From left to right (combination of pilot project team + RBA/Kneat Team): Marlene du Toit, Marcel Tan, Henk Stittelaar, Remco Verwoerd, Marco Bakker, Metaxenia Stampologlou, Etienne Loots, Ed van Winden and Josep Amengual Villarino
Significant progress on
Validation Process
We are thrilled to share some significant progress on our journey towards enhancing our validation processes. As part of our digitalization initiatives, we are actively working towards achieving a paperless factory, which aligns with our commitment to efficiency and sustainability. By implementing a Risk-Based Approach (RBA) to validation, we are also reinforcing our commitment to quality and compliance. This enhances our operational capabilities and reflects our adherence to the latest industry guidance on risk-based validation strategies, empowering us for the future.
Recently, our core team, along with the Pilot Project Team and all of the SPOCs, have successfully completed training in both the Risk-Based Approach (RBA) to validation and the Kneat Digital Validation System. This foundational knowledge will be instrumental as we move forward together. Following this training, we are excited to announce the kick-off of collaboration between the pilot project team (BCU Replacement Program) and the RBA/Kneat Team. This collaboration is essential for ensuring a seamless integration of the new processes.
“Preparing our site for the future”
Kneat Digital Validation System
Overwhelmingly positive
Furthermore, to ensure everyone is on board, we have conducted presentations across various departments. These sessions highlighted the impact this process change will have on their areas of expertise. The feedback has been overwhelmingly positive, and it’s inspiring to see so many of you excited about the prospects that lie ahead. Looking ahead, in the coming weeks, we will focus on preparing life-cycle documentation for the BCU pilot project using the new RBA methodology. Following this preparatory phase, we will perform initial qualifications on the BCUs this summer. We are committed to addressing any challenges that may arise during the pilot phase before we officially go live in Q4 of this year.
Heartfelt thank you
We'd like to express a heartfelt thank you to everyone involved in this project. Your dedication and hard work are the driving forces behind our success. We look forward to continuing this journey together, bringing remarkable improvements to our validation processes and preparing our site for the future.
Let’s keep this momentum going!
Coen Szkudlarek
Sr. Qualification Engineer