đź’ˇ At a Glance
If you work in an FDA-regulated industry, electronic signatures must meet particularly strict requirements. The U.S. Food and Drug Administration (FDA) defines in 21 CFR Part 11 how digital signatures must be implemented to be legally secure, traceable, and tamper-proof. With sproof Sign you can configure your signature processes accordingly.
đź“‘ FDA-compliant Signing with sproof Sign
1. What is the FDA?
The FDA (Food and Drug Administration) is the U.S. authority for health and product safety. It regulates, among other things, pharmaceuticals, medical devices, food, cosmetics, and biotechnology products—with the goal of ensuring quality and safety.
2. Why is FDA compliance important for electronic signatures?
In FDA-regulated industries, comprehensive, audit-proof documentation of all review and approval processes is essential. Electronic signatures are regularly used here—but they must meet the requirements of 21 CFR Part 11 to be legally recognized.
3. Requirements according to 21 CFR Part 11
The signature must:
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contain the name, date/time, and purpose of the signature
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be linked to the document in a tamper-evident manner
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be uniquely attributable to a person
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be protected by two-factor authentication (e.g., password + PIN)
Additionally required:
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An assignment procedure that prevents misuse (e.g., four-eyes principle)
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Unique, non-duplicated access credentials
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Procedures for disabling lost access credentials
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Protective measures against unauthorized access
4. Activate FDA Compliance: How to with sproof Sign
In your admin area under Plan Settings > FDA Compliance you can enable the following options:
Automatic Download of the Audit Trail
Every download of a document or folder automatically generates a ZIP file with the complete audit trail.
FDA Compliance for Signature Cards
Only signature cards that meet FDA requirements can be created and used.
Use of a Standard Signature Card
All team members use the same standardized FDA-compliant signature card—for maximum consistency and traceability.
Enable PIN
Before each signature, an individual 4-digit PIN must be entered. This fulfills the requirement for a second authentication component.
Would you like to sign in an FDA-compliant way?
We are happy to assist you with the correct configuration of your account and compliance with all regulatory requirements.
📧 Contact: support@sproof.com
🤝 We look forward to your inquiry!