4/20/15 7:30 AM
Understanding Electronic Signatures for the Life Sciences
In many years dealing with Part 11 compliance, I have often seen confusion over exactly what constitutes an “Electronic Signature.” The FDA’s definition is found in 21 CFR Part 11; Electronic Records, Electronic Signatures, the regulations specifying the FDA’s requirements for using records and signatures in electronic form to meet the record-keeping requirements of Agency regulations in the Life Sciences industry.
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