Live Webinar: The Ultimate Cleaning Validation Audit Readiness Blueprint. Register Now
Live Webinar: The Ultimate Cleaning Validation Audit Readiness Blueprint. Register Now
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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.

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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.

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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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CLEEN - Cleaning Validation

Cleaning Validation Software
for Effortless FDA Compliance

Automate safe carryover limit analysis and real-time residue trend monitoring with CLEEN. Validate worst-case product cleaning protocols, generate audit-ready documentation, and ensure seamless FDA compliance effortlessly.

Request a Demo
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.

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Compliant Change Impact Assessment

Automate risk evaluation for process and product changes, ensuring compliance while minimizing disruptions to production timelines.

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Adhere to FDA Regulations

Automated HBEL-based residue calculations eliminate manual errors, ensuring adherence to FDA and global regulatory standards.

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Accelerate New Drug Introduction

Instant risk-based assessments enable rapid carryover limit calculations, expediting go/no-go decisions for manufacturing expansions.

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Real-Time Validation Tracking

Track validation status across equipment and processes from a central dashboard—enabling faster audits and proactive decisions.

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
Evaluates all residue types and APIs, then uses a rule-based calculation engine to define safe carryover limits that reduce human error.
CLEEN software interface calculating HBEL-based residue limits to prevent cross-contamination
CLEEN software assessing new drug introduction risk with automated carryover limit calculations
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.
Auto-generate standardized, compliant protocols
Combines limit data, worst-case scenarios, and essential cleaning parameters to auto-generate validation protocols tailored to specific products and equipment.
CLEEN interface auto-generating standardized cleaning validation protocols
CLEEN software integrating LIMS data to generate cleaning validation reports
Integrate Residue Data from LIMS to generate Reports
Ensure seamless data integration with LIMS for comprehensive validation reports.
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.
CLEEN dashboard tracking real-time equipment cleaning validation status
CLEEN audit portal showing historical validation data for FDA inspection readiness
Leverage Audit Portal during Inspections
Retrieve historical validation data instantly for audits. Generate configurable reports that meet specific regulatory requirements.
Download Guide to Cleaning Validation
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 Cleaning Validation Software help achieve FDA compliance?

CLEEN automates residue limit calculations, generates audit-ready documentation, and ensures alignment with FDA and global cleaning validation guidelines.

2. Can CLEEN integrate with LIMS and QMS systems for cleaning validation?

Yes, CLEEN integrates seamlessly with LIMS, QMS, and ERP systems to eliminate manual data silos and provide a connected validation ecosystem.

3. Does CLEEN support HBEL-based cleaning validation protocols?

Absolutely. CLEEN automatically calculates HBEL-based residue limits, minimizing human error and meeting regulatory expectations.

4. How does CLEEN speed up new drug introduction in manufacturing?

CLEEN instantly calculates carryover limits, risk scores, and worst-case scenarios, reducing manual validation effort and accelerating batch approvals.

5. Is CLEEN compliant with 21 CFR Part 11 for data integrity?

Yes, CLEEN fully complies with 21 CFR Part 11, providing secure audit trails, electronic signatures, and role-based access control.

Experience CLEEN — The Smarter Way to Achieve FDA Cleaning Validation Compliance
Simplify cleaning validation, reduce compliance risk, and accelerate audit readiness with CLEEN Software for Cleaning Validation.
Audit Readiness Resources

Access Expert-Curated Cleaning Validation Resources to Streamline Compliance and Ace Your Next Audit

MES software ESSENTIALS

Have a look at our other suite of MES Essentials to 10x your process

Investigator Writer

Streamline Investigations

FDA Tracker

Track FDA Actions

Market Compliant Manager

Market Compliant