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2022 ISPE Annual Meeting & Expo

SES201 - Concurrent Session: Moving from Pharma 3.0 to 4.0

Nov 1, 2022 10:45am ‐ Nov 1, 2022 12:15pm


Digitalization opens new horizons to achieve new levels of connectivity, transparency, agility and productivity through the application of faster and more accurate information to enable (automated) decision-making. The fundamentals of the digitalization process lies in in the structure underneath the data being created, used, reported, stored, and destroyed. Currently, in the Pharma 3.0 environment the approach for automation is in a process-centric environment. However, moving to Pharma 4.0, a different approach in which the data life cycle is centralized, will lead to a data-centric approach. Each data life cycle needs to be completed and aligned to be considered a data set. In current production processes different data sets are created for each process. Visualizing the data sets amongst different process steps will automatically trigger missing data, misaligned data or duplicate data. Moving to Pharma 4.0, each data set will need to be assessable at any time in any business layer. Therefore, a system needs to be in place to show the data architecture and how it interacts with various processes. This session will discuss the status and examples of practical transformational methodologies to a digitalized Pharma 4.0 Operating Model-based organization.


  • Robert E. Perks, MSc, CEng, Regional Manager, Cognizant Life Sciences Manufacturing

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