Seal vs Qualio

1Qualio and Seal, side by side.

Qualio and Seal are both cloud systems for regulated life sciences teams, and both keep documents, training, events and change control connected. They differ in what they hold. Qualio is a quality management and compliance platform that keeps the quality system’s documents, events, training and evidence, and uses AI to map that evidence against regulatory frameworks.¹ In Seal, teams configure lab, manufacturing and quality workflows on one platform around a shared ontology, so the procedure, the step that executes it and the qualification it requires can change together.

2What Qualio is built for.

Qualio is built for life sciences companies that want quality management and regulatory compliance in one cloud system that a small quality team can run. Qualio, founded by its chief executive Robert Fenton and based in San Francisco, describes itself as a life sciences governance, risk and compliance platform for biopharma, medtech and diagnostics companies, connecting quality, regulatory and product development.²¹ It offers solutions for medical devices, pharmaceuticals, biotech, software as a medical device, contract research organisations and cannabis.³

The platform covers document management, design controls, risk management against ISO 14971 and ICH Q9, training, change control, audits, CAPA and nonconformances, suppliers and analytics.⁴ For pharmaceutical teams, Qualio describes CAPA, deviation and OOS tasks, periodic review cadences and pharmacovigilance event reporting.⁵ More than 20 self-serve integrations connect it to tools such as Jira, Azure DevOps, GitHub and TestRail for design controls, Zendesk, Salesforce and HubSpot for complaints, and ComplianceWire for training. A Resource Library imports reference data such as batch numbers, equipment, customers and products, so events can be linked to them.⁶ Its Developer API gives token-based, programmatic access to documents, events, training, users and other resources.⁷

Qualio’s AI centres on compliance. Compliance Intelligence, generally available since October 2025, scans the QMS and connected data, maps evidence to regulatory requirements and flags gaps, monitors compliance continuously and guides remediation. Its frameworks include the FDA QMSR, ISO 13485, ISO 9001, ISO 27001 and MDSAP, alongside custom frameworks.¹ Qualio describes these as AI agents that monitor regulatory changes, run gap analyses and execute quality workflows, with humans always in the loop.⁸

3How a procedure change reaches the people doing the work.

Both products connect a procedure change to training. In Qualio, the change updates the training assignments; in Seal, the change can also update what a person is allowed to do at the step.

In Qualio, change control tracks each change and connects it to the documents, training and CAPAs it affects, so changes driven by a complaint or an audit finding can be shown to auditors.⁹ When a record changes, affected training assignments update automatically. Training is assigned by role, bundled into training plans for groups and departments, and routed so that only those who need training on a new procedure are notified, with Part 11 and Annex 11 compliant e-signatures.¹⁰

In Seal, qualification belongs to the work a person will perform. In the example in Seal’s training blueprint, method AM-014 is at v04. J. Patel is authorised for AM-014 but not AM-022, and M. Chen the reverse. M. Chen’s acknowledgement of AM-014 is still on v03, and the revision-impact assessment calls for reassessment. A. Lewis has acknowledged AM-014 but has no recorded practical assessment. A completion tick would not separate these cases; a record of scope shows who may run which method today.

The change record decides the response for each affected role and task: no training, awareness, read-and-understand, a knowledge check, a practical demonstration or requalification. Where the workflow is configured with a training prerequisite, a person without the current qualification cannot complete the step that depends on it, and historical work keeps the version and authorisation that applied when it was done. The document control blueprint follows a procedure revision through approval, training and effectiveness.

4How each approaches validation.

Both vendors take a risk-based, computer software assurance approach. They differ because they validate different things.

Qualio describes its validation as computer software assurance rather than traditional computer system validation, based on FDA and ISPE GAMP guidance. It treats its eQMS as a low-risk system that is not part of the product, weaves assurance tasks into onboarding with templates and automated document packs, and refreshes the assurance packs with each new release. Responsibility is divided between the vendor, for the system, and the customer, for the configuration, and Qualio says its approach was reviewed and approved by the editor of GAMP 5.¹¹ It says only 1% of its customers choose to validate the system themselves.³

In Seal, the depth of assurance follows the intended use. Where a Seal workflow runs a batch step or a release test, the configured process is part of how the product is made or tested, so your team defines its requirements and failure consequences and verifies the workflows, calculations, permissions and approvals it will rely on. The URS, FS, DS and configuration specification are kept in the platform, and when a changeset is prepared for review its selected user acceptance tests run; publication requires current passing results for the required tests. Earlier runs keep the version they used. The regulatory guide sets out the approach.

5Where Qualio is the better fit.

Qualio is the better fit for growing life sciences companies that want an accessible quality system, quickly, with the vendor carrying most of the validation.

• You are setting up your first electronic QMS, moving from paper, or working towards ISO certification or FDA clearance.³
• You develop software as a medical device and want design controls fed from Jira, Azure DevOps, GitHub or TestRail.⁶
• You need gap analysis across several frameworks at once, such as the FDA QMSR, ISO 13485, ISO 27001 and MDSAP.¹
• You want the vendor to supply validation templates and refresh its assurance packs at each release.¹¹
• Your quality work centres on documents, training, events and suppliers, and you want complaints raised from tools such as Zendesk or Salesforce.⁶

6Where Seal is the better fit.

Seal is the better fit when quality should change how the work itself runs, across laboratory, manufacturing and quality.

• You want laboratory, manufacturing and quality work on one set of records. In Seal they use a shared ontology: a sample belongs to a batch, a result comes from a test, and an investigation links to the affected work.
• You want qualification checked at the point of work, so a step can require current training for the procedure version it runs.
• You want a corrective action released as a verified change to the workflow, with its effectiveness measured on the runs that follow.
• You expect to keep changing the process. Each improvement becomes a new process version with its specifications, test evidence and approvals, and earlier runs keep the version they used.
• You want an AI agent that configures the work. Neil configures the workflow from your procedure, assembles investigation evidence and drafts the configured change with its verification. It works within the requester’s permissions, never releases a change on its own, 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 Qualio.

You do not need to replace Qualio to start. Seal’s Qualio connection is set up per project on Qualio’s Developer API, using an administrator-issued token and the permitted resources, after confirming endpoint access and account requirements. In scope are the documents, events, suppliers, users and training data available through the Developer API. Start with read access; any change in Qualio needs separately configured actions and controls.

Once API access and mappings are configured, Neil can:

• identify the training and quality-event context for a changed procedure;
• bring supplier records and related quality events into a supplier review draft;
• review the exposed event and training status fields and prepare an action summary for each owner.

Each connection’s scope also records which system stays the source of truth. For example, Qualio can remain the home of the quality manual, procedures and training records while one laboratory or manufacturing process runs in Seal and reads the documents it needs.

8Moving from Qualio to Seal.

Move one process first, and keep Qualio for the rest until you decide otherwise.

1. Choose a process where a procedure change has to reach the work, such as a test method that needs a practical assessment, or a step that should be blocked without current training.
2. Bring the procedure, the roles that perform it, a representative record and the training evidence behind it. Start with sample material, or arrange an NDA before sharing confidential records.
3. Neil proposes the workflow from that procedure, including the qualification checks, and your quality team checks it against how the work runs. Once the scope is agreed and the inputs received, Seal prepares the first working process and its validation pack within 48 hours. Production timing then depends on scope, interfaces, migration and your release requirements.
4. Connect Qualio read-only for the documents and training records the process needs, and exercise the blocked paths: a superseded procedure, a missing assessment and an expired qualification.
5. Agree which records move and which stay retrievable in Qualio. Within that scope, relationships, attachments, versions and available audit context are preserved, and representative records are reconciled and retrieval verified before you rely on the new workflow. Procedures can be imported in bulk as PDFs and converted to structured Seal documents as they are revised.

Retention obligations continue for the records that stay in Qualio. The training and document control blueprints show those workflows in detail.