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QT9 takes quality records off spreadsheets. Seal runs the work they record.

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 QT9 QMS.

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Where QT9 QMS falls short.

From QT9’s own pages and its reviewers on G2.

  • QT9’s own claim
    30 days
    G2’s average
    3 months
    Seal, a first process
    48 hours

    Three months to go live.

    QT9 says implementation is completed within 30 days; G2 lists the average time to implement as three months. Seal has a first process working for you to evaluate within 48 hours, once the scope is agreed and the inputs received.

    G2, October 2026
  • A device reviewer
    “fairly basic”
    Another reviewer
    “not met, notably for CAPA”
    A third
    “some limitations in how much customization”

    A CAPA module reviewers call basic.

    On G2, a device reviewer calls QT9’s CAPA module “fairly basic”, and another finds some ISO 13485 best practices “not met, notably for CAPA”. In Seal, Neil configures the first process from your procedure, and your team approves it.

    G2, October 2026
  • 2008
    10 ISO modules
    Today
    28+ standard modules

    ISO paperwork, made electronic.

    In 2008 QT9 made the “paper pushing” of an ISO quality system electronic, in ten modules; today it sells 28 or more standard modules. In Seal, your team composes record types, their relationships, steps and checks.

    QT9, August 2008
  • Quality
    QT9 QMS
    Batch records
    QT9 ERP
    QT9 ERP
    US and Canada only

    Batch records in a second product.

    QT9’s electronic batch and device history records come through QT9 ERP, a second product, available only in the United States and Canada. In Seal, the batch, the lab and quality are one set of records.

    QT9 Software, QT9 ERP
  • Calibrations
    A QT9 module
    LIMS
    Not on the list
    ELN
    Not on the list

    No LIMS among its modules.

    For laboratories QT9 offers calibration and test method controls, and its list of QMS modules names no LIMS or ELN. In Seal, the lab, the batch and quality are one set of records.

    QT9 Software, QMS Modules

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

QT9 QMS and Seal, side by side.

Every source is listed under References.

QT9 QMSSeal
What it isQuality management software, with a separate ERP¹The GxP execution system: your eBR, your QMS and more
Built forEleven industries, aerospace to plastics²Devices, diagnostics, drugs, biologics
Data model28+ standard quality modules³Primitives your team composes: record types, their relationships, steps and checks
CAPAA standard module; a device reviewer calls it “fairly basic”⁴Configured from your procedures
Production recordsBatch and device history records through QT9 ERP¹Batch and device records, same system
LaboratoryCalibration and test method controls⁵LIMS and ELN on the same records
TraceabilityA timeline of actions, with lot and serial traceability²⁶Genealogy across lots and shipments
A recallTargeted recalls from traceability³One case from signal to termination
Getting started“Within 30 days”; three months on G2’s average³⁴A 48-hour evaluation of one process, once the scope is agreed and the inputs received

Summary

The story
QT9 QMS is good for manufacturers moving their quality records off spreadsheets.⁷ Its founder, a software developer, designed the first version himself,⁸ and in 2008 it was sold as ISO quality management software that took the paperwork of an ISO quality system electronic, in modules from document control and CAPA to audits.⁹ It has served regulated manufacturers since 2005,¹⁰ and its standard modules now number 28 and more.³ QT9 says implementation is completed within 30 days,³ yet G2 lists the average time to implement as three months, and its reviewers report limits on how far the product can easily be customised and a CAPA module too basic for managing investigations.⁴ If your processes fit its standard modules and will stay that way, it can work well. That is rare, and rarer now that the work changes so fast.

1What QT9 QMS offers.

QT9 Software reports more than 1,200 customers² and prices by concurrent licence, with training, support, upgrades and a dedicated implementation team in every quote.¹¹ It began as ISO quality management software sold by Innovative Custom Software, which in 2008 listed modules for document control, corrective and preventive actions, nonconforming products, calibrations, customer surveys, supplier evaluations, training, management review and audits.⁹ QT9 QMS now offers 28 or more standard modules, adding deviations, risk, inspections, engineering change control, design controls and others,³¹² and QT9 sells QT9 ERP beside it for jobs, inventory, and electronic batch and device history records.¹ QT9 says implementation is completed within 30 days in a pre-validated environment, with IQ, OQ and PQ executed by QT9;³² the same QMS page says implementation time varies with company size and complexity, current procedures and the internal resources dedicated to it.³

2Running Seal alongside QT9 QMS.

Teams usually move to Seal one process at a time. Seal has no dedicated QT9 connector, so the route is the one Seal uses for any system not on its integrations list: its REST API and Scripts, with Seal reviewing QT9’s available interfaces and exports with you.

Seal’s API serves systems that need to read or write Seal records, with the credentials, direction of transfer and failure handling set before go-live; Scripts, Seal’s versioned Python, can call an external system’s interface on a schedule or after an event, and change only through a tested change. For a recall, ERP, warehouse, serialisation and distributor systems can remain authoritative for their own records, and Seal does not invent distribution events that partners cannot provide; Seal owns the recall case, the population logic, the obligations, the reconciliation and the decisions. While the move is under way, QT9 can keep its quality modules and, through QT9 ERP or another ERP, the shipment records the recall reads. Start by reading, treat any write-back as a separate decision, and qualify the connection with the identifier, mapping and reconciliation checks in the regulatory guide.

3Moving from QT9 QMS to Seal.

Begin with one difficult scenario run as a mock recall.

  1. Choose a product with mixed or multi-market distribution.
  2. Bring the recall procedure, the genealogy and distribution records for a few lots, and the consignee contacts. Use sample material, or put an NDA in place before sharing your own.
  3. Neil proposes the recall workflow from the procedure: scope versions, consignee obligations, the effectiveness-check plan and the reconciliation. Once the scope is agreed and the inputs received, Seal prepares the working process and its supporting validation pack to evaluate within 48 hours; your intended-use assessment and quality controls govern production release.
  4. Rehearse the awkward branches: incomplete genealogy, a stale contact, onward distribution, a serial mismatch, a failed field correction and a scope expansion.
  5. Agree which records move and which stay retrievable in QT9. 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 QT9. The recall and complaint handling blueprints show the workflows in detail.

References

  1. 1QT9 QMS and QT9 ERP, QT9 Software. https://qt9software.com/qms/erp-software (read 5 November 2026)
  2. 2QT9 Software home page, QT9 Software. https://qt9software.com/ (read 5 November 2026)
  3. 3QT9 QMS, QT9 Software. https://qt9software.com/qms (read 5 November 2026)
  4. 4QT9 QMS reviews, G2, as archived on 12 October 2026. https://web.archive.org/web/20261012114911/https://www.g2.com/products/qt9-qms/reviews (read 5 November 2026)
  5. 5QMS Software for Pharmaceuticals, QT9 Software. https://qt9software.com/qms/industry/pharmaceutical (read 5 November 2026)
  6. 6Electronic batch record software, QT9 Software. https://qt9software.com/ebr-software (read 5 November 2026)
  7. 7QT9 Software LLM Interaction Guidelines (llms.txt), QT9 Software, last updated October 2025. https://qt9software.com/llms.txt (read 5 November 2026)
  8. 8Brant Engelhart, author page, QT9 Software Blog, QT9 Software. https://qt9software.com/blog/author/brant-engelhart (read 5 November 2026)
  9. 9QT9 ISO Quality Management Software home page, QT9 (Innovative Custom Software), as archived on 31 August 2008. https://web.archive.org/web/20080831072159/http://www.qt9software.com/ (read 5 November 2026)
  10. 10About QT9 Software, QT9 Software. https://qt9software.com/about (read 5 November 2026)
  11. 11QT9 Software Pricing, QT9 Software. https://qt9software.com/pricing (read 5 November 2026)
  12. 12QT9 QMS Modules, QT9 Software. https://qt9software.com/qms/modules (read 5 November 2026)

AQuestions and answers

Is Seal better than QT9 QMS?

Yes. QT9 QMS is good for manufacturers moving their quality records off spreadsheets. Its founder, a software developer, designed the first version himself, and in 2008 it was sold as ISO quality management software that took the paperwork of an ISO quality system electronic, in modules from document control and CAPA to audits. It has served regulated manufacturers since 2005, and its standard modules now number 28 and more. QT9 says implementation is completed within 30 days, yet G2 lists the average time to implement as three months, and its reviewers report limits on how far the product can easily be customised and a CAPA module too basic for managing investigations. If your processes fit its standard modules and will stay that way, it can work well. That is rare, and rarer now that the work changes so fast. 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 QT9 QMS?

Yes. QT9 QMS is built for quality management in any industry. Seal covers QT9’s core quality modules, including document control, CAPA, nonconformances, deviations, audits, training, suppliers, risk, design controls, calibration and maintenance, built for regulated life sciences and configured from your procedures, and runs laboratory, batch and device records on the same records. A recall’s scope is derived from the genealogy of the lots, each consignee is tracked to closure and quantities are reconciled as the action runs.

Can Seal work alongside QT9 QMS?

Yes. Seal has no dedicated QT9 connector, but Seal’s REST API and Scripts can connect the two, starting with read access, after reviewing QT9’s available interfaces and exports with you. QT9 can keep its quality modules while one process, such as recall management, runs in Seal.

Does QT9 QMS include a LIMS?

No LIMS is listed. QT9 QMS modules cover documents, quality events, suppliers, training, maintenance, calibration and design, and for laboratories QT9 offers calibration and test method controls and audit-ready lab records. In Seal, LIMS, ELN and stability run on the same records as quality and batch work, so an investigation starts from the sample, method and result behind it.

How does Seal handle a recall?

Seal keeps the recall as one case, from the signal and health-hazard evaluation through scope, consignee responses, reconciliation and termination. The scope is derived from genealogy, with each inclusion and exclusion justified, and termination rests on evidence rather than elapsed time.

Does QT9 QMS keep batch records?

Through QT9 ERP. QT9 sells electronic batch and master batch records, and device history records, through its separate QT9 ERP integrated with QT9 QMS, and QT9 ERP is available only in the United States and Canada. Seal runs batch and device records itself, on the same records as quality and the laboratory, and connects to ERP systems such as SAP, NetSuite, Oracle Fusion and Dynamics 365.

How long does it take to start with Seal?

For a recall workflow rehearsed as a mock recall, Seal prepares a first working process, configured from your recall procedure, and its supporting 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 QT9 QMS.

Start with one process, such as a mock recall. Seal’s REST API and Scripts read what it needs from QT9, so nothing has to move on day one.

Book a demo