Eri Hirumi is a Group Manager of Regulatory Affairs at Beckman Coulter. Armed with a bachelor’s degree and classwork in Biochemistry and Molecular Biology from Purdue and California State University at Long Beach, Eri started her career 24 years ago as a Development Chemist for a very small diagnostic electrophoresis product line. The small product line provided training on a broad spectrum of skills sets. One of which sparked a passion for regulatory science. Working on the labeling requirements led to becoming a project manager on a development for an internally developed chemical hazard management system. Since this product was instrumental in providing chemical hazard information for diagnostic products, this in turn provided a demand to understand software development and establishing a system which would become 21CFR Part 11 complaint.