|Articles|February 1, 2005
- LCGC Europe-02-01-2005
- Volume 18
- Issue 2
Taming the Regulatory Beast: Regulation versus Functionalism
Author(s)Virginia L. Corbin, Michael P. Balogh
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.
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