Recap GAMP COP Benelux event "How to survive an inspection?"

On December 12th, 2025, GAMP CoP Benelux community organizes an event about sharing good practices how to survive an inspection about computerized systems at High Tech Campus, Eindhoven (The Netherlands). We welcomed more than 50 delegates and thanked KEMBIT (host/sponsor) and Optimum Quality BV (sponsor) for supporting in organizing this event.   

New regulatory development updates are ongoing, e.g Eudralex Chapter 4 (Documentation), Annex 11 (Computerized Systems) and Annex 22 (Artificial Intelligence), FDA CSA (Computer Software Assurance), etc. Subsequently ISPE has  recently published new guidances (Digital Validation, Validation 4.0., Artificial Intelligence,  etc.), with focus on risk-based validation, critical thinking, digital and data driven validation, leveraging validation deliverables (e.g. from vendors), implement artificial intelligence tools. All these initiatives can really help companies to maintain computerized systems in validated state, being ready for inspection. 

Business experts talked about do's and don'ts. It's important to understand the investigator's mindset, learn about (non)verbal communication techniques, don't forget the data integrity behaviours (ALCOA+), do mock interviews to practice and coach your Subject Matter Experts, use digital tools provided or hosted by vendors, implement a risk-based approach, all focussing on actions to avoid, mitigate, transfer or even accept risk. Check upfront if your documents are inspection-ready, and even if your inspection ends up in an audit finding, keep calm, clarify issues with inspector, analyze root-cause and define SMART CAPAs. 

Gathering of information to determine the audit strategy (audit agenda, self-inspections findings, ad-hoc assessments, regulatory compliance questions, …) is key activity to prepare regulatory as well as client audits. 

Keep in mind that compliance is more than just only to survive your next inspection. Compliance enables operational excellence (reduce operational risks, generate more transparency, build trust, improve time/cost efficiency, handle first-time-right).  

At the end of the day, there was a discussion forum, facilitated by Ron van Uden & Tom De Rudder, with real-life examples how to prepare, how to act and what to show in order to survive your next inspection. Success with your next inspection! 

Thanks to all, and see you next time in 2026!

See photo link: https://photos.app.goo.gl/n4nB2PprSqrQ4yKx8