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Entries related to: 21-cfr-part-11

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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Which Electronic Signature Vendors Comply With 21 CFR Part 11?

“What makes an electronic signature vendor 21 CFR Part 11 compliant?” This is a common question in the pharmaceutical industry, and the answer isn’t always immediately clear. Several e-signature vendors claim to be compliant, but upon closer inspection, that’s not always true.
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