Tuesday, September 13, 2011

"The Art of Compliance" by Robert A. Rhoades of Quintiles Consulting.


"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 profitable. 

This short white paper describes a strategic vision and business justification for the idea of "sustainable compliance", and moving up the "compliance maturity curve".   The use of maturity smells too much like CMM for my tastes, and I'm working on combining Robert's concepts with Jerry Weinberg's software engineering cultural patterns. Jerry gives each pattern a name, then describes for each pattern: view of themselves, metaphor, management understanding and attitude, problem handling, when the pattern is successful, and process results. 


I will keep working on recasting regulatory compliance into a model using a cultural view.


Meanwhile, where is your organization on Robert's Compliance Maturity Curve?

No comments:

Post a Comment