Regulatory Open Forum

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  • 1.  Docusign

    Posted 30-Oct-2018 12:54
    I'm wondering if anyone has implemented Docusign as their electronic signature mechanism and making it meet part 11. Any thoughts on using DocuSign within the medical device regulation would be greatly appreciate.

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    Thi Nguyen
    Director of Quality Assurance
    Hayward CA
    United States
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  • 2.  RE: Docusign

    Posted 30-Oct-2018 13:16
    Hello,

    Docusign has a new CFR 11 compliant module: https://support.docusign.com/en/guides/ndse-admin-guide-part-11-compliance

    Without this add-on module, docusign is not compliant with 21 CFR 11. 

    Hope this helps.

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    Saurabh Kothari MSRA, MSBE, RPh, CCRP, RAC
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    Original Message


  • 3.  RE: Docusign

    Posted 06-Nov-2018 12:18
    Thank you, Saurabh.

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    Thi Nguyen
    Director of Quality Assurance
    Hayward CA
    United States
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    Original Message


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