What is Title 21 CFR Part 11 (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

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

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