Electronic Signatures

The Electronic Signatures module provides 21 CFR Part 11 compliant electronic signatures for documents, approvals, and other quality system records. Electronic signatures serve as the legal equivalent of handwritten signatures, capturing the signer’s identity, intent, and the date and time of signing.

Sign a pending signature from the queue

1. On the left sidebar, select Signatures.
2. In the Pending Signatures Queue (highlighted at the top of the page), locate the signature request.
3. Select the Sign button next to the item.

Sign a signature from the table

1. On the left sidebar, select Signatures.
2. In the signatures table, locate a signature with Pending status.
3. Select Sign in the Action column to open the signing page.
4. Review the document or record details.
5. Provide your electronic signature.

Verify a signature

1. On the left sidebar, select Signatures.
2. In the signatures table, locate the signature you want to verify.
3. Select Verify in the Action column to open the verification page.
4. Review the signature authenticity and audit trail details.

Request signatures from multiple users

1. On the left sidebar, select Signatures.
2. Select Request Signatures at the top of the page.
3. On the bulk signature request page, configure the signature request details.
4. Select the users who should sign.
5. Submit the request.

Note

The signatures list polls for updates automatically every 10 seconds, so new signature requests appear without requiring a page refresh.

Caution

Electronic signatures carry the same legal weight as handwritten signatures. Only provide your signature after thoroughly reviewing the associated document or record.

Signature statuses

Status	Description
Pending	The signature has been requested but not yet provided
Completed	The signature has been successfully applied

Signature display on records

Signatures are also displayed inline on document and resource detail pages through the Signature Display component. This component shows:

• The type of signature action (for example, Approve, Acknowledge)
• The signature meaning
• The date and time the signature was applied
• The IP address of the signer
• A validity indicator (Valid badge)

21 CFR Part 11 compliance

The electronic signature system is designed to support compliance with FDA 21 CFR Part 11 requirements:

• Unique identification — Each signature is tied to a specific authenticated user
• Signature meaning — Every signature includes the meaning of the signature (for example, approval, acknowledgement)
• Timestamp — Signatures are recorded with precise date and time stamps
• Non-repudiation — Signed records include IP address and user agent information
• Integrity verification — Cryptographic checksums ensure signatures have not been tampered with
• Audit trail — Complete audit trail is maintained for all signature activities

Permissions

Action	Allowed Roles
View signatures list	All authenticated users
Sign a pending request	The designated signer
Verify a signature	All authenticated users
Create bulk signature requests	All authenticated users

Practical example: Signature workflow for making an SOP effective

A quality manager makes a revised cleaning validation SOP (SOP-CLN-005, Version 3.0) effective and needs electronic signatures from relevant personnel before the document becomes effective.

1. Request signatures: The quality manager navigates to Signatures, selects Request Signatures, and creates a bulk request:

   • Documents: SOP-CLN-005 v3.0
   • Recipients: 3 production supervisors, 2 QA specialists, and the validation manager
   • Action: Acknowledge Review
   • The system creates 6 individual pending signature requests.

2. Sign pending requests: Each recipient sees the request in their Pending Signatures Queue. They open the signing page, review the SOP content, confirm all three acknowledgement checkboxes, and provide their electronic signature. The signature is recorded with their identity, timestamp, and IP address.

3. Verify signatures: The quality manager periodically checks the Signatures page to monitor completion. Once all 6 signatures are provided, they verify each one by selecting Verify and confirming the cryptographic integrity checks pass (digital signature valid, timestamp integrity confirmed, user authentication verified).

4. Compliance record: The completed signatures and verification results form part of the 21 CFR Part 11 compliant audit trail for the SOP effectiveness determination, available for regulatory inspection at any time.