Electronic Signature Compliance (21 CFR Part 11)

What Is Electronic Signature Compliance?

Electronic signatures are now integrated into your approval and release workflows. When you approve, review, or release a shipment, you'll encounter a signature modal that:

• Captures your intent — Shows whether you're approving, reviewing, or releasing

• Requires re-authentication — Confirms your identity before signing

• Creates an audit trail — Records your printed name, date, time, and signature meaning

• Binds to records — Signatures are attached to specific shipment records and cannot be altered

• Generates reports — PDF exports include all signature details for regulatory compliance

Who Needs This?

Your system administrator controls whether electronic signatures are required based on your User Access Group. Check with your team lead if you're unsure whether signatures apply to your role.

Main Workflow: Signing a Shipment Approval

Step 1: Initiate an Approval or Release

1. Open a shipment record

2. Click Approve, Review, or Release

3. Complete any required pre-approval steps

Step 2: Complete the Signature Modal

1. A modal window appears showing:

   • The action you're performing (Approve/Review/Release)

   • Disclaimer text explaining the legal meaning

   • A disclaimer acknowledgment checkbox

2. Enter your printed name (up to 150 characters)

3. Click Sign

Step 3: Re-Authenticate

1. You'll be prompted to confirm your identity

2. Enter your password or complete your authentication method

3. Your signature is recorded and bound to the shipment record

Step 4: Confirmation

1. The signature modal closes

2. The approval is processed

3. Your action is logged in the shipment's audit trail

Downloading Signature Reports

When you export a shipment to PDF, the report now includes:

• Signature date and time

• Printed name of signatory

• Meaning of signature (Approve/Review/Release)

• Verification status

To download a report:

1. Open the shipment record

2. Click Export to PDF or Download Report

3. The PDF includes all signature details in the audit section

Signature Records and Audit Trails

Every signature is stored with:

• Your printed name (as you entered it)

• Date and time of signature

• Meaning (the action taken)

• Shipment record reference

• Authentication method used

This information is viewable in the shipment's audit trail and cannot be modified after signing.

Permissions & Access Control

Tips and Best Practices

• Use a consistent printed name — Use the same spelling every time for clear audit trails

• Review before signing — Ensure all shipment details are correct before you enter the signature modal

• Keep your credentials secure — Your re-authentication is the final verification step

• Understand the meaning — Each signature type (Approve/Review/Release) has a specific legal meaning; confirm you understand it before signing

Need Help?

• I don't see a signature modal — Your User Access Group may not require signatures. Contact your administrator.

• I forgot my password during re-authentication — Use your standard password reset process, then retry the approval.

• I need to view past signatures — Open the shipment record and check the audit trail section.