2025 has been a landmark year for digital validation — and for the global community of validation, quality, and manufacturing professionals who continue to push the industry forward. Across life sciences, organizations accelerated their transition to fully digital processes, embraced AI-enabled tools, and invested in more sustainable, data-centric validation strategies.
At Kneat, our mission remains constant: helping Life Sciences develop, manufacture and deliver therapies to their patients to the highest safety standards. This year, we were proud to support more than 80,000 validation and quality assurance professionals across the globe, as they leveraged Kneat to harmonize validation programs, reduce compliance risk, and strengthen inspection readiness.
Before we look ahead to 2026, we’re celebrating the customers, partners, and innovators that made 2025 one of our most impactful years.
1. Kneat earns top industry recognition in 2025
We’re proud to share that Kneat has been named #1 in Pharma and Biotech Software in G2’s Winter 2025 Reports — and in the Fall 2025 Reports, marking two consecutive quarters as the top-rated solution in our category.
This recognition, driven entirely by verified customer reviews, highlights what matters most: consistent customer success, proven outcomes, and industry-leading digital validation capabilities.
2. Customer success
At Kneat, customer success is a commitment. From onboarding to expansion, our team partners with you every step of the way to help you scale, stay compliant, and succeed in delivering your business goals. Here are two success stories our customers shared in 2025.
Video: Sanofi delivers on digital future
See how global biopharmaceutical company Sanofi delivers by using Kneat Gx to digitalize, standardize, and futureproof CQV.
Featuring Patrick Mullin, Commissioning and Qualification Lead, Global Engineering SCO, Sanofi
Webinar: How MSD stays inspection ready
One of the year’s most attended webinars, this session takes you inside MSD’s approach to staying continuously inspection ready. Featuring Senior Automation Engineer Russell Irvin, the discussion explores digital documentation strategies, risk-based processes, and real-world lessons learned from a global validation organization. Watch on-demand
3. A taste of what we published in 2025
Kneat’s thought-leadership library grew significantly this year, providing critical data and practical guidance for a rapidly evolving validation landscape.
Report: 2025 State of Validation
The industry’s most comprehensive benchmark study returned with powerful insights from 300+ validation professionals — that are shaping investment strategies across validation, engineering, and quality teams worldwide.
Authored by a leading life sciences market research expert, this year’s report revealed a surge in digital validation adoption, rising audit pressures, and how teams are adapting through smarter resourcing and improved digital maturity. Download the full report
Whitepaper: Sustainable validation with Kneat Gx
Validation has a critical role to play when it comes to sustainability. Authored by Kneat Director of SaaS Engineering Sean Daffy, this whitepaper explores how a digital, data-centric validation platform can dramatically reduce paper waste, streamline documentation processes, and support long-term operational sustainability. Read the whitepaper
eBook: Breaking down the ISPE digital validation guide
With the release of ISPE’s Good Practice Guide: Digital Validation, many teams sought clarity on what the guidance means in practice.
This Kneat eBook distills the key concepts, explains the regulatory expectations, and provides practical commentary from Kneat SMEs — to help organizations confidently interpret the guidance and advance their digital validation programs. Get the eBook
Looking for deeper insights? Watch the on-demand webinar ISPE Digital Validation Guide: Expert Insights featuring co-authors of the ISPE Digital Validation Guide, for expert insights and real-world context.
Article: The FDA’s final CSA guidance
The long-awaited final CSA guidance reshaped how the industry approaches software assurance.
Authored by Kneat CSV expert Darren Geaney, this article breaks down what changed, what stayed the same, and how teams can adopt risk-based, least-burdensome assurance principles using digital tools. Read the article
These resources helped validation teams benchmark performance, support internal transformation initiatives, and align with global regulatory expectations.
4. VALIDATE: Global community growth
VALIDATE 2025 Boston brought together the world’s largest community of digital validation professionals for two days of learning, collaboration, and hands-on innovation.
Featuring Kneat CEO Eddie Ryan and 2025 VALIDATE attendees
This year, Alexion Pharmaceuticals, GSK plc, and MSD were recognized for outstanding achievement at the Kneat Innovation Awards, highlighting real-world transformation across cycle time reduction, operational efficiency, and enterprise-level digital validation strategies.
Are you a Kneat customer with a digital validation success story to share?
Whether your team has:
- Transformed a legacy validation program
- Improved compliance outcomes
- Reduced cycle time or cost
- Leveraged Kneat Gx to achieve measurable operational value
— we want to hear from you!
Applications for the 2026 Kneat Innovation Awards are now open. Award winners will be recognized live at VALIDATE 2026 and featured across Kneat’s global channels.
This is your opportunity to showcase your team’s excellence and inspire peers across the industry. Apply now!
Early Access: VALIDATE 2026 registration is now open
This April 29 – 30, validation professionals from around the world will gather in Dublin, Ireland for two unforgettable days of learning, networking, and innovation at the five-star Marker Hotel — and we don’t want you to miss it.
You’ll join interactive sessions and connect with leaders who are redefining validation in the digital age.
Cap off your experience with a special offsite evening at Croke Park, Ireland’s most iconic stadium — featuring a private tour, live hurling demos, a visit to the GAA Museum, and dinner in the historic Cusack Stand.
Early-bird tickets are available through January 31, and we expect the 2026 program to be our most technology-forward event yet! Register here
5. Kneat Gx 25-R3: Empowering your data
The latest Kneat Gx 25-R3 release marks a major milestone in our platform evolution, delivering more configurability, stronger security, and enhanced automation across the full validation lifecycle.
These updates give validation teams more control, faster execution paths, and clearer oversight — while supporting global scaling and compliance demands.
Highlights include:
- Multi-factor authentication for granular control of third-party access
- Ability to set due dates for document and template review/approval
- Language localization
- New filter options
- Enhanced permission capabilities
- Search functions directly within documents
25-R3 reflects our ongoing commitment to building the most capable and intuitive digital validation platform on the market — one that scales seamlessly as organizations grow. To learn more read this article
Looking ahead to 2026
As we move into 2026, Kneat will continue investing in innovation, customer experience, and the community that drives our industry forward. Thank you to our customers, partners, and team members for an extraordinary year. Together, we’re shaping the future of validation — one digital process at a time.
Kickstart 2026 by empowering your teams with the right digital validation tools.
Book a 1-1 demo and discover why Kneat Gx is the #1 rated digital validation platform on the market.
