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CLEEN Validation Module
An intelligent solution built to streamline, automate and standardize cleaning validation for life sciences organizations.
Modernizing Cleaning Validation
As the time, costs and complexity of cleaning validation challenges grow, savvy life sciences companies are building a competitive advantage around smarter approaches to cleaning validation.
Modernize Cleaning Validation With Intelligent Automation
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Ensure Compliant Validations
Based on continuously updated regulatory guidance and Ecolab’s deep expertise, receive in-app guidance as you build cleaning validations. Automatically calculate carryover limits and worst-case product rankings, and leverage automated compliance interlocks for CHT/DHT.
Accelerate Re-Validation
Receive dynamic alerts when an operational change requires re-validation—complete with the auto-generated new documents for review.
Simplify Audit-Readiness
Automatically generate validation reports and store all necessary information in the built-in Audit Portal for immediate access that enables continuous audit-readiness with minimal administrative burden.
Key Cleaning Validation Features
- Pre-Loaded Validation Guidance
Instantly run validation calculations and auto-generate new validation protocols in seconds to dramatically accelerate cleaning validation workflows and simplify the challenge of staying up-to-date with the latest regulatory guidance. - Comprehensive Digital Audit Trail
Be prepared for an inspection any day at any time with immediate access to all the supporting materials to be requested — with complete confidence in data integrity. - Automated Alerting
Accelerate cleaning validation review, and instantly receive notification when a new document is ready for your review or when a new validation is required. - Risk-Based (and Worst-Case) Recommendations
Receive recommendations and get ahead of trending issues or emerging problems to support a modern, risk-based product safety and quality program.
Out-of-the-Box Data Connections for Rapid Integrations
ERP | QMS | LMS | DMS | SSO | EM
Security Certifications and Compliance
Compliant and Scalable Cloud Infrastructure
GxP Compliant, ISO 27001 Certified
Data Centers
- Data centers are certified by 3rd party auditors for ISO 9001:2015, ISO 27001
- GxP guidelines available and implemented
SSO and LDAP
- Single sign-on (SSO) and lightweight directory access protocol (LDAP) allow you to authenticate users in systems
- Configurable by customer IT team
Vulnerability Assessment and
Penetration Testing
- Periodic VAPT
- Performed by certified 3rd party
- Results shared with customers on-demand
End-to-End Data Encryption
for Virtual Machines
- Server side encryption with PMK
- Data sent to or from Leucine is encrypted in transit using 256 bit encryption
Domain Whitelisting
- Allow or disallow domains that can access the platform
- Configure by customer IT team
Backup and Disaster Recovery
- Daily backups available
- Disaster recovery Regions
- Complete and incremental backups