FDA 21 CFR 11: A set of regulations issued by the U.S. Food and Drug Administration (FDA) that establishes a comprehensive set of procedures for assuring secure, reliable, and accurate records in the electronic form. The aim is to ensure the security of sensitive data regarding medical products which are important to public health and safety. It also serves as a shield for organizations who take the initiative to implement such measures to maintain compliance with industry standards. FDA 21 CFR 11 has become an integral part of pharmaceutical companies’ business operations and plays an important role in providing assurance to consumers about the safety of drugs and medical products.