Yves Samson initially graduated as automation engineer and computer scientist. After his studies in Grenoble (France) and Münster (Germany), he joined Novartis (formerly Ciba-Geigy) where he worked during 11 years as application engineer for process control systems, project engineer, technical project manager, and site engineer (maintenance & projects). Yves takes care of computerised system validation since 1992. Since 2000, he works as consultant, auditor and trainer for all aspects of quality management in automated and IT environments particularly within the regulated industry – pharmaceutical industry, medical device manufacturing, blood transfusion services – and for its suppliers. He supports Quality Assurance and development departments regarding e-compliance for automated and IT systems. In 2002, he founded the consulting company Kereon AG, Basel. Yves is strongly engaged within ISPE; he edited the French version of GAMP® 4 and GAMP® 5. He is also member of the French affiliate board. Yves is co-founder and chair of the French Speaking GAMP® Community of Practice “GAMP® Francophone” and member of the GAMP Europe Steering Committee. He translated and edited the French version of the PIC/S Guidance PI 011 about: “Good Practices for computerised systems in regulated ‘GxP’ environments”.