Taming the Regulatory Beast: Regulation versus Functionalism

Published on: 

LCGC Europe

LCGC Europe, LCGC Europe-02-01-2005, Volume 18, Issue 2
Pages: 78–83

The authors discuss the issue of meeting the demands of regulatory compliance whilst ensuring good scientific practice. A number of requirements from 21 CFR Part 11 are cited to demonstrate the importance of applying the principles of risk analysis.