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Cc electronic signature trial

hello and welcome to my next executive series video our topic today is electronic records electronic signatures aaron snyder here from quality systems explained where we make quality systems simple for you if you're new to my channel please hit the subscribe button if this is the first video that you've seen please go back check out my introduction video you can look at the video description for links to any supporting information and an outline of the material that we will cover in the executive series we have a standard agenda which covers four main areas you can see those in the progress bar below make sure you stick around to the end of the video to get those three bonus questions our requirement electronic records electronic signatures comes directly from 21 cfr part 11 and 1345 section 4.1.6 electronic records electronic signatures in five words validate signature and record software when we choose to use a software system or an electronic system for any quality system requirement where signatures and records are actually maintained we have to meet the requirements of part 11. in the medical device space the fda is currently exercising enforcement discretion against part 11. the reason for this is part 11 was written in a way that it's very difficult to comply with and in 820 we have another section 820.70i where we have to validate software for its intended use so what the fda is looking for here is that when we have electronic systems that have signatures and records that we validate those for their intended use according to an established protocol when we do that validation we have to consider the requirements of part 11 but in our validation itself we have to do the verification activities needed to show that signatures and records are handled appropriately so how do i know this is working well first my software it's validated for its intended use and that includes electronic records and electronic signatures how do i know it's not working well first i have electronic signatures or records that aren't invalidated systems and those signatures and those records they aren't backed up they aren't maintained basically i'm not complying with the software validation requirements and i'm not complying with the part 11 requirements now for those three bonus questions how do we ensure part 11 compliance when we do a software validation what testing do we do around electronic signatures electronic records and what type of training and awareness do we do so that employees understand that their electronic signature is the same as a handwritten physical signature thank you for watching if you found this video helpful please like subscribe share and comment if you have any questions please send me an email at qms.jedi gmail.com this is aaron snyder from quality systems explained never stop learning