Rolf Blumenthal is a Senior Consultant at Körber Pharma (former Werum) and has many years of experience in the pharmaceutical industry. He holds a degree in mathematics and computer science from the University of Dortmund, Germany. He joined Werum in 1979 and is one of the 15 employees who took over the company after the death of the founder in 1982. Initially, he gained expertise in the management of large MES software projects. In the following years he headed the development of Werum's MES product, established a consulting division and started a new division to unlock the added value of data from the pharmaceutical industry. Rolf is a recognized expert with extensive knowledge and hands-on experience in cGMP, US FDA requirements, GAMP guidelines, and computer validation. He is member of the GAMP® D/A/CH Steering Committee and the AI Validation Working Group. Rolf has been an ISPE member since 2002.