Quality & Compliance for TechBio

Compliance built for the speed of software.

Techbio and life sciences software companies face a regulatory burden traditional tools weren't designed for and move at a pace traditional compliance approaches cannot keep up with. Qualio closes that gap.

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Trusted by techbio & life science software leaders

The Challenge

Life sciences is changing. Compliance needs to keep up.

43%+

increase in warning letters

1st

warning letter issued, AI misuse in drug manufacturing

The Solution

Compliance that scales with you

Build compliance into your development cycle

Qualio integrates with Jira, GitHub, Azure DevOps, and more so compliance evidence builds as your team ships.

Start compliant & stay ahead

Build in clause-level compliance with FDA, ISO, and GxP standards, monitor for regulatory updates and risks, and catch issues before they become findings.

Scale faster with the same compliance team

Maintain traceable, audit-ready evidence across your quality system so you're prepared for pharma partner due diligence and regulatory scrutiny without a compliance sprint.

Built for AI-native life sciences

AI-first companies need traceability, data lineage, and model verification built into their quality system. Automate ISO 42001 and ISO 9001 compliance as you build and capture evidence as your team works in Jira.

Qualio supports the full compliance stack for handling regulated data in one system and makes customer audits manageable without adding compliance headcount.

Eliminate audit scramble and support more industries with automated compliance against standards like ICH E6, ISO 27001, ISO 13485, and more.

Audit & Partner Readiness

Generate audit packages with full traceability against compliance requirements for customer and partner reviews
- ISO 27001, ISO 27701, and ISO 42001 for InfoSec and AI governance
- ICH E6 for GCP compliance
- IEC 62304 and ISO 13485 for medical device software requirements
- ISO 9001 as a quality management foundation from day one
Automate mapping of SOPs and evidence to regulatory requirements
Risk analysis refreshes as you manage documents, change control, training, CAPAs, and supplier managements in one validated system

Dev Tool Integrations

Connect Jira, GitHub, Azure DevOps, and more to pull compliance evidence directly into Qualio
Automate objective evidence collection so audit readiness builds as your team ships
Keep quality and engineering aligned without forcing a context switch

Connects to the tools you already use

Azure AD

Google Suite

Okta

Jira

OneDrive

+ more

Qualio Copilot answers quality questions on demand

AI Governance & Regulatory Monitoring

ISO 42001 framework support for AI governance and model transparency requirements
Agents monitor FDA guidance affecting your program
Maintain an auditable record of how AI outputs were validated and incorporated

Don't just take our word for it!

Hear from our innovative customers

“Qualio simplified things immensely.”

Andrew Breite

Director of Quality Assurance, VitaCyte

“We needed something that was user-friendly, easy to onboard new team members, and easy to get up and running. Qualio has surpassed our expectations on those metrics.”

Stephana P.

VP of Quality, Alphazyme

“Using Qualio allowed management to review work in real time, mentor our team and build towards 'design-lock-ready' processes far more quickly than with a paper-based experimental tracking system.”

Christopher B.

CEO, Alphazyme