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21 CFR part 11 is a set of rules that allows electronic records and signatures to be equivalent to paper records and handwritten signatures. This means you can replace paper documents and handwritten signatures with an electronic system and still comply with FDA regulations. The focus of this video is on the requirements for signing documents electronically, such as personal username and password, verification of the individual's identity, and notifying the FDA about the use of electronic signatures. Users must use two components - username and password - when signing records with electronic signatures.
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