SANTA CLARA, Calif.: ValGenesis, Inc., the global innovator in digital validation lifecycle management, today announced the launch of ValGenesis Smart GxP™, the first AI-enabled platform purpose-built to unify validation and process lifecycle management across the life sciences industry. Smart GxP digitally connects all stages of the product lifecycle to provide a closed-loop feedback cycle, from process development and validation to commercial manufacturing. It delivers unprecedented efficiency, streamlined digital tech transfer, enhanced visibility, compliance through intelligent automation, seamless data integration, and accelerated time to market.

AI-Enabled from Design to Delivery

Built to transform the way life sciences companies manage data, processes, and compliance, ValGenesis Smart GxP™ bridges the gap between R&D, validation, quality, and manufacturing. It unifies validation and process development in a single, scalable platform, enabled by AI to support smarter, faster decision-making across the product lifecycle.

Smart GxP features two integrated suites:

Validation Lifecycle Suite

This suite automates the commissioning, qualification, and validation (CQV) of processes, equipment, and systems. It includes three AI-enabled applications:

• ValGenesis iVal™: Automates and streamlines equipment qualification, CSA, CSV, and manufacturing systems, enabling end-to-end validation lifecycle management that ensures greater efficiency, consistency, and compliance.
• ValGenesis iClean™: Digitalizes and automates risk-based cleaning process development, validation, and ongoing monitoring to enhance compliance, efficiency, and traceability.
• ValGenesis iOps™: Captures real-time operational data, including equipment, cleanroom, and process logs, ensuring complete traceability and cross-site visibility.

Together, these systems work in tandem to accelerate scale-up, reduce time to production, improve asset utilization, and boost resource efficiency while enabling strict compliance standards.

Process Lifecycle Suite

Designed to support science- and risk-based process development, this suite ensures end-to-end quality from design to commercial launch:

• ValGenesis iCMC™: Purpose-built digital platform that streamlines CMC process development by embedding Quality by Design (QbD) principles. It provides a structured, science-based approach to identify, quantify, and prioritize risks, enabling robust control strategies and lifecycle de-risking. Integrated knowledge management ensures that risk insights and development rationales are captured and reused to drive consistency and accelerate innovation.
• ValGenesis iCPV™: Enables Continued Process Verification (CPV) through real-time monitoring, while supporting digital APQR, predictive analytics, and real-time performance insights to ensure ongoing process control and compliance.

Together, these applications create a unified, scalable platform that seamlessly connects teams, systems, and data from lab to launch, driving end-to-end digitalization, enhanced quality, and accelerated speed across the product lifecycle.

VAL™ AI-Powered Validation Assistant

At the core of ValGenesis Smart GxP™ is VAL™, ValGenesis’ AI-powered validation assistant. Designed to deliver up to 80% faster document generation and reduce review cycles from weeks to hours, VAL automates validation end to end, generating protocols from existing documents and enterprise data, capturing results through image-based verification, flagging exceptions for review, and analyzing content to detect gaps or GDP issues based on approved SOPs.

Smarter Integration Leads to Stronger Outcomes

Smart GxP is designed to work seamlessly within the broader enterprise ecosystem, integrating with systems such as LIMS, MES, ERP, and QMS to ensure end-to-end data continuity. Its cloud-native architecture supports organizations of all sizes, from small teams to global operations, with enterprise-grade security features, including encryption, audit trails, and role-based access controls.

Accelerating Innovation While Ensuring Compliance

With its AI-first foundation, Smart GxP helps companies reduce manual effort, mitigate compliance risk, and increase the speed and quality of tech transfer across sites and programs. By digitalizing the entire lifecycle—from product development to commercial scale, Smart GxP enables organizations to transform validation from a bottleneck into a strategic advantage.

“ValGenesis Smart GxP represents a new generation of intelligent, connected systems,” said Dr. Siva Samy, CEO and Chief Product Strategist at ValGenesis. “By embedding AI across a unified platform that spans product and process development, validation, cleaning, and CPV, we’re enabling life sciences organizations to digitalize and streamline every stage of the lifecycle. This seamless integration eliminates data silos, accelerates tech transfer, and ensures a consistent thread of compliance and insight from lab to launch. With Smart GxP, life sciences companies can reduce risk, improve agility, and bring therapies to market faster, with confidence.”

ABOUT VALGENESIS INC.

ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life sciences companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005. For more information, visit https://www.valgenesis.com/.

Fonte: Business Wire