
CLEEN Batch Execution Module
Transform your manufacturing operations by moving to a paperless batch record system that enhances process efficiencies. Streamline production workflows, identify and eliminate bottlenecks and improve accuracy for better batch acceptance rates.

Embracing Pharma 4.0
Why operational digitization must be the top priority for pharma and biopharma manufacturers.
This free eBook outlines the fundamental shifts associated with embracing Pharma 4.0—and how they can empower organizations to improve efficiency, agility, and maintain product quality while driving business profitability.
Digitize Essential Workflows
To Drive Performance and Compliance
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Seamless Paperless Batch Execution
Enhance efficiency, accuracy, and collaboration on the production floor, allowing for agile responses to changing production demands and ensuring uninterrupted workflows.

Automate Data Capture for Enhanced Accuracy
Utilize automated data capture and embedded media instructions to help reduce human error. Improve batch acceptance rates through in-process checks and interlocks, ensuring trained operators complete tasks accurately while verifying that equipment is calibrated and ready for use.

Simplify Audit-Readiness
Help support regulatory compliance with detailed audit logs that provide complete traceability of batch processes. Automate in-process check scheduling, integrate quality control data, and utilize exception highlighting for collaborative reviews.
Key Benefits
Compliance and Quality Assurance
- Automated Data Capture: Replace manual data entry with automated data capture directly from production equipment, reducing human error and enhancing production timelines. Automatically verify that all release criteria have been met.
- Comprehensive Audit Logs: Support complete traceability with detailed chronological audit logs, providing full transparency for compliance and quality assurance throughout your manufacturing processes.
- Streamlined Check Scheduling: Set up and assign in-process checks with automated reminders and assignments for consistent checks. Receive instant notifications for any overdue or missed checks.

Process Efficiencies
- Optimize Production Processes: Increase overall efficiency and gain real-time visibility into your operations to identify bottlenecks to improve Overall Equipment Effectiveness (OEE), enabling flexible shifts to optimize manufacturing floor management.
- Improve Accuracy: Enhance batch acceptance rates with embedded process checks and interlocks, utilizing imbedded videos and images and linked SOPs to guide operators, ensuring tasks are completed accurately.
- Monitor Equipment and Area Readiness: Start batches without delays with automated pre-batch readiness checks, ensuring equipment status, material availability, and operator readiness before execution begins.

Real-Time Monitoring and Collaboration
- Exception Highlighting: Focus on exceptions highlighted in batch summary reports streamlining review processes and helping improve decision-making.
- Collaborative Review: Share batch summary reports electronically with team members for collaborative reviews and timely responses to potential issues.
- Downtime and Stoppage Tracking: Record and categorize equipment downtime and stoppages, pinpointing issues that affect efficiency.

Improve Data, Reduce Risk, Monitor Parameters with CLEEN
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