We use IOT to create digital clones of physical resources and make them accessible from anywhere, anytime.
Integrations with existing IT systems towards sharing data and removing the virtual barriers to data transmission.
An Orchestration layer of reified physical resources and integrated IT systems ensures compliance and efficiencies.
CLEEN re-imagines Cleaning Validation. It is designed to enable Drug Manufacturers ensure validated Cleaning Procedures through its intelligent algorithms to assist decision making at every step and thereby reducing human dependency.
CLEEN is the only Cleaning Validation compliance software solution that automates the entire cleaning validation lifecycle: Design, Qualification & Monitoring - 100% Paperless.
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.
Pharma companies have a great opportunity to recover lost productivity, as much as $50 Billion every eear.
We analysed 155 FDA warning letters from 2015-2018 and found some surprising trends.
See inside: A brief history of the 21 CFR Part 11 guideline on using Electronic Records & Electronic Signatures.
Production of Multi-API products is a common scenario in every drug manufacturing site. However, we have observed variances in the approach to establish residue limits of these. Primary points of debate are around Shared Surface Area calculations and batch size. In this Micro Article, we will put these confusions to rest.
All the changes are tracked, evaluated and documented.
Health based Residue Limits are evaluated within seconds.
CLEEN automatically finds the Worst Case Molecules based on Risk Assessment.
All transactions are tracked, logged & reviewed into a secure, traceable audit trail.
CLEEN is 21 CFR Part 11 ready and meets Data Integrity guidelines.
CLEEN seamlessly integrates with your ERP, DMS and LIMS softwares
A Risk-based predictive approach to automate the entire Cleaning Validation Lifecycle. Learn how Top10 Pharma companies reduce the cleaning requirement by 50% by 3 simple ways.