What is Title 21 CFR Part 11 (CFR Part 11)?

Title 21 CFR Part 11 Definition

FDA Title 21 CFR Part 11 regulates electronic records and electronic signatures (ERES) for life science companies. Part 11 establishes when electronic signatures are considered to be trustworthy, reliable, and/or the equivalent to paper records.


What is the main purpose of 21 CFR Part 11?

Title 21 CFR Part 11 helps life sciences companies establish security controls, workflows, audit trails, and checks to ensure the integrity, confidentiality, and authenticity of electronic records and signatures.

*Source: https://content.intland.com

What is FDA 21 CFR Part 11 compliance?

To demonstrate Title 21 CFR Part 11 compliance, companies must:

  • Validate their product software and electronic quality management system to verify that they function as they should. This encompasses installation, operational, and performance qualifications.
  • Establish security measures to control user access and ensure proper retrieval of electronic records
  • Assign a unique electronic signature to each user that includes a user ID and password
  • Maintain a complete revision history and audit trail for all electronic records

*Source: https://www.fda.gov

What does Title 21 of CFR describe?

Title 21 is the section of the Code of Federal Regulations that governs food and drugs within the U.S. for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP).

*Source: https://en.wikipedia.org

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