The Covid-19 pandemic has cast into stark relief the fact that, in this increasingly VUCA (volatile, uncertain, complex, and ambiguous) world, THE key to competitive advantage is the organization’s culture. So, what makes someplace a great place to work? Based on my experience, there are five things. And I don’t care what kind of organization...Read More

Our Certified Agile Regulatory Specialist or CARS™ program is designed to help leaders, Quality Assurance and Compliance personnel, program managers and development team leaders (definers, designers, developers and testers) employ an Agile development framework within their FDA-regulated and QMS-governed organizations. Why Choose CARS™ Certification? Although Agile methods don’t conflict with FDA regulations, they do often...Read More

Agile product development within FDA-regulated industries requires determination, industry knowledge and skill. Each step in the process must comply with FDA regulations as well as your own Quality Management System (QMS). To help you successfully employ Agile in this environment, we offer our Certified Agile Regulatory Specialist™ (CARS™) program.     What Is CARS™? Our...Read More

In the past, our company has seen success through referrals and a small amount of marketing. When we decided to take it up a notch to be more intentional in our growth, we reached out to Barb Bertsch, a marketing wiz, to evaluate our efforts. What we learned was enlightening. Although we felt like we...Read More

As a sports fan, I enjoy watching a number of different sports. One of my favorites; however, is baseball. I played the game when I was younger and have always enjoyed the strategy of it. Should we bunt here? We could steal, but if we’re caught, that ends the inning. Is it time to pull...Read More