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.
Where,
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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