Qualio

Qualio helps life sciences organizations run quality, manage regulated product lifecycle work, and prove compliance with a connected system that links quality, product, and compliance activities.

The platform centers on “Compliance Intelligence,” where AI assesses records clause-by-clause, identifies gaps, and drafts suggested fixes such as procedures, change controls, or CAPAs—citing the relevant clause and evidence. Risk alerts and board-ready views help teams prioritize remediation and stay audit-ready as work progresses.

Qualio also supports key quality management workflows and regulated lifecycle needs in one place, including QMS maturity evaluation, controls and requirement mapping, and audit-focused navigation between processes. When records change, the automated assessment reruns, keeping recommendations and audit evidence aligned with the latest approved work.

Qualio is built for quality, regulatory, and engineering teams, with outputs designed to be approval-gated so human reviewers remain in control. It connects with tools teams already use via integrations and APIs, linking requirements and tests from Jira, GitHub, and Azure DevOps-style workflows, and importing documents maintained in systems such as SharePoint. For pricing, demo availability is provided, and teams can request a demo to discuss options.

What does Qualio help life sciences teams do?

Qualio helps teams run quality and regulated product lifecycle work while staying audit-ready by connecting evidence, requirements, and controls into one system and using AI to assess and surface gaps.

How does Qualio perform gap analysis and compliance assessment?

Qualio’s AI assesses records clause by clause, provides recommendations for each gap, and drafts proposed fixes (such as procedures, change controls, or CAPAs) with cited clauses and evidence. When records change, the assessment can rerun.

Can teams keep working in their existing engineering tools?

Yes. Qualio is designed to sit on top of work in tools where engineers already work, such as Jira and GitHub, and rebuilds traceability so teams can keep their workflows while the compliance proof stays current.

How does Qualio handle review and approval?

Qualio’s AI outputs are approval-gated, with human approvals recorded along with who approved, when, and on what evidence—so nothing enters the quality system without review.

Which quality and compliance workflows are supported?

Qualio supports quality management and regulated product lifecycle workflows such as document control, training, CAPA, change control, supplier quality, QMS maturity evaluation, controls and requirement mapping, and audit-focused navigation across processes.

How do I find pricing for Qualio?

Pricing details aren’t provided in the available page copy; the next step is to request a demo to discuss options.