Glossary of terms

Glossary of computer and software terms.

An audit trail is a secure, computer-generated, date- and time-stamped record that allows the reconstruction of the course of events relating to the creation, modification, and deletion of an electronic record.

Biometrics is a method of verifying an individual's identity based on the measurement of physical feature(s) or repeatable action(s) that are unique to that individual and measurable.

A closed system is an environment in which system access is controlled by people who are responsible for the content of the system's electronic records.

A digital signature is 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. Digital signatures are required for open systems and need higher security levels.

Electronic records are "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."

An electronic signature is "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." They are the electronic equivalent to handwritten signatures on paper and may be based on biometric identification methods or facial and voice recognition. A simple combination of a user ID and password also is sufficient. Within a company, the user ID must be unique to a specific person.

Hybrid systems combine electronic and paper records. Raw data are recorded electronically to reconstruct the analysis but the final results are printed and signed on paper.

Meta data is information that describes the content and context of the data. They are important for reconstructing a final report from raw data. In chromatography, they include are integration parameters and calibration tables.

An open system is 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.

Secure sockets layer is a network protocol that seamlessly encrypts data over unsecured networks. This protocol is used during Web access to the electronic laboratory notebook using Web-client options.

Predicate rules are the 21 CFR Food and Drugs regulations (besides 21 CFR Part 11). They are promulgated under the Food Drug and Cosmetic Act or under the authority of the Public Health Service Act.

Public key infrastructure is a trusted security facility that uses digital certificates to provide a full set of security services.

Additional terms are defined on FDA's Web site, http://www.fda.gov/ora/inspect_ref/igs/gloss.html.