Frank Henrichmann, Sr. Executive Consultant at Q-FINITY is an expert in quality management, computer system validation and compliance, especially in Clinical Trials and Pharmacovigilance. Over the last 22 years he gained extensive experience in planning, development, execution, documentation, and auditing of strategies, projects and measures for GxP-regulated environments working for PAREXEL and Bayer. In his current position, he is helping life sciences companies and supporting technology providers find innovative answers to the quality and validation challenges created by operating in a highly regulated industry. Frank has co-authored the ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data. He has been an ISPE member since 2001 and is a member GAMP® Editorial Board, the Knowledge Network Council and the global GAMP® Steering Committee Co-chair. He also contributed to the GAMP 5 2nd Edition guide as a chapter lead.