CLEEN is the only Cleaning Validation compliance software solution that automates the entire cleaning validation lifecycle: Design, Qualification & Monitoring - 100% Paperless.
Nearly 24% of all the issues in the FDA warning letters are related to the inefficiencies in the processes to manage cross-contamination. CLEEN is designed scientifically to eliminate the risk of non-compliance by at least 78%.
CLEEN comes with integrated tools for Risk Identification, Risk Analysis & Risk Evaluation. Risk analysis is categorised based on the product and equipment data such as Toxicity, Potency, Solubility & Cleanability. All the risk evaluation settings are completely configurable.
Based on the level of hazard identified, the software identifies risk control measures and assists in performing the necessary workflows to manage the risk.
All the changes are tracked, evaluated and documented.
Cleaning Validation lifecycle is fully automated and 100% paperless.
Health based Residue Limits are evaluated within seconds.
All transactions are tracked, logged & reviewed into a secure, traceable audit trail.
Integrated Risk Assessment is done for all the products/facilities.
CLEEN is 21 CFR Part 11 ready and meets Data Integrity guidelines.