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i am aaron wright iamp;#39;m a product manager over at master control and weamp;#39;ll be talking about the future validation current state what whatamp;#39;s really the appropriate interpretation of the software validation looking at csa and whatamp;#39;s coming down the road from cdrh as well as how we can get into self-validating software and having a much more forward-thinking approach to how we validate our software so the first thing we should touch on is current state right computer computer software validation uh this came out of uh the obviously 21cfr part 11 which came out in 1997 and it has a very documentation heavy mindset right is that the whole point of the validation is to create uh whatamp;#39;s colloquially called the thump factor so the large the bigger the thump that your validation package makes when you put it on the table in front of your auditors or your inspectors the more impressive that your validation process is and weamp;#39;ve all i personally say th
