Electronic signature

Part 11 expects each electronic signature to be unique to one person and never reassigned, and the signed record to show the printed name, date and time, and meaning of the signature. Companies also certify to FDA that their electronic signatures are intended to be legally binding.

(7) Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.

21 CFR, 11.3