Glossary

(IEEE) A graph in which direction is implied in the internode connections. Synonym: Digraph.

Alteration of DNA at a specific site and its reinsertion into an organism to study ant effects of the change.

Successively sequencing DNA from adjacent stretches of chromosome.

Written information to the site and/or subject on how to use the investigational products.

Any information that includes personal identifiers. To determine what data may be considered identifiable, please see items that must be removed under the HIPAA Privacy Rule's definition of deidentified.

Division of Information Resources Management

A relative term indicating the condition of being contaminated.

Draft International Standard (ISO document stage)

Division of Inspections and Surveillance (CBER)

Division of Information Services (CDER)

Any accidental, natural, or malicious event which threatens or disrupts normal operations, or services, for sufficient time to affect significantly, or to cause failure of, the company.

The sudden and unanticipated loss of use of one or more systems due to an adverse event which may involve the recovery of any or all of the system components, i.e., hardware, software or data. A disaster is an event that if unmitigated, will interrupt business processes which the system supports.

Any event (i.e. fire, earthquake, power failure etc.), which could have a detrimental effect upon an automated system or its associated information.

The act of planning for the restoration of systems and facilities after a major incident, for example the loss of telecommunications, power, buildings, or major computer facilities. It is essentially a reactive process.

A plan to resume a specific essential operation, function, or process of an enterprise.

Time required to reduce the voltage to the level, positive or negative, to which an isolated conductive monitoring plate was originally charged.

A release of identifiable health information to anyone or any entity outside of the partners affiliated covered entity.

Any change in surface color from that of the base metal. Usually associated with oxidation occurring on the weld and heat affected zone (HAZ) on the outside diameter and inside diameter of the weld joint as a result of heating the metal during the welding. Colors may range from pale bluish-gray to deep blue, and from pale straw color to a black crusty coating.

Interruption of the typical structure of a weldment, such as lack of homogeneity in the mechanical, metallurgical, or physical characteristics of the material or weldment. A discontinuity is not necessarily a defect.

A discrepancy is a condition that is unexpected or involves some variation from the expected condition (i.e., an event or occurrence outside the acceptable limits for a system).

Instrument having a means of displaying and recording the count and size of discrete particles (with a size discrimination) for specific air volume.

The opposite of ease. Any alteration from the state of metabolism necessary for the normal development and functioning of an organism, usually associated with infection by a pathogen or the malfunction or absence of one or more genes.

The ability to remain healthy by resisting disease or the disease agent. Disease resistance or tolerance is a subject of intense interest in biotechnology.

Alleles carrying particular DNA sequences associated with the presence of disease.

Any oxidant, including but not limited to chlorine, chlorine dioxide, chloramines, and ozone added to water in any part of the treatment or distribution process, that is intended to kill or inactivate pathogenic microorganisms.