Cross-Contamination Control

Cleaning Validation

Digitize your cleaning validation lifecycle. Automated MACO calculations, HBEL-based residue limits, risk-based sampling plans, and 21 CFR Part 11 compliant execution — from design through ongoing monitoring.

Cleaning Validation — Lifecycle Dashboard
Validation Overview
Live · Updated 22s ago
12 Active Protocols
5 Pending Reviews
18 Ongoing Monitoring
Protocol — CV-2025-0038 Granulator Suite
Stage 3 of 5 complete · QA review pending
In Review
MACO Calculation — Product B → Product A
HBEL-based limits derived · Swab & rinse criteria set
Approved
Sampling Plan — Blending Bin BB-012
6 swab locations mapped · Justification documented
Active
Cleaning Validation

End-to-End Cleaning Validation Lifecycle Management

Voyantix Cleaning Validation replaces paper binders and spreadsheets with digital lifecycle management. Cleaning Validation is a GxP-validated system that manages the entire cleaning validation lifecycle — from risk assessment and MACO calculations to protocol execution, sampling plan management, and ongoing monitoring. It prevents cross-contamination in multi-product manufacturing facilities by ensuring cleaning procedures consistently remove product residues, cleaning agents, and other contaminants to acceptable levels.

  • Automated MACO calculations based on HBEL, batch sizes, and shared surfaces
  • Risk-based worst-case product and equipment selection with FMEA
  • Swab and rinse sampling plan management with equipment mapping
  • Digital protocol execution with electronic signatures and audit trails
100%Paperless — Complete digital cleaning validation lifecycle
21 CFR 11Validated — Electronic records and signatures pre-validated for FDA compliance
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Core Capabilities

Six Capabilities. One Cleaning Validation System.

Every stage of your cleaning validation program — from risk assessment through ongoing monitoring — is managed, executed, and archived within a single audit-ready system. No spreadsheets, no paper binders, no compliance gaps.

MACO Calculations

Automated Maximum Allowable Carry Over calculations based on HBEL (PDE/ADE), batch sizes, and shared surface areas. Limits are derived with appropriate safety factors, traceable to the scientific rationale, and ready for regulatory review.

Risk Assessment

Risk-based worst-case product and equipment selection using FMEA and scientific rationale. Rank products by toxicity, solubility, and cleanability to determine the most stringent cleaning scenario for validation.

Sampling Plans

Swab and rinse sampling location management with equipment mapping and scientific justification. Define worst-case locations on shared equipment, track sampling frequency, and ensure every sample links back to validated limits.

Protocol Execution

Digital execution of cleaning validation protocols with electronic signatures and audit trails. Operators follow guided workflows, QA reviews with eSignatures, and every action is recorded with full traceability for inspection readiness.

Lifecycle Monitoring

Ongoing cleaning process verification with trending, change control, and requalification triggers. Monitor residue results over time, detect drift, and automatically flag when revalidation is required due to process or product changes.

Residue Limits

HBEL-based acceptance criteria with automated limit derivation for MACO, swab, and rinse samples. Acceptance limits are calculated consistently, linked to analytical methods, and maintained as part of the validated cleaning state.

Platform Architecture

Cleaning Validation at the Center of Your Quality Ecosystem

Voyantix Cleaning Validation shares a unified data model with every Voyantix application. Analytical results flow from LIMS. Deviations trigger CAPAs in QMS. Sampling procedures link to SOPs in DMS. No integrations to build. No data silos.

Cleaning Validation
QMS
LMS
DMS
LIMS
E-Logs
QMS → Deviation & CAPA Trigger
DMS → SOP & Method Linkage
LIMS → Analytical Results
LMS → Sampler Training
E-Logs → Cleaning Log Execution
Proven Impact

Cleaning Validation Performance, Measured.

Organizations using Voyantix Cleaning Validation achieve measurable improvements in validation cycle time, cross-contamination control, and regulatory compliance outcomes.

100%
Paperless
Complete digital cleaning validation lifecycle
Zero
Cross-Contamination
Risk-based worst-case control
70%
Faster
Protocol preparation and execution time reduced
21 CFR 11
Validated
Fully validated electronic records and signatures
21 CFR Part 11 Validated

Ready to Digitize Your Cleaning Validation Program?

See how Voyantix Cleaning Validation automates MACO calculations, HBEL-based residue limits, risk-based sampling plans, and 21 CFR Part 11 compliant execution. Book a personalized demo tailored to your manufacturing operations.

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