EQMS and Quality 4.0: Build a Successful Quality Strategy for a Life Science Company

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.

An advanced EQMS plays a critical role in Quality 4.0. An advanced EQMS enables quality information to be captured as data versus documents. It captures the context for quality data, where the context is an explorable association between the quality data and information such as lots, parts, suppliers, and failure modes, allowing analytics to consider how performance may change across these contexts and thereby drive better insights. It centralizes the data, permitting global comparisons and oversight. Ultimately, these factors allow the quality data to connected with other enterprise data to drive broader insights across operations. Advanced EQMS is critical to Quality 4.0 success.

The following white paper by LNS Research discusses:

• How Quality 4.0 and traditional quality are interconnected
• Techniques, frameworks, and strategies to build a quality strategy and upgrade it to Quality 4.0
• How life science manufacturers are adopting Quality 4.0 today

Click through to access the full white paper here.