ValGenesis

Founded by Siva Samy in 2005

Manage validation lifecycles for life sciences companies with AI automation

Cost

Demo

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Time to value

Requires Expertise

You can use ValGenesis to digitalize and manage the full validation lifecycle for pharmaceutical and biotech companies. It lets you author, execute, and track validation documents with AI assistance, automate cleaning validation calculations, monitor processes in real time with statistical controls, manage equipment logbooks digitally, and maintain compliance-ready audit trails. It connects process design, validation execution, and continuous process verification in one system built for GxP regulatory requirements.

What ValGenesis does

Author validation protocols with AI-generated content suggestionsExecute validation tests on mobile devices with QR code scanningCalculate MACO limits automatically for cleaning validationGenerate CPV reports across multiple sites and batches automaticallyCreate deviation reports and link them to validation recordsMonitor batch data in real time with multivariate statistical controlsTrack user role permissions at a granular level for complianceManage qualification documents with one-click access and digital sign-offAI-assisted validation document authoring that reduces authoring time significantlyAutomated MACO calculations and ADE-aligned limits for cleaning validationReal-time anomaly detection during validation execution2D and 3D equipment maps for cleaning validation sampling point trackingMultivariate analytics and SPC control charts for continuous process verificationMobile QR-enabled forms for capturing equipment use, cleaning, and calibration eventsEnd-to-end audit trail and traceability from design to commercial manufacturingBuilt-in FMEA and HAZOP risk scoring linked to quality targets