In the last year, innumerable blogs have been written about how to do everything remotely.  On those days when our glass is half-full and COVID fatigue is low, we can appreciate that we live in a time with advanced remote working capabilities.  Despite our preference for colocation and face-to-face communication, Scrum teams are beneficiaries of...Read More

The Tipping Point We’ve seen many articles recently about how our society is finally demanding change related to racial bias in policing.  We are seeing reforms proposed at local, state and national levels.  Some of these proposals are small and incremental in nature while others are radical transformations.  As is typical in change efforts, these...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