Skip to main content

Configuring Part 11 E-Signature with DocuSign

DocuSign integration in Kivo enables 21 CFR Part 11 compliant electronic signatures for document approvals. Learn how to enable e-signature accounts, configure workflows, assign approvers, and troubleshoot common signing issues.

C
Written by Casey Huxtable
Updated over a week ago

Required Roles: Edit, Reviewer, Viewer (to sign documents)
Required Permissions: Workspace Manager (for configuration)

Overview

Kivo integrates with DocuSign to enable 21 CFR Part 11 compliant electronic signatures across documents in any module.

This integration allows organizations to capture secure, traceable electronic approvals on controlled documents. Signatures are executed through DocuSign while remaining fully embedded within the Kivo document workflow.

To use electronic signatures in Kivo, three elements must be configured:

  1. The user must have a Kivo e-signature account enabled

  2. The workflow must allow e-signature approvals

  3. The appropriate users or groups must be assigned to the approval step

Once configured, users will be prompted to complete a DocuSign signature when approving documents within Kivo.


Step 1: Enable a User for E-Signature

Workspace Managers must first enable a user’s e-signature account.

  1. Navigate to User Management

  2. Locate the user and select Edit

  3. Scroll down to the E-Sign Accounts section

  4. Enter the user’s email address

  5. Click Invite User

The user will receive an email invitation to create their Kivo Part 11 DocuSign account and password.

After completing the registration process, the user will be able to perform electronic signatures within Kivo workflows.


Step 2: Enable E-Signature in the Workflow

Electronic signatures must be enabled in the workflow used by the document.

  1. Navigate to Workspace Settings > Workflow Settings

  2. Open the workflow(s) used for your documents

  3. Locate the Approve step

  4. Under Approval Type, enable E-Signature

Once enabled, documents using this workflow will require a DocuSign signature when the approval step is completed.


Step 3: Assign Approvers to the Workflow

Users must be assigned to the Approve step in the workflow either by group or individual, in order to sign documents.

  1. Navigate to the cabinet or folder where the document resides

  2. Confirm the workflow assigned to that location

  3. Verify that the correct user group or users are assigned to the Approve step

Only users who are:

  • Enabled for e-signature

  • Assigned to the approval step

will appear as available approvers.


Performing an Electronic Signature

When a document reaches the Approve step, Authors will have the ability to select E-Signature and assign users assign eligable users to approve the document. FOr more infomration see Approving a Document - Sign & Approve Workflow for more information.

Kivo will automatically generate a DocuSign envelope and guide the user through the signing process. Once the signature is completed, the document approval is recorded and the workflow proceeds.


Troubleshooting DocuSign Approvals

Below are the most common issues encountered when using electronic signatures.

User Does Not Appear in the Approver List

If a user does not appear when attempting to approve a document, verify the following:

  • The user has been invited and activated for e-signature

  • The user is included in the group assigned to the Approve step

  • The workflow assigned to the document location includes e-signature approval

If all of these items are correctly configured, reach out to [email protected] to check whether the signer has accepted their invite.


Error During Signature Attempt

If a user receives an error while attempting to sign, it is commonly caused by being logged into a different DocuSign account.

Kivo expects the user to authenticate with their Kivo Part 11 DocuSign account. If another DocuSign account is active in the browser, the signature may fail.

To resolve this:

  1. Log out of other DocuSign sessions

  2. Retry the approval

  3. Authenticate in using the email and password associated with your Kivo e-signature account

Clearing browser cache or using a private browsing window may also help resolve account conflicts.


Important Items to Consider

Interaction with Existing Docusign Account

If you already had an existing Docusign account with the email specified in Kivo. Docusign will create a second account associated with your email address. When you log into Docusign directly, it will likely default to your original account. If you would like to see your Kivo Dashboard, you'll have to sitch accounts by doing the following.

  1. Log into Docusign.

  2. Click your initials.

  3. Click Switch Account

Missing DocuSign Email Notifications from Externally Generated Envelopes

Note: If you did not previously have a Docusign account associated with your email and often signed documents, the email notifications you are used to may be disabled once you are added to Kivo.

Kivo sends its own email notifications when a document requires approval. For this reason, DocuSign email notifications are disabled by default on your new Docusign account to prevent duplicate messages.

If you rely on DocuSign notifications for other envelopes outside of Kivo, you can enable them.

To adjust notification settings:

  1. Log in to DocuSign.com with your

  2. Navigate to My Preferences

  3. Select Notifications

  4. Expand Envelopes

  5. Enable:

    • I have an envelope to sign
      or

    • All recipient notifications (optional)


Summary

The Kivo DocuSign integration enables secure, Part 11 compliant electronic approvals directly within document workflows. By enabling e-signature accounts, configuring workflows, and assigning approvers, organizations can streamline compliant document approvals across all modules.


Related Articles and Next Steps

Did this answer your question?