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21 Cfr Part 11 Checklist Form

21 Cfr Part 11 Checklist Form

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Instructions and help about 21 Cfr Part 11 Checklist

hello Ellie Reynolds here from the team at Proxima Clinical Research in today's video we're exploring part 11 compliance which is a critical aspect of data integrity and electronic record keeping in various Industries so what exactly is part 11 compliance part 11 refers to title 21 part 11 of the code of federal regulations and is otherwise known as 21 CFR part 11. in the U.S all regulated Industries must adhere to the code of federal regulations or CFR which is backed by law medical device and drug companies that have chosen to maintain records or submit information electronically are subject to part 11 compliance overall part 11 ensures that electronic records and signatures are trustworthy reliable and legally equivalent to paper records and handwritten signatures 21 CFR part 11 consists of three main subparts the first is subpart a general Provisions the subpart includes definitions of key terms that are used in part 11 and outlines the scope and applicability of th

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