|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||
(IEEE) A condition or capability needed by a user to solve or achieve an objective. Also, a condition or capability that must be met or possessed by a system or system component to satisfy a contract, standard, specification, or other formally imposed documents.
Publication Source: GAMP® 4: Good Automated Manufacturing Practice Guide for Validation of Automated Systems
(ISO) Need or expectation that is stated, generally implied or obligatory.
Publication Source: GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems
Publication Date: 2008
A documented representation of a condition or capability.
Publication Source: FDA Glossary of Computerized System and Software Development Technology
Do you have a term that should be included in the glossary?
Submit a term for review