Digitalization has reached the Pharmaceutical Industry. The ability to leverage the potential of data to master processes and products as differentiator has been understood. The transformation from a classical documentation-based, functionally segregated towards a data-driven, end-to-end integrated production and quality management is one major objective towards the Pharma 4.0. The Holistic Control Strategy and Digital SOPs are enabler and accelerator for Pharma 4.0. The panel/roundtable session will be introduced by two presentations addressing the ISPE Pharma 4.0 Holistic Control Strategy Model and the concept of the SOP of the Future – the right information at the right time and what the world might look like under the assumption of full digital implementation. This session will include a short mock-up demo in which digital SOPs are seamlessly integrated into the shop floor execution. The interactive Panel Discussion will be initiated by the following questions: • What kind of initiatives do you run to improve/transform your product supply and/or SOP Management towards digitalization? • What are the benefits you are expecting? • What are the challenges and risks?