REIFICATION

We use IOT to create digital clones of physical resources and make them accessible from anywhere, anytime.

INTEGRATION

Integrations with existing IT systems towards sharing data and removing the virtual barriers to data transmission.

ORCHESTRATION

An Orchestration layer of reified physical resources and integrated IT systems ensures compliance and efficiencies.

CLEEN: Proactive Cleaning Validation Software.

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.

A Risk Based Approach to Automated Cleaning Validation.

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.

Featured Insights

Our latest thinking on the issues that matter most for pharma executives

Cleaning Validation Software

Digitising Cleaning Procedures: A $50 Billion Opportunity

Pharma companies have a great opportunity to recover lost productivity, as much as $50 Billion every eear.

FDA Non Compliance

Top 5 Trends in GMP Non Compliance

We analysed 155 FDA warning letters from 2015-2018 and found some surprising trends.

FDA Title 21 CFR Part 11

A Brief History of the guideline
21 CFR Part 11

See inside: A brief history of the 21 CFR Part 11 guideline on using Electronic Records & Electronic Signatures.

MICRO ARTICLE OF THE MONTH (JULY 2019)

How to Calculate Residue Limits for Multi-API Products

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.

Suite of Features

Change Evaluation

All the changes are tracked, evaluated and documented.

Health Based Limits

Health based Residue Limits are evaluated within seconds.

Risk Based Worst Case

CLEEN automatically finds the Worst Case Molecules based on Risk Assessment.

Audit Log

All transactions are tracked, logged & reviewed into a secure, traceable audit trail.

21 CFR Part 11

CLEEN is 21 CFR Part 11 ready and meets Data Integrity guidelines.

Integration

CLEEN seamlessly integrates with your ERP, DMS and LIMS softwares

Download FREE White Paper

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.

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