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21 CFR part 11 sets rules for electronic records and signatures to be equivalent to paper records. This allows replacing paper documentation with an electronic system to comply with FDA regulations. The focus is on requirements for signing documents electronically and electronic record-keeping, including system validation and audit trails. Electronic signatures require personal username and password, verification of user identity, and notifying FDA about using electronic signatures. Users must use two components (username and password) when signing records electronically.
