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STRATEGIC INSIGHTS

Regulatory Compliance

Introduction

BY ANTHONY STRATTNER 

Strategic Insights 
· Introduction
· PDMA Compliance in 12 Steps
· What's the Problem?
· Systematize Your Regulatory Info!
· The Quality System Edge
Process integration isn't just good insurance.
By Lisa Griffith
January 12, 2004 | Since the year 2000, drug companies have been charged with more than $2.5 billion in fines by the U.S. government. Many of these fines have been for deliberate drug-pricing fraud, but many others were for regulatory noncompliance post facto. Once a drug company becomes the target for litigation, and comprehensive compliance documentation fails to materialize, the feds assume negligence.

Moreover, senior managers no longer get a pass by claiming that they didn't know what was happening in their companies. That's only fitting because, as the first story in this special report points out, compliance programs must have total buy-in and oversight from top management to be effective. The mere existence of a program is no guarantee it will work. Culture trumps technology every time.



PDMA Compliance in 12 Steps 










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