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21 CFR part 11 outlines rules for electronic records and signatures to be equivalent to paper records. This allows for the replacement of paper-based documentation with electronic systems while complying with FDA regulations. The focus of this video is on the requirements for electronically signing documents, including the personal nature of user names and passwords. Additional requirements, such as system validation and audit trails, will be covered in a separate video. Companies must verify user identities and inform the FDA about using electronic signatures. Electronic signatures require two components: a username and password for signing records.
