Glossary

Written and approved procedures to ensure that activities are performed the same way each time. A comprehensive SOP program must be in place in any regulated organization.

A wet or dry system of piping, valves, outlets, and related equipment designed to provide water at specified pressures and installed exclusively for the fighting of fires.

A type of indication created during the reaction of electrochemical etching process on the foreign or refractory material (dross) on the welds or base metal.

A complex insoluble carbohydrate, consisting of various proportions of two glucose polymers, amylose and amylopectin; the chief food storage substance of plants, which is composed of several hundred hexose sugar units and which easily breaks down on hydrolysis into these separate units.

The set of three nucleotides in an mRNA molecule with which the ribosome starts the process of translation. The start codon sets the reading frame for translation. The most commonly used start codon is AUG, which is decoded as methionine in eukaryotes and as N-formylmethionine in prokaryotes. AUG appears to be the only start codon used by eukaryotes, while in bacteria, GUG (valine) may sometimes be employed.

Act of preparing and bringing an installation into active service, including all systems.NOTE: Systems may include procedures, training procedures, training requirements, infrastructure, support services, statutory undertakings requirements. ISO 14644-4

The initial operation of equipment to prove that it is installed properly and operates as intended. Start-Up is considered complete when the selected equipment will adequately process product as specified.

(ICH Q3A (R2)) A material used in the synthesis of a new drug substance that is incorporated as an element into the structure of an intermediate and/or of the new drug substance. Starting materials are normally commercially available and of defined chemical and physical properties and structure.

(IEEE) A condition or mode of existence that a system, component, or simulation may be in; e.g., the pre-flight state of an aircraft navigation program or the input state of a given channel.

(IEEE) A diagram that depicts the states that a system or component can assume, and shows the events or circumstances that cause or result from a change from one state to another. Synonymous: State Graph.

A condition in which a pre-defined parameter is observed to remain within a pre-defined range of operation.

(ICH Q10) A condition in which the set of controls consistently provides assurance of continued process performance and product quality.

A condition in which all operating variables that affect performance remain within such ranges that the system or process performs consistently and as intended.

A representation of a state graph that specifies the states, the inputs, the transitions, and the outputs.

Document that defines how the business will measre a successful project, at what capital cost the business case will no longer be viable, valid business reasons for expending additional funds to accelerate the project and project options to be assessed.

(NIST) Testing to satisfy the criterion that each statement in a program be executed at least once during program testing. Synonymous: Statement Coverage.

(NBS) Analysis of a program that is performed without executing the program.

(IEEE) The process of evaluating a system or component based on its form, structure, content, documentation.

(ANSI/IEEE) A software tool that aides in the evaluation of a computer program without executing the program. Examples include checkers, compilers, cross-reference generators, standards enforcers, and flowcharters.

Data/records, including metadata, that are not subject to change. To carry out a change of static data/records often entails code changes that can only be carried out by a privileged user, and normally only in a development/test environment as opposed to alive environment. The opposite to dynamic data/records.

A stationary sealing device.