Glossary

The pharmaceutical customer or user organization contracting a supplier to provide a product. In the context of GAMP 5 it is, therefore, not intended to apply only to individuals who use the system, and is synonymous with customer.

The person or persons who operate or interact directly with the system.

(ANSI) Any person, organization, or functional unit that uses the services of an information processing system.

The person, or persons, who operate or interact directly with the system. The User(s) and the Customer(s) are often not the same person(s), but may be.

Defines precisely and clearly what the user expects the system to do. The document contains information about the operating environment, the required data for processing, and the functionality that the system should carry out. Additionally, the URS can contain non-process-related topics, such as processing time requirements, cost, etc. In a regulated environment, the URS should have a reference on the GxP regulation and must interpret it.

Building or area owned by the end user of the pharmaceutical drug manufacturing process, and/or equipment to be tested.

Dials, knobs, operating system commands, graphical display formats, and other devices provided by a computer or a program to allow users to communicate and use the computer or program. A Graphical User Interface (GUI) provides its user with a “picture oriented” way to interact with technology.

A requirement specification that describes what the equipment or system is supposed to do, thus containing at least a set of criteria or conditions that have to be met.

Generally the first in a series of specification documents. It provides a high level description of the user's expectation of the project scope, with emphasis on product parameters and process performance parameters.

A description of the requirements of the facility in terms of product to be manufactured, required throughput and conditions in which the product should be made.

A description of the requirements of the facility in terms of product to be manufactured required throughput and conditions in which the product should be made.

(ISO) Documentation that describes how to use a functional unit, and that may include description of the rights and responsibilities of the user, the owner, and the supplier of the unit. Synonymous: User Manual, Operator Manual.

United States Green Building Council

United States Geological Survey

United States Pharmacopeia

Published by U.S. Pharmacopeia (USP), a private nonprofit organization, the USP is a compendium of drug uses, covering both on-label and off-label uses. Using panels of expert physicians who evaluate the literature and clinical practice, the USP presents information on which drugs are recommended for which uses, warnings, contraindications, dosages, etc. To keep up with best practices, it is updated regularly. The USP is the best known of several such compendia. The USP also publishes the National Formulary. The Complete Drug Reference, published jointly with Consumer Reports, is the consumer version of the USP. The Complete Drug Reference contains more information than the Physicians Desk Reference (PDR), which is useful but compiles product label information only and thus does not deal with off-label usages.

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United States Public Health Service

United States Trade Representative

Ultrasonic Testing

Coordinated Universal Time (GMT)

Temps Universel Coordonné - Coordinated Universal Time

(ISO) A computer program in general support of the processes of a computer; e.g., a diagnostic program, a trace program, a sort program. Synonymous: Service Program.

(IEEE) Computer programs or routines designed to perform some general support function required by other application software, by the operating system, or by the system users. They perform general functions such as formatting electronic media, making copies of files, or deleting files.