Propel's Quality Management solution empowers manufacturers to streamline, automate, and regulate their quality management processes. It offers a cohesive platform to manage nonconformances, corrective and preventive actions (CAPAs), deviations, complaints, and audits, all directly linked to product and change information.
Implement a fully-featured, cloud-based electronic Quality Management System (eQMS) within 8 weeks, which includes essential modules such as CAPA, Complaints, Non-Conformance Reporting (NCMR), Audits, Deviations, Training, Equipment Calibration, and Supplier Quality, without the need for Product Lifecycle Management (PLM) systems.
Designed specifically for regulated sectors like medical devices, this solution ensures compliance with FDA 21 CFR Part 820 & Part 11, ISO 13485:2016, EU MDR, and DHF/DMR through validated Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation.
Incorporating AI-driven features, it can create training quizzes based on quality data to enhance compliance awareness. Integrated workflows promote uniform processes while allowing for flexibility.
With comprehensive traceability, teams can achieve a flawless audit pass rate and continually enhance product quality, all while being supported by robust enterprise-level security measures.