Data, Decisions & Dinner: A Walk Through Pharma 4.0 & GAMP

The Future of Pharma is Here – and We’re Leading the Way!

The CoP Pharma 4.0, in collaboration with the Benelux CoP GAMP, is proud to host its first (joint) event on November 6th, 2025. The central theme of the event is Validation 4.0. 

Validation 4.0 represents a transformative approach to pharmaceutical validation, emphasizing: 

• Continuous validation throughout the product lifecycle 

• Real-time use of online data for process assurance 

• Integrated validation of equipment, processes, and computerized systems 

The event will have a focus on the newly issued ISPE best practices guide Validation4.0.

Validation 4.0 

Validation 4.0 is a modern, digital-first approach to pharmaceutical validation. It aligns with the principles of Pharma 4.0, focusing on continuous assurance, real-time data, and integrated systems. 

• Continuous Validation: Ongoing assurance of process performance and product quality. 

• Real-Time Data Use: Online monitoring and analytics replace static reports. 

• Integrated Validation: Equipment, processes, and computerized systems are validated as a whole. 

• Risk-Based Approach: Focuses effort where it matters most, using data to guide decisions. 

• Digital Tools: Uses automation, AI, and cloud platforms to streamline validation.