Why Validate?
We validate because it’s required!
But beyond that, let’s think about it a bit.
When you buy a car, you do more than kick the tires (does anybody do that anymore?), you probably look at the tires to see if they have tread. If they didn’t, and you bought the car, it’s likely you’d have a blowout (failure) without expecting it. Not the greatest analogy but you want to take precautions to minimize the likelihood of a “software blowout” (failure).
And in the life sciences, it could be the difference between patient life and death!
Of course, not all software applications used can impact the quality of the product. That’s why everything we’ll discuss herein revolves around a risk-based approach.