As part of the Quality Leaders Forum, we sat down (virtually) with Steve Diedrich for a primer on compliance vs. quality and how we might use Simon Sinek's framework of "finite and infinite games" to think about quality management. Register now for "Playing the Infinite Game in Quality," an interactive forum with Steve Diedrich.
As COVID-19 continues to spread across the globe, governments urge citizens to self-quarantine, and the U.S. economy faces an uncertain future, the life sciences industry is under more pressure than ever. Pharmaceutical and healthcare companies continue to work toward the development of a vaccine and therapies for the respiratory infection that was declared a pandemic by the World Health Organization last week. And the FDA is rolling out updated policies to streamline the path to an effective vaccine and protecting the public from fraudulent products.
Intelligent Quality is an approach that is rooted in the digital transformation that we’ve seen across all lines of business over the past decade or so. The complex, modern organization has tools available in their ‘back office’ that offer data analytics and valuable insights to company leaders- enabling them to make informed decisions about their business strategy. We have seen the explosion of growth and advancement in CRM and ERP, for example, and there is no reason for quality and compliance teams to continue to use stone- age tools.
Maintaining quality is everyone’s job and a team effort. And when it is overlooked, bad things happen.
After supporting more than a hundred eQMS implementations in my role as head of Operations here at ZenQMS, I have observed that the conversion from a paper-based to electronic quality management system (eQMS) can be either painful and cumbersome or quick and easy. The determining factors seem to be centered on the ‘health’ of the business’ quality processes- especially those related to document management and training.
Effective quality leaders know that securing executive support and buy-in are key factors in successfully selecting and implementing an eQMS. Convincing skeptical C-suite colleagues of the strategic implications and costs of the current state can be challenging, especially in documenting both hard costs and intangible benefits/risks. It is necessary to speak in terms that they understand and appreciate, starting with Return on Investment (ROI).