Glossary

A matrix that records the relationship between two or more products; e.g., a matrix that records the relationship between the requirements and the design of a given software component.

(ICH Q10) The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality.

(ICH Q8 (R2)) The multidimensional combination and interaction of input variables (e.g. material attributes) and process parameters that have been demonstrated to provide assurance of quality. Working within the design space is not considered as a change. Movement out of the design space is considered to be a change and would normally initiate a regulatory post-approval change process. Design space is proposed by the applicant and is subject to regulatory assessment and approval.

A specification that defines the design of a system or system component.

(NIST) A specification that documents how a system is to be built. It typically includes system or component structure, algorithms, control logic, data structures, data set (file) use information, input/output formats, interface descriptions, etc.

(IEEE) Standards that describe the characteristics of a design or a design description of data or program components.

A value for a critical parameter that is more conservative than its acceptance criterion, used by designers to assure that the system is capable of meeting the acceptance criterion. Design targets should not be used for system qualification; they are “wishful” values that may not be achieved in reality.

The expected (design) upper and lower points of the normal operating range.

Maximum allowable penetration, which is determined by agreement between customer and supplier, through a leak, detectable during scanning of an installation with discrete-particle counter or aerosol photometer.

A health care provider's medical and billing records about individuals and any records used by the provider to make decisions about individuals. Individuals, including research subjects, have the right under the HIPAA Privacy Rule to access and amend protected health information in a Designated Record Set.

(ICH Q6B) (1) The protein which has the expected structure, or (2) the protein which is expected from the DNA sequence and anticipated post-translational modification (including glycoforms), and from the intended downstream modification to produce an active biological molecule.

The application of code audit, inspection, review and walkthrough techniques to source code and other software documents usually by an individual (often by the person who generated them) and usually done informally.

The opposite of adsorption; the release of adsorbed molecules, particles, or cells into the surrounding medium.See also: Adsorption

The result of the process in the previous definition.

(IEEE) The process of refining and expanding the preliminary design of a system or component to the extent that the design is sufficiently complete to be implemented.

Design stage when the documents required for construction bidding and contracting, as well as system and equipment purchase, fabrication, installation and testing are produced.

An automation specification document, which builds on the Functional Requirement Specification (FRS) adding sufficient detail to allow programmers to encode the control system.

Provides the detailed design requirements. The DDS specifies how to build the direct impact water or steam system. Typically, the DDS is tested or verified during commissioning or qualification.

(ICH Q9) The ability to discover or determine the existence, presence, or fact of a hazard.

(ICH Q2 (R1)) The detection limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be detected but not necessarily quantitated as an exact value.

Substance which lowers the surface tension of a solution, improving its cleaning properties.

Process by which undifferentiated cells in an embryo become committed to develop into specific cell types, such as neurons, fibroblasts or muscle cells.

An exothermic reaction characterized by the presence of a shock wave in a material that establishes and maintains the reaction. The reaction zone progresses through the material at a rate greater than the velocity of sound. The principal heating mechanism is one of shock compression. Detonations have an explosive effect.

Division of Emerging and Transfusion Transmitted Diseases (CBER)