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hi everybody today weamp;#39;re going to talk about validation of quality system software and a question from one of our uh employees that they thought would be great to ask because we see this from other customers all the time do we have to validate something simple and silly like Microsoft Word so if you have any kind of familiarity with the quality system requirements in ISO 134 3 5 Clause 4.1.6 it says you have to validate software that affects the quality system so quality system software has to be validated but what is quality system software they donamp;#39;t Define that um they do say that it would be any software that could affect the quality of your product or affect the quality um the quality system itself so if you have it for recordkeeping if youamp;#39;re using software for record keeping thatamp;#39;s going to affect the quality system if you have software to keep track of your lots that automatically assigning lot numbers that would be qualified if you keep track of