Achieve 21 CFR Part 11 compliance with Signeasy

21 CFR Part 11 is a regulation by the U.S. Federal Drug Administration (FDA) that outlines how electronic records and electronic signatures must be handled to be considered trustworthy and equivalent to paper records and handwritten signatures.

Any company regulated by the FDA, such as pharmaceutical, biotech, medical device, and clinical research organizations, that uses electronic records/signatures for regulated activities must comply.

Signeasy provides:
• Signer Authentication — Multifactor authentication before signers access the documents.
• Timestamping — Record when the document was signed and sealed.
• Tamper-evident PAdES digital seal — Prevent unauthorized edits of the signed documents.
• Signature linking — Signatures are uniquely bound to their respective records.
• Signature manifestation — With name, email, and reason for signing.
• Access controls and permissions — Role-based access to protect critical data.
• Comprehensive audit trail — Trail of document events for full traceability of every action.
• Compliant records retention — Store and retrieve compliant documents on demand.

Signeasy offers features that support compliance with Part 11, but full compliance also depends on your internal procedures and validation efforts. Think of it as a shared responsibility between you and the platform.

Yes. The FDA requires that systems used for regulated activities be validated. We offer documentation and support to help you conduct your own validation in line with your QMS (Quality Management System).

Absolutely. We offer a 21 CFR Part 11 compliance package on request, including technical features, validation support info, and best practices.

Yes. 21 CFR Part 11 support is available under our custom plan. Contact us to discuss your compliance needs and pricing.

Part 11 requires stricter controls like identity verification, secure audit trails, and electronic signature manifestation (printed name, timestamp, and purpose). Our compliance-grade eSignature offering includes these.

Yes. When configured correctly and validated by your team, Signeasy can be used in Good Practice (GxP) environments, including,
• GLP (Good Laboratory Practice) – covering non-clinical laboratory studies that support research or regulatory submissions.
• GMP (Good Manufacturing Practice) – governing the manufacturing, quality control, and storage of drugs and medical devices.
• GCP (Good Clinical Practice) – ensuring ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials.
Signeasy provides audit trails, access control, time-stamped signatures, and identity verification features critical for maintaining data integrity and traceability in GxP-compliant workflows.

Signeasy is still around 17% more affordable than Docusign’s Part 11 pricing, which averages $3.60 per envelope. Plus, Signeasy includes SMS verification and digital trust seals at no extra cost — no added setup or integration fees.

Our 21 CFR pricing includes premium compliance infrastructure — like tamper-evident PAdES seals and SMS verification — which are provisioned separately from our standard plans. That’s why it’s available only through a custom plan with sales support.

That’s absolutely fine. We can start you on the 1,000–10,000 document tier and revisit pricing as you scale. You’ll still get access to enterprise-grade compliance and a partner that grows with your needs.

We’ve bundled them intentionally to eliminate gaps. This way, you don’t need to cherry-pick controls or worry about missing critical requirements during audits. It’s a audit-ready setup from day one.

Many of our customers have made the switch from Docusign. The transition is smoother than you’d expect — our pre-configured workflows reduce the validation burden, and the improved UX and cost savings make the move worth it.

These aren’t optional add-ons — they’re core to achieving full compliance. SMS verification ensures signer identity, and the Trust Seal makes each document tamper-evident. We’ve bundled them to simplify procurement and ensure complete audit readiness.

21 CFR compliance requires additional infrastructure, controls, and onboarding support. It’s not just a feature toggle — it’s a compliance-grade configuration available only through custom plans, with white-glove onboarding and ongoing assistance.