''Software Validation'' is a part of the [[Design Validation]] for a finished device, but is not separately defined in the Quality System regulation. For purposes of this guidance, FDA considers software validation to be:
''//confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled//''
In practice, software validation activities may occur both during, as well as at the end of the software development life cycle to ensure that all requirements have been fulfilled. Since software is usually part of a larger hardware system, the validation of software typically includes:
//''evidence that all software requirements have been implemented correctly and completely and are traceable to system requirements''//

A conclusion that software is validated is highly dependent upon comprehensive software testing, inspections, analyses, and other verification tasks performed at each stage of the software development life cycle. Testing of device software functionality in a simulated use environment, and user site testing are typically included as components of an overall design validation program for a software automated device
bag
fda_public
created
Thu, 06 Sep 2012 20:21:33 GMT
creator
dirkjan
modified
Thu, 06 Sep 2012 20:21:33 GMT
modifier
dirkjan
tags
Term
creator
dirkjan