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21 CFR Part 11 & e-Signatures

New Here ,
Apr 28, 2017

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When using the "send for signature" option in Adobe DC that distributes a PDF with regular electronic signature blocks to multiple email recipients, is that e-signature considered Part 11 compliant? The fully distributed form appears to contain the required elements of Part 11 compliance, but confirmation is appreciated.

If not, is it safe to say that only "digital signature" blocks used in (or added to) forms are considered Part 11 compliant? This would mean only 1 person could sign using the digital signature, correct (ie, it's locked down via checksum, etc, following signature 1 and another signature would modify the document such that it would negate the original signature)?

Thank you,

Mark

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21 CFR Part 11 & e-Signatures

New Here ,
Apr 28, 2017

Copy link to clipboard

Copied

When using the "send for signature" option in Adobe DC that distributes a PDF with regular electronic signature blocks to multiple email recipients, is that e-signature considered Part 11 compliant? The fully distributed form appears to contain the required elements of Part 11 compliance, but confirmation is appreciated.

If not, is it safe to say that only "digital signature" blocks used in (or added to) forms are considered Part 11 compliant? This would mean only 1 person could sign using the digital signature, correct (ie, it's locked down via checksum, etc, following signature 1 and another signature would modify the document such that it would negate the original signature)?

Thank you,

Mark

Topics

Questions Need Help

Views

661

Likes

Translate

Translate

Report

Report
Community Guidelines
Be kind and respectful, give credit to the original source of content, and search for duplicates before posting. Learn more

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