(a) The definitions and translations of terms contained in section 201 of the Act shall apply equally to those terms used in this clause.

(b) The following definitions of terms shall apply to this article

(1) Act means the Federal Food, Drug, and Cosmetic Act

(2) Agency Refers to the U.S. Food and Drug Administration (FDA)

(3) Biometrics refers to a method based on an individual’s physical characteristics and repetitive behaviors that are unique to that individual and can Measurement) A method of measuring to verify an individual's identity.

(4) A closed system is an environment in which access to the system is controlled by those who are responsible for the content of electronic records on the system.

(5) Digital signature refers to a method of encryption based on the authentication of the sender, using a set of rules and a series of parameter calculations to verify the identity of the signer and the integrity of the data.

(6) Electronic records refer to any mixture of text, graphics, data, sounds, diagrams or other information expressed in electronic form, its creation, modification, maintenance, archiving, retrieval or distribution It is done by the computer system.

(7) Electronic signature means an arbitrary symbol or compilation of a series of symbols executed, adopted, or approved by a person to become computer data with the same legal effect as that person's handwritten signature.

(8) A hand signature refers to an individual's handwritten signature or legal mark, which is a personal signature or legal mark adopted to write the true intention in a permanent form. The act of signing with a writing and marking instrument (such as a pen or stylus) is preserved. A handwritten signature or legal mark applies conventionally to writing and may also apply to other devices for capturing names and marks.

(9) Open system means an environment in which access to the system is not controlled by those responsible for the contents of electronic records on the system.