The Case for Quality System Transformation

The Case for Quality System Transformation

Kari Miller, VP of Regulatory and Product Management, Pilgrim Quality Solutions

Recently, Pilgrim was a sponsor and a presenter at the American Medical Device Summit. The conference examined the challenges and opportunities currently facing the medical device industry. It also focused on the journey to best practices in the area of design, quality, compliance, technology, and strategy.

The quality track examined the value of creating an environment conducive to building a quality culture, with change management, harmonization, and collaboration as central themes. In fact, collaboration was a key theme throughout the conference as an element of innovation, risk management, sustainability, and compliance.

During the conference, I presented a session titled “The Case for Quality System Transformation.” This presentation described the business value of creating a global, enterprise quality system that achieves a single source of quality truth. For most businesses, building a global quality system involves changes to processes, systems, and culture.

As a quality professional, you likely understand the business value of a mature, global quality management system. As quality professionals, one of our jobs is to help the organization understand how the business is impacted by the quality journey. However, this can be challenging to articulate to a larger organization that does not yet grasp its value. During the presentation, I provided some pointers on how to make the business case for a global quality system, and offered ideas on how compliance, quality system maturity, and a quality culture all feed into a successful global eQMS.

If you weren’t able to attend the American Medical Device Summit, but are interested in transforming your quality system, you can watch the recorded version of my presentation here.

The Medical Device industry is experiencing unprecedented levels of change in the areas of regulations, customer expectations, and speed of information. Value chains are getting longer and more complex, and the focus on patient care and safety is higher than ever. Navigating this environment will require the highest levels of collaboration. The American Medical Device Summit provided a platform for the exchange of ideas, best practices, and case studies that can be leveraged in all organizations.


The Case for Quality System Transformation

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Kari Miller

Regulatory & Product Management Leader, IQVIA Quality Compliance