21 CFR Part 11: Electronic Records; Electronic Signatures - Final Rule and Preamble (U.S. FDA Regulations)
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Regulations issued by the U.S. Food and Drug Administration (FDA) on March 20, 1997, and effective on August 20, 1997. The regulations provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper.
These regulations, which apply to all FDA program areas, are intended to permit the widest possible use of electronic technology, compatible with FDA's responsibility to promote and protect public health. The use of electronic records as well as their submission to FDA is voluntary.