Throwback to ISPE GAMP CoP Benelux event on Different Perspectives of SAAS Validation

19 June, 2025

SaaS validation proved to be a topic of a lot of interest for all attendees joining ISPE GAMP CoP Benelux event on June 19th, hosted by UCB, Anderlecht.

The event was opened by Natasja Bastiaens, ISPE GAMP CoP Benelux Chair and the event sponsor UCB. Tom De Rudder set the stage for the rest of the day by comparing SaaS validation and on-premise validation. Who knew that only 10 years ago, an overwhelming majority thought SaaS would never work for the Life Sciences Industry? How different that is today.

From an auditor’s perspective, Jeroen Leemen explained the regulatory framework, different audit models, key considerations and best practices. This clearly resonated and sparked a lively discussion and lots of questions.

Next up was the vendor perspective. René van Opstal and Jordy Gouwy shared a practical SaaS eQMS implementation and emphasized the importance of leveraging core validation by the supplier, pursuing a collaborative approach, and using the right tools.

Kristel Borremans and Robert Weisz showcased the implementation of their eQMS at UCB. They made a case for clear roles and responsibilities, setting the right expectations early on, and managing requirements and configuration throughout the validation process.

Shikha Raikundalia tackled the complexities of bridging the QMS gap in cloud data platforms and showed that validation is possible even in the absence of a well-established QMS – but it’s not easy, and requires critical thinking, risk assessment, controls, and engagement from all involved parties from start to finish.

From a cloud provider perspective, Hans de Raad highlighted the advantages of collaborative standardization (e.g. through the Cloud Security Alliance’s CAIQ), and provided several frameworks and controls for cloud security.

Last but not least, there was an interactive session to shed light on opportunities and challenges for SaS validation using the latest ISPE’s GAMP 5 Guide 2nd Edition.  following by a panel discussion with all speakers.

The day concluded with an endnote of UCB, a fantastic networking dinner (sponsored by UCB), leaving attendees informed, inspired, and well-fed.

See photo album