Title 21 Code of Federal Regulations (21 CFR) Part 11 report

This report displays 21CFR11 (Code of Federal Regulations, Title 21, Part 11) issues found on your site. Many web application vulnerabilities might lead to security breaches of personal information, directly or indirectly, and might be considered as violations of the regulation.

Why it matters

Section 21 Part 11 of the Code of Federal Regulations establishes the standards by which the Food and Drug Administration (FDA) will accept electronic records and electronic signatures as equivalent to paper records and handwritten signatures. The rule governs electronic records throughout their life cycle from creation through modification, storage, and final transmission to the FDA. This rule places a significant burden on the developers and users of data collection, management, reporting, and analysis software in regulated industries.

Best practices for complying with Title 21CFR11

  • Gain a detailed understanding of the regulation and how it affects your organization.
  • Practice secure coding techniques.
  • Thoroughly test web applications before deploying in a production environment.