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computerized system validation was perceived by many companies to be a barrier to innovation as i mentioned and this is certainly not what the fda wants and they saw that some of the practices in companies werenamp;#39;t actually reflecting um current industry best practice as described in gamp for instance but rather was reflecting a traditional paper work approach that was that was developed decades ago but had got ingrained and enshrined into the into the industry and had never really moved on so they were keen to help the industry to basically adopt good current i.t practices good current software engineering practices and to truly adopt the principles in game 5 for instance because game 5 has always been about risk management critical thinking and thatamp;#39;s thatamp;#39;s something that weamp;#39;re working even more on at the moment but itamp;#39;s all about doing the right thing and following good practices so the fda wanted to play their part in explaining to the indust