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Native Part 11 E-Signatures: What's New & How to Get Started

Kivo now supports fully native Part 11 electronic signatures — built into your document workflow, with no third-party tools required. Here's what's new, why it matters, and how to get started.

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Written by Casey Huxtable

Kivo now supports fully native Part 11 electronic signatures — no third-party tools required.

For quality and compliance teams, that means fewer failure points, a cleaner audit trail, and a signing experience that lives entirely within your document workflow.

Have questions or ready to turn this on? Reach out anytime via the messenger icon in the bottom right of your screen or at [email protected].

Have questions or ready to turn this on? Reach out anytime via the messenger icon in the bottom right of your screen or at [email protected].


What This Means for Your Team

One system. One audit trail. Signatures are captured natively in Kivo — not handed off to a third-party service. Every review, approval, and signature is recorded in a single, immutable audit trail, exactly where your documents live.

21 CFR Part 11 and EU Annex 11 compliant — by design. Authentication at time of signature, unique user credentials, role-based access controls, and tamper-evident records are all built in. Compliant by architecture, not by configuration workaround.

Fewer failure points, cleaner records. No external logins, no sync delays, no authentication conflicts. Signers complete their approvals in one step, directly inside Kivo.

Want the full technical and compliance breakdown? See Trust, Compliance, and Data Integrity with Kivo Part 11 E-Signatures →


See It Live

Watch the complete signing process - from document approval to signed, audit-ready record.

Ready to try it yourself? Here's how to get started.


Next Steps

Try It First: Enable on a Sandbox Workflow

The easiest way to get comfortable with the new experience is to enable it on a workflow in your sandbox environment before going live. Here's how:

  1. Navigate to Workspace Settings → Workflow Settings

  2. Open any workflow and locate the Approve step

  3. Under Approval Type, enable E-Signature and save

  4. Go to a document in a sandbox cabinet using that workflow and submit it for approval

  5. You'll see the native signing experience in action — no external tool required

Need to set up users first? See the full configuration guide: Configuring Part 11 E-Signature →

Ready to Enable in Production?

When you're ready to go live, contact us via the chat icon on the bottom right this page or email us at [email protected].

We'd love to help you get your team set up.

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