Date Added: Sep 2009
Software validation is required by any company covered by the Food, Drug and Cosmetic Act and 21 CFR Parts 210 & 211. Many small to midsized companies see this as an overwhelming task, but when approached in a logical manner, it does not have to be. This guide will assist you through 10 steps in making your validation run more smoothly and successfully. Software validation is confirmation that software specifications conform to user needs and the intended use of the software.