Quality is a critical concern in life science manufacturing industries, and leaders across life science companies have many quality and compliance considerations. However, few of those concerns have the strategic impact that Quality 4.0 does. Quality 4.0 is the digitalization of quality management through the application of traditional and Industry 4.0 technologies to improve quality monitoring and outcomes. At its core, Quality 4.0 is the digital continuum of quality data combined with other data from sources such as manufacturing, machine sensors, supplier management, and in-service across a product’s life, new analytical insights derived from that data, and the organization-wide transparent consumption of insights.