ValGenesis to Showcase AI-Enabled Validation at 2025 ISPE Annual Meeting and Expo

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SANTA CLARA, Calif.--(BUSINESS WIRE)--Oct 22, 2025--

ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems, will be on-site at the ISPE Annual Meeting & Expo, taking place October 26–29 in Charlotte, North Carolina. The company will showcase its AI-enabled ValGenesis Smart GxP™ Platform, which helps life sciences organizations modernize validation through intelligent automation, predictive insights, and continuous compliance.

As part of its ISPE presence, ValGenesis is offering attendees exclusive access to the new ARC Advisory Group report, “Accelerating Innovation and Time to Market in Life Sciences through AI-Powered Validation.”

Developed in collaboration with ValGenesis and enriched by insights from leading industry experts — including Dr. Alton Johnson, Mr. José Caraballo Oramas, and Dr. José Vidal — the report explores how artificial intelligence is transforming validation from a costly constraint into a strategic driver of speed, accuracy, and innovation across the product lifecycle. ARC highlights how AI-powered platforms such as ValGenesis Smart GxP™ deliver measurable ROI, improve documentation consistency, and enable predictive control in alignment with evolving global regulatory frameworks.

ValGenesis Smart GxP™ unifies validation, quality, and manufacturing processes in a single, AI-enabled ecosystem. Anchored by VAL™ Smart Agents, the platform automates protocol authoring, risk assessments, anomaly detection, and compliance tracking through secure, lifecycle-governed AI models. Designed in alignment with global standards — including the FDA’s CSA guidance, EU Annex 11, the EU AI Act, and ISPE GAMP 5 Second Edition — ValGenesis Smart GxP™ enables life sciences organizations to achieve faster validation cycles, reduce rework, and maintain continuous audit readiness.

ValGenesis recently kicked off a pilot program with select customers to implement its VAL™ Smart Agents in real-world validation environments. These pilots are designed to quantify time and cost savings, demonstrate compliance readiness, and showcase how AI can deliver measurable business value across regulated operations.

“AI in validation is moving from concept to reality,” said Dave Medina, Chief Marketing Officer at ValGenesis. “Our pilot programs mark the start of a new chapter where VAL™ Smart Agents are being applied in real-world environments to help life sciences companies rethink what’s possible in validation. At ISPE 2025, we’re excited to share how this transformation is beginning to take shape.”

Visit ValGenesis at Booth #925

Attendees visiting Booth #925 at ISPE 2025 can see live demos of the ValGenesis Smart GxP™ platform and receive a premium, limited-edition access card linking to ARC Advisory Group’s full report on AI-powered validation. This nine-page report is typically available only to ARC Advisory Group clients through the ARC Client Portal.

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™ 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.

View source version on businesswire.com:https://www.businesswire.com/news/home/20251022105527/en/

CONTACT: For more information, contact:

Lisa Weeks, ValGenesis Communications, (+1) 510-445-0505

[email protected]

KEYWORD: CALIFORNIA NORTH CAROLINA UNITED STATES NORTH AMERICA

INDUSTRY KEYWORD: DATA MANAGEMENT HEALTH TECHNOLOGY SOFTWARE ARTIFICIAL INTELLIGENCE PHARMACEUTICAL BIOTECHNOLOGY

SOURCE: ValGenesis, Inc.

Copyright Business Wire 2025.

PUB: 10/22/2025 08:15 AM/DISC: 10/22/2025 08:17 AM

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