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Kivo Part 11 E-Signatures: Setup, Configuration, and Use

Kivo’s native Part 11 e-signature enables secure, compliant document approvals without DocuSign. Learn how to configure workflows, select signature formats, place signatures, and complete approvals with full audit traceability.

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Written by Casey Huxtable
Updated yesterday

Required Roles: Editor, Reviewer, Viewer (to sign)

Required Permissions: Workflow Manager (to configure)

Kivo’s native Part 11 e-signature platform enables secure, compliant electronic signatures directly within the application, without requiring third-party integrations.

Unlike external solutions such as DocuSign, Kivo e-signatures:

  • Use the same authentication as your Kivo login

  • Eliminate external authentication handoffs

  • Prevent sync or envelope update failures

  • Improve reliability, auditability, and compliance

This approach enhances data integrity, traceability, and user experience, while reducing the complexity and potential points of failure associated with external signature providers.


Section 1: Enabling E-Signature in Workflows

E-signatures are configured at the workflow level.

Step 1 – Navigate to Workflow Settings

  1. Enter Workspace Settings

  2. Open the relevant Workflow

Step 2 – Enable E-Signature Approval

  1. Locate the Approve step

  2. Under Approval Types, enable E-Signature

You may also see other approval types (e.g., DocuSign). E-Signature is Kivo’s native option.

Step-3 Configure Signature Manifest Options

After enabling e-signature, select which signature formats are available to users.

These options determine what the document author can choose during approval setup.

Available formats:

  • Embedded Signature
    Signature is placed directly within the document. The signature page is also appended, and details are captured in the audit trail.

  • Signature Page (Appended)
    A separate signature page is added to the end of the document, and signature details are captured in the audit trail.

  • Audit Trail Only
    No visible signature on the document; all signature details are captured in the audit trail.

Note: You are selecting which options are available for the author to choose from, not which one is required. If your organization prefers to require a single format for all folders using that workflow, only enable that option.

Step 4 - Assign Workflow to Cabinets or Folders

If the workflow you enabled e-signature is already assigned to the appropriate cabinets/folders, this step can be skipped. To activate e-signatures for documents:

  1. Enter Manager Mode

  2. Navigate to the relevant Cabinet or Folder

  3. Select Edit

  4. Assign the workflow with e-signature enabled

Once assigned, all documents in that location will follow the configured workflow.


Sending a Document for E-Signature

Step 1 – Route for Approval

When your document is ready:

  1. Select Send for Approval

  2. Choose approvers

  3. Set due date, message, and version label lifecycle dates (if applicable)

Step 2 – Select Approval Type

  1. Choose E-Signature as the approval type

  2. Select the desired signature format (if multiple are enabled)

  3. If Sequential signing order was selected, click next and finalize order of approval signatures.

Step 3 – Configure Signature Placement

  1. A new tab will open displaying the document

  2. Use the signature panel to drag and place signature blocks

  3. Position signatures as needed (resizing is not currently supported)

  4. Click Finish

This sends notifications to approvers and initiates the signing process.


Completing an E-Signature

When an approver is ready to sign:

Step 1 – Open the Document

Navigate to the document and click Sign and Approve

Step 2 – Apply Signature

  1. Confirm or update your signature

  2. Navigate to the assigned signature location

  3. Click Sign

Step 3 – Enter Signature Details

  1. Enter a reason for signing (based on configured options)

  2. Click Approve

Step 4 – Authenticate

Re-enter your Kivo credentials to verify identity. This may be username and password authentication or SSO authentication, depending on your organization's user management configuration.

Once complete, a confirmation message will appear.


What Happens After Signing

After signature completion:

  • The document is versioned (e.g., v1.0)

  • The signed document (PDF) is available, including:

    • Embedded or appended signature(s) (if applicable)

    • Signature manifest with event history (if applicable)

  • Full approval audit trail (timestamps, users, actions)

This ensures complete traceability for compliance and inspection readiness.

Embedded Signature Example:

Signature Page Example:

Audit Trail Example


Key Benefits of Kivo E-Signatures

By keeping workflows entirely within Kivo, this approach eliminates reliance on third-party systems and leverages existing authentication—no separate logins required. Operating in a single system reduces the risk of sync issues and envelope failures while strengthening audit integrity through consistent, end-to-end traceability.

  • Built natively within Kivo, keeping workflows centralized

  • Uses existing authentication without added credential management

  • Improves traceability and audit integrity across the lifecycle

  • Reduces user error and ongoing support overhead

  • Fully aligned with 21 CFR Part 11 requirements


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