21 CFR Part 11 Compliant Digital Signatures for Clinical Trials and Healthcare

21 CFR Part 11 Digital Signature Compliance

Our digital signature technology satisfies FDA requirements through[1]:

• Unique, non-reusable signatures for each individual per ESIGN and UETA standards[2]
• Multi-factor signer authentication using ISO 32000-1 protocols[2]
• Cryptographic protection against tampering based on RSA standards[2]
• Complete audit trails with time stamps and transaction IDs
• Secure system access controls validated against Title 21 CFR Part 11
• Independent signature verification
• Permanent signature-to-document binding using PKI technology

Streamlined Clinical Trial Documentation

Speed up your clinical trials with compliant digital signatures:

• Secure electronic signing for informed consent forms
• Remote document completion for distributed research teams
• Built-in regulatory compliance across global regions, including EU regulations[2]
• Automated workflow management
• Integration with existing clinical systems
• Permanent, independently verifiable audit trails through TotalAudit™

Advanced Security Features

Enterprise-grade security protects sensitive clinical data:

• PKI-based digital signatures cryptographically embedded in PDF documents per ISO 32000-1[2]
• Encrypted data transmission and storage
• Role-based access controls
• Detailed system activity logging including IP address, browser, and transaction metadata[2]
• Tamper detection and alerts
• Continuous security monitoring
• Multi-factor authentication options, including knowledge-based authentication[3]

Remote Online Notarization Built on Digital Signature Technology

When your clinical documents require notarization, our RON solution leverages the same secure digital signature infrastructure[3]:

• Cloud-based platform accessible from any web browser
• Multi-factor identity verification
• Video recording of notary sessions
• Secure electronic notary journal
• Tamper-evident notary certificates
• Compliant with state RON regulations
• No special hardware required for notaries[3]

Implementation and Support

We guide you through validation and deployment:

• Dedicated implementation support
• System validation assistance aligned with FDA requirements
• Integration with existing workflows
• Staff training and certification
• 24/7 technical support
• Regular compliance updates
• Comprehensive validation documentation

Legal Validity and Enforceability

Our solution provides robust legal protection:

• Legally binding and enforceable around the world[2]
• Compliant with international standards, including EU regulations[2]
• Lower legal risk compared to other electronic signature providers[2]
• Complete evidence packages including:
  
  • • Detailed audit trails
    • Signer authentication methods
    • Document integrity validation
    • Time-stamped transaction logs

Why Life Sciences Organizations Choose SIGNiX

• Validated E-Signatures: Digital signatures that meet FDA requirements with complete technical documentation
• Implementation Expertise: Deep experience with life sciences validation
• Long-term Reliability: Signatures remain valid and verifiable for decades
• Integrated Notarization: Remote Online Notarization built on the same secure technology
• Cost Efficiency: Reduce paper handling and courier costs
• Global Acceptance: Compatible with international regulations
• Risk Mitigation: Comprehensive audit trails and evidence packages

Ready to Streamline Your Clinical Documentation?

Contact our life sciences team to discuss your specific requirements and see how SIGNiX can accelerate your clinical trials with FDA-compliant digital signatures.

References:

[1] https://www.identrust.com/partners/signix

[2] https://www.signix.com/digital-signature-legality-and-compliance

[3] https://www.signix.com/remote-online-notarization-solution