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CLEEN Digital Logbook Module
A purpose-built digital logbook for life sciences manufacturing operations that goes beyond the standard logbook to rapidly convert any process into a self-enforcing digital workflow with a comprehensive audit trail for confident data integrity.
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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Enforce SOP Adherence By Design
Digitize the processes throughout your facility to enable real-time performance tracking, customize interlocks, and create self-enforcing workflows to ensure compliance.
Proactively Manage Compliance
Digitizing processes and the related documentation enables several key benefits for your team — from real-time insight and compliance tracking for steps taken to complete a process, to alerts that will flag new reviews by exception and emerging issues.
Optimize Operations
Use performance benchmarking and embedded analytics to uncover your opportunities to improve operations — reducing downtime, improving equipment availability, and increasing the efficient utilization of resources.
Improve Data, Reduce Risk, Monitor Parameters with CLEEN
Key Logbook Features
- No-Code Process Builder
Update and manage SOPs without intervention or assistance from a developer or CLEEN technical expert.
- Self-Enforcing Digital Workflows
Build compliance assurance into digital processes with automated interlocks to drive SOP adherence.
- Comprehensive Digital Audit Trail
Automatically generate documentation and reports that will be requested during an inspection — with complete confidence in data integrity.
- Automated Alerting and Review by Exception
Accelerate review of reports by up to 90% and stay ahead of potential production disruptions. Review by exception and instantly surface risks for rapid remediation.
- Digitally-Powered Benchmarking
Put cleaning SOPs and operational performance in context through comparisons within your organization, over time, and against industry standards. Identify opportunities and emerging problems to protect quality and drive performance.
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