CFR 21 Part 11 is a federal regulatory code that ensures the electronic storage, control, and archiving of documents and records. Established by the FDA in 1997, this regulation was designed to control the validation, registration, and electronic signature of documents. The purpose of the regulation is to ensure that documents stored in electronic systems are maintained with the same security as paper documents.
CFR 21 Part 11 requires that electronic documents be reliable and can be stored, retrieved, and reproduced accurately. The regulation applies to all organizations that collect or store information electronically or maintain an electronic database containing transaction data or other information that may be used as evidence in any legal proceeding.
“Records” refer to all tangible objects, including paper documents and magnetic tapes. Part 11 is a set of rules that outlines the methods for creating and storing electronic documents. It also contains information about the safeguard measures necessary to ensure the accuracy of these documents.
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