CFR Part 11 Signature Field

Capture the reason for signing alongside the signature to meet CFR Part 11 regulatory requirements.

The CFR Part 11 Signature Field enables organisations needing stricter regulatory compliance to document not only who signed a document, but also why they signed it. This specialised field differs from SignedX's standard signature offering and applies specifically when CFR Part 11 compliance is mandatory.

What is the CFR Part 11 Signature Field?

This field type extends standard electronic signatures by recording additional regulation-specific details at the signing moment.

When employed, SignedX captures:

• The signer's full name
• The reason for signing
• The exact signing date and time
• The applied electronic signature

All information is permanently embedded into the document to support audit and compliance obligations.

Who is this field designed for?

The CFR Part 11 Signature Field targets US-based organisations operating in regulated industries, particularly pharmaceuticals, life sciences, and drug development where FDA regulatory compliance applies.

These sectors must document signer intent, identity, and timing within electronic records, and this field supports those requirements in an auditable manner.

Using the CFR Part 11 Signature Field when preparing an envelope

When setting up an envelope, the CFR Part 11 Signature Field appears alongside the regular signature field.

Key points:

• This represents a different field from the standard signature option.
• You must intentionally select the CFR Part 11 field when compliance is necessary.
• A standard signature field will not prompt for a signing reason.

Once added, the field functions like a signature placeholder with additional compliance logic engaged at signing time.

What signers see when signing

Recipients encounter the following steps:

This additional step documents signer intent according to CFR Part 11 standards.

How the signature appears on the document

Following signature completion, SignedX embeds:

• The signer's name
• The selected reason for signing
• The exact signing timestamp
• The applied electronic signature

This directly integrates into the document, establishing a transparent, tamper-resistant audit trail for regulatory and legal examination.

When should I use this field?

Deploy the CFR Part 11 Signature Field when:

• You must satisfy CFR Part 11 or equivalent regulatory obligations.
• Recording signer intent is mandatory.
• Your documents face potential audits or regulatory examination.

For routine agreements or standard approvals, SignedX's standard signature field typically suffices.