21 CFR Part 11

What is 21 CFR Part 11?

The Code of Federal Regulations (CFR) are general and permanent rules published by the executive departments and agencies of the U.S. federal government. Title 21 of the CFR contains all regulations of the Food and Drug Administration (FDA).

Part 11 of 21 CFR pertains to the rules that make electronic records and signatures valid. Electronic documents and signatures that adhere to all regulations under Part 11 are considered equivalent to physical paper records.

Popular industries

• Drugs and pharmaceuticals
• Food and beverage
• Medical devices
• Tobacco products
• Cosmetics
• Radiation-emitting devices
• Animal and veterinary
• Vaccines, blood, and biologics
• Dietary supplements
• Food and color additives

If you don't comply with 21 CFR Part 11, you can face:

• Notices of inquiry
• Warning letters
• Initiation of disqualification proceedings
• Seizure of FDA-regulated products
• Criminal fines
• Recalls
• Retention orders
• Criminal prosecution

How Zoho Sign can help you comply

Zoho Sign helps FDA-regulated businesses use digital signatures instead of signing documents with pen and paper. Businesses can stay compliant with the following software features:

• Electronic signature with printed name of the signer
• Signing date and time, unique user ID, PKI cryptography, and signing reason
• Signer identity verification and authentication
• Customized legal disclosure
• Security, control, and validation
• Free onboarding and training sessions

Key benefits

• Single-click account setup and configuration
• Easy compliance with 21 CFR Part 11 module for electronic signatures
• Enhanced audit trails and reports

How to enable the integration

1. Go to left navigation pane
2. Click Settings
3. Go to Account Settings
4. Toggle 21 CFR Part 11 to ON.