|Browse All Terms|
|Beginning With||By Language|
|A B C D E F G H I J K L M N O P Q R S T U V W X Y Z :: All||
The documented verification that the facilities, systems and equipment, as connected together, can perform effectively and reproducibly, based on the approved process method and product specification
Publication Source: ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification
Publication Date: 2011
Documented verification that a system is capable of performing or controlling the activities of the processes it is required to perform or control, according to written and pre-approved specifications, while operating in its specified operating environment.
Publication Source: GAMP® 4: Good Automated Manufacturing Practice Guide for Validation of Automated Systems
For “Direct Impact” systems - The documented verification that all aspects of a facility, utility or equipment that can affect product quality, perform as intended meeting predetermined acceptance criteria.
Publication Source: ISPE Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems
Publication Date: 2007
Do you have a term that should be included in the glossary?
Submit a term for review