Glossary

Evaluates the sequence of operations represented by the coded program and detects programming errors that might create hazards.

A user based authentication access to a platform or application and the data is processed. The logical access is provided via human or computerized interface with the system or platform.

The features embedded in software programs combined with specific settings (Access Control Lists) that are used to authenticate a user requesting access to computerized resources.

(ICH Q1A (R2)) Stability studies under the recommended storage condition for the re-test period or shelf life proposed (or approved) for labeling.

A string of bases that occurs at each end of the “genome” of a retrovirus that has become integrated into the host genome. Involved in the integration process.

Restriction enzymes are proteins that cut DNA at precise locations. Restriction maps depict the positions on chromosomes of restriction enzyme cutting sites. These are used as biochemical “signposts”, or markers of specific areas along the chromosomes. The map will detail the positions on the DNA molecule that are cut by particular restriction enzymes.

(IEEE) A system of error control based on the formation of a block check following preset rules.

A study designed to follow subjects forward through time.Masked Study Designs: Study designs comparing two or more interventions in which either the investigators, the subjects, or some combination thereof do not know the treatment group assignments of individual subjects. Sometimes called "blind" study designs.

Fermenters in which the fermenting material is cycled between a bulk tank and a smaller tank or loop of pipes. The circulation helps to mix the materials and to ensure that gas injected into the fermenter is well distributed in the liquid. The reactors are also very useful for photosynthetic fermentations, where they allow the photosynthesizing organisms to be passed along a large number of small pipes, where the light can get to them easily, rather than inside a single volume, where only the organisms near the edges get much light.

Testing in which control system inputs and outputs are exercised and their functionality verified.

Limit of Quantitation

(ICH Q7)

(ICH Q7)

Representative sampling from the lot is tested as a requirement for lot release.

Lock Out Tag Out

Systems or functions that typically have a negligible impact on data integrity, product quality or patient safety.

The advantage of assembly language is that it provides bit-level control of the processor allowing tuning of the program for optimal speed and performance. For time critical operations, assembly language may be necessary in order to generate code which executes fast enough for the required operations. The disadvantage of assembly language is the high-level of complexity and detail required in the programming. This makes the source code harder to understand, thus increasing the chance of introducing errors during program development and maintenance.

The LEL depends on the mixture of product vapor and oxygen necessary to produce fire of explosion in the presence of an ignition source. LEL is expressed as the percent of product vapor by volume in air.

The minimum concentration of vapor in air at which propagation of flame will occur in the presence of an ignition source. LFL is sometimes referred to as LEL or Lower Explosive Limit.

(ICH Q3C (R4)) The lowest dose of substance in a study or group of studies that produces biologically significant increases in frequency or severity of any effects in the exposed humans or animals.

Liters Per Minute

Lipopolysaccharide