Glossary

(IEEE) A language designed to enable humans to communicate with computers.

Computerized system plus its operating environment.

(ISO) The branch of science and technology that is concerned with methods and techniques relating to data processing performed by automatic means.

(ICH Q7) A group of hardware components and associated software, designed and assembled to perform a specific function or group of functions.

(ANSI) a functional unit, consisting of one or more computers and associated peripheral input and output devices, and associated software, that uses common storage for all or part of a program and also for all or part of the data necessary for the execution of the program; executes user-written or user-designated programs; performs user-designated data manipulation, including arithmetic operations and logic operations; and that can execute programs that modify themselves during their execution. A computer system may be a stand-alone unit or may consist of several interconnected units.

(IEEE) A system containing one or more computers and associated software.

(ISO) An examination of the procedures used in a computer system to evaluate their effectiveness and correctness and to recommend improvements.

(IEEE) The protection of computer hardware and software from accidental or malicious access, use, modification, destruction, or disclosure. Security also pertains to personnel, data, communications, and the physical protection of computer installations.

A sequence of bits or characters that is stored, addressed, transmitted, and operated on as a unit within a given computer. Typically one to four bytes long, depending on the make of computer.

(ICH Q7) A process or operation integrated with a computer system.

Includes hardware, software, peripheral devices, personnel, and documentation; e.g., manuals and Standard Operating Procedures.

All of the computers with their associated hardware, software, and documentation needed to satisfy specific user requirements, e.g., Laboratory Information Management System.NOTE: This Guide does not consider standardized components such as routers and switches to be computerized systems.

All of the computers with their associated hardware, software, and documentation needed to satisfy specific user requirements, e.g., Laboratory Information Management System.

A broad range of systems including, but not limited to, automated manufacturing equipment, automated laboratory equipment, process control and process analytical, manufacturing execution, laboratory information management, manufacturing resource planning, clinical trials data management, vigilance and document management systems. The computerized system consists of the hardware, software, and network components, together with the controlled functions and associated documentation.

Achieving and maintaining compliance with applicable GxP regulations and fitness for intended use by:- the adoption of principles, approaches, and life cycle activities within the framework of validation plans and reports- the application of appropriate operational controls throughout the life of the system.

Compliance Status information System

A DNA segment made up of repeated sequences linked end to end.

A condition in which the surface of a welded joint is depressed relative to the surface of the tube or pipe. Concavity is measured as a maximum distance from the outside or the inside diameter surface of a welded joint along a line perpendicular to a line joining the weld toes.

The liquid containing dissolved and suspended matter that concentrates on one side of a membrane.

The amount of a specific substance mixed into a given volume of air or liquid.

The phenomenon in ultrafiltration (UF) in which solutes form a dense, polarized layer next to the membrane surface eventually blocking further flow. UF systems counteract this by continuously flushing the solute away from the membrane surface.

(IEEE) The initial phase of a software development project, in which user needs are described and evaluated through documentation; e.g., statement of needs, advance planning report, project initiation memo. Feasibility studies, system definition documentation, regulations, procedures, or policies relevant to the project.