Pharma 4.0 Concepts & Cases | The ISPE Pharma 4.0TM Operating Model was developed as a practical model for implementing a holistic approach for the digitalization of a pharmaceutical organization end-to-end. – While we are not there yet, some interesting case studies are available, showing the concepts are working and providing expected benefits. This session will overview how we can adjust our Pharmaceutical Quality Management System to embrace technology and increase data integrity, use our massive data stores for action by leveraging data analytics for Container System optimization and capping, and how facility management and building system support can increase productivity and reduce costs for pharmaceutical firms. For example, one core component of the Pharma 4.0TM Operating Model is the digitalization of the ICH Q10 Pharmaceutical Quality System (PQS), which is enabled by a Data Integrity by Design approach and a clear definition of Process Maps and Data Flows. Having this in place, data analytics will help to improve quality, performance and robustness of the processes and help to prevent drug shortages for the benefit of the patient.