Taming the Regulatory Beast: Regulation versus Functionalism


LCGC Europe

LCGC EuropeLCGC 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.

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