Quality culture has been something that has been really hard to create tight, and kind of, geometric bounds around. But, in fact, it’s something that’s critically important for industry to understand how to essentially establish a measure of culture…because you really need to know where you are, such that you can achieve where you want to be.

Culture has been recognized by the Food and Drug Administration as being critically important…and both on the device and the pharmaceutical side… has been something that the Agency is looking at in their risk based inspection principles as making a cornerstone of how they want to determine what companies’ cultures’ are so they can determine what is it appropriate risk based inspection schedule.

…because they know that companies with good cultures perform better.