Reducing Technology Transfer Risk: Using Collaborative Data Access, Aggregation, Trending, Reporting and Analytics that Connect Process Development, Manufacturing and Outsourcing

The need for successful technology transfer exists in many areas of a modern global pharmaceutical manufacturing network. Technology transfer must succeed not only between operations within the same company at the same site, but also between geographically dispersed operations within the same company and between different companies with nearby and distant outsourced manufacturing relationships. A critical success factor for reducing technology transfer risk is to provide on-demand data access and aggregation capabilities directly to end-users in a collaborative analytics, trending and reporting environment so that the multidisciplinary tech transfer team can collaborate productively.

The most important requirements for this system are: a practical user-centric interface to provide direct on-demand access to all the data from disparate sources; capture of data from paper records to make it easily available in electronic form; the ability to work with continuous (on-line) and discrete data together; sharing data, analysis results and reports across disciplines, scales of operation, and geographically dispersed locations; and simplifying the preparation and distribution of descriptive (dashboard) and investigational (cause-and-effect) analysis results, as well as automated generation of periodic reviews and reports of batches and campaigns.

This presentation will discuss the dimensions of this problem and illustrate how it has been solved for several pharmaceutical manufacturers using technologies readily available today.

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