Quality & Compliance: Optimizing Organizational Structures

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"Quality & Compliance: Optimizing Organizational Structures"

Study Overview
In light of increased FDA scrutiny, Quality and Compliance among pharmaceutical and healthcare companies have become an increased area of focus. Many companies are restructuring or have recently restructured to improve their approach to Quality and Compliance management. This study benchmarks the organizational models employed by 10 pharmaceutical and healthcare companies to manage quality and compliance.  In this benchmarking study, Best Practices, LLC examines types of Quality and Compliance models; effectiveness of Quality and Compliance models; reorganization trends and lessons learned.

The insights, performance benchmarks and trends identified in this 25-slide presentation will help Quality and Compliance executives:

• Understand the two primary types of Quality and Compliance models
• Benchmark current models against and elite class of companies
• Learn the benefits and challenges of each model
• Benefit from other executives' lessons learned in establishing an effective Quality and Compliance model

• Most companies in the benchmark class have completed a major reorganization within the past three years. All of those that have not already reorganized plan to do so within the next three years.
• One particular model is most effective in assuring that standard procedures and practices are fully implemented and in avoiding regulatory fines and citations. This same model is least effective at increasing internal efficiency, facilitating rapid learning, and reducing operational costs.
• A second model is the most effective in avoiding regulatory fines and citations, and it is stronger in internal efficiencies. However, it is least effective in supporting career planning, and reducing operational costs remains a challenge in this model as well.
• Alternative models rank highest across the models in business contingency and continuity. However, they exhibit low effectiveness at using standard procedures – a goal achieved highly in the other models.

Industries Profiled:
Consumer Products; Diagnostic; Pharmaceutical; Health Care


Companies Profiled:
Bayer Healthcare; Sanofi-aventis; Abbott Laboratories; MDS Pharma Services; Medrad; GE Medical System; Eli Lilly; GlaxoSmithKline; Johnson & Johnson Healthcare Systems; Janssen Cilag Pharmaceutical

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