Glossary

A report summarizing the results and conclusions of a validation or qualification exercise.

(FDA) Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics.

(FDA) Validation conducted prior to the distribution of either a new product, or product made under a revised manufacturing process, where the revisions may affect the product's characteristics.

(FDA) Validation of a process for a product already in distribution based upon accumulated production, testing and control data.

Retrospective validation can also be useful to augment initial premarket prospective validation for new products or changed processes. Test data is useful only if the methods and results are adequately specific. Whenever test data are used to demonstrate conformance to specifications, it is important that the test methodology be qualified to assure that the test results are objective and accurate.

(NBS) Determination of the correctness of the final program or software produced from a development project with respect to the user needs and requirements. Validation is usually accomplished by verifying each stage of the software development lifecycle.

(NIST) Used as an entity to define a procedure of review, analysis, and testing throughout the software lifecycle to discover errors, determine functionality, and ensure the production of quality software.

Focus on the entire project lifecycle costs and benefits of the project rather than just the initial “up front” capital investment.

A measure of the tendency of a liquid to evaporate and become a gas. The pressure exerted by a saturated vapor above its own liquid in a closed container at a given conditions of temperature and pressure, usually expressed in mmHg. The higher the vapor pressure, the greater the tendency of the substance to evaporate. Dalton’s Law for a mixture of perfect gases states that the mixture pressure is equal to the sum of the partial pressures of the constituents. The partial pressure of moisture is called vapor pressure, and is expressed as:Total Pressure (Pt) = Partial Pressure of Air (Pa) + Partial Pressure of Moisture (Pv)

A name, label, quantity, or data item whose value may be changed many times during processing.

Regions of antibody chains that have different amino acid sequences in different antibody molecules. These regions are responsible for the antigen-binding specificity of the antibody molecule.

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(IEEE) A record of the name and values of variables accessed or changed during the execution of a computer program. Synonymous: Data-Flow Trace, Data Trace, Value Trace.

An organism that is genetically different from the wild type organism. Also known as mutant.

A change to any aspect of a pharmaceutical product, including but not limited to a change to formulation, method and site of manufacture, specifications for the finished product and ingredients, container and container labeling, and product information.

Multifunctional agents that are home to the capillaries and vessels of solid tumors.

Variable Air Volume

Virtual Address Extension

Visual Basic for Applications