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21 CFR Part 11

eSignGlobal has adapted to the 21 CFR Part 11 signature compliance requirements, ensuring the legality and validity of electronic signatures in relevant scenarios.

Initiating Envelope

  1. After enabling 21 CFR Part 11 compliant signatures, all envelopes sent from the workspace must be signed according to the relevant requirements. The workspace card in the upper right corner displays the compliance signature activation indicator. 1.png

  2. When initiating an envelope, the signer’s identity verification method must be selected as “Identity Verification”. The envelope does not currently support setting a digital signature. 2.png

  3. When setting the signing control, please specify at least one signing area for each document. 3.png

Signing Envelope

  1. When signing, the signer needs to draw a signature and select a signing reason. 4.png

  2. After the signer completes the signing, the signature will include:

    1. The signer’s handwritten signature
    2. The signer’s printed name
    3. The signing reason
    4. The signing time 5.png
  3. When submitting the signature, facial recognition is required to complete the signing. 6.png