FDA 21 CFR Part 11

FDA 21 CFR Part 11 is a United States federal regulation issued by the Food and Drug Administration (FDA) that establishes the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.

For temperature monitoring systems, 21 CFR Part 11 compliance requires: tamper-proof audit trails recording every data modification, secure user authentication with unique credentials, electronic signatures for record approval, system validation documentation, and the ability to generate accurate and complete copies of records for FDA inspection.

Any pharmaceutical company, biotech firm, or clinical research organisation operating in the US must ensure their electronic monitoring systems comply with 21 CFR Part 11. Non-compliance can result in FDA Warning Letters, Form 483 observations, product recalls, or facility shutdowns. It is one of the most commonly cited deficiencies in FDA inspections.