FDA Regulated Industry / Life Sciences Quality Culture Diagnostic
The Quality Pulse® quality culture diagnostic is a scientific, research-based quality culture assessment model designed specifically for FDA-regulated and life sciences companies. The methodology was developed and adapted from well-established research, including:
- Organizational culture principles of Edgar H. Schein (MIT/Sloan);
- System dynamics principles of Peter Senge (MIT/Sloan);
- Dozens of research articles on corporate culture, quality culture, and organizational behavior, many in the life science context from 2000-present; and
- Decades of direct experience in quality operations across a variety of life science (pharma/device/biotech) organizations (100-100,000 employees).
Developed specifically to help organizations of all sizes understand the drivers of their culture of quality, the methodology and outcome reporting provides actionable intelligence that helps company leadership direct and implement improvement programs that will result in better quality outcomes and improved organizational excellence.