Purpose-built life science compliance and quality management software

Learn why Qualio's cloud-based QMS software is used by over 700 life science companies for airtight quality & compliance

Modern life science compliance is tough - and getting tougher

Your focus is always on compliance and patient safety. But admin, manual upkeep and silos pull quality and regulatory teams away from their vital work and make errors and costly compliance lapses more likely. Qualio's QMS software replaces manual, time-consuming tasks like paper-pushing and gap analysis to lift your operational quality and compliance to new levels.

• Information and data centralized
• Processes and documents standardized
• Admin eliminated and automated
• Automatic, AI-powered gap analysis

Our QMS software is trusted by growing life science companies across the globe

Qualio is a holistic compliance and quality management system software platform, purpose-built for medical device, pharmaceutical, biotech and contract research/manufacturing companies

Document management

Make paper, filing cabinets, folders and spreadsheets a thing of the past.

Supplier management

Control and categorize suppliers and third parties with complete visibility.

Design control management

Supercharge your product development from a single source of truth.

Risk management

Detect and mitigate risks and comply with ISO 14971 and ICH Q9.

Training management

Build a competent, confident, compliant, continuously improving workforce.

Change control management

Manage change activity easily and effectively with complete traceability.

Audit management

Make compliance and audit readiness the natural core of your business DNA.

CAPA & NCR management

Build automated response workflows for any quality event.

Compliance management

Get audit-ready in weeks, stay audit-ready forever.