Qualio

Qualio is a cloud-based quality management software provider founded in 2012 in Dublin, Ireland, and now headquartered in San Francisco, United States. The company built its platform to help life sciences organizations, including pharmaceutical, biotechnology, medical device and clinical research companies, meet FDA, ISO and GxP regulatory requirements without relying on paper records or spreadsheets.

The platform combines document control, training management, risk assessment, change control, supplier management, CAPA and non-conformance handling, and audit management into a single system with real-time compliance dashboards. Qualio is used by more than 500 companies across over 80 countries, from early-stage startups preparing for their first regulatory audit to established manufacturers running multi-site quality operations.

1. Document Control: version-controlled creation, review and approval workflows for SOPs and quality records.

2. Training Management: assign, track and verify employee training tied directly to controlled documents.

3. CAPA and Non-conformance: manage corrective and preventive actions from root cause analysis to closure.

4. Audit Management: plan, execute and track internal and external audits with centralized evidence.

5. Supplier Management: qualify, monitor and score suppliers against quality criteria.

6. Compliance Analytics: real-time dashboards on training status, open CAPAs and audit readiness.