A Smarter Way to Manage Process Lifecycle in Pharma and Biotech

Built for High-Stakes Process Management—Designed to Ensure Product Quality

The ValGenesis Process Lifecycle Suite  was designed specifically for life sciences manufacturers navigating complex tech transfers, CPV, and regulatory expectations.

With iCMC and iCPV at its core, the suite brings together data, teams, and process knowledge in one platform—empowering faster decision-making, more effective risk mitigation, and audit-ready compliance from day one.

• Integrated iCMC and iCPV Modules – Manage process design, risk, CPV, and change in one digital environment—no more jumping between systems or formats.
• Science-Based Process Design – Apply QbD principles to design robust manufacturing processes and analytical methods that consistently meet target CQAs.
• Real-Time CPV and Risk Control – Monitor CPPs and CQAs across sites with multivariate tools and guided workflows that detect issues before they escalate.
• Centralized Knowledge Base – Capture, store, and reuse validated process knowledge to accelerate tech transfer and support continuous improvement.
• Regulatory Alignment by Design – Fully aligned with FDA 21 CFR Part 11, EU Annex 11, ICH Q8–Q14, ALCOA+, and GAMP 5—ensuring data integrity, audit trails, and validation support.
• Enterprise-Ready Scalability – Deploy globally with configurable workflows, offline execution, and interoperability with LIMS, MES, ERP, and QMS systems.