The Quality Pulse® culture diagnostic tool is appropriate for all companies in biopharma and pharma, in regulated consumer products, in devices, and in combination products.
Companies that do not have a culture supportive of enabling quality…they suffer poor health authority outcomes, there is a lack of trust amongst healthcare providers and patients, there are unplanned financial impacts as a result of aggressive remediation, or delays in new product launches. These issues exist across companies in the regulated healthcare industry, and as I said, those with a good quality culture suffer from those things to a much lesser degree or not at all.
Another thing that the companies’ would benefit for in the industry is… as the quality culture reaches toxic levels, you begin to see recalls, you begin to see more recalls, you begin to see shortages and outages, interruptions in supply chain, company reputation suffers, and I’ve seen in our industry, even company stock performance suffer, as a result of what the media chronically represents as quality issues in a given company or associated with a given brand. I certainly wouldn’t want to name names, but I have several clear examples of those companies in mind, to be honest.
Quality Pulse

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 provide actionable intelligence that helps company leadership direct and implement improvement programs that will result in better quality outcomes and improved organizational excellence.
To learn more about Quality Pulse click here.
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