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Is 21 CFR Part 11 required for electronic signature software?

  • 1.  Is 21 CFR Part 11 required for electronic signature software?

    Posted 06-22-2022 09:04
    Dear BioA community,

    If you have started to use electronic signature software, eg. Docusign, Adobe, to sign off documents such as contract, study plans, SOPs, reports ect. , have you ever questioned by regulatory agencies or auditors if the electronic signature software must comply with 21 CFR Part 11? Both Docusign and Adobe provide both version, ie. with and w/o 21CFR Part 11, of course with differenct price, but I am wondering if only the version  with 21CFR Part 11 (more costly one)  should be used for signing those document.

    Thanks,

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    Jason (Hao) Wang, Ph.D.
    Brisbane
    Australia
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