Category: Health
Created by: nicktruth
Number of Blossarys: 1
A generally available software component for which the user can not claim complete software life cycle control.
Any requirements set forth in the Act (Federal Food, Drug and Cosmetic Act), the PHS Act (Public Health Service Act), or any FDA regulation (GxP: GLP, GMP, GCP, etc.), with the exception of part 11. ...
A software verification and validation task to determine the extent of verification and validation analysis and testing that must be repeated when changes are made to any previously examined software ...
The ability of a system or component to perform its required functions under stated conditions for a specified period of time.