Defining key terms

Within the regulation are seven key terms that the FDA has defined:

Closed system:

An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. This document assumes that a closed system is used.

Open system:

An environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.

Electronic record:

Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.

Biometrics:

A method of verifying an individual’s identity based on measurement of the individual’s physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable.

Electronic signature:

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. 

Digital signature:

An electronic signature based on cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.

Handwritten signature:

The scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.