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software validation

   Also found in: Acronyms 0.01 sec.
software validation
The certification that an information system has been implemented correctly and that it conforms to the functional specifications derived from the original requirements. Such validation is often performed by a third party consulting organization.


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Software validation was the most common infraction with two additional reasons listed as: 1) some validation studies were accepted despite results that did not demonstrate validated conditions, and 2) some validation testing was conducted in an inappropriate manner or insufficient data were available to support its processes.
One of the simplest yet powerful software validation tools is hazard analysis, which helps to semi-quantify and standardize the assessment you go through to identify risk.
A specific example was that "electronic records are used, but there was no software validation.
 
 
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