Title 21
PART 11
Part 11 - Electronic Records; Electronic Signatures
- Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.
- Source: 62 FR 13464, Mar. 20, 1997, unless otherwise noted.
21:1.0.1.1.9.1 | SUBPART A | Subpart A - General Provisions | |
21:1.0.1.1.9.1.63.1 | SECTION 11.1 | 11.1 Scope. | |
21:1.0.1.1.9.1.63.2 | SECTION 11.2 | 11.2 Implementation. | |
21:1.0.1.1.9.1.63.3 | SECTION 11.3 | 11.3 Definitions. | |
21:1.0.1.1.9.2 | SUBPART B | Subpart B - Electronic Records | |
21:1.0.1.1.9.2.63.1 | SECTION 11.10 | 11.10 Controls for closed systems. | |
21:1.0.1.1.9.2.63.2 | SECTION 11.30 | 11.30 Controls for open systems. | |
21:1.0.1.1.9.2.63.3 | SECTION 11.50 | 11.50 Signature manifestations. | |
21:1.0.1.1.9.2.63.4 | SECTION 11.70 | 11.70 Signature/record linking. | |
21:1.0.1.1.9.3 | SUBPART C | Subpart C - Electronic Signatures | |
21:1.0.1.1.9.3.63.1 | SECTION 11.100 | 11.100 General requirements. | |
21:1.0.1.1.9.3.63.2 | SECTION 11.200 | 11.200 Electronic signature components and controls. | |
21:1.0.1.1.9.3.63.3 | SECTION 11.300 | 11.300 Controls for identification codes/passwords. |