Digitalize cleaning validation and stay inspection-ready

What’s in it

This brochure explains how Valgenesis iClean™ supports end-to-end digital cleaning validation by bringing process design through continuous monitoring into a single platform. It covers risk-based worst-case assessments built on scientifically justified evaluations, automated MACO calculations with residual limit management based on regulatory guidance and business rules, and intelligent sampling support using 2D/3D imaging.

You’ll also see how structured change control helps assess impact consistently, plus how automated documentation, audit trails, and built-in best practices support audit readiness and help prevent Form 483 findings.

Who this is for

• Cleaning validation engineers and specialists
• CQV and validation managers responsible for validation execution and oversight
• Quality assurance leaders focused on compliance and inspection readiness
• Manufacturing or operations leaders accountable for line turnover and execution efficiency
• MSAT or process engineers supporting cleaning strategies, limits, and risk assessments
• Regulatory compliance professionals supporting audit preparation and response

What it helps with

• Reduces paper-based errors, delays, and rework by digitalizing and automating workflows
• Speeds cleaning validation cycles by up to 50% through automation that reduces cycle times
• Improves consistency with risk-based controls and decision trees for lifecycle delivery
• Supports defensible worst-case selection with scientifically justified risk evaluations
• Automates MACO calculations and residual limit enforcement using defined rules
• Simplifies sampling location decisions with 2D/3D imaging support
• Streamlines change impact assessments with structured change control
• Keeps teams audit-ready with automated documentation and audit trails