Hi Srini, 

I'm interested in this as well.  We are currently in talks with Adobe and DocuSign regarding CFR Part 11 compliant signatures and it would be amazing if that can be achieved in Box Sign instead.

I'm interested in this as well. We currently use DocuSign. 

Can BOX help in setting up an Electronic Signature Report to meet the CFR PART 11.

My company just received our MDR Certification and this is required to monitor and confirm the Electronic Signatures used in the company.

We launched support for 21 CFR Part 11 compliance last January. You can learn more about it by leveraging these resources:
 

• Support for 21 CFR Part 11 in Box Sign
• 21 CFR Part 11 Solution Brief
• 21 CFR Part 11 Datasheet
• Box Sign 21 CFR Part 11 Informed Consent Demo
• How 21 CFR Part 11 for Box Sign works

In regards to your requirements:

1) The name of the signee must be printed - if we send email for signature then it only adds email address but no full name. Not sure how to accomplish this.

Where does the name need to be printed? You can drag and drop a name fields within a Part 11 request or template. The signature field also includes the signer name as part of the 21 CFR Part 11 requirementation. Please review the above materials to learn more.

2) Date and time stamp when the signature was completed - This is generated in the signature log

This is also generated in the signature field/frame for each signer as well. Please review the above materials to learn more.

3) Reason for approving the document: Approver, Acknowledgement etc.

This is also included. Admins can use default signing reasons for signers to pick from or they can include custom reasons as well. Additionally, Admins can enable signers to include their own customizable reasons as well. Please see the materials above or click here to learn more about configurable signing reasons.
 

4) Potentially asking for another authentication - I think this can be accomplished by using two factor authentication

We have this capability as required by 21 CFR Part 11 requirements. We required signers to log in to their Box account using their login credentials to authenticate themselves any times they initiate a Part 11 signature request and for every signature and initials field.

Please speak with your account manager or customer success manager to learn more. 

This is available for Box Sign for customers with GxP Validation. You can learn more about it by leveraging these resources:
 

• Support for 21 CFR Part 11 in Box Sign
• 21 CFR Part 11 Solution Brief
• 21 CFR Part 11 Datasheet
• Box Sign 21 CFR Part 11 Informed Consent Demo
• How 21 CFR Part 11 for Box Sign works

The main difference between leveraging Box Sign for this capability vs Adobe or Docusign is:
 

• You unlimited e-signaure requests/envelopes/transactions at no additional cost in Box Sign. Docusign and Adobe charge you per-envelope or per-transaction any time you send a document out for signature. 
• Box does not charge extra for authentication. Docusign and Adobe both charge to use SMS authentication for every signer in a Part 11 envelope or signature request. Box enables signers to use their Box account to authenticate without extra charges. 
• You get everything else that Box has to offer, including enterprise grade security and compliance, 21 CFR Part 11 compliance for electronic records, GxP Validation, and more!

Hello ​@aabbatan,

Can you share more information on what you’re looking for specifically? Are you looking for an e-signature solution that supports 21 CFR Part 11 compliance to send signature requests that are 21 CFR Part 11 compliant? We launched support for 21 CFR Part 11 compliance last January. You can learn more about it by leveraging these resources:
 

• Support for 21 CFR Part 11 in Box Sign
• 21 CFR Part 11 Solution Brief
• 21 CFR Part 11 Datasheet
• Box Sign 21 CFR Part 11 Informed Consent Demo
• How 21 CFR Part 11 for Box Sign works