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U.S. Code of Federal Regula...
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Title 21-Food and Drugs
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CHAPTER I—FOOD AND DRUG ADM...
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PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
§ 11.1 - Scope.
§ 11.2 - Implementation.
§ 11.3 - Definitions.
§ 11.10 - Controls for closed systems.
§ 11.30 - Controls for open systems.
§ 11.50 - Signature manifestations.
§ 11.70 - Signature/record linking.
§ 11.100 - General requirements.
§ 11.200 - Electronic signature components and controls.
§ 11.300 - Controls for identification codes/passwords.