Qualio is a cloud-based quality management system (eQMS) designed to streamline quality processes for life science companies. It integrates document management, design controls, training management, risk management, and compliance intelligence into a single platform. Key features include:
- Automated Gap Analysis: Identifies gaps in compliance across various regulatory standards (FDA, ISO, EMA).
- Cross-Mapping of Evidence: Allows evidence to be mapped once and reused across multiple submissions.
- Real-Time Risk Alerts: Provides alerts for potential risks and board-ready dashboards for monitoring.
- Document Management: Digitize and organize entire document stack.
- Training Management: Track and demonstrate competence.
- Audit Readiness: Tools to ensure continuous audit readiness.
Qualio targets medical device, pharmaceutical, and biotech companies aiming to accelerate market entry, reduce audit preparation time, and maintain compliance with evolving regulations. It helps transition from paper-based systems to a digital, integrated eQMS.
