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 request

Someone else’s signature request for you does not appear in the signatures table — that table lists records of signatures already applied, not requests still outstanding. A pending request reaches you two ways, both pointing at the same page:

1. A notification (bell icon) is created the moment the request is sent.
2. It also appears on My Tasks, under Signature requests — this is the reliable place to find it if the notification was missed or dismissed.

Either path opens the request’s own page:

1. On the left sidebar, select My Tasks (or select the notification).
2. Under Signature requests, select the request.
3. Review the record, the requester, and the meaning of the signature.
4. Provide your electronic signature (see Signing Process).

Once you sign, the request is resolved automatically — including for anyone else it was also sent to, if the same approval is satisfied by your 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
Signed	The signature has been applied and its record-integrity checksum verifies
Signed — integrity check failed	The signature record exists but its stored checksum no longer matches a recomputation — investigate before relying on it
Invalidated	The signature was soft-invalidated (most commonly because the document was later re-signed, or an approval was reverted). Checked ahead of the integrity verdict, so an invalidated signature reads as Invalidated even if its checksum still reproduces cleanly. Per 21 CFR Part 11 the record is never deleted — it stays in this table with its invalidation reason and timestamp.
Pending	A signature request that has not yet been signed. It does not appear in this table (which lists applied signatures) — find it via a notification or under Signature requests on My Tasks
Unknown	The record carries no recognisable status information

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 your own signatures	All authenticated users
View the organisation’s signatures	Admin, QA Team, Auditor
Sign a pending request	The designated signer
Verify a signature	All authenticated users
Create bulk signature requests	All authenticated users

Everyone can see the signatures they executed themselves — you can always produce your own signed record, for example to evidence a completed training. Reviewing other people’s signatures is a quality-oversight activity and is limited to the Admin, QA Team and Auditor roles.

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 as a notification and under Signature requests on their My Tasks page. They open it, 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 record-integrity check passes (the stored SHA-256 checksum matches a recomputation of the signature record).

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.