21 CFR Part 11: Where Are We Now?

Goebel,William;

Publication

Article

November 1, 2003

Pharmaceutical Technology

Pharmaceutical Technology-11-01-2003

Volume2003 Supplement

Issue 5

21 CFR Part 11: Where Are We Now?

Author(s):

William Goebel

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.