Glossary

Restore ion exchange of resins by reversing the process. An acid rinse is used to restore cation resin capacity and a sodium hydroxide rinse is used to restore anion resin capacity.

The growth of new tissues or organs to replace those injured or lost. In tissue culture, regeneration is used to define the development of organs or plantlets from a tissue, callus culture or from a bud.

The act of returning a column to its native state (packed with resin but otherwise empty) by washing or other methods.

A clearly described area within the computer's storage that is logically and/or physically distinct from other regions. Regions are used to separate testing from production (normal use). Synonymous: Partition.

A small, high speed memory circuit within a microprocessor that holds addresses and values of internal operations; e.g., registers keep track of the address of the instruction being executed and the data being processed. Each microprocessor has a specific number of registers depending upon its design.

Models the relationship between one or more independent variables and a dependent variable.

(IEEE) A software V&V task to determine the extent of V&V analysis and testing that must be repeated when changes are made to any previously examined software products.

Testing geared toward demonstrating that a change has not affected a system or part of a system that it was not intended to affect.

(NIST) Rerunning test cases which a program has previously executed correctly in order to detect errors spawned by changes or corrections made during software development and maintenance.

Is one required to be maintained or submitted by GxP regulations. A regulated record may be held in different formats, for example, electronic, paper, or both.

Is one required by a GxP regulation. The term signature and signed are defined as “The record of the individual who performed a particular action or review. This record can be initials, full handwritten signature, personal seal, or authenticated and secure electronic signature.”

The process of adjusting a system, or elements of it, to operate within the required tolerances. This includes activities such as balancing of chilled water and air conditioning systems, and the adjustment of a reject mechanism on a packaging line.

With respect to clinical research, the federal statutes, codes, and laws that govern the conduct of federally funded clinical trials and privately sponsored clinical trials for new drugs, devices, biologics, and procedures.

Substance regulating growth and development of cells, organs, etc.

Drug companies must show that their products consistently meet standards set by government agencies. Regulatory affairs departments document those activities, submit proposals, and follow those proposals through completion or approval.

A project’s satisfactory compliance with the regulations as required by the governing regulatory bodies.

Governmental or industry regulations that impose criteria upon a project which must be satisfied in order for the project to meet its business case.

A gene that acts to control the protein-synthesizing activity of other genes.

A DNA base sequence that controls gene expression.

A plastic material with enhanced mechanical properties due to the addition of high strength fillers imbedded in the composition.

In reverse osmosis and ultrafiltration, those impurities not able to permeate the membrane are said to be rejected (removed). They are flushed away in the reject (waste) stream.

Recommended Exposure Limit

An adverse event that is related to the use of the study drug, device or intervention is one for which there is a reasonable possibility that the adverse event may have been caused by the drug, device or intervention. A related event has a temporal relationship to the drug, device or intervention, and an alternative etiology is unlikely. Our local policies require that PIs further define the adverse event by stating whether the event is “possibly related”, “probably related”, or “definitely related” to the study intervention or treatment.

Programs/procedures implemented at a facility to ensure that operations are conducted as per GMP.