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21 CFR Ch I 4 1 04 Edition 101 5 Gpo Form

21 CFR Ch I 4 1 04 Edition 101 5 Gpo Form

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[Music] section one the digital signature on the dotted line understanding 21 CFR part 11 in an increasingly digital world even the most regulated Industries are transitioning from paper to electronic records this shift brings efficiency but also requires careful consideration of data integrity and security this is where the US fda's 21 CFR part 11 comes in this regulation established in 1996 7 sets the standard for ensuring electronic records and signatures used in the pharmaceutical biotechnology and medical device Industries are as trustworthy as their paper counterparts imagine a scientist meticulously recording data in a lab notebook each entry is handwritten dated and signed now picture that same scientist entering data directly into a computer system how can we be sure this electronic data is accurate reliable and tamperproof 21 CFR part 11 provides the answer it lays out a clear framework for creating maintaining and transmitting electronic records and signatures in a w

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