The Part 11 Controversy: A Root Cause Analysis and Science-Based Solutions

June 1, 2005
Pharmaceutical Technology, Pharmaceutical Technology-06-01-2005, Volume 205 Supplement, Issue 3

The confusion surrounding the application of 21 CFR Part 11 can be solved by focusing on the common rationale that both protects the public health and drives the fundamental basis of the industry's business: good science.