Glossary

Database organization method that links files together as required. Relationships between files are created by comparing data such as account numbers and names. A relational system can take any two or more files and generate a new file from the records that meet the matching criteria. Routine queries often involve more than one data file; e.g., a customer file and an order file can be linked in order to ask a question that relates to information in both files, such as the names of the customers that purchased a particular product.

A type of database system that stores data in related tables. A relational database is powerful because it does not assume how data are related or how they will be extracted from the database. As a result, the same database can be viewed in many different ways.

A measure of the water vapor content of room air, expressed in percent.

The ratio (measured in percent) of actual water vapor pressure in air to the pressure of saturated water vapor in air at the same temperature and pressure.

(IEEE) The formal notification and distribution of an approved version.

The discharge of a microbiological agent or eukaryotic cell from a containment system.

(ICH Q5B) Those markers permitting the identification of the strain of the cell line which should include the expression of the recombinant protein or presence of the expression construct.

(ICH Q5A (R1)) Virus used in process evaluation studies which is either the identified virus, or of the same species as the virus that is known, or likely to contaminate the cell substrate or any other reagents or materials used in the production process.

(IEEE) The ability of a system or component to perform its required functions under stated conditions for a specified period of time.

(ANSI/IEEE) The process of determining the achieved level of reliability for an existing system or system component.

An automatic pressure relief device actuated by the static pressure upstream of the valve which opens further with the increase in pressure over the opening pressure. It is used primarily for liquid service.

ASME) A pressure relief valve actuated by inlet static pressure which opens in proportion to the increase in pressure over the opening pressure.

The part of the label that can be either removed or detached from the booklet label itself. A tear-off/peel-off label acts as a self-adhesive label used for documentation at the site.

Risk Evaluation and Mitigation Strategy

Payment and reimbursing expenses for participation in research. An attempt should be made to avoid the term, "compensation" in this context.

The restoration of biological activity to a denatured protein or nucleic acid. The strands of a DNA duplex, for example, are denatured at high temperatures but can be correctly reformed by a slow cooling.

Relating to a natural resource, that is never depleted or that can be replaced, such as water, wind, geothermal or solar power.

Energy derived from generally renewable resources including hydro, solar, wind and geothermal.

An organic natural resource which is replaced naturally and can be used again to overcome utilization, either through biological reproduction or other naturally recurring processes, (e.g., oxygen, fresh water, solar energy, timber, and biomass.

An enzyme secreted by cells lining the stomach in mammals, and that is responsible for clotting milk.

A sequence of bases that occurs repeatedly in the genome, often end-on-end, i.e., tandemly.

(ICH Q2 (R1)) Repeatability expresses the precision under the same operating conditions over a short interval of time. Repeatability is also termed intra-assay precision.

Sequences of varying lengths that occur in multiple copies in the genome; it represents much of the genome.

The administration of metabolites, co-factors or hormones that are deficient as the result of a genetic disease.

The synthesis of duplex (double-stranded) DNA by copying from a single-stranded template.