Section 11.3 establishes the Part 11 definitions: (a) ACT = the Federal Food + Drug + and Cosmetic Act. (b) AGENCY = the Food and Drug Administration. (c) 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. (d) 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. (e) DIGITAL SIGNATURE = an electronic signature based upon 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. (f) 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. (g) ELECTRONIC SIGNATURE = a computer data compilation of any symbol or series of symbols executed + adopted + or authorised by an individual to be the legally binding equivalent of the individual's handwritten signature. (h) 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. (i) 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.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.