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Powered Pharma Operations

Transform Your Pharma Operations with AI-Powered Intelligence. Experience how Leucine's integrated platform brings together manufacturing, quality, and laboratory operations in one digital ecosystem. Schedule a personalized demo to see how our AI solutions can optimize your processes, ensure compliance, and drive operational excellence.

See How AI Transforms Your Shop Floor Operations.
Experience firsthand how Leucine's 10x MES digitalizes batch records, streamlines production, and provides real-time monitoring of your manufacturing operations. Schedule a personalized demo to discover how our AI-powered platform can enhance your productivity while maintaining compliance.

Experience AI-Driven Quality Management in Action.
See how Leucine's 10x QMS automates compliance workflows, streamlines change control, and ensures regulatory adherence. Schedule a demo to learn how our AI-powered platform can help you manage quality processes more efficiently while reducing compliance risks.

Discover Smart Laboratory Operations Management.
Watch how Leucine's 10x LES orchestrates your lab operations, automates documentation, and ensures data integrity. Schedule a demo to see how our AI-powered platform can accelerate your testing processes while maintaining audit-readiness.

Optimize your manufacturing processes with paperless operations
Strengthen quality management and regulatory compliance
Accelerate laboratory operations and testing workflows

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Schedule a 30-Minute Product Demo with Expert Q&A

CLEEN - Cleaning Validation

Cleaning Validation Software, for Effortless FDA Compliance

Cleen is an advanced cleaning validation software for Pharma manufacturers, designed to streamline FDA compliance. It integrates cleaning agents into risk assessments, automates MACO calculations, and enhances evaluation of factors impacting product quality. Cleen optimizes the cleaning process and ensures consistent cleanliness across equipment and batches, while keeping digital documentation audit-ready.

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Cleen software dashboard showing automated cleaning validation workflow in pharma setting

Effortless Cleaning Validation That Meets FDA Inspection Standards.
Stay audit-ready with automated residue monitoring,
compliant change assessments, and seamless FDA alignment.

Icon representing FDA and ICH compliance document
Regulatory Compliance Made Simple

Cleen automates documentation, calculations, and reporting to ensure full adherence to FDA cleaning validation guidelines, ICH Q7, and APIC standards — without the manual human errors.

Icon representing FDA and ICH compliance document
Automated Risk-Based Assessments

Leverage built-in tools to assess cleaning validation risk based on product toxicity, solubility, and cleaning difficulty — ensuring consistent and accurate evaluations.

Icon representing FDA and ICH compliance document
Real-Time Validation Tracking

Track cleaning validation status across all equipment and processes from a centralized dashboard — enabling proactive decision-making and faster audits

Icon representing FDA and ICH compliance document
Seamless Digital Integration

Cleen integrates with your existing QMS, LIMS, and ERP systems for a fully connected cleaning validation ecosystem — eliminating data silos and duplications.

Efficient Protocol Execution

Streamline cleaning validation protocols, reduce batch downtime, and optimize productivity by minimizing interruptions during protocol execution.

Ensure accurate HBEL-based residue limit calculations.
Automatically calculate safe residue limits using HBEL data to ensure worst-case MACO compliance. Cleen supports risk-based cleaning validation in pharma aligned with FDA and ICH expectation.
Cleen software interface displaying automated MACO calculation for cleaning validation
Cleen software interface displaying New drug introduction analysis
New Drug Introduction Risk Assessment
Assess the impact of introducing new drugs into existing production lines. Calculate carryover limits, risk scores, and worst-case scenarios instantly. Cleen's risk matrix ensures cleaning validation regulatory compliance and operational efficiency.
Auto-generate standardized, compliant cleaning validation protocols
Cleen automates documentation, calculations, and reporting, ensuring compliance with regulatory standards to maintain product quality and adhere to stringent regulations. Adhering to global regulatory standards is crucial for maintaining compliance with key organizations like the FDA, PDA, and EMA, contributing to ongoing compliance and improvement in business practices. Cleen ensures full adherence to FDA cleaning validation guidelines, ICH Q7, and APIC standards — without the manual errors.
Cleen software interface displaying Auto-generated cleaning validation protocol
Cleen software interface displaying API residue inspection stage with sample data for cleaning validation
Integrate Residue Data from LIMS to generate Reports.
Import residue data directly from LIMS to auto-populate reports — saving time and ensuring compliance & traceable, validated documentation.
Track real-time Validation Status for all equipment.
Pulls residue results and key parameters from LIMS to create a coherent final validation summary, ensuring alignment with FDA expectations and helping pharma QA teams stay inspection-ready.
Cleen software interface displaying Live dashboard with cleaning validation timelines and alerts
Cleen software interface displaying Audit portal interface with downloadable compliance records
Leverage Audit Portal during Inspections.
Leverage a dedicated audit portal to access every document, record, and protocol instantly during regulatory inspections. Generate configurable reports that meet specific regulatory requirements, simplifying inspection day prep for FDA cleaning validation reviews.
Download a comprehensive Solution white Paper and ensure you’re fully prepared for FDA inspections.

Frequently Asked Questions

Can I trial Webflow before paying?

Sure! You can test out Webflow on our free plan where you can experiment with 2 projects. Your unhosted projects will have a two-page limit, but you can purchase a site plan on a per-project basis to unlock up to 100 static pages and additional CMS pages.

What is a project?

A project is a website that you build in Webflow. You can publish projects to a webflow.io staging subdomain for free, export the code on a paid plan, or add a site plan to connect your custom domain and unlock hosting features.

What can I white label?

Pro accounts can add their own logo to Client Billing forms and the Editor. Pro accounts can also remove references to Webflow in the source code and form submission emails, and hide the Webflow badge from their staging sites.

Frequently Asked Questions

1. How does Cleen help meet FDA cleaning validation guidelines?

Cleen automates MACO calculations, residue limit assessments, and standardized reporting to align with FDA, EMA, and ICH cleaning validation standards. Its audit-ready documentation ensures you’re always inspection-prepared.

2. Can Cleen integrate with our existing QMS, LIMS, or ERP systems?

Yes. Cleen is built to integrate seamlessly with your current Quality Management Systems, Laboratory Information Management Systems, and ERPs — eliminating data silos and ensuring a connected validation ecosystem.

3. What makes Cleen different from other cleaning validation software vendors?

Cleen offers end-to-end automation, real-time tracking, and configurable workflows designed specifically for pharmaceutical industry. It’s built with audit-readiness and regulatory alignment at its core — no generic solutions here.

4. Is Cleen compliant with 21 CFR Part 11 and other data integrity regulations?

Absolutely. Cleen is fully compliant with 21 CFR Part 11, offering secure audit trails, electronic signatures, role-based access control, and data encryption to meet all global data integrity requirements.

5. How does Cleen support risk-based cleaning validation approaches?

Cleen allows you to assess risks based on product toxicity, solubility, batch size, and more, helping to prevent cross contamination. It calculates worst-case scenarios automatically and supports ICH and APIC cleaning validation frameworks

6. What kind of ROI can we expect by switching to Cleen?

Customers typically reduce manual validation effort by up to 60%, speed up audit prep by 80%, and reduce compliance risks significantly. Cleen also saves costs by streamlining documentation and reducing rework.

7. How long does it take to implement Cleen in a pharmaceutical facility?

Implementation time depends on your facility size and system integrations. Most clients are fully operational within 4–8 weeks, with support from our dedicated onboarding and validation teams.

8. Is Cleen a cloud-based solution?

Yes. Cleen is a secure, cloud-based platform accessible from anywhere, enabling real-time collaboration across global teams while maintaining regulatory compliance.

9. Do you offer product training or support for Cleen users?

We do. Cleen includes hands-on onboarding, live training sessions, detailed documentation, and 24/7 customer support to ensure your team gets up to speed quickly and confidently.

10. Can I see a demo of Cleen before making a purchase decision?

Absolutely. You can request a personalized demo tailored to your facility’s needs. We’ll show how Cleen fits into your existing workflows and regulatory strategy.

Experience Cleen — The Smarter Way to Achieve FDA Cleaning Validation Compliance
Join successful pharma facilities already using Cleen to digitize, streamline, and automate their cleaning validation process. See how Cleen can reduce your compliance burden, increase efficiency, and help you stay inspection-ready.
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