iCMC

ValGenesis iCMC™ is a science-driven, risk-controlled software platform designed to enable Quality by Design (QbD) in pharmaceutical CMC (Chemistry, Manufacturing, and Controls) development. Built for life sciences organizations, it provides intelligent frameworks that drive robust processes, consistent product quality, and regulatory alignment—supporting teams from early development all the way through to commercialization.

Part of the ValGenesis Process Lifecycle Suite, iCMC centralizes process and analytical development in a collaborative, traceable environment. It is trusted by leading pharmaceutical and biotech organizations, including GSK, where it is used to digitalize QbD frameworks for vaccine development, supporting simplification, acceleration, and knowledge management across global teams.

Core QbD and Risk Assessment Capabilities

• Structured QTPP (Quality Target Product Profile) definition to anchor development decisions in patient and product requirements
• Critical Quality Attribute (CQA) and Critical Process Parameter (CPP) analysis, including documented linkage between CQAs and CPPs to support control strategy design
• Built-in industry-standard risk assessment tools including FMEA, PHA, HAZOP, and Ishikawa diagrams, with guidance for regulatory alignment
• Support for science- and risk-based decision-making consistent with QbD principles throughout all development phases
• Linking of design space decisions with risk rationales to support lifecycle risk management

Advanced Analytics and Machine Learning

• Predictive insights powered by machine learning to identify trends and flag potential issues early in development
• Data-driven analytics to optimize development strategies and reduce bias in risk assessments
• CPV (Continued Process Verification) evidence integration to inform and refine risk evaluations

Process and Analytical Development Support

• Digital validation planning and analytical method validation capabilities
• Project coordination tools to align cross-functional teams and manage timelines
• Structured reporting to maintain audit-ready documentation at every development stage
• Knowledge reuse across products and facilities to reduce variability and accelerate future programs
• Support for technology transfer risk management, including assessment of process knowledge gaps, equipment risks, and environmental factors during site or technology transfers

Consistency, Traceability, and Regulatory Alignment

• Standardized, traceable workflows that unify process knowledge and reduce variability across products and sites
• Full lifecycle traceability from early development through to commercialization
• Alignment with global regulatory guidelines and ICH compliance requirements
• Audit-ready documentation maintained throughout the entire development lifecycle

Integration and Deployment

• Integration capabilities with QMS, MES, LIMS, and ERP systems for seamless data connectivity
• Operates as part of the broader ValGenesis Process Lifecycle Suite alongside ValGenesis iCPV™
• Designed to replace scattered CMC documents and manual spreadsheet-based QbD workflows with structured, connected digital processes

ValGenesis iCMC™ is purpose-built for pharmaceutical and biotech organizations seeking to accelerate time to market while maintaining rigorous compliance. With rapid implementation support—including customer-reported rollouts completed within six months—and deep expertise from the ValGenesis team, iCMC provides a comprehensive digital foundation for CMC development from molecule to market.