E-Book | November 15, 2021

Digitalized Quality In Life Sciences: Roadmap To Sustainable Growth And Speeding Products To Market

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Medical products, device, pharmaceutical, and other healthcare manufacturers have felt even more pressure in recent years as regulators have emphasized the importance of metrics, quality, and continuous improvement. The systems and processes life sciences have used to manage quality are now inadequate. However, while current external conditions require manufacturers to adapt and change, they also have a new opportunity to formulate a strategy that creates market differentiation and improves operational and financial performance. The new strategy must align quality with success by design, and transform quality and quality data into a competitive asset. The forward-thinking life sciences enterprise will achieve it by digitalizing data, connecting the digitalized data to related business and operational systems, and applying analytics to identify new insights.

We refer to digitalization of quality across business and operational systems as Quality 4.0. While technology isn’t the entire story, Quality 4.0 does require mature traditional quality data and a data-driven enterprise quality management system (EQMS). Furthermore, it builds on and incorporates mature traditional systems, processes, teams, data from other business systems, sensor data from operations and devices, and advanced analytics. Enterprise leaders in discrete, process, and batch industries have leveraged Quality 4.0 to achieve unprecedented insights and performance.

This research report addresses life sciences challenges and how Quality 4.0. Digitalization – broadly termed Digital Transformation, can align people, processes, and technology to overcome market pressures and their own deficiencies, to transform quality and quality data into a competitive asset.

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