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21 CFR part 11 specifies requirements for electronic records and signatures to be equivalent to paper records and handwritten signatures. This allows for the replacement of paper documentation with electronic systems while complying with FDA regulations. The focus of this video is on the requirements for signing documents electronically, with system validation and audit trails covered in another video. Primary requirements include ensuring unique username and password usage, verifying user identity, and notifying FDA when implementing electronic signatures. Users must use two components (username and password) when signing records with electronic signatures.
