Cleaning Validation Platform
CLEEN
The most advanced cleaning validation platform in pharma — purpose-built to replace spreadsheets, paper logs, and fragmented point solutions for good.
Cleaning EfficiencyValidation built-in, not bolted on.
Built for Audit Readiness
Every module purpose-built for cleaning validation — from risk assessments and limit calculations to audit-ready reports.
CLEEN digitises your entire cleaning validation lifecycle into a single connected workspace. Protocol design, residue calculations, risk assessments, hold time studies, and regulatory reporting — with real-time visibility, automated compliance, and audit-ready documentation built in.
Download CLEEN Product Review →Protocol Builder
Design cleaning validation protocols with AI-assisted worst-case selection and automated acceptance criteria — so every protocol is defensible before the first swab is taken.
AI-Assisted Worst-Case Selection.
Automatically identifies worst-case products based on toxicity, solubility, and cleaning difficulty — no manual matrix juggling.
Automated Acceptance Criteria.
Calculates MACO, PDE-based, and visual limits from your product data, with full regulatory traceability to FDA and EMA guidance.
Risk-Based Sampling Plans.
Generates sampling point strategies based on equipment complexity, product contact area, and historical cleaning data.
Protocol Template Library.
Version-controlled templates that standardise protocol design across products, equipment, and sites.
Residue Tracking
Real-time visibility into residue levels across every piece of equipment — with automated limit comparison, trend analysis, and instant alerts when results drift.
Real-Time Results Dashboard.
Swab and rinse sample results flow in as they're recorded — no waiting for batch compilation to see where you stand.
Automated Limit Comparison.
Every result is instantly compared against acceptance limits with automatic pass/fail determination and deviation triggering.
Equipment Surface Mapping.
Visual maps of sampling points across equipment surfaces — ensuring consistent, repeatable sampling every time.
Historical Trend Analysis.
Track residue trends over time to catch drift early, justify continued process verification, and support lifecycle management.
Risk Assessment
Structured, ICH Q9-aligned risk assessments that combine toxicity data, equipment complexity, and historical outcomes into defensible, audit-ready risk evaluations.
Toxicity-Based Risk Scoring.
PDE and ADE values integrated directly into risk calculations — linking cleaning limits to patient safety data.
Equipment Complexity Classification.
Score and rank equipment by cleaning difficulty, dead legs, surface materials, and disassembly requirements.
Product Grouping Matrices.
Bracket products by shared characteristics to reduce validation scope while maintaining scientific justification.
AI-Recommended Mitigations.
Historical cleaning outcomes inform suggested risk mitigation strategies — learning from your own data.
Hold Time Studies
Design, execute, and validate dirty and clean hold time studies with automated scheduling, real-time countdowns, and statistical analysis that establishes defensible time limits.
Study Design Workflows.
Structured workflows for both dirty and clean hold time studies — from planning through execution to report generation.
Automated Scheduling & Alerts.
Time-point scheduling with automated reminders so sampling windows are never missed.
Statistical Validation.
Built-in statistical analysis to establish hold time limits with the confidence intervals regulators expect.
Lifecycle Documentation.
Complete audit trail from study design through data collection to validated time limit — in one place.
Audit Portal
Every cleaning validation record — organised, linked, and ready to present the moment an auditor walks in.
CLEEN's Audit Portal transforms inspection prep from a weeks-long scramble into a single click. All protocols, residue data, risk assessments, hold time studies, and approval records are continuously indexed and cross-referenced — giving auditors a complete, navigable view of your cleaning validation programme without your team pulling a single file.
The portal doesn't just compile documents. It connects them — linking every residue result back to the protocol that required it, the risk assessment that justified the limit, and the approval chain that signed it off.
Inspection-Ready Packages
One-click export of complete audit packages — protocols, execution data, residue results, risk assessments, and approval records — pre-formatted for FDA, EMA, and WHO expectations.
Cross-Reference Engine
Every record is automatically linked to its source — residue results trace back to protocols, limits trace to risk assessments, and approvals trace to training records. Auditors navigate the full evidence chain without asking.
Validation Status Dashboard
Real-time overview of your entire cleaning validation programme — which protocols are current, which equipment is validated, which studies are due, and where gaps exist — so you're never caught off guard.
Continuous Indexing.
Every protocol execution, residue result, and approval is indexed in real time — the audit portal is always current, not a snapshot compiled the night before an inspection.
Auditor-Friendly Navigation.
Browse by equipment, product, time period, or validation lifecycle stage. Auditors find what they need in seconds — without your team scrambling to locate files.
21 CFR Part 11 Compliant.
Full electronic signature trails, tamper-evident audit logs, and role-based access controls on every document and data point in the portal.
Multi-Site Rollup.
Aggregate cleaning validation status across all manufacturing sites into a single corporate view — giving quality leadership instant visibility into global programme health.
See What CLEEN Can Do
Explore how CLEEN transforms cleaning validation workflows with intelligent automation, risk-based protocols, and continuous compliance monitoring.
CLEEN brings together every critical function in cleaning validation—protocol design, residue tracking, risk assessment, hold time studies, and audit-ready reporting—into a single intelligent platform that eliminates manual paperwork, automates compliance, and turns your cleaning data into defensible, audit-ready documentation.
