The times, they are a changin’ and for validation and quality professionals that means digital maturity. Accelerating Digital Maturity was the theme of VALIDATE 2025 — the largest validation-specific industry conference in the world.
The 2025 VALIDATE, held in Boston, MA, was the fifth conference and biggest one yet, with 30% more attendees from around the world coming together to share, learn, and have some fun. The two-day event had valuable presentations, surprising awards, and the hottest takes on emerging tech like AI. Here are some of the top highlights that I saw from VALIDATE 2025.
Keynote Set the Tone
The conference was kicked off with keynote Dr. Shawn DuBravac, an acclaimed futurist and New York Times best-selling author who dove into the challenge of evolving from Digitization to Datafication.
It was an eye-opening presentation, delving deep into the subject of datafication and why adopting a data culture is critical in today’s business environment. He explained why fostering a mindset to maximize digital transformation is crucial and provided actionable strategies specifically for life sciences professionals.
Almost every validation and quality professional has heard about digital transformation, but Dr. DuBravac put it into context as to why transformation is more important now than ever. It set the table for an invigorating VALIDATE that left attendees better prepared to manage just such a transformation.
Customer Sessions Dominated Discussion
Sanofi: Reducing C&Q Costs in CAPEX Projects with Digital Validation
Capital projects, or CAPEX, can boost a business to the next level, but they require a significant investment of time and money. Finding savings on a CAPEX project can produce significant ROI for your organization.
Sanofi’s Global Commissioning and Qualification lead, Patrick Mullin has led huge projects and uses digital Commissioning and Qualification through Kneat to cut as much as 50% of protocol time. He walked VALIDATE attendees through it all, showing how he benchmarks his projects and why he thinks the future of C&Q is digital. he also provided a model for measuring the hard and soft cost savings and efficiencies.
“The potential savings are huge,” Patrick said, showing how generative AI, data lakes, and a data-centric approach to C&Q can transform project timelines.
Thermo Fisher Scientific: Utilization of Kneat e-Logbooks
Innovative uses for Kneat were showcased by several industry leaders at VALIDATE, but it was Thermo Fisher’s use of Kneat for eLogbooks that had people talking. Krishna Patel, who managed multiple projects at Thermo Fisher Scientific, showcased how she used Kneat for e-logbooks and what she learned by implementing it. And how they expect $1 million USD in savings.
From plans to reality, she walked attendees through the pitfalls and triumphs of her project and presented clear takeaways that empowered the audience to better plan and execute their own.
This flexibility is a core component of digital maturity and Krishna showed exactly why it’s so important for organizational growth.
Alcon: Harmonization with Kneat
It’s hard to separate the idea of harmonization from that of digital maturity and Alcon articulated why digital validation is necessary to move to one business process that satisfies requirements without creating more work.
Clayton Mercer, Alcon’s project lead of their initiative — dubbed digitEYES — (well named by a leading manufacturer of contact lenses) showed attendees how Alcon brought 14 global sites into a streamlined process. Through harmonization, Alcon found a more than 50% reduction in process time and an almost 25% increase in value for harmonized teams.
Harmonization is a big topic, but Clayton walked through the lessons learned, including rollout tips and when to engage site functions. We look forward to hearing more from Clayton and others harmonizing at the next VALIDATE.
New Customer Innovation and Partner Awards
VALIDATE consistently receives a 95%+ satisfaction rating by attendees as we strive to consistently implement feedback. We were so excited to bring something new to VALIDATE this year: awards. This year we added customer and partner awards. Kneat celebrated innovative uses of the Kneat Gx platform, with the Kneat Customer Innovation Awards. The three finalist organizations: Alexion, MSD, and GSK presented their innovations, the audience voted, and the winner was….
Alexion! Lizzandra Rivera showcased Alexion’s use of Kneat for elogbooks and how they started with three QC labs and 18 templates, growing to all GxP labs with over 30 templates just a year later. Alexion eliminated paper archives, reduced time and errors, strengthened compliance and unlocked new reporting and analytical insights. An award well deserved.
Kneat thanks all customers who participated in this year’s awards.
It wasn’t only customers who went home with an award. Kneat’s Partner Network was also honored for the first time at VALIDATE 2025 with two award categories.
I am pleased to introduce Körber Pharma as the first-ever New Partner of the Year! Since joining the Kneat network in 2024, Körber Pharma has shown a commitment to quality and innovation that aligns well with Kneat’s mission statement. We can’t wait for more success with them in the years to come.
A long-standing partner was also rightfully acknowledged for their cutting-edge work in validation. MMR Consulting won the Transformational Partner of the Year award for their work in helping Kneat evolve through product roadmap consultations and innovative uses of the platform.
AI Breakthroughs
Artificial intelligence was a big topic of discussion at VALIDATE, weaving through many presentations including the keynote. Everyone wants to know how others are using it or plan to use it. Multiple speakers touched on the topic, including Kneat’s own AI expert Daniel Tobin.
He showed how AI can be used for customer-owned data sets and even how it could enable predictive analysis.
Korber Pharma, an organization new to VALIDATE this year, leaned into the topic. Stefan Munch, VP of Validation & Qualification, spoke to the many challenges in validation AI and machine learning while also looking at how both can be valuable tools for validation.
From the current regulatory landscape to what GAMP 5 has to say about AI, few know as much as Stefan and I’m willing to bet everyone left his session more informed.
Caught in the Splash Zone
You know what they say about all work and no play… VALIDATE treated attendees to a different kind of deep dive, one at the world-class New England Aquarium. Surrounded by stunning sea life, attendees were able to mix, mingle, and swap stories. Almost everyone was treated to a delicious raw bar and a tasty dinner. I didn’t get to the raw bar in time – the penguins may have beaten me to it.
THANK YOU
I can’t say enough about the success of VALIDATE 2025, measured by the feedback validation professionals shared. Here are a few:
“VALIDATE has been a great opportunity to network and connect with leading experts and SMEs in digital validation”
“I learned so much from this one, I would love to attend the next one”
I had an opportunity at the conference close to share some preliminary results from this year’s State of Validation survey. It strongly indicates that validation workloads consistently increase along with demands for speed to market and cost reduction. Proving now more than ever, that validation professionals need this event and community dedicated to addressing these challenges.
The success of VALIDATE 2025 wouldn’t have been possible without the great participation of the Kneat community of customers, partners, and validation professionals. Of course, the hard work of literally everyone at Kneat, with special thanks to the Marketing team. Thank you. Of course, the incredible support of our sponsors made the conference possible. A special shoutout goes to:
VALIDATE 2026
Your next chance to experience VALIDATE for yourself will be in Dublin, Ireland May 13–14, 2026 at the beautiful Marker Hotel. We expect tickets to be in hot demand, so register your interest today.
