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URL: http://www.fda.org
The
rule provides criteria under which FDA will consider electronic records to be
equivalent to paper records, and electronic signatures equivalent to
traditional handwritten signatures. Part 11 (21 CFR part 11) applies to any
paper records required by statute or agency regulations and supersedes any
existing paper record requirements by providing that electronic records may be
used in lieu of paper records. Electronic signatures which meet the
requirements of the rule will be considered to be equivalent to full
handwritten signatures, initials, and other general signings required by agency
regulations.
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