Continued process verification, fast and error-free

This datasheet explains how Valgenesis iCPV™ supports continued process verification with real-time monitoring of CPPs and CQAs, guided CPV program setup, automated reporting, and instant notifications when signals indicate potential drift. It also outlines built-in analytics (including multivariate analysis and statistical control), a centralized knowledge base for reuse, and data integrity controls such as audit trails with immutable timestamps. You’ll also find integration and scalability details (SAP, LIMS, MES, ERP, QMS; multisite and cloud options), plus compliance and security coverage (21 CFR Parts 210/211, Part 11, EU Annex 11, ISO 27001/9001, GAMP 5, ALCOA+), and core technical specs (cloud-native, web-based).

Who this is for:

• MSAT leaders and process scientists responsible for CPV strategy and trending

• Process engineers and manufacturing engineers managing CPP/CQA control

• Quality assurance managers and quality systems teams overseeing CPV documentation

• Manufacturing and technical operations leaders accountable for process performance and deviation reduction

• Data/analytics and business intelligence teams building dashboards and reports for operations and quality

• IT and digital manufacturing teams supporting integrations across MES, LIMS, ERP, and QMS

• Regulatory and compliance teams preparing for inspections and data integrity reviews

What it helps with:

• Speeds CPV program creation with guided workflows

• Reduces manual effort and errors in CPV reporting through automation and scheduled distribution

• Improves early detection of out-of-trend conditions with statistical rules and configurable alerts

• Supports cross-site comparability and standardization of CPV monitoring

• Makes audit preparation easier with clear traceability, audit trails, and documented controls

• Enables knowledge reuse by centralizing production data and learnings for future changes