"The Art of Compliance - Turning Regulatory Compliance into Sustainable Business Advantage" by Robert A. Rhoades - Practice Leader, Quality Systems at Quintiles Consulting.
The last few years have presented extraordinary regulatory and
quality compliance challenges for pharmaceutical, biotechnology, and
medical device companies charged to do more with less as a result of
consolidation, restructuring, and economic uncertainty. Without the
right attention, these challenges can permit systems and processes to
weaken, domain and critical thinking expertise to erode, and core
quality principles to be neglected, leaving companies vulnerable to
compliance lapses and enforcement action.
Companies can no longer
afford to take a traditional compliance approach in this heightened
regulatory environment. In the traditional compliance approach, Quality
Assurance and Compliance are backroom cost centers, the internal police
or “sales prevention” departments perceived as piling on non-value added
requirements that detract from the company’s ability to innovate and be