eSign documents in compliance with 21 CFR Part 11

signNow helps food and drug organizations manage their documents with maximum efficiency while maintaining the security and authenticity of electronic records.

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How signNow ensures 21 CFR Part 11 compliance support

Maintain secure paperless workflows while reducing operating costs and increasing productivity.

Signature stamps

signNow displays a user’s electronic signature along with their printed name, signing date, and time.

Audit Trail

signNow users and authorized parties can easily retrieve a complete history of changes made to their documents.

Signature IDs

Every signNow eSignature is linked to an electronic record via a unique ID code which prevents signatures from being removed or replaced after signing.

Session inactivity timeouts

signNow automatically logs users out after remaining idle in the background for several minutes.

Two-factor authentication

signNow users can prevent unauthorized access to their documents by requesting signers to verify themselves via a password, phone number, or text message (SMS).

Advanced encryption

signNow maintains the safety of electronic records at transfer and at rest with the Secure Sockets Layer (SSL) and 256-bit AES encryption. signNow only stores one-way encrypted passwords.

Ready to enable 21 CFR Part 11 compliance support for your organization?

Contact our Support Team to start eSigning documents in accordance with FDA regulations. Once your CFR settings are active, other settings will be configured to meet CFR requirements as well:

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  • Two-factor authentication will be turned on for all signers
  • Document histories for exports and email deliveries will be enabled
  • Sessions will time out due to inactivity after a maximum of 90 minutes
  • Organization admins will be emailed whenever login attempts are made
  • Mobile web access won’t be supported (the Android or iOS app will be required)
  • Accounts will lock after six or fewer (user sets a limit) unsuccessful login attempts
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Join companies that speed up processes with signNow

National flour mills limited
Integra lifesciences

Watch how signNow achieves 21 CFR Part 11 compliance

Author, track, and manage routine tasks while providing a safe, consistent, and compliant signing process.


Get 21 CFR Part 11 compliant eSignatures now!

Connect signNow with your apps

Drive your business forward with signNow integrations. Initiate eSignature workflows without leaving your CRM, productivity app, or cloud storage.

Why users choose signNow over other eSignature providers

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Louisa, Trustpilot
Life Changing Program

Easy, straightforward system that allows for the secure, online, encrypted signing of documents. Can add multiple signatures to one document. The process is as simple as sending an email. I taught myself how to use the program. Highly recommend it for any business or individual who requires signed documentation.

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Verified User, G2
Easy to integrate into a workflow and makes document workflows faster and more efficient

signNow makes it easy for multiple teams to collaborate on the same document at the same time. Sending a document to all parties for signature simultaneously cuts down on processing times and makes our document workflows more efficient while saving valuable time. signNow features offer functionality, security, and compliance and are easy to implement...

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Josh Elledge, Trustpilot
Satisfaction & Privacy is Great

This has allowed our contractors the satisfaction and confidence that their documents remain secure and private.

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Enterprise-grade security and compliance

signNow is committed to protecting your sensitive information by complying with global industry-leading security standards.

GDPR compliance
SOC 2 Type II Certified
PCI DSS certification
21 CFR Part 11
HIPAA compliance
CPA compliance
Security and compliance

21 CFR Part 11- compliant eSignature solution

  • Information security. We conduct regular risk management reviews, performance auditing, risk classification, and guidance.
  • Vulnerability testing. We perform internal vulnerability scanning and retain external subject matter experts to conduct penetration tests.
  • Access control. signNow’s system of access controls ensures that access granted to each environment is appropriate and authorized.