|Articles|February 1, 2005

LCGC Europe

  • LCGC Europe-02-01-2005
  • Volume 18
  • Issue 2

Taming the Regulatory Beast: Regulation versus Functionalism

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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