Digital signature
Digital signature means a record created when a file is algorithmically transformed into a fixed length digest that is then encrypted using an asymmetric cryptographic private key associated with a digital certificate. The combination of the encryption and algorithm transformation ensure that the signer's identity and the integrity of the file can be confirmed.
Source
21 CFR § 1300.03
Scoping language
For the purposes of this chapter, the following terms shall have the meanings specified: