Improving productivity with the FDA Electronic Records and Electronic Signatures Rule

Authors
Harnois, M
Citation
M. Harnois, Improving productivity with the FDA Electronic Records and Electronic Signatures Rule, AM LABORAT, 33(18), 2001, pp. 42
Categorie Soggetti
Spectroscopy /Instrumentation/Analytical Sciences
Journal title
AMERICAN LABORATORY
ISSN journal
00447749 → ACNP
Volume
33
Issue
18
Year of publication
2001
Database
ISI
SICI code
0044-7749(200109)33:18<42:IPWTFE>2.0.ZU;2-G
Abstract
The nation's pharmaceutical laboratories, the FDA, and many other regulator y bodies are drowning n paper. The FDA's recently introduced Electronic Rec ords and Electronic Signatures Rule (21 CFR Part 11) was intended to improv e productivity, but complying with the new rule is not a simple task.