LeucineTech is the only solution that completely automates the entire cleaning process in shared equipment facilities: Design, Qualification & Monitoring.
Nearly 15% of all the issues in the FDA warning letters are related to the inefficiencies in the processes to manage cross-contamination. LeucineTech is designed scientifically to eliminate the risk of non-compliance by at least 78%.
LeucineTech 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 that can have a likely impact on the cleaned state of the plant, are evaluated and documented.
The system executes the entire Cleaning Process Lifecycle in a paperless manner and all the supporting documentation can be generated, communicated & approved within the system.
Evaluation of Cleaning Acceptance Limits based on Toxicity & Dosage data. Evaluate individual or group wise limits for API, detergent & Microbial Contamination within seconds.
All the events and transactions are logged into a secure, timestamped audit trail. The audit trail logs can be filtered based on the user activity or the entity under investigation.
A thorough Risk Assessment is done for all the products/facilities and control measures are prepared in proportion to the risk evaluated.
LeucineTech meets all the requirements specified under the 21 CFR Part 11 and the Data Integrity Guidelines.