in Seal from day one, answering the batch questions a complaint raises from Seal’s own records, while complaints follow one type at a time. Start with read access, treat any write-back as a separate decision, and qualify the connection with the identifiers, mappings and reconciliation checks in the regulatory guide.

3Moving from AssurX to Seal.

Start with one complaint type, so nothing else has to move on day one.

  1. Choose a complaint type whose investigations depend on batch and laboratory records.
  2. Bring the procedure, a representative report and the records it touches. Start with sample material, or arrange an NDA before sharing your own.
  3. Neil prepares the intake, the separate follow-ups and their review states from that material, and your team inspects them against how the work should run. 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. Test the cases that matter: a report with several concerns, a missing lot or serial, a product that cannot be returned, new facts after a decision, and a closure attempted while an assessment is open.
  5. Agree which records move and which stay retrievable in AssurX. Within that scope, relationships, attachments, versions and available audit context are preserved, and representative records are reconciled before you rely on the new workflow.

Retention obligations continue for the records that stay in AssurX. The complaint handling and CAPA blueprints show the workflows in detail.

References

  1. 1About AssurX, AssurX, as archived on 18 May 2026. https://web.archive.org/web/20260518034121/https://www.assurx.com/assurx/ (read 5 November 2026)
  2. 2Enterprise Quality Management Software, AssurX, as archived on 9 June 2026. https://web.archive.org/web/20260609152452/https://www.assurx.com/enterprise-quality-management-software/ (read 5 November 2026)
  3. 3Meet Stephanie Ojeda, AssurX’s new VP of Product Management, Life Sciences and Manufacturing, AssurX, 20 January 2026, as archived on 12 February 2026. https://web.archive.org/web/20260212092115/https://www.assurx.com/meet-stephanie-ojeda-assurxs-new-vp-of-product-management-life-sciences-and-manufacturing/ (read 5 November 2026)
  4. 4AI Powered Transformation: Elevating User Experience and Compliance in Quality Management, Axendia, 30 July 2024. https://axendia.com/blog/2024/07/30/ai-powered-transformation-elevating-user-experience-and-compliance-in-quality-management (read 5 November 2026)
  5. 5Professional Services brochure, AssurX. https://www.assurx.com/wp-content/uploads/resources/brochures/assurx-services-brochure.pdf (read 5 November 2026)
  6. 6Training, AssurX, as archived on 9 May 2026. https://web.archive.org/web/20260509204604/https://www.assurx.com/training/ (read 5 November 2026)
  7. 7Complaint Management Software, AssurX, as archived on 11 June 2026. https://web.archive.org/web/20260611001149/https://www.assurx.com/complaint-management-software/ (read 5 November 2026)
  8. 8Integration Services, AssurX, as archived on 18 May 2026. https://web.archive.org/web/20260518033643/https://www.assurx.com/integration/ (read 5 November 2026)
  9. 9AssurX, Inc. company profile, Pharmaceutical Online, 16 March 2001. https://www.pharmaceuticalonline.com/doc/assurx-inc-0001 (read 5 November 2026)
  10. 10AssurX home page, AssurX, as archived on 11 October 2026. https://web.archive.org/web/20261011175647/https://www.assurx.com/ (read 5 November 2026)
  11. 11Professional Services, AssurX, as archived on 18 May 2026. https://web.archive.org/web/20260518035538/https://www.assurx.com/professional-services/ (read 5 November 2026)

AQuestions and answers

Is Seal better than AssurX?

Yes. AssurX is good for corrective action tracking across regulated industries. It began in 1993, and launched CATSWeb in 2000 as a corrective action tracking system, and it sells today to industries from devices and pharmaceuticals to aerospace, government and energy. AssurX says “No other system is easier to deploy, configure, and modify”, yet its brochure assigns each customer a Professional Services expert, blueprints the build and says its pre-configured solutions “will likely require some level of modification”. Manufacturing, laboratory and product records stay in other systems, reached through integrations. Its AI tool, Izzy, was at version 1.0 in January 2026, trained on its own user and configuration guides, and in 2024 it described AI that generates IMDRF codes. If quality is a function of its own, joined to other systems by interfaces, it can work well. Most teams need the deviation, the batch and the test 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, Skye Biologics cut non-conformances by 40%, with training checked before execution.

Is Seal an alternative to AssurX?

Yes. Seal covers the quality processes AssurX runs, including complaints, CAPA, deviations, nonconformances, change control, documents, training and audits, and runs them on the same platform as your laboratory results and batch records. A complaint in Seal links to the batch once its identity is confirmed, and a corrective action is released as a verified change to the workflow.

Who configures AssurX and who configures Seal?

AssurX assigns each customer a Professional Services expert who blueprints the system, configures it to that plan and manages later enhancements, sells migration and upgrade services, and sells configuration courses so that customers can become self-sufficient. In Seal, your own team configures the system from your procedures: Neil prepares each change, your team approves it, and selected tests run before it is published.

Can Seal work alongside AssurX?

Yes. Seal has no dedicated AssurX connector, but AssurX provides web services and an open API, and Seal’s REST API and Scripts can connect the two, starting with read access. Teams can move one complaint type or one laboratory or manufacturing process to Seal first and bring the rest across over time.

How does Seal handle medical device reportability?

Each complaint has a reportability assessment that records the criteria applied, the facts known and still missing, and the reviewer’s rationale for each jurisdiction in scope. When new facts arrive it is revised, and the earlier decision stays in its history.

Is Seal a LIMS and MES as well as a QMS?

Yes. Seal runs LIMS, ELN, electronic batch records and device history records on the same platform as its QMS, so a complaint, deviation or CAPA links to the batch, serial and laboratory results it concerns. Paradromics runs manufacturing execution and quality management for its implantable device in Seal.

Does AssurX hold batch and laboratory records?

AssurX is designed for quality management and regulatory compliance, and it reaches the batch, its laboratory results and its manufacturing history through integrations with ERP, PLM, MES and LIMS systems. In Seal, a complaint links to the batch, its laboratory results, its deviations and its release on one platform, so the investigation starts from those records rather than from an interface to another system.

How does AssurX’s AI compare with Neil?

In January 2026 AssurX described its AI tool, Izzy, at version 1.0, trained on its user, configuration and troubleshooting guides. In 2024 it described AI that generates IMDRF codes for device complaints, with corrective action, complaints and audits on a roadmap. Neil prepares changes to the process itself, with their tests, for your approval, and each change is released as a new version. Neil is not used in GMP execution.

How long does it take to start with Seal?

For one complaint type, Seal prepares a first working process, configured from your complaint procedure, and its validation pack to evaluate within 48 hours of agreeing the scope and receiving the inputs. Production timing then depends on scope, interfaces, migration and your release requirements.

Start beside AssurX.

Start with one complaint type. Seal’s REST API and Scripts can read from AssurX’s web services and open API, so nothing has to move on day one.

Book a demo