What is 21 CFR 11 ?

21 CFR 11 is about:

CFR: Code of Federal Regulations (CFR)

  • It is categorization of the general and permanent regulations published in the Federal Register by the executive departments and agencies of the Federal Government of the United States (US).
  • CFR Contain total 50 titles.


Title 21: Food and Drugs

  • Chapter I: Food and Drug Administration
  • Chapter II: Drug Enforcement Administration
  • Chapter III: Office of National Drug Control Policy (ONDCP)

Chapter I: Food and Drug Administration

Sub Section 11 is electronic records and electronic signature related.

So, Its called as 21 CFR 11, mainly related to electronic data record and e-sign in pharmaceutical compliances.

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