21 CFR Compliance when receiving signature requsts

Hello ​@AWGAL,

Thank you for reaching out, and welcome to the Docusign Community! We are glad to have you here and can't wait to help share as much knowledge as possible.

I see that you are a user of the CFR Part 11 module and you are inquiring whether the signature remains compliant when sending a signature request to another user who has a free DocuSign account that does not include this module. I understand that you are unable to locate a definitive answer. I sincerely apologize for any confusion, and I will make every effort to assist you.

To access and sign Part 11 envelopes, signers must log in using their DocuSign account credentials, specifically their username and password. Envelopes sent from a DocuSign Part 11 account do not require signers to have an enabled CFR Part 11 account. Signers simply need to possess a DocuSign account, which may be a free version. This is perfectly acceptable. If a signer does not already have a DocuSign account, they are required to create one prior to signing. Upon receiving their signing notification, the signer will be prompted to establish a password for logging in before they can view the contents of the envelope. After successfully authenticating and signing, the signatures will be compliant.

Here are the authentication methods available for Part 11 signers, based on the sender’s selection:

1. Account Login for Access & Signatures (Default)
   This method necessitates a DocuSign account. If the signer does not already possess a DocuSign account, they will need to create one prior to signing.

2. SMS for Access & Signatures
   With this option, the signer is not required to have a DocuSign account. Instead, signers authenticate by providing the last four digits of their phone number along with a code received via SMS.

3. Two Different Methods:

   • SMS and Account Login for Access
     This method requires both SMS verification and an account login.

   • Identity Verification and Account Login for Access & Signatures
     In this case, signers authenticate using the chosen Identity Verification (IDV) method along with an account login for both access and signatures.

Just sharing articles and videos that might be helpful:

Part 11 Envelope Access and Signatures

Authentication Methods for Part 11 Signers

Signing Experiences for Part 11 Accounts

Settings and Features That Affect Part 11 Module Configuration

DocuSign CFR Part 11 Module: How to Sign a Document

Docusign CFR Part 11 Module: How to Send an Envelope

I hope I answered your question. Let me know if you need further assistance. Thank you!

Best regards,

Melanie | Docusign Community Moderator

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