Quality Management System (QMS)
Overview
The Quality Management System suite in Labii provides integrated applications for organizations operating under rigorous regulatory and quality frameworks. These applications cover the full spectrum of quality management activities—from controlling documents and managing non-conformances to conducting formal risk assessments and tracking personnel training. Whether you are maintaining compliance with ISO 9001, ISO 13485, FDA 21 CFR Part 11, GMP, or GLP requirements, these tools provide the structured workflows, audit trails, and traceability needed to demonstrate a robust and effective quality system.
Applications
- Quality Management System (QMS) - Manage document control, non-conformances, CAPAs, change controls, and audits
- Risk Assessment - Identify, evaluate, control, and verify risks across laboratory operations and processes
- Training Management - Plan, assign, track, and document personnel training and certifications