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
Enter Workspace Settings
Open the relevant Workflow
Step 2 – Enable E-Signature Approval
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:
Enter Manager Mode
Navigate to the relevant Cabinet or Folder
Select Edit
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:
Select Send for Approval
Choose approvers
Set due date, message, and version label lifecycle dates (if applicable)
Step 2 – Select Approval Type
Choose E-Signature as the approval type
Select the desired signature format (if multiple are enabled)
If Sequential signing order was selected, click next and finalize order of approval signatures.
Step 3 – Configure Signature Placement
A new tab will open displaying the document
Use the signature panel to drag and place signature blocks
Position signatures as needed (resizing is not currently supported)
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
Step 3 – Enter Signature Details
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










