Qualio

Qualio is a leading provider of electronic Quality Management System (eQMS) software, purpose-built to help life sciences organisations manage the complexity of regulatory compliance. Recognising that traditional QMS solutions are often too cumbersome for agile startups and SMEs, Qualio offers a streamlined, cloud-based platform that unites teams, processes, and data.

Key Functionality The Qualio platform addresses the core pillars of ISO certification and regulatory maintenance:

• Document Control: Automates the entire lifecycle of quality documents, from initial drafting and collaborative review to electronic signatures and controlled distribution.

• Training Management: Ensures that all personnel are trained on relevant Standard Operating Procedures (SOPs). The system tracks completion records and alerts managers to any training gaps, which is essential for demonstrating competence during an ISO audit.

• Quality Events (CAPA & NC): Provides structured workflows for handling non-conformances (NC) and Corrective and Preventive Actions (CAPA). This ensures that deviations are investigated, root causes are identified, and effective actions are implemented and verified.

• Design Controls: Specifically for medical device companies, Qualio helps maintain the Design History File (DHF) and ensures traceability throughout the product development process.

• Supplier Management: Allows for the central tracking of supplier performance, audits, and approved vendor lists, directly supporting the supply chain requirements of ISO 9001 and ISO 13485.