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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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