Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter A - General |
Part 11 - Electronic Records; Electronic Signatures |
Subpart A - General Provisions |
§ 11.1 - Scope. |
§ 11.2 - Implementation. |
§ 11.3 - Definitions. |
Subpart B - Electronic Records |
§ 11.10 - Controls for closed systems. |
§ 11.30 - Controls for open systems. |
§ 11.50 - Signature manifestations. |
§ 11.70 - Signature/record linking. |
Subpart C - Electronic Signatures |
§ 11.100 - General requirements. |
§ 11.200 - Electronic signature components and controls. |
§ 11.300 - Controls for identification codes/passwords. |