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EduQuest was founded in October 1995 by former FDA investigators. Since that time, our staff has grown to include additional former FDA personnel as well as experienced technical, quality, and compliance experts from the regulated industries. The officers and employees of EduQuest thus offer a comprehensive knowledge of FDA and quality auditing procedures and practices and a unique awareness of regulatory enforcement policies and activities. We believe that tremendous synergy comes from having experienced, senior level personnel from both FDA and the industry. Our combined experience also gives us a broad and detailed understanding of the complex business and compliance challenges faced by today's regulated companies. The EduQuest team is led by Martin Browning, the company's President and co-founder. Martin spent 22 years with FDA as a local, national, and international expert investigator, and then as a Special Assistant to the Associate Commissioner for Regulatory Affairs. While with FDA, he also served as the Vice Chair of the agency's Electronic Record and Signature Working Group, which drafted the 21 CFR Part 11 regulations. Martin also served as the Chair of the U.S. Government ISO-9000 Committee; on the Global Harmonization Task Force; and on the committee that developed the Good Manufacturing Practice regulations for medical devices, otherwise known as the Quality System Regulation (QSR). The relatively brief history of EduQuest, however, does not fully reflect our extensive experience in addressing regulatory compliance, validation, and related technical issues.