21 CFR Part 11: Where Are We Now?

November 1, 2003
William Goebel

William Goebel is a director of quality at CimQuest Inc.

Pharmaceutical Technology, Pharmaceutical Technology-11-01-2003, Volume 2003 Supplement, Issue 5

FDA's revised guidance on 21 CFR Part 11 offers relief to the regulated industry by providing for enforcement discretion and suggesting a risk-based approach to compliance.