ValGenesis provides a cloud-based Validation Lifecycle Management System (VLMS) that digitizes the entire validation lifecycle from planning to archiving for life sciences, delivered as a SaaS and compliant with FDA 21 CFR Part 11 and EU Annex 11. The platform includes AI-enabled modules like iVal, iClean, and iRisk, and expanded after acquiring 4Tune Engineering to add risk management and continuous process verification, plus the 2025 Smart GxP AI-powered platform and VLMS Express for rapid deployment to smaller firms. It differentiates from competitors by offering a fully paperless, end-to-end validation lifecycle and a large installed base including 30 of the top 50 global life sciences companies. Its goal is to reduce validation costs and cycle times while preserving regulatory traceability and compliance across validated operations.
Company Size
501-1,000
Company Stage
Debt Financing
Total Funding
$40.4M
Headquarters
Santa Clara, California
Founded
2005
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ValGenesis welcomes David Horn as president. * October 6, 2026 ValGenesis announced the strategic appointment of David Horn as corporate president today. His official leadership appointment takes effect on October 5, 2026. Furthermore, Horn joins ValGenesis during an aggressive global expansion of its Smart GxP platform. He will focus on strengthening financial foundations and expanding international customer relationships. Additionally, he will collaborate directly with chief executive officer Siva Samy on long-term initiatives. Specifically, Horn brings over two decades of financial and operational experience to ValGenesis. Most recently, he served as president and chief financial officer at Seer, Inc. In that executive role, he directed core finance operations and key commercial functions. Previously, Horn spent over 20 years at Morgan Stanley as managing director. He led the global Life Science Tools practice and advised public life sciences companies. Earlier in his career, he directed business development across medical device sectors. "ValGenesis has significant opportunities ahead as we continue to grow and expand how we serve life sciences organizations," Samy said. "David brings a rare combination of operating leadership, financial expertise, and industry knowledge. His experience helping companies navigate growth and strategic change will strengthen our leadership team as we enter this next stage." "ValGenesis has built a strong position in life sciences, with deep customer relationships and significant innovation underway across its Smart GxP and VAL platforms," Horn said. "I'm excited to work with Siva and the broader ValGenesis team at this important stage in the company's growth and help realize the exciting opportunities ahead." Expanding leadership capabilities and modernizing GxP operations. Academic accomplishments further solidify his strategic business expertise across global markets. Horn holds a Bachelor of Arts degree from Princeton University. In addition, he earned an MBA from the Stanford Graduate School of Business. Consequently, this executive appointment accelerates the software innovation strategy at ValGenesis. The organization continues investing heavily in digital validation solutions for global life sciences leaders. Ultimately, his arrival positions ValGenesis to scale operations and modernize global GxP compliance workflows. For more stories on technology leaders shaping the future of enterprise solutions, visit its CXO Insiders.
ValGenesis to bring real-world AI-Assisted Validation insights to KENX Europe 2026. * 1 hr ago ValGenesis Inc., the leader in enterprise digital validation, will explore real-world insights into the practical application of AI-assisted validation at KENX Europe 2026: Harnessing the Power of AI in GxP, taking place Oct. 14-15, 2026, at the Four Elements Hotel Amsterdam in Amsterdam, the Netherlands. As life sciences organizations move from exploring AI's potential to applying it in regulated environments, questions around performance, governance, and human oversight are becoming increasingly important. ValGenesis is addressing these challenges through AI-native digital validation and VAL(TM)(ValGenesis AI), the governed AI natively built into the ValGenesis Smart GxP(TM) platform. VAL applies AI throughout the validation lifecycle while keeping humans in control of oversight, approval, and critical decisions. Its capabilities include generating validation documents, identifying potential compliance and test-coverage gaps, interpreting execution evidence, detecting anomalies, and analyzing document changes. "AI is moving beyond theory and into practical use in GxP environments," said David Medina, chief marketing officer at ValGenesis. "The challenge now is understanding where it adds meaningful value, how to evaluate the results, and how to maintain appropriate control. At KENX Europe, we'll share what we're learning from practical applications of AI in validation and the considerations organizations should address as they expand its use." Kenneth Pierce, Ph.D., director of product growth at ValGenesis, will lead two sessions focused on evaluating AI performance and building trust in its use in GxP environments. "How Would You Know It Worked? Measuring AI-Assisted Validation in Practice" will draw on customer pilot studies, implementation lessons, and measurable performance outcomes to examine how organizations can evaluate AI-assisted validation. "Pacing the Frontier: AI in GxP Life Sciences Operations" will introduce an AI maturity model for building trust in AI-supported processes and expanding adoption through clearly defined intended-use frameworks. ValGenesis is a Platinum Sponsor of KENX Europe 2026 and will host an exhibit booth and sponsor the event's cocktail reception. About ValGenesis, Inc. ValGenesis, Inc. is the global leader in enterprise digital validation. Serving the life sciences industry for nearly two decades, ValGenesis enables companies to digitize their commissioning, qualification, and validation processes through its AI-enabled ValGenesis Smart GxP(TM) platform, which includes solutions for risk management, cleaning validation, continued process verification, and CMC development. ValGenesis helps customers worldwide reduce costs, improve compliance, and accelerate innovation. For more information, visit valgenesis.com. Media gallery
ValGenesis, the digital validation lifecycle management platform provider, has appointed Wayne Baker as chief revenue officer. Baker will oversee global sales strategy, customer expansion, and commercial execution across key markets. Baker brings over 25 years of experience in technology and life sciences. He previously served as chief commercial officer at Greenphire and chief sales officer at Advanced Health Media. The appointment comes as life sciences companies increasingly adopt AI-enabled validation processes. ValGenesis offers Smart GxP, an AI-native validation platform, and VAL, a governed AI system for executing validation work. Baker will focus on scaling global sales and helping customers adopt the company's platform across validation, process development, and manufacturing. ValGenesis serves life sciences companies worldwide, digitising commissioning, qualification, and validation processes.
Ulrich Medical Selects ValGenesis iVal(TM) for SAP-Driven CSV Upgrade. SANTA CLARA, Calif.-(BUSINESS WIRE)-ValGenesis Inc., the market leader in enterprise digital validation, announced that Ulrich Medical has selected ValGenesis iVal(TM) to modernize computer system validation (CSV) processes in support of its broader digital transformation and upcoming SAP implementation. Ulrich Medical has selected ValGenesis iVal(TM) to modernize computer system validation (CSV) processes in support of its broader digital transformation and upcoming SAP implementation. Share The Germany-based medical device company will replace manual validation processes with a digital approach to manage increased CSV activity associated with the SAP rollout. The initial deployment will begin at Ulrich Medical's headquarters, with plans for global expansion. Part of the AI-enabled ValGenesis Smart GxP(TM) platform, iVal centralizes validation planning, test authoring, and execution to enable more efficient and scalable CSV processes. With offline execution, automated deviation management, integrated risk assessments, and change impact analysis, the platform helps organizations streamline validation workflows, improve traceability, and maintain regulatory compliance across global operations. "Modernizing CSV was a prerequisite for our SAP rollout," said Matthias Novotny, Head of Process and Lean Management at Ulrich Medical. "ValGenesis gives us the efficiency we need to manage a significantly higher validation workload with greater accuracy and consistency, allowing us to keep pace with evolving global regulations without overstretching our team." "As medical device companies expand digital transformation initiatives and enterprise system deployments, they face growing pressure to manage validation activities more efficiently while maintaining compliance," said Anna Beamish, vice president of global sales at ValGenesis. "By implementing iVal, Ulrich Medical is moving toward a digital validation approach that can scale with its global operations and long-term growth." About Ulrich Medical Ulrich Medical develops, manufactures, and markets innovative medical technology. Founded in 1912, the company celebrates its 114th anniversary this year. Healthcare professionals worldwide rely on its decades of expertise. With product divisions in spinal implants and contrast media injectors for CT and MRI, Ulrich Medical offers a broad portfolio of advanced solutions. The company is among the few in the industry to retain both development and production in Germany, supported by state-of-the-art manufacturing technologies. As an owner-operated business, it remains independent and continues to deliver steady, sustainable growth. For more information, visit ulrichmedical.com About ValGenesis Inc. ValGenesis, Inc. is the global leader in enterprise digital validation. Serving the life sciences industry for nearly two decades, ValGenesis enables companies to digitize their commissioning, qualification, and validation processes through its AI-enabled ValGenesis Smart GxP(TM) platform, which includes solutions for risk management, cleaning validation, continued process verification, and CMC development. ValGenesis helps customers worldwide reduce costs, improve compliance, and accelerate innovation. For more information, visit valgenesis.com Contacts. Althea D'Sylva, ValGenesis Communications, +1 510-445-0505 Ex.1026 [email protected]
ValGenesis has launched the next generation of VAL (ValGenesis AI), bringing governed artificial intelligence to the validation lifecycle for life sciences companies. The platform will debut at INTERPHEX on 21-23 April in New York City, with a limited pilot programme for qualified firms. VAL operates within governed workflows in digital validation systems, using companies' approved validation documents, enterprise data, policies and regulatory guidance as guardrails. The system supports protocol generation, gap assessment, execution review and anomaly identification whilst maintaining human oversight and regulatory traceability. ValGenesis claims the AI-enabled platform can achieve up to 80% reduction in validation time and cost compared with manual processes, and deliver at least 50% greater efficiency than conventional digital validation. The company is the market leader in digital validation lifecycle management.