Qualio

Qualio is a cloud-based electronic quality management system (eQMS) designed for small to medium-sized companies in the life sciences industry, including biotech, medical device manufacturers, and clinical research organizations. It helps these companies efficiently manage their quality processes to comply with regulatory requirements from bodies like the FDA, ISO, and GxP.

Qualio's core eQMS features include document management, training management, corrective and preventive action (CAPA) management, non-conformance reporting, and supplier management. The platform allows users to create, review, approve, and electronically sign controlled documents like standard operating procedures, forms, and policies. The training module tracks training assignments, completion status, and sends automatic notifications for required retraining when procedures change.

Qualio streamlines quality event reporting by providing automated workflows to record, investigate, and resolve events like complaints, deviations, and non-conformances throughout their lifecycle. Its supplier management capabilities enable tracking supplier performance, quality issues, and maintaining approved vendor lists.

The eQMS is designed with an intuitive user interface requiring minimal training to navigate. It provides each user with a custom dashboard displaying their open tasks, due dates, and links to access those tasks directly. Search functionality allows finding documents by titles, references, templates, and tags.