Valgenesis iVal™ for faster validation, stronger compliance, and less manual work

What’s in it

This brochure explains how Valgenesis iVal™ digitalizes and automates equipment qualification and computer systems validation, using generative AI to speed test generation and execution while supporting compliance. It outlines a risk-based approach for focused testing, end-to-end CQV support for facilities, equipment, and systems, and connected processes that centralize data and reduce handoffs between teams.

You will also find practical outcomes and product capabilities such as automated verification with full audit trails, intelligent data entry and anomaly detection to reduce human error, shorter review cycles to reduce manual effort, controlled access to protect sensitive data, and a stated potential reduction of validation cycle time by up to 80%.

Who this is for

• VP/Director of validation (CQV)
• VP/Director of validation (CSV/CSA)
• CQV engineers and qualification leads (IQ/OQ/PQ owners)
• QA and quality systems leaders responsible for inspection readiness
• Engineering and facilities leaders running CAPEX and equipment readiness
• Manufacturing and technical operations leaders accountable for release timelines
• IT quality and digital quality leaders supporting validated systems and access controls
• Regulatory affairs and compliance leaders overseeing audit readiness

What it helps with

• Reduce validation cycle time with AI-powered content generation and automated execution
• Support risk-based CSV/CSA practices with focused testing to cut effort where it is not needed
• Keep audit readiness with automated verification, complete audit trails, and consistent documentation
• Lower manual errors using intelligent data entry, verification, and anomaly detection
• Improve cross-team delivery by reducing silos through centralized data and connected workflows
• Protect sensitive information with controlled access and no third-party exposure