EXECUTIVE SUMMARY Pharmaceutical, medical device, food & beverage and other companies in regulated markets are required to comply with government regulations, standards and guidelines that are designed to ensure the safety and quality of the products manufactured, as well as the security and integrity of data sup- porting such production. The U.S. Food and Drug Administration introduced 21 CFR Part 11 to regulate electronic records and electronic signatures used in several industries, while the European Union’s EudraLex issued Annex 11 to cover computerized systems in pharmaceutical companies producing medicinal products for both human and veterinary use. This paper outlines the requirements of 21 CFR Part 11 and Annex 11, and provides information on how LabVantage software suppor

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