What if your GxP validation lifecycle was designed for scale, speed, and control?

What’s in it

This brochure presents the ValGenesis Smart GxP platform vision and explains how the Validation Lifecycle Suite and Process Lifecycle Suite connect development, design, commissioning, qualification, validation, process performance qualification, and continued process verification. It outlines the roles of ValGenesis iVal™, iClean™, iOps™, iCMC™, and iCPV™, including digital workflows, risk-based approaches, structured data capture, process monitoring, trend analysis, and shared execution context. It also describes the enterprise value of replacing fragmented, paper-based activities with connected GxP data and greater visibility into execution status, risk, and process performance.

Who is this for

• Validation and CQV leaders managing qualification and validation programs

• Quality assurance and quality systems leaders overseeing GxP compliance and traceability

• Manufacturing and technical operations leaders responsible for execution and process performance

• MSAT and process engineering teams supporting PPQ and continued process verification

• CMC and pharmaceutical development leaders managing process design and control strategies

• Cleaning validation specialists responsible for cleaning process design and execution

• Digital transformation and IT leaders connecting GxP systems and data across sites

What it helps with

• Understand how ValGenesis applications support the lifecycle from process design through continued process verification

• Identify opportunities to replace paper-based and disconnected workflows with structured digital processes

• Connect validation, cleaning, operational execution, CMC, and CPV activities through shared data

• Improve visibility into execution status, process risk, and performance trends

• Standardize GxP data and workflows across products, teams, and sites

• Build a connected digital foundation for process knowledge, decision-making, and continuous improvement