A Platform for Satisfying Process Development, Manufacturing and Quality End-user Requirements, in a Standardizing IT Landscape

Although much attention has recently been directed at PAT and quality by design, there are in fact many initiatives underway that share the goal of reducing the variability, cost and risks of life science manufacturing processes. Despite their different sounding names and different styles of execution, at several points along the way they all depend fundamentally on identifying cause-and-effect relationships among Critical Process Parameters and Critical Quality Attributes using this process understanding to improve process control. Thus, one of the most critical aspects of many process improvement initiatives is a single point of easy on-demand access to all the relevant data in a context meaningful to diverse groups of users and fully integrated with a collaborative, graphical data investigational analysis and reporting environment for identifying and understanding cause-and-effect relationships in the process data.

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