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  • 2018-11-09
    FDA 21 CFR part 11
    FDA 21 CFR part 11

    Subpart A--General Provisions Sec. 11.1 Scope. (a) The regulations in this part setforth the criteria under which the agency considers electronic records,electronic signatures, and handwritten signatures executed to electronicrecords to be trustworthy, reliable, and generally equivalent to paper recordsand handwritten signatures executed on paper. (b) This part applies to records inelectronic form...

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