Turn Validation Into a Competitive Advantage

Purpose-Built for Compliance, Consistency, and Speed to Market

ValGenesis Validation Lifecycle Suite is built to accelerate timelines, enforce compliance, and eliminate errors across your enterprise.

From protocol creation to cleaning validation and operational execution, the suite digitizes the entire validation lifecycle so your teams can focus less on documentation and more on quality, performance, and speed to market.

• End-to-End Lifecycle Management - Digitize validation planning, execution, documentation, and monitoring in a single system—reducing delays, version conflicts, and manual handoffs.
• Built-in Intelligence - AI-powered content generation, gap assessor, validation execution, anomaly detection, and risk prioritization streamline decisions and reduce review cycles without compromising compliance.
• Audit-Ready by Design - Every user action is time-stamped, every record traceable, and every report built for regulatory alignment with FDA 21 CFR Part 11, EU Annex 11 & 15, ALCOA+, and GxP standards.
• Enterprise-Wide Standardization - Ensure consistent validation practices across systems, teams, and sites with no-code form builders, configurable workflows, and centralized data access.
• Operational Efficiency That Scales - Synchronize validation, cleaning, calibration, and maintenance activities—online or offline—on one platform to eliminate rework, accelerate throughput, and cut cycle times.
• CAPEX and Resource Optimization - Improve equipment utilization, minimize revalidation needs, and reduce project overhead by enforcing smarter, risk-based validation strategies.