Free Download: KenX Webinar Slides - AI & Data Integrity: Navigating Compliance in the Digital Age

On October 15, 2025, ERA Sciences partnered with KenX for an incredible webinar on AI Validation and Compliance in Life Sciences. The turnout was fantastic; a mix of quality, validation, and IT leaders all eager to discuss how artificial intelligence fits into today’s regulated environments. The engagement and discussion on the webinar was fantastic.

If you could not attend, or attended and wanted another look at the slides, you can download the slides via the form below to explore the insights we shared during the session.

What We Covered

The webinar explored how life sciences companies can embrace innovation without compromising compliance. We talked about how regulators are beginning to align, from the EU AI Act and FDA’s AI/ML guidance, to the draft EMA Annex 22 and the ISPE GAMP Guide on Artificial Intelligence, all pointing toward a future where AI systems are expected to be transparent, explainable, and risk-managed within familiar GxP frameworks.

We also discussed the rapid adoption of AI features across established SaaS tools and how validation practices must evolve to keep pace. The conversation returned again and again to a central message: ALCOA++ still applies. Data integrity, traceability, and organizational oversight remain the foundation, even as technology evolves.

The Takeaway

What made this webinar so successful wasn’t just the topic, it was the dialogue. Attendees shared real challenges, asked the right questions, and walked away with practical ideas for bringing AI into regulated systems responsibly.

It was a reminder that while the technology is new, the principles that keep patients safe and organizations compliant remain the same.

Thank you to everyone who joined and contributed to the conversation!

Want to explore the discussion?
Fill out the form below to download a copy of the AI Validation and Compliance in Life Sciences slides and see the frameworks, trends, and insights shaping this next chapter in digital compliance

 


Free Download: KenX Webinar Slides

 

Ben O'Brien

Ben O'Brien

Ben holds an honors degree in Chemical and Pharmaceutical Sciences from Dublin City University and has over 8 years of experience in the pharmaceutical industry, with a strong focus on Quality roles involving SAAS and hosted QMS and LMS applications. He has contributed to large-scale GxP implementation projects, gaining expertise in quality and validation deliverables. Now with ERA Sciences, Ben brings a drive for innovation, particularly in paperless validation and QA best practices in software applications. Proficient in both Waterfall and Agile methodologies, he has recently worked on data migration and validation coordination for Veeva QMS at a Life Sciences company. Ben is passionate about lean methodology and advancing ALM through software QA test automation for the pharmaceutical sector.

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