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Electronic Record - Electronic Signatures
21 CFR Part 11 Guidance Documents
Dockets Established - Topics for Guidance Development

Subject

Docket Number - Dockets Management Branch
Archiving 00D-1539
Audit Trails 00D-1541
Electronic Copies for FDA 00D-1540
Glossary 00D-1543
Time Stamps 00D-1542
Validation 00D-1538
   
The contents of dockets may be reviewed at the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, room 1061, Rockville, MD 20852. The office is open to the public between 9 a.m. and 4 p.m., Monday through Friday.

Issued October, 2000
Hypertext updated November 27, 2002 tc