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.
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Effortless Cleaning Validation
that Meets FDA Inspection StandardsStay audit-ready with automated residue monitoring, compliant change assessments, and seamless FDA alignment.
that Meets FDA Inspection Standards
Automate risk evaluation for process and product changes, ensuring compliance while minimizing disruptions to production timelines.
Automated HBEL-based residue calculations eliminate manual errors, ensuring adherence to FDA and global regulatory standards.
Instant risk-based assessments enable rapid carryover limit calculations, expediting go/no-go decisions for manufacturing expansions.
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.
Access Expert-Curated Cleaning Validation Resources to Streamline Compliance and Ace Your Next Audit
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