Digital cleaning validation, built for speed and control

What’s in it

This datasheet explains how ValGenesis iClean™ supports a fully digital cleaning validation lifecycle, from process design and qualification through continued process verification. It details automated workflows that reduce manual effort and execution errors, built-in frameworks for change assessment, and centralized audit trails that maintain continuous inspection readiness. You’ll see how iClean manages worst-case assessments, MACO calculations, residual limits, and hold times using structured data and business rules. The document also outlines advanced capabilities such as 2D and 3D sampling visualization, risk-based prioritization, requalification scheduling, and dashboards for real-time oversight, along with enterprise-grade security, integration, and regulatory compliance coverage.

Who this is for

• Cleaning validation and CQV leaders responsible for global cleaning programs

• Quality assurance managers overseeing data integrity and inspection readiness

• Manufacturing and technical operations leaders managing changeovers and equipment readiness

• Process engineers and validation engineers designing and maintaining cleaning strategies

• Regulatory and compliance professionals supporting audits and regulatory submissions

• IT and digital quality teams integrating validation systems with MES, LIMS, and ERP

What it helps with

• Reducing cleaning validation cycle times through automated, standardized workflows

• Improving consistency and lowering human error with rule-driven execution and documentation

• Managing worst-case scenarios, MACO calculations, and residual limits with traceable logic

• Simplifying change assessments and requalification planning across products and equipment

• Maintaining continuous audit readiness with complete, immutable audit trails

• Scaling cleaning validation across sites while enforcing global standards