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CFR Part 11 Support ​

What is CFR Part 11 ​

CFR (Code of Federal Regulations) is a regulatory framework issued by the U.S. government. CFR Part 11, established by the FDA (U.S. Food and Drug Administration), specifically regulates the use of electronic records and electronic signatures in pharmaceuticals, medical devices, clinical trials, and scientific research within regulated industries.

This regulation ensures that:

  • Electronic records have the same legal validity as paper records.

  • lectronic signatures have the same legal validity as handwritten signatures.

Typical Use Cases ​

The CFR Part 11 module is mainly applicable to the following scenarios:

  • Pharmaceutical Companies: Replace paper-based signatures in drug development, clinical trials, and production quality control to meet FDA audit requirements.

  • Healthcare Institutions: Use electronic signatures in laboratory reports and medical record archiving to ensure data integrity and immutability.

  • Medical Device Companies: Apply electronic signatures in product design verification and quality processes to comply with FDA review standards.

  • Global Operations: Help enterprises meet compliance requirements in international markets, improving product certification and sales efficiency.

CFR Part 11 Feature Support in Nota Sign ​

Nota Sign provides verifiable, auditable, and traceable compliance mechanisms to ensure electronic workflows are secure, reliable, and compliant with strict international standards.

  • Workspace Management: Flexibly switch or disable the CFR Part 11 module, allowing administrators to configure compliance options centrally based on business needs.

  • Electronic Signature Compliance: All signing actions require mandatory identity verification, ensuring security and preventing tampering.

  • Envelope and Template Compliance: Signing envelopes and templates are marked with CFR Part 11, and the signing process is strictly controlled.

  • Audit Trail and History Records: The system logs detailed information for every signing action, and administrators can export complete audit logs at any time.

  • Security and Access Control: Supports user permission mapping, password expiration settings, and member deactivation to prevent unauthorized access and account misuse.