Balancing Act

Abstract:In life sciences manufacturing organizations, as well as in other manufacturing organizations, data management is crucial for mitigating risk and should be a central part of any quality strategy. With the large amounts of data collected during process development and manufacturing, quality teams need easy ways to get accurate views of product quality, and better manage the time and resources required to produce standard quality reports. The life sciences industry is behind other industries in reducing risk through the management of quality data. Collaboration of quality and manufacturing teams for the sake of quality data management requires a paradigm shift that organizes data around the manufacturing process and resulting product control strategy, rather than around samples, control of analytical workflows, control and standards and analysts. Critical success factors include providing end users with on-demand access to data in a collaborative analytics, trending, and reporting environment in …

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