Content Video
ValGenesis iClean™: Risk-based. Justified Limits. Digital Cleaning Validation.
0:11 Paper-based cleaning validation creates delays, inconsistencies, and compliance risk.
0:15 It’s time to modernize your cleaning validation process—from initial design to continuous monitoring—using intelligent workflows and centralized data control.
0:27 ValGenesis iClean is purpose-built for cleaning validation—combining automation, scientific justification, and risk-based control to deliver compliance excellence and process consistency.
0:39 iClean automates MACO calculation and residual limit management, applies scientifically justified worst-case assessments, visualizes sampling in 2D and 3D, and streamlines change control through structured impact analysis — all within a single, integrated application
0:56 Centralize your cleaning validation data—linking agents, equipment, and methods—and scale consistent practices across every site.
1:04 Ensure audit readiness with automated documentation, real-time compliance dashboards, and traceable, deviation-aware audit trails.
1:13 ValGenesis iClean — the smart, compliant, and consistent way to streamline cleaning validation and stay inspection-ready.
Summary
Paper-based cleaning validation can slow execution, introduce inconsistencies, and increase compliance risk. This video shows how to shift from manual documentation to a digital, workflow-driven approach.
ValGenesis iClean™ supports the full lifecycle—from design through ongoing monitoring—by automating MACO and residual limit management, standardizing worst-case assessment, and centralizing cleaning data across sites for audit readiness.
Key takeaways
• Replace paper steps with risk-based digital workflows from initial design through continued monitoring.
• Automate MACO calculations and residual limit management using scientifically justified worst-case assessments.
• Improve inspection readiness with centralized data, structured change impact analysis, and traceable audit trails with real-time dashboards.
Who is this for
• Cleaning validation engineers and specialists
• Quality assurance (QA) and compliance teams
• Manufacturing science and technology (MSAT) leaders
• Process engineers and equipment owners responsible for cleaning programs
• Quality control (QC) and analytical teams supporting residue testing and sampling plans
• Validation managers overseeing multi-site standardization and inspection readiness
Relevant entities and links
• U.S. FDA — 21 CFR Part 11 (Electronic Records; Electronic Signatures) — https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
• European Commission — EudraLex Volume 4, Annex 11 (Computerised Systems) PDF — https://health.ec.europa.eu/system/files/2016-11/annex11_01-2011_en_0.pdf
• FDA — Data Integrity and Compliance With Drug CGMP: Questions and Answers (guidance page) — https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers
• FDA — Data Integrity and Compliance With Drug CGMP: Questions and Answers (PDF) — https://www.fda.gov/media/119267/download
• ICH — Q9(R1) Quality Risk Management (PDF) — https://database.ich.org/sites/default/files/ICH_Q9-R1_Document_Step2_Guideline_2021_1118.pdf
• PIC/S — PI 041-1 Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments — https://picscheme.org/docview/4234
• UK MHRA — Guidance on GxP data integrity (PDF) — https://assets.publishing.service.gov.uk/media/5aa2b9ede5274a3e391e37f3/MHRA_GxP_data_integrity_guide_March_edited_Final.pdf
