The pharmaceutical, life sciences, and healthcare industries are highly regulated due to their direct impact on customer health and safety. A Quality Management System designed specifically for these industries should address the complex product development lifecycle of these industries. A Quality Management System’s use in the organization is to ensure compliance with FDA and other ISO standards, specifically ISO 13485. Quality Management System helps improve product quality and safety, eliminate manual quality processes, reduce overall costs, standardize processes and documentation, and enhance operational efficiency.