Seal vs AssurX

1AssurX and Seal, side by side.

AssurX and Seal both run complaints, investigations and CAPA through configured workflows, and both can sit beside your ERP, MES and LIMS. AssurX is a quality management and regulatory compliance platform whose workflows of tasks, alerts, escalations and approvals are configured to map to how a business operates, in AssurX’s cloud or on premises.¹ In Seal, teams configure laboratory, manufacturing and quality workflows on one platform around a shared ontology, so a complaint, the batch it names and that batch’s records are connected.

2What AssurX is built for.

AssurX is built for regulated companies that want one configurable platform for their quality and compliance processes, with the vendor’s implementation and validation services alongside. The company began as Intuitive Data Solutions; its founders renamed it AssurX and incorporated it in California in March 2000, the month its web-native software launched. That software began as CATSWeb, promoted as a corrective action tracking system, and AssurX says today’s software incorporates CATSWeb’s features within a full enterprise QMS.² Tamar June is president and chief executive, and co-founder Sal Lucido is chief product officer.³

AssurX serves medical device, pharmaceutical, biotechnology, food, cosmetics, electronics, aerospace, government, energy and utilities and general manufacturing companies.² Alongside the quality platform it sells the AssurX Energy Compliance System (ECOS) for NERC and regional standards.⁴ Its workflows come pre-configured, and AssurX says all its solutions come pre-validated with complete documentation.⁴ EyePoint Pharmaceuticals, for example, moved from separate document and training systems to AssurX for document management, training, supplier quality, CAPA and audits.⁵

The same software runs in AssurX’s single-instance, multi-tenant cloud or on premises, from one code base, and the on-premises option is designed for strict isolation requirements, including air-gapped deployments.¹ The cloud is hosted in a private cloud at Switch, and AssurX is certified to ISO 27001:2022 and SOC 2 Type 2 compliant.² AssurX provides web services and an open API for integration,¹ and lists integrations with SAP, Salesforce, Oracle, PTC Windchill and MES systems.⁶ Its AI assistant, Izzy, was at version 1.0 in January 2026: trained on AssurX’s user, configuration and troubleshooting guides, it answers how-to questions, and AssurX plans later versions that work with customers’ own documents and data.⁷

3How a complaint becomes an investigation.

Both products take a complaint from intake to closure under configured rules. AssurX moves a complaint through intake, review and investigation, with tasks and sub-tasks beneath it; Seal gives each question a report raises its own record, all pointing to the report as it was received.

AssurX’s complaint management standardises intake forms, triage and routing, with pre-configured categories to prioritise severity. Review establishes whether a complaint is valid and whether it is reportable, valid complaints are prioritised by risk for investigation, and workflow rules move the complaint through tasks and sub-tasks to manage deviations and nonconformances. Configurable decision trees set the enforcement path, including launching corrective actions and submitting regulatory reports.⁸ For devices, AssurX eMDR generates MedWatch 3500A reports, including five-day, 30-day and follow-up reports, submits them directly to FDA’s Electronic Submissions Gateway through WebTrader or AS2, and attaches the acknowledgements to the MedWatch record as they arrive.⁹

In Seal, the report is kept as it was received, and the work it creates is separate. In the example in Seal’s complaint handling blueprint, report INT-031 says a device stopped during use, the patient needed assistance and the packaging has gone; no lot or serial was supplied. Three records point to INT-031 v1, each with its own owner and state: the technical investigation INV-031, the request for the product’s identity REQ-031 and the safety assessment SAFE-031. Finishing one does not close the others. The reportability assessment MDR-031 records the criteria applied, the facts known, what is still missing, here the patient outcome and the device’s identity, and the reviewer’s rationale. When new facts arrive it is revised, and the earlier decision stays in its history.

The lot is never inferred from a similar complaint. Once REQ-031 confirms it, INT-031 links to the batch, its records, the deviations on that batch, its release and its distribution on the same platform, so the investigation starts from those records rather than from exports. Trends compare complaints with the population exposed: in the blueprint’s TRD-012, the same 12 reports in two quarters show a rate per 1,000 units shipped rising from 2.0 to 3.0.

4Validation packages and tests that run with each change.

Both vendors take a risk-based view of validation. AssurX supplies validation packages, services and test automation for the platform as configured; Seal runs selected acceptance tests on each change before it can be published.

AssurX’s Validation Management Services assess business and system requirements, environment and architecture to create validation packages for 21 CFR Part 11, EU Annex 11, ISO 13485 and other requirements. In response to FDA’s shift to computer software assurance, AssurX has developed a risk-based model that supports GAMP 5; its packages include pre- and post-environment validation for intended use, and its validation team works independently of implementation.¹⁰ AutoValidator is a record-and-playback testing tool for reusable test scripts,¹¹ and the Validation Management Solution automates user and functional requirement specifications, risk assessments, a requirement traceability matrix, test protocols and the validation summary.¹²

In Seal, requirements and specifications are controlled records linked to the configuration and its tests. When a changeset is prepared for review, its selected user acceptance tests run in a background simulation, and publication requires current passing results for the required tests; missing or stale results are not run automatically. A reviewable result names the test version, configuration, environment, input data, expected and actual outcome, execution time and runner. The same applies to the complaint workflow itself: a changed triage rule or closure gate carries its own verification. An automated check supports your team’s release decision; it does not make it.

In an evaluation, ask each vendor to change one complaint triage rule after go-live and show the evidence that remains afterwards.

5Where AssurX is the better fit.

AssurX is the better fit when you want a long-established, configurable platform across several regulated businesses, with device reporting and deployment choices built in.

• You manufacture medical devices and want MedWatch reports submitted to FDA’s gateway, with their acknowledgements, from inside the quality system.⁹
• You need an on-premises or air-gapped deployment, or want to move between cloud and on-premises on the same software.¹²
• You run an energy or utility business and want NERC compliance management from the same vendor.⁴
• You operate across several regulated industries and want one quality system for all of them.²
• You want validation services from a team separate from implementation, with record-and-playback test automation.¹⁰¹¹

6Where Seal is the better fit.

Seal is the better fit when a complaint should lead straight to the batch, the laboratory evidence and the change it needs.

• You want each complaint linked to the batch, its laboratory results, its deviations and its release on one platform, through a shared ontology in which a sample belongs to a batch and a result comes from a test.
• You want each question a complaint raises owned and closed separately, with missing facts kept unknown until a source confirms them.
• You want trends read against the population exposed, with the definition of each trend versioned.
• You want a corrective action released as a verified change to the workflow, with its effectiveness read against the complaints that follow.
• You want Neil to prepare the follow-up: the linked requests and investigation tasks for a report, comparable complaints with their differences, and the configured intake workflow with its verification cases. Nothing it prepares takes effect until a qualified person has reviewed it. 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 AssurX.

There is no dedicated AssurX connector on Seal’s integrations list. The general route is Seal’s REST API and Scripts, and Seal can review AssurX’s web services and open API with you.¹ Data can reach Seal in two ways: another system writes it through Seal’s API, under agreed credentials, direction and failure handling, or a Script, versioned Python in Seal, calls the other system’s API after an event or on a schedule. Scripts are tested and published through a changeset.

Decide first which system owns the complaint record and how status crosses the boundary. One workable split keeps AssurX as the complaint system of record, including its eMDR submissions, while a manufacturing or laboratory process runs in Seal and the batch questions a complaint raises are answered from Seal’s records. Start with read access, treat any write-back as a separate decision, and qualify the connection against the source with the identifiers, mappings and reconciliation checks in the regulatory guide.

8Moving from AssurX to Seal.

Move one complaint type first, and keep AssurX for the rest.

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. Within 48 hours of the agreed scope and inputs, Seal has the first working process and its supporting validation pack ready to inspect; production release follows your intended-use assessment and quality controls.
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.