Is your compliance team able to stay up-to-date and compliant with regulatory change? As a compliance or risk officer, do you have the capabilities to effectively manage the risks associated with regulatory change? If you hesitated...

Automation What comes to mind when you hear the term 'automation'? Do you ever think of how many processes in your daily life are automated? Automation is used pretty much every day in our lives. How many times do you run to an ATM...

With next year's planning cycle looming ahead, risk and strategy are big buzz words this time of year, and for good reason. Today's business environment demands agility from organizations to be successful. It's agility that allows ...

“Fickle-natured with copious details” Time and again we commit ourselves to stay on top of required regulations for our specific business. But do we really? Yes, we keep everything organized electronically but how effective is...

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) Good Clinical Practice (GCP) initiative started a joint inspection program in September 2009. The program targets investigator sites, sponsors and contr...

A Safety Management System (SMS) is intended to serve as a solution that, at a minimum, allows organizations to meet their legal obligations under state and federal law.  An effective SMS seamlessly integrates all aspects of safety o...