Title 21 Code for Federal Regulations (CFR) Part 11 outlines criteria that must be met in order for electronic records to be considered reliable, and equivalent to paper records. Essentially, files must be considered 'valid' and contain original recordings, and the user must be recognized and held accountable for the data.
Under this code, electronic signatures are the equivalent of handwritten signatures, and indicate that specific actions have been approved, reviewed and verified.
An electronic signature also indicates non-repudiation – i.e. the signer is unable to deny the validity of the digital signature.
A digital signature on a document guarantees that the owner of the signature knowingly signed the document. This ensures that the owner is responsible for all electronic documents containing this signature.
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