Availability:
Plans: Enterprise plans + $650 per 21 CFR Part 11-compliant workspace annual workspace fee + additional per-document fee
How to buy: Reach out to our Sales team for a demo and purchase.
What is 21 CFR Part 11?
21 CFR Part 11 is a U.S. FDA regulation that sets requirements for using electronic records and electronic signatures in regulated industries (e.g., life sciences, medical devices, biotech, clinical research). If you submit electronic records to the FDA, your e‑signature workflows must meet Part 11 requirements.
Important: This article is for informational purposes only and is not legal advice. Your organization is responsible for validating that your specific use cases meet applicable regulations.
Who should use a 21 CFR Part 11-compliant workspace
Use a 21 CFR Part 11-compliant workspace if your organization:
Operates in FDA‑regulated industries (pharma, biotech, medical devices, healthcare, CROs, labs) or conducts FDA‑regulated activities
Needs strong signer identity verification and auditability
Requires signature manifestation (signer name, timestamp, intent) on documents
If you don’t have FDA‑regulated use cases, our standard eSignature plans (ESIGN/UETA compliant) are typically sufficient.
What’s included
Mandatory identity verification. Every signer must complete identity verification before signing.
Documents cannot be sent unless verification is configured for all signers.
Incompatible signing methods disabled. Sharing by link and In-person signing are disabled in CFR mode.
Signature manifestation. Signer name, timestamp, and signing intent are visibly displayed on signed documents.
Exportable audit trail. A comprehensive record of document events (send, view, verify, sign, complete) is available for export and regulatory inspection.
Note: Document and Signature forwarding are disabled for CFR 11-compliant workspaces to maintain control and traceability.
How 21 CFR Part 11 compliance works in PandaDoc
Once the feature is purchased and enabled:
Create a dedicated workspace for 21 CFR Part 11-compliant documents.
PandaDoc provisions the workspace and enables compliance functionality. You’ll see the CFR compliance label next to the workspace name and in the workspace switcher.
You select your preferred identity verification method for document recipients.
When a document is sent, signers will need to confirm their signing intent. Signature manifestation (signer name, timestamp, and intent) will appear each signature for every document in the 21 CFR Part 11 compliant workspace.
The audit trail can be exported for compliance review and validation.
Configure identity verification
Use these options to ensure every regulated document enforces ID verification:
Set up required identity verification methods in workspace settings.
Go to Settings > Recipient experience, and choose your preferred verification methods . The selected method must be configured for each document recipient in every new document created in this workspace. Users in this workspace won’t be able to send a document unless verification is configured.
Note: We recommend enabling SMS, ID Check, or KBA verification methods in a 21 CFR Part 11 compliant workspace. Passcode verification is not recommended.
2. Set up per-document verification
When creating a document, set verification for each signer before sending.
Note: Share by link and in-person signing options are unavailable. In a 21 CFR part 11-compliant workspace, you can send documents only via email.
Warning: Document senders will be unable to send a document in a 21 CFR part 11-compliant workspace without setting up an identity verification method.
Use signature manifestation
Signature manifestation is automatically enabled in CFR workspaces. When a recipient signs, PandaDoc captures and displays:
Signer name
Timestamp
Signing intent (reason for signing)
These details appear directly on the signed document next to each signature (and initials, where applicable).
Export the audit trail
After document completion, admins can export a detailed audit trail that includes all key document events as a CSV file by opening the document and clicking Export as CSV in the Audit trail.
Store audit trails according to your organization’s record retention and validation policies.
Best practices
Maintain separate workspaces for regulated and standard workflows.
Train senders on compliance-specific steps before launch.
Periodically test your process end-to-end and store validation evidence (sample signed documents, audit trail exports, screenshots).
FAQ
Is CFR Part 11 available on Business plans?
No. It’s available on Enterprise and Application Volume plans.
How do usage limits and overages work?
When you reach your purchased volume, compliant sending is disabled in the editor until more volume is added. In‑flight recipients can still complete, and overages are billed at your standard per‑document rates.
© PandaDoc. This content is provided for general information and may change. Always consult your legal/compliance team to validate your use cases.