Oliver Herrmann, Founder and CEO of Q-FINITY Quality Management, Germany, Member of the Steering Committee ISPE GAMP D-A-CH, Chair ISPE GAMP Global R&D and Clinical Systems SIG His academic study in business process and workflow management finished Oliver with a Degree of Computer Science. He worked for a consulting and software development company in Germany. In 2004, Oliver founded Q-FINITY. The intent was to combine process management with the requirements for the validation of computerized systems and share this experience via an integrated service portfolio. Over the last ten years he gained extensive experience in planning, development, execution, documentation, and auditing of strategies, projects and measures for GxP regulated environments. Amongst other there are key projects with the focus on chromatography LIMS, PCS and MES through ERP, Pharmacovigilance, EDC, Efficacy, DMS and so on. Oliver is a CSV Trainer, a CSV Coach, and in 2009 he started the GAMP DACH working group. Currently, he is Chair of the ISPE GAMP Global R&D and Clinical Systems SIG. Actual activities include the leadership for CSV in a large project for setting up an automated production plant for pharmaceutical products including the full electronic automatic data acquisition and data processing.