Skip to main content
All CollectionsFAQs
How do I sign a TWALA CFR Part 11 Document?
How do I sign a TWALA CFR Part 11 Document?

Organizations from the Health and Life Sciences industry use TWALA to comply with FDA 21 CFR Part 11 eSignature regulations. This module ensures your digital signatures meet the highest security and compliance standards

Jeffrey Reyes avatar
Written by Jeffrey Reyes
Updated over 2 weeks ago

The CFR Part 11 signing process works similarly to regular TWALA document signing, but with additional security layers to protect sensitive information.

________________________________________

Who Can Use This Feature?

This feature is exclusive to Enterprise Plan users.

________________________________________

Step-by-Step Guide to Signing a TWALA CFR Part 11 Document

  1. Open the document for signature

When you open your document for signature, an E-signature Disclosure window will pop up on your screen.

2. Agree to the E-signature Disclosure

A window will pop up explaining the e-signature process and its legal binding under FDA 21 CFR Part 11.

Click "Agree" to proceed.

3. Review the Document

Carefully read the entire document before signing to ensure all information is accurate.

4. Sign the Document

Click the yellow "Click to Sign" indicator to place your e-signature on the designated field.

5. Fill in Required Fields

Complete any additional fields requested by the sender.

6. Submit Your Signature

Once all required fields are filled out, click the "Submit Signature" button.

7. Signing Reason

A Signing Reason window will prompt you to indicate your reason for signing. Select the option that applies to you. Once done, click the "Sign" button.

Did this answer your question?