Frank Henrichmann, Senior Executive Consultant at Q-FINITY Quality Management, is an expert in quality management, computer system validation, and compliance, especially in the context of clinical trials and pharmacovigilance. Over the last 20 years, he has gained extensive experience in strategies, projects, and measures for GxP-regulated environments at a CRO as well as a major pharmaceutical company. In his current position, he helps life sci-ences companies and supports technology providers to find innovative answers to quality and validation challenges. Frank has been a member of the Clinical Systems Special Interest Group (SIG) and is a coauthor of the GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Sys-tems and Data. A member of the GAMP® Editorial Board, he has been an ISPE member since 2001.