Cleaning Validation Software for Effortless FDA Compliance
Cleen is an advanced cleaning validation software for pharma manufacturers that streamlines FDA compliance. It automates MACO calculations, integrates cleaning agents into risk assessments, and ensures consistent equipment cleanliness with audit-ready documentation.
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Seamless Cleaning Validation Aligned with FDA StandardsStay audit-ready with automated residue monitoring, compliant change assessments, and seamless FDA alignment.
Cleen automates validation tasks to ensure compliance with FDA, ICH Q7, and APIC—removing manual errors.
Use built-in tools to assess cleaning validation risk by toxicity, solubility, and cleaning difficulty—ensuring accurate, consistent evaluations.
Track validation status across equipment and processes from a central dashboard—enabling faster audits and proactive decisions.
Cleen integrates with QMS, LIMS, and ERP systems—creating a connected validation ecosystem and eliminating data silos.
Frequently Asked Questions
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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.
View and learn more about Cleaning Validation with our comprehensive list of resources
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