“Qualio gives everyone a roadmap in this time when we're having to move very quickly. Having that structure for everyone to work within is going to be essential for us to really succeed.”
Heather Underwood
CEO, EvoEndo
One system.
Always audit-ready.
Qualio is the Agentic Compliance Platform for Life Sciences. Bring quality, regulatory, and product compliance into one easy system that keeps you ready for every audit, inspection, and submission.
Trusted by the life sciences companies building what comes next.
4.4/5 on
(767 reviews)4.5/5 on Capterra (129 reviews)
Why teams choose Qualio
Everything in one place
Documents, training, events, suppliers, and design controls in one source of truth. Replace the spreadsheets, shared drives, and e-signature tools; keep the systems your teams already use, connected out of the box.
Ready before the auditor arrives
Continuous gap assessment across every standard you carry, issues surfaced before they become findings, evidence exportable on demand.
A switch you can defend
Validation, migration, and training on Qualio; value in under 60 days; AI that is validated, provenance-answerable, and operates under your SOPs with every action logged and approved.
How Qualio keeps you audit-ready.
Compliance Frameworks
Continuous gap analysis across every standard you hold.
From ISO 13485 and 21 CFR Part 11 to EU GMP Annex 11, MDSAP, and ISO 42001, Qualio assesses your standards continuously and flags gaps before an auditor does. Product frameworks such as 510(k) and CE Mark come with AI-assisted technical file assembly.
Built for regulated work
Agentic where it helps. Bounded where it matters.
General-purpose AI is fast and unaccountable. Qualio's AI is validated, regulatory-grade, and built on a compliant system of record. Every output is defensible and every action leaves an audit trail — agents execute, your team approves.
Agents execute
Draft, analyze, and assemble the work.
Your team approves
Human sign-off on every action.
Audit trail
Every step logged, defensible, timestamped.
One connected system
Built into how your teams already work.
Qualio replaces scattered spreadsheets and episodic audit prep with one connected system and continuous readiness — connected to the tools your developers already use, with the largest catalog of self-serve integrations in the category.
Connects to the tools you already use
Azure AD
Google Suite
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Jira
OneDrive+ more
Qualio Copilot answers quality questions on demand
Our Customers
Helping quality & regulatory teams stay audit ready, every day.
“I contacted Qualio in November. We went live mid-December. We had all users in by January. And we had our ISO 13485 certification in July. Without Qualio, we'd never have done that.”
Karen H.
Head of Quality & GxP Compliance, 30 Technology
“CI surfaces gaps automatically. We resolve issues faster and walk into audits with confidence.”
Christophe Dohr
Site Quality Manager, Sentec
Get started
See what continuous compliance can do for your business.
Compliance is no longer a cost of doing business. It is a lever for competitive advantage, revenue and valuation growth.