ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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System

An organization of engineering components, which have a defined operational function, e.g., piping, instrumentation, equipment, facilities, computer hardware, computer software, etc.

Publication Source: ISPE Baseline® Guide, Vol. 5: Commissioning and Qualification

Publication Date: 2001

System

Equipment, procedures, and other resources required to perform or control a process.

Publication Source: GAMP® 4: Good Automated Manufacturing Practice Guide for Validation of Automated Systems

System

(ISO) Set of interrelated or interacting elements.

Publication Source: GAMP® 4: Good Automated Manufacturing Practice Guide for Validation of Automated Systems

System

(ANSI) People, machines, and methods organized to accomplish a set of specific functions.

Publication Source: FDA Glossary of Computerized System and Software Development Technology

System

(DOD) A composite, at any level of complexity, of personnel, procedures, materials, tools, equipment, facilities, and software. The elements of this composite entity are used together in the intended operational or support environment to perform a given task or achieve a specific purpose, support, or mission requirement.

Publication Source: FDA Glossary of Computerized System and Software Development Technology

System

An organization of engineering components, which have a defined operational function, e.g., piping, instrumentation, equipment, facilities, computer hardware, computer software, etc.

Publication Source: ISPE Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems

Publication Date: 2007

System

An organization of engineering components that have a defined operational function and can include: processing equipment, facilities, utilities, etc.

Publication Source: ISPE Good Practice Guide: Maintenance

Publication Date: 2009

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