Zdrowie i gospodarka · 25.07.1997
General Principles of Software Validation; Draft Guidance; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``General Principles of Software Validation.'' This guidance is applicable to medical device software and to software used to design, develop, or manufacture medical devices. This guidance discusses how the general provisions of the Quality System Regulation apply to software and the agency's current approach to evaluating a software validation system.