I have over 25 years of experience in the FDA regulated industries from medical device to pharmaceutical. I started my career working in the laboratories as a bench scientist. For the past 20 years I have been working in the pharmaceutical IT environment in multiple disciplines such as Computer System Validation and managing global support teams. I have worked on a variety of systems including Laboratory Information Management Systems, Chromatography Data Systems, Pharmacology systems, Adverse Events Reporting Systems, and Clinical Trial Data Management systems to list a few. These systems have ranged in size from multi-site global systems such as the Darwin implementation at Lilly, the ArisG implementation at J&J and the Millennium 4.0 CDS /NuGenesis Scientific Data Management System implementations at Schering-Plough to small standalone systems such as the UV spectrometers.