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21 CFR part 11 outlines rules for electronic records and signatures to be equivalent to paper records and handwritten signatures. This allows for the replacement of paper documentation and handwritten signatures with an electronic system to comply with FDA regulations. The focus of this video is on the requirements for signing documents electronically, including the need for personal usernames and passwords that cannot be shared. The company must verify the user's identity and notify the FDA about using electronic signatures, requiring the use of two components (username and password) when signing records electronically.
