Norm Howe's blog

Actually, no, you don’t.  But you might want to know what the conditions are.  First, you need to know the difference between validation and verification.  Let’s review how FDA defines validation.  From FDA's Guidance for Industry, Process Validation:  General Principles and Practices

“…the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.”

Hey FDA, you do a necessary job.  And you’re good at it.  Mostly.

But you could do a lot better.

When you inspect us, you require consistency; rightfully.  You tell us that we have to be consistent in our application of our procedures within an individual site, and between sites.

When a patient comes into a physician's office, the patient is looking for the best, most modern care they can get.  And a physician certainly wants the same thing.   

This search for the best possible treatment presents a dilemma, however.  When might the best treatment also be a treatment that is still in the process of being developed?  When might a physician's search for the most advanced treatment cross over into medical research, and where does FDA draw the line between the two.  The answer is clear in some cases, but not so clear in others. 

Are you thinking of automating a business process?  If not, you should be or you’re going to get left behind.  But before you do, listen to this true story.  It was told to me many years ago and it occurred many years before that. 

“Oh, forget it Howe!”  I hear you saying.  “Business isn’t the same as it used to be.  Everything’s changed.”

To that I say read on.  You’ll be amazed.  The applications of this tale were valid then; they’re valid now; and they will be valid a hundred years from now.

Want to lower costs?  Want to reduce the risk of problems with FDA?  Train as many people in your organization as possible to write good Root Cause Analyses.  You will eliminate repeat errors, save prodigious quantities of money, and improve critical thinking skills.