Seal vs QT9 QMS

1QT9 QMS and Seal, side by side.

QT9 QMS and Seal both connect quality records to production and inventory, and both treat traceability as the test of a recall. QT9 QMS offers 28 or more modules, and with QT9 ERP it links nonconformances, deviations and corrective actions to jobs, inventory and production data.¹² In Seal, teams configure laboratory, manufacturing and quality workflows on one platform around a shared ontology, so a recall’s scope is derived from the genealogy of the lots and the records of where they went.

2What QT9 QMS is built for.

QT9 QMS is built for regulated manufacturers that want a broad quality system, with every module included and the validation done by the vendor. QT9 Software has served regulated manufacturers since 2005; its founder, Brant Engelhart, is chief executive, and the company has more than 60 team members.³ It reports more than 1,200 customers in industries from aerospace and automotive to food, medical devices and pharmaceuticals,⁴ with offices in Aurora, Illinois, in Ireland and in Australia.⁵

The modules include document control, audits, risk, CAPA, nonconforming products, quality events, supplier evaluations and a supplier portal, customer feedback and a customer portal, employee training, preventive maintenance, calibrations, change control, management review, product design controls, engineering change orders, inspections, deviations and FMEA.¹ QT9 says all 28 or more modules are included, implementation is completed within 30 days, and the QMS runs in the cloud, on premises or as a hybrid, with hosting in the US or Europe.⁶ Rules, fields and approvals are configured without code, and the platform offers full API access.⁷ QT9 develops annual upgrades, driven by user feedback and changes in regulatory standards.³

For production, QT9 ERP, available in the US and Canada, keeps jobs, inventory and supplier records in step with the QMS, links nonconformances, deviations and corrective actions to jobs and inventory items, and creates electronic batch records and device history records.² For pharmaceutical manufacturers, QT9 describes linking deviations, investigations and batch release, and supporting ISO 17025 laboratories with calibration and test method controls.⁸

3How a recall reaches the affected population.

Both products help a quality team find the product a problem touched. QT9 describes traceability as a timeline of actions and records; Seal keeps the recall as one case, with its scope derived from genealogy and every consignee tracked to closure.

QT9 says its timeline traceability tracks every action, change and event, supports inspections, audits and product recalls, and makes it easier to trace defective batches for targeted recalls; it invites manufacturers to test how quickly they can trace products in a recall scenario.⁴⁶ With QT9 ERP, purchase-order receiving can generate the matching inspection record, and reports draw on linked ERP and QMS data to show traceability across products, jobs and quality events.²

In Seal, the recall connects the signal, the health-hazard evaluation, genealogy, distribution, consignee responses and reconciliation in one case. In the example in Seal’s recall blueprint, market action RA-024 is on scope version 3: three lots and 18,420 units, with lot L2403 excluded through filter lineage, so the reason it is out of scope stays on record. All 42 direct consignees have been notified, and 5,376 units, 3 consignees and 4 checks remain open before termination. Each consignee is a tracked obligation, from notification and acknowledgement to stock on hand, returns and closure, and distributed, returned, corrected, destroyed and unaccounted quantities form a running balance rather than a figure recounted for each status report.

The scope comes from genealogy rather than from a shipment list. Materials, intermediates, packaging orders, labels and released inventory trace forward and backward, so a scope can separate units made before and after an equipment intervention or an artwork change, and widening or narrowing it records the evidence, approver and time. Effectiveness checks are designed before they begin, and termination rests on evidence, such as recovery, correction, reconciliation and disposition, not on elapsed time.

A mock recall is the fairest test of either system: start from a supplier defect affecting part of several lots, and see whether the scope, the consignees and the open quantities can be explained at each step.

4Pre-validated modules and a validated configuration.

QT9 validates its software for you; in Seal, the configured process carries its own validation evidence as it changes.

QT9 describes a fully pre-validated environment, with every module and global feature taken through step-by-step validation, so customers do not have to carry that work themselves.⁶ It executes the installation, operational and performance qualification protocols, and describes continuous validation and updates as regulations and processes evolve.⁴

Seal’s regulatory guide sets three boundaries for assurance. For the managed platform, your team reviews Seal’s development, verification and release evidence for the version in scope and reuses it where its assessment supports. For your configured process, your team defines the intended use, requirements and failure consequences and verifies the workflows, calculations, permissions and approvals it will rely on, in proportion to risk. Scripts, integrations, instruments and migrated data are assessed within their actual operating boundary. Requirements and specifications can live in the platform, linked to the configuration, and when a changeset is prepared for review its selected acceptance tests run; publication requires current passing results. A change to the recall workflow itself, such as a new effectiveness-check rule, is released the same way. The regulatory guide sets out the approach.

5Where QT9 QMS is the better fit.

QT9 is the better fit when you want a broad, pre-validated QMS running quickly across a manufacturing business.

• You want every quality module, from document control to calibration and FMEA, in one system that QT9 has already validated.⁶¹
• You want to be live within about a month.⁶
• You work across several manufacturing industries, such as plastics, metals or electronics as well as medical devices or pharmaceuticals.⁴
• You want QMS and ERP from the same vendor in the US or Canada, with nonconformances linked to jobs and inventory.²
• You need on-premises or hybrid deployment, or hosting in Europe.⁶
• You want customer, supplier and employee portals inside the quality system.⁴

6Where Seal is the better fit.

Seal is the better fit when the question after a defect is exactly which product, where, and whether it was controlled.

• You want a recall’s scope derived from batch genealogy, with every inclusion and exclusion justified, and each consignee tracked from notification to closure.
• You want the complaint, the batch, its laboratory results and its shipments on connected records, so an investigation and a recall start from the same facts.
• You want quantities reconciled as a running balance and termination decided on evidence.
• You want corrective actions to change the configured process itself, each change carrying its specifications, test evidence and approvals.
• You want Neil to prepare the work: the evidence for an investigation across records and connected systems, and the configured change with its verification. Neil never releases a change itself, and AI can be switched off for the whole organisation. 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.

7Running Seal alongside QT9 QMS.

You can start with one process beside QT9. 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 the interfaces with you. On its side, QT9 offers full API access.⁷

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 QT9’s API on a schedule or after an event, and change only through a tested changeset. 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. 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.

8Moving from QT9 QMS to Seal.

Begin with one difficult scenario run as a mock recall, and keep QT9 for the rest.

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. Seal prepares the working process and its supporting validation pack within 48 hours once scope and inputs are settled; 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.