Clinical Regulatory Inspections – and why I love them

By Jane Wood, Principal, Quality Center of Excellence

Jane Wood, Principal of YourEncore’s Quality Center of Excellence, discusses the importance behind clinical regulatory inspection readiness.

I love a good GCP or GVP Regulatory Sponsor Inspection! There, I’ve said it. My colleagues think I’m a little crazy, but let me tell you why. They are the most marvelous opportunity to showcase your work, to be proud of what you and your colleagues have accomplished together. You can use them as an opportunity to test your systems, to make adjustments and talk (or Huddle) things through with each other.

Now don’t get me wrong; when an inspection doesn’t go well, it’s totally nerve wracking, but those are the moments when the tough get going, and you can actually make significant strides forward in your quality system. So, let’s talk about how to make those regulatory inspections a delightful experience. It’s all in the preparation. Here are some thoughts:

Assume every day an Inspector will walk through the door. Most inspections are announced, but some are not, so be ready. Be aware of the triggers that can bring an unannounced inspection.

Is your Regulatory Inspection process documented?

Do you have your logistics mapped out – front room, back room? Have you briefed your gatehouse staff on how to react? Do you have dedicated photocopiers or can you get them at short notice? You are going to need scribes, runners, systems to record what’s going on in the front room (late night food delivery!).

Whoever will host the inspection (and it’s not always Quality): are they trained and ready to go?

Are you up on your Regulatory Intelligence of observational trends? There are some great websites that capture FDA & other findings, look at FDA 483’s ( – inspection observations). I also particularly like These sites can give you focus of where to concentrate inspection readiness efforts.

Do you know of vulnerabilities in your system? If yes, then you have already made the first step of issue self-identification. Now think about root cause or impact analyses; (prepare story boards) is the who, what, when & why of resolution clear? Get those CAPAs wrapped up tight (documented). No system is ever perfect, but a great, well-documented plan of action is half the battle.

Perform mock inspections:

  • Give people first hand experience of what its like to be questioned in a formal manner; give coaching, give encouragement
  • Have your trial files ready and available
  • Have your documentation, Quality Policy and SOP system in tip top shape
  • Training records – can you get them quickly, are they current?

Of course, there is so much more to being inspection ready, but upfront planning goes a long way. For those being inspected and interviewed – be proud of what you have in place and achieved. Enthusiasm and positivity go a long way in creating a great impression. Lastly and most importantly – smile!

Jane Wood

About the Author: Jane Wood is the Principal of YourEncore's Quality Center of Excellence. With over 40 years global experience, Jane has led small and large teams of Quality professionals to mitigate risk and develop R&D Quality solutions. Jane currently leads a team of subject matter experts offering in-depth experience in all sections of Quality and GxP.

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