Process lifecycle intelligence for development, transfer, and CPV

What’s in it

This datasheet explains how ValGenesis Process Lifecycle Suite supports process development, scale-up, technology transfer, and lifecycle management with two connected applications, ValGenesis iCMC™ and ValGenesis iCPV™. You’ll see how iCMC replaces disconnected spreadsheets with a centralized QbD and Quality Risk Management approach for mapping CQAs, CMAs, and CPPs, running structured risk workflows, enabling knowledge reuse, and generating reports from predefined templates. It also details how iCPV digitalizes continued process verification with guided CPV program setup, real-time monitoring and trending, configurable alerts, advanced charting and multivariate analysis, and automated reporting.

The document also outlines the suite’s shared data backbone and closed-loop flow between iCMC and iCPV, plus integration options (API connections and template uploads) with systems such as ERP, LIMS, MES, and historians. Finally, it covers standards and controls for compliance, audit trails, and data security, including role-based access, encryption, and support for FDA 21 CFR Part 11, EU Annex 11, ALCOA+, and relevant ICH guidelines.

Who this is for

• CMC leaders and process development teams standardizing QbD and risk management across programs
• MSAT and tech transfer leaders responsible for scale-up and transfer readiness across sites
• Process engineers and manufacturing engineers managing CPP/CQA control strategies and process performance
• Quality assurance and quality systems teams overseeing CPV documentation, audit trails, and data integrity
• Manufacturing and technical operations leaders focused on continuous monitoring and deviation prevention
• Data analytics and business intelligence teams supporting dashboards, trend analysis, and reporting
• IT and digital manufacturing teams planning integrations, hosting, access controls, and security requirements

What it helps with

• Builds structured CMC knowledge so teams can capture, reuse, and govern process and analytical development work
• Improves scale-up and technology transfer execution with consistent workflows and shared configuration
• Automates CPV program setup, monitoring, and reporting to reduce manual effort and report risk
• Detects signals early with configurable rules, alerts, and trend visualization to support timely action
• Supports multi-site standardization with a single source of truth for parameters, attributes, and monitoring plans
• Strengthens compliance with built-in audit trails, electronic controls, and data integrity practices
• Simplifies integration planning with documented interoperability across common enterprise and manufacturing systems