The ISPE Baseline® Guide: Pharma 4.0 provides the structural capabilities framework needed for realizing successful and lasting transformations. It contains tools and advice for companies in achieving their digitization and financial goals while maintaining/improving product quality and meeting regulatory requirements and expectations. In addition, this Guide outlines various starting points, prerequisites, governance structures, and strategies for achieving transformational success tailored to an organization’s size, risk tolerance, flexibility, and maturity level.
The Industrial Digital Transformation is more than just an approach to implement digital technologies; it is a shift in mindset and a fundamental shift in the way companies operate their business to deliver value for patients and customers. Smart organizations will not only have capabilities but will also be highly adaptable. The Guide covers all areas of transformation including the benefits of a holistic control strategy, opportunities opened by digital transformation in quality management, and the foundational processes and principles for interconnected plant architecture. It includes organizational change management practices to help workers adapt to confounding challenges from new technologies and acquire the necessary skills to thrive in a changing culture.
Christian Woelbeling is Executive Industry Advisor & Senior Strategic Account Manager Software at Körber Business Area Pharma, based in Lüneburg, Germany.
Christian holds a Master Degree in Mechanical Engineering. For over 32 years working in Life Sciences Manufacturing IT, Christian has great experience in all GMP-related processes. He is actively involved in the ISPE, e.g. as Founder & Leader of the Community of Practice / CoP “Pharma 4.0”, ISPE GAMP Member at large of the European Steering Committee, ISPE “Advancing Pharmaceutical Quality” APQ Core Team Member, “PAT & Lifecycle Control Strategy” CoP Steering Member, and ISPE Affiliate DACH Board Member. Chrisian was named a “Pharma Industry Leader” by the ISPE Pharmaceutical Engineering Magazine in 2020. He is one of the lead authors of the ISPE Pharma 4.0 Baseline Guide.
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