Powering Smart Manufacturing in Life Sciences

ValGenesis Briefing Note

Axendia was recently briefed by the executive team at ValGenesis.  Participants included Jeff Russell, VP of Customer Success & Growth, David Medina, Chief Marketing Officer, Steve Reynolds, Chief Revenue Officer and Narayan Raj, Chief Operating Officer.

Founded in 2005, ValGenesis has been at the forefront of digital validation, addressing the fragmented, manual, and time-consuming validation steps that characterized the life sciences industry at the time. As Russell explained, “Validation steps were disconnected… Siva Samy, Ph.D. CEO & Chief Product Strategist, saw the islands of data and chaos, and out of that, ValGenesis was born.”

ValGenesis introduced Validation Lifecycle Management System (VLMS), its patented flagship product, in that same year with large, global life sciences brand name companies being instrumental in shaping ValGenesis’ VLMS roadmap. Customer input continues to influence ValGenesis’ global product strategy, organic growth and expansion through strategic acquisitions such as the purchase of 4TE, a company from Lisbon specializing in quality, risk management, and continuous process verification (CPV).

Russell noted that ValGenesis currently supports over 61,000 users across hundreds of sites globally, and its customers include major global players in the pharmaceutical, biotechnology, and medical devices industries, including CMOs and CDMOs. These customers play a key role in the development and refinement of ValGenesis’ offerings. As Russell emphasized, ValGenesis is proud to have “defined the digital validation market” and continues to innovate in this space. Recent milestones include the release of VLMS 5.0, which introduces a fresh, user-friendly interface to meet the evolving needs of the market.

The company’s success and future growth have been bolstered by investment from Morgan Stanley.  In May 2021, ValGenesis secured a $24 million investment from Morgan Stanley Expansion Capital.  As Russell pointed out, “Morgan Stanley invested significantly into ValGenesis to fuel our growth. They believed in our vision.”  To support its expanding operations, ValGenesis has increased its workforce by bringing in experienced professionals across financial, sales, marketing, and technical domains.

Customer Success

ValGenesis aims to empower life sciences companies to deliver safe products faster and more consistently.  Its core philosophy is to focus on customer success.  “The success of our customers is our success,” said Russell.

Additionally, Russell pointed to the JP Morgan Healthcare Conference, where a major theme was the “continuity of supply,” as CEOs discussed investments in IT, capital assets, and equipment to ensure the steady supply of life-saving products. “We’re making an impact on getting those products to market,” said Russell, aligning ValGenesis’ vision with the industry’s broader goals.

Expanding the Product Suite

ValGenesis’ product suite is centered around the digitalization of the validation lifecycle, but the company is also expanding into adjacent areas such as cleaning validation, electronic logbooks, and risk management for CMC (Chemistry, Manufacturing and Control), CPV (Continuous Process Verification) to support the third stage of the process validation and technology transfer processes. Russell noted that there is still significant market opportunity, with roughly a 10% market penetration in validation and even less in areas like cleaning validation and continuous process verification.

The expanded product suite includes five core products that form a comprehensive suite for validation and quality management. According to Russell, “Our suite of products includes VLMS, Process Manager (for cleaning validation), eLogbook (digital logbooks ), Process Insights for CPV (continuous process verification), and iRisk (risk management for the CMC process).” Together, these solutions support the entire lifecycle of manufacturing assets and product development from QbD to CPV in the unified single platform.

Source: ValGenesis

ValGenesis’ product suite, particularly the iRisk and Process Insights products, enables a critical feedback loop driven by actual manufacturing data. This loop enhances technology transfer and enhances CPV programs by automatically integrating CQAs and CPPs defined in the control strategies. These integrated insights are then compared with real-world data to refine and guide risk assessments effectively.

Russell highlighted the potential in these areas, stating, “There’s lots of opportunity for us as a business in these adjacent spaces… We believe there’s a huge total addressable market (TAM) that is only about 5% penetrated.” With this expansion, ValGenesis aims to bring its validation expertise to broader functions, helping clients streamline production, enhance data integrity, and achieve more robust compliance.

AI, Automation and Efficiency

VLMS offers substantial efficiency gains, with Russell noting, “A benchmark we have is at least a 50% reduction in the time it takes to validate. The question is, ‘what can you do if you could eliminate 50% of that time?’  The answer our customers say is they are seeing more validation throughput with their current teams.  This translates into accelerated time to productivity for IT and capital assets, faster time to market, and bulletproof compliance.”

Axendia’s latest research report, Digital Transformation Across the Total Product Lifecycle: Realizing the Benefits of Advanced Technologies, reveals 36% of medical device professionals reported spending at least 50% of project budgets creating documentation aimed at fulfilling quality and regulatory requirements.  Moreover, Russell emphasized that up to 30% of a project’s budget can be tied to validation activities, a significant area where ValGenesis’ solutions drive value. “In some cases, we hear from customers that it’s even north of that. This highlights the impact of VLMS on both time and cost savings,” noted Russell.

The recent launch of VLMS 5.0—a new AI-enabled validation solution—demonstrates ValGenesis’ commitment to continuous innovation. As Russell explained, “We can imagine a future state where validation programs are automated by AI, leveraging a knowledge base of prior validations… driving even more efficiencies into the validation space.”

Looking Ahead

ValGenesis is positioning itself for continued growth, with plans to expand its global footprint and enhance its product offerings with next-gen technologies like AI.

The company’s core values—customer success, innovation, teamwork, and impact—guide its ongoing efforts to support life sciences companies in bringing life-saving products to market more efficiently. As ValGenesis continues to innovate and expand, it remains committed to transforming validation and quality management in the life sciences sector.

In Brief

ValGenesis is leveraging its decades-long experience in life sciences to drive digital transformation in validation and quality management. Strategic investments in AI and smart validation are positioning the company to lead the intelligent digital validation platform market.

The leadership team is focused on presenting their solutions in terms that resonate with the C-suite—cost savings, quality improvements, and speed to market. ValGenesis is positioning itself for global expansion, bolstered by strong customer success stories and plans to integrate next-gen technologies like AI. ValGenesis’ continued focus on innovation, automation, and strategic investments makes it a key player in the evolving landscape of life sciences validation and quality management.

We will continue to provide updates on ValGenesis as they become available.

To discuss how this initiative impacts your organization.  Click on this link to schedule an Analyst Inquiry on this topic.

The opinions and analysis expressed in this post reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this post is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This post is not intended to endorse any company or product and should not be attributed as such.

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