![Batch Manufacturing Screenshot.png](https://en-ie.ecolab.com/-/media/Widen/Life-Sciences/Personal-Care-Manufacturing/Batch-Manufacturing-Screenshot_Pad_550x310.jpg?h=310&iar=0&w=550&hash=449BD6AEE232647174A078308AC0ABD8)
CLEEN Batch Execution Module
The CLEEN Batch Execution Module helps drive efficiency and compliance in Pharmaceutical, Personal Care, and Cosmetic industries with paperless production, helping reduce manual errors. With features designed for quality assurance and operational efficiency, CLEEN helps your operations stay responsive, compliant, and efficient which can help you quickly adapt your manufacturing to meet changing production demands and maintain uninterrupted workflows.
![Modernizing Cleaning Validation e-Book](https://en-ie.ecolab.com/-/media/Ecolab/Ecolab-Home/Images/Markets/Life-Sciences/Form-Images/Modernizing-cleaning-validation_e-Book_550x310-png.png?h=310&iar=0&w=550&hash=965666135BA8C149C2409375D2243EB0)
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.
Digitize Essential Workflows To Drive Performance and Compliance
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![Two persons with a shield with a checkmark icon](https://en-ie.ecolab.com/-/media/Ecolab/Ecolab-Home/Images/Markets/Life-Sciences/CLEEN/Icon_OptimizeOperations-png.png?h=310&iar=0&w=550&hash=DCA31416B8A2B69D3C8B911EAF3858D4)
Enhanced Efficiency
Automate scheduling and documentation processes to maximise productivity and reduce operational delays.
![Checkmark in a seal icon](https://en-ie.ecolab.com/-/media/Ecolab/Ecolab-Home/Images/Markets/Life-Sciences/CLEEN/Icon_EnsureValidations78-png.png?h=310&iar=0&w=550&hash=417A9DB9410A9CF48D066B9C736E8A04)
Streamlined Compliance
Help ensure adherence to regulations with automated documentation and real-time monitoring, simplifying audits and investigations.
![Gear icon with arrows circling around it](https://en-ie.ecolab.com/-/media/Ecolab/Ecolab-Home/Images/Markets/Life-Sciences/CLEEN/Icon_SimplifyAudit-png.png?h=310&iar=0&w=550&hash=3DF2C2170BFA285C15193D4E67590941)
Continuous Monitoring and Data Accuracy
Reduce manual errors through automated paperless data capture and logging, facilitating efficient decision-making.
Improve Data, Reduce Risk, Monitor Parameters with CLEEN
Key Features
Dynamic Production Planning
- Real-time Production Schedule Optimization: Automate scheduling adjustments to respond swiftly to demand changes, ensuring efficient resource allocation.
Streamlined and Compliant Line Clearance
- Automated Clearances: Transition from manual checklists to an automated system that guides operators through the process
- Instant Documentation: Automatically generate clearance documentation, facilitating audits and compliance checks.
Digital Batch Instruction Execution
- In-Process Interlocks: Assign tasks to the right personnel at the right time and implement built-in checks to ensure critical steps are performed correctly.
- Interactive Instructions: Offer multimedia-supported guidance for complex tasks.
- Automated Data Capture: The Batch Execution module has the capability to integrate with process equipment for real-time data logging which can help minimise manual errors.
Proactive Monitoring of Batch Parameters
- Live Data Visualization: Utilize a real-time dashboard for immediate monitoring of batch parameters.
- Proactive Alerting System: Configure alerts for parameter deviations to enable corrective actions.
- Integrated Quality Checks: Merge quality control data with in-process checks.
Automated Batch Release and OEE Calculation
- Integrated Data Checks: Verify that all release criteria are met through automated data integration.
- Real-Time OEE Calculation: Capture metrics on machine availability, performance, and quality to track efficiency.
- Downtime and Stoppage Tracking: Record categorizations to pinpoint operational issues.
Intelligent Root Cause Analysis
- 1-Click Access to Relevant Data: Easily access batch records with complete traceability with comprehensive, chronological Audit Logs.
- Collaborative Investigation Workflow: Facilitate seamless collaboration across departments during root cause analysis.
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 Centres
- Data centres 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
![FDA 21 CFR Partt 11 Compliance logo](https://en-ie.ecolab.com/-/media/Ecolab/Ecolab-Home/Images/Markets/Life-Sciences/CLEEN/FDA-21-CFR-11_stacked-png.png?h=180&iar=0&w=508&hash=8D3E3CD0F858CBE6C78C2BCB5E451ECA)
Backup and Disaster Recovery
- Daily backups available
- Disaster recovery Regions
- Complete and incremental backups