US-based digital platform expert ValGenesishas launched its new Smart GxP (trademarked).
The Pennsylvania-based company works to create digital validation lifecycle management solutions for various industries.
Created for the life science industry, Valgenesis says Smart GxP is the first AI-enabled platform designed to unify validation and process lifecycle management across the sector. This includes everything from process development and validation, through to commercial manufacturing.
The platform aims to provide a closed-loop feedback system that enhances operational efficiency, streamlines technology transfer, improves visibility and compliance, and accelerates time to market.
Dr Siva Samy, CEO and Chief Product Strategist at ValGenesis, said: “By embedding AI across a unified platform that spans product and process development, validation, cleaning, and continued process verification, we enable life sciences organisations to digitalise and streamline every lifecycle stage.
“This integration eliminates data silos, accelerates tech transfer, and maintains consistent compliance and insight from lab to launch. With Smart GxP, companies can reduce risk, increase agility, and bring therapies to market faster and with greater confidence.”
Bridging validation and process development
Smart GxP is purpose-built to change how life sciences companies manage data, processes, and regulatory compliance.
It bridges the traditional divide between research and development, validation, quality assurance, and manufacturing teams by unifying validation and process development within a scalable, AI-driven platform.
This integration supports smarter, faster decision-making throughout the product lifecycle.
The platform is composed of two core suites:
Validation Lifecycle Suite
This suite automates commissioning, qualification, and validation (CQV) activities for processes, equipment, and systems. It features three AI-enabled applications:
- ValGenesis iVal automates equipment qualification and manufacturing system validation to ensure efficiency and consistency.
- ValGenesis iClean digitises risk-based cleaning process development and validation to enhance compliance and traceability.
- ValGenesis iOps captures real-time operational data from equipment and cleanrooms, ensuring traceability and visibility across sites.
Together, these applications accelerate scale-up, reduce time to production, optimise asset utilisation, and improve resource efficiency—all while maintaining strict compliance standards.
Process Lifecycle Suite
This suite supports science- and risk-based process development to guarantee quality from design through to commercial launch. It includes:
- ValGenesis iCMC, a platform that embeds Quality by Design (QbD) principles to streamline Chemistry, Manufacturing, and Controls (CMC) process development through structured risk management and knowledge capture.
- ValGenesis iCPV, which facilitates Continued Process Verification (CPV) via real-time monitoring, predictive analytics, and digital Annual Product Quality Review (APQR) capabilities.
This suite creates a unified, scalable digital environment that connects teams, systems, and data seamlessly from laboratory research to commercial production.
VAL: The AI-powered validation assistant
At the heart of Smart GxP is VAL, ValGenesis’ AI-powered validation assistant. VAL automates protocol generation, data capture, and document review, enabling up to 80% faster document creation and reducing review cycles from weeks to hours.
It uses image-based verification and content analysis to flag exceptions and identify compliance gaps in line with approved SOPs.
Integration and security
Smart GxP is designed to integrate smoothly with existing enterprise systems such as Laboratory Information Management Systems (LIMS), Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP), and Quality Management Systems (QMS).
Its cloud-native architecture supports organisations of all sizes with enterprise-grade security, including encryption, audit trails, and role-based access controls.
With an AI-first approach, Smart GxP aims to reduce manual workloads, lower compliance risks, and accelerate the quality and speed of technology transfer across multiple sites.
By digitalising the entire lifecycle from development to commercial scale, the platform turns validation from a regulatory bottleneck into a strategic asset.
Top image: Smart GxP
