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ValGenesis Acquires 4Tune Engineering

Building a vision for new manufacturing intelligence across the GMP lifecycle

Back in 2005, ValGenesis pioneered the idea of paperless validation. Our founder’s vision made that possible.

ValGenesis believes that regulatory requirements for documentation of procedures and outcomes in pharmaceutical operations could be met with a higher degree of assurance and efficiency through paperless, digitized systems. This is the foundational idea behind the industry’s first, proven, 100% paperless Validation Lifecycle Management System (VLMS). This presented customers with a “lifecycle approach” to managing validation processes while enforcing consistency and compliance through a risk-based approach.

Today, our ValGenesis VLMS remains an industry-leading system of record, trusted by hundreds of life sciences companies to validate over 100,000 GMP systems.

A truly synergistic product story with 4TE

Portugal-based 4Tune Engineering (4TE) is a leader in manufacturing sciences and technologies that enables the world’s most successful life sciences companies to model their risk and improve process performance across the GMP lifecycle. 

Our move to acquire 4TE first commenced when we realized excellent product synergy that had potential to offer customers a completer and more integrated platform across the GMP lifecycle.  

A net gain opportunity for both our companies, we signed the agreement on June 6, 2022. 

The road ahead

The acquisition of 4TE accelerates ValGenesis’ vision of becoming the most trusted Validation 4.0 company. 4TE’s advanced Risk Management Module (iRisk Platform®) enables comprehensive risk management across all stages of the GMP lifecycle, and its Continuous Process Verification tool (iSee Platform™) enables real-time Stage 3 monitoring and supports Annual Product Quality Reviews (APQR). Our Validation Lifecycle Management System (VLMS) remains the industry standard for Stage 2 validation. A truly synergistic product story!

This is great news for ValGenesis and 4TE customers as our combined offering is the most complete “Validation Lifecycle” platform on the market delivered by a single vendor. It’s great news for partner organizations too as the expanded portfolio of products and services gives them an opportunity to explore new avenues of engagement with their clients.

We’re excited about where we’re headed! Our newly unified development team, a more robust roadmap, and an expanded services portfolio are helping us achieve our vision of becoming the de facto Validation 4.0 standard to lead life sciences companies on their journey toward Pharma 4.0.

“The future never looked brighter for ValGenesis and 4TE employees, partners, customers, and the entire life sciences industry. This acquisition advances our Validation 4.0 strategy. 4TE’s product quality, individual talent, and passion for customers perfectly match ValGenesis’ corporate culture. We look forward to Prof. Dr. José Menezes and 4TE’s talented team joining ValGenesis, further cultivating a shared culture of innovation and driving even greater value for our customers. As Pharma 4.0 becomes a reality, we continue to expand our product roadmap beyond core validation, driven by strong business values and commitment to the life sciences.”

Dr. Siva Samy | CEO, ValGenesis

“We are excited to join ValGenesis. We share a similar vision about the challenges and solutions required by pharma, biopharma, and the new advanced medicinal therapeutic products, in terms of accelerated development and robust science- and risk-based approaches to better serve patients. Our integration into ValGenesis will provide our worldwide customers access to automated, systematic, and user-friendly tools for risk and validation lifecycle management programs to improve mission-critical business processes in the life science companies. Our unified company will also accelerate the development and innovation of future-ready solutions targeting advanced product portfolio management.”

Prof. Dr. José C. Menezes | Chairman and Founder of 4TE