New professional society journal article a maturity model for transforming organizations within the context of effective governance of global market clearance operations.
NATICK, MA – December 1, 2008 – Clinivation, Inc. announced today the publication of a new professional society journal article coauthored by clinivation thought leaders in the areas of global market clearance operations, organizational transformation, and regulatory affairs.
The article entitled “Effective Governance of Global Market Clearance Operations” is published in the December, 2008 edition of the Regulatory Affairs Professional Society journal Regulatory Affairs Focus.
The article addresses the need for effective governance of global market clearance operations and SarbOx drivers, industry losses from market clearance noncompliance, and the low-maturity current state of the medtech industry.
The article also presents the Market Clearance Compliance Maturity Model, developed by clinivation Founder and CEO Joseph Kozikowski, M.D. and clinivation thought leaders.
As described in the article, the intent of the Market Clearance Compliance Maturity Model is manifold:
- To describe the maturity state of those key attributes (i.e., control, intelligence, automation and infrastructure) central to an organization’s ability to achieve sustainable market clearance compliance;
- To provide a common language for cross-organizational communication and benchmarking;
- To guide market clearance compliance improvement efforts within a framework that helps organizations establish and achieve improvement goals; and
- To provide specific guidance to organizational leaders in executive, risk management, regulatory and commercial roles regarding which specific practices to perform, how to improve capabilities in performing those practices, and how to prioritize areas targeted for improvement.
To enable companies to easily integrate market clearance compliance into their ongoing, enterprise-wide risk management activities, the Market Clearance Compliance Maturity Model has been conceptually and tactically aligned with the framework of the widely accepted, more generalized, enterprise-level Open Compliance and Ethics Group (OCEG) Corporate Compliance Maturity Model™. Accordingly, the model seamlessly “bolts on” to any well-structured approach to corporate compliance, risk management and governance.
The attributes of the Market Clearance Compliance Maturity Model are:
- Control—the organization’s disposition with respect to controls and compliance;
- Intelligence— the organization’s knowledge and intelligence about market clearance compliance boundaries (e.g., regulations), activities in progress and the current state of global market clearance compliance;
- Automation—the processes and controls by which market clearance compliance is effected, and the standardization and integration thereof; and
- Infrastructure—information technology capabilities and resources to store and process data and interconnect the organization
The article is authored by clinivation Founder and CEO Joseph Kozikowski, M.D., and Pamela Siska, MA, clinivation, Inc.
Quotes & Commentary:
“Maturity models are very important tools for organizational transformations,” said clinivation Founder and CEO Joseph Kozikowski, M.D. “Maturity models demonstrate how software platforms enable organizations to evolve from states of noncompliance, poor risk management, and opacity to states of operational excellence,” he continued.
Supporting Resources:
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