Glossary

A list of instrumentation which includes the instrument tag number, instrument name, manufacturer name, model and serial number, P&ID reference, critical or non-critical, and local or panel mounted.

A group of instruments connected together to monitor, or control, a process variable.

(NBS) The insertion of additional code into a program in order to collect information about program behavior during program execution. Useful for dynamic analysis techniques such as assertion checking, coverage analysis, tuning.

A peptide hormone secreted by the Langerhans islets of the pancreas, and that regulates the level of sugar in the blood

Small wafers of semiconductor material (silicon) etched or printed with extremely small electronic switching circuits. Synonymous: Chip.

Standard interface for hard disks which provides for building most of the controller circuitry into the disk drive to save space. IDE controllers are functionally equivalent to ST-506 standard controllers.

(IEEE) The process of combining software components, hardware components or both into and overall system. Sometimes described as software integration and system integration respectively.

The recombination process which inserts a small DNA molecule (usually by homologous recombination) into a larger one. If the molecules are circular, integration involves only a single crossing-over; if linear, then two crossings-over are required. A well known example is the integration of phage lambda DNA into the E. coli genome.

(ICH Q5B) The site where one or more copies of the expression construct is integrated into the host cell genome.

(IEEE) An orderly progression of testing of incremental pieces of the software program in which software elements, hardware elements or both are combined and tested until the entire system has been integrated to show compliance with the program designed, and capabilities and requirements of the system.

(IEEE) Testing in which software components, or both are combined and tested to evaluate the interaction between them.

(IEEE) An orderly progression of testing in which software elements, hardware elements, or both are combined and tested, to evaluate their interactions, until the entire system has been integrated.

Non-destructive, non-contaminating test used to determine whether or not a filter has a defect capable of passing particles that should be retained

Method used to evaluate HEPA filter performance, as described in FS209B and IES RP-006.2.

Any and all patent applications or patents, or trade secrets that make up the proprietary information of a company.

Patents, copyrights, and trademarks.

Microprocessor based instrumentation with extended functionality that can be configured remotely and may contain programmable algorithms.

Type of final product, e.g., oral, cream to be applied to skin, sterile, etc.

The objective is to compare one or various parameters from a set of various batches, operated from one recipe or from variants of this recipe.

(EMEA –CHMP) Studies to detect any effects between plastic packaging component and product, leading to unacceptable changes in the quality of the product or the packaging under normal storage/use conditions.

(IEEE) Pertaining to a system or mode of operation in which each user entry causes a response from or action by the system.

Interactive response technology is a tool that can be used to support multiple business processes and this Guide describes how the pharmaceutical industry can apply the technology to support various clinical trial activities.

Centralized electronic randomization system used in clinical trial for, but not limited to, randomization and medication management. Two methods included: voice and/or web.