SmartReg
Voice-Driven Electronic Batch File
SmartReg is a digital GMP control platform designed to free operators' hands and ensure reliable and efficient data recording. The operator interacts with the system via voice, in real time, throughout the process.
✓ Eliminates manual data entry in the cleanroom
✓ Full traceability and GAMP 5 / Eudralex / FDA 21 CFR Part 11 compliance
✓ Connection with equipment and automatic generation of reports
eBR/MES for GMP production
A robust solution that optimizes your operations and significantly reduces production costs
Key Features
✓ Real-time monitoring of production operations and critical parameters.
✓ Electronic batch management and complete traceability.
✓ Integration with existing systems for automatic data collection.
benefits
✓ Significant reduction in human errors thanks to the digitalization of processes
✓ Reduction of costs related to non-conformities and waste of raw materials.
✓ Accelerated production and better visibility for operational managers.
✓ Compliance with GMP standards ensured and audits facilitated.
eStudy Report for CRO
Improve the efficiency of clinical study report generation and delivery
Key Features
✓ Automated generation of final reports in customer format.
✓ Immediate creation of SEND (Standard for Exchange of Nonclinical Data) files for FDA.
✓ Centralized management of study data and associated metadata.
benefits
✓ Drastic reduction in delivery times to the customer.
✓ Limiting transcription errors and inconsistencies between data and reports.
✓ Facilitation of regulatory submission thanks to standardized formats.
✓ Productivity gain
eTR for Quality Control
Optimize quality control while reducing costs and improving compliance.
Key Features
✓ Electronic management of tests and results.
✓ Automatic alerts in case of deviation or non-compliance.
✓ Real-time reporting and complete traceability of samples and analyses.
benefits
✓ Reduction of operational costs related to manual quality control.
✓ Simplified regulatory compliance and time savings with automatic generation of contextualized reports
✓ Less risk of errors and better visibility for quality managers.
Digital Companion for Equipment Suppliers
SmartReg enhances your solution by adding a digital layer to the equipment and thus offering more value to your customers.
Key Features
✓ Intuitive digital interface for equipment optimization.
✓ Remote support and predictive maintenance via the platform.
benefits
✓ Customer loyalty through tangible and measurable added value.
✓ Optimizing equipment performance while reducing customers' operational costs.
✓ Increased sales and business opportunities for equipment suppliers.
✓ Solution compliant with regulatory and GMP standards.
Standard Features
Free your operators' hands, secure your processes with an intelligent voice interface,
SmartReg eBR transforms the way your teams interact with manufacturing processes. Each order is recorded by voice, validated, logged, and associated with the relevant step in the Master Batch Record.
Intuitive voice control
The operator communicates with SmartReg: voice instructions received, responses recorded in real time.
Creation & management of Master Batch Records
Automatic calculations and deviation detection
Key Benefits
A powerful digital tool, serving compliance and productivity
SmartReg transforms your production or QC operations by delivering a hands-free, reliable, and compliant experience. The result: fewer errors, greater agility, and true regulatory peace of mind.
✔ Natural dialogue between the operator and the system
✔ Full traceability with timestamp and voice recording
✔ Significant reduction in manual tasks and risk of error
✔ Saves time for operators and quality teams
✔ Immediate compliance with FDA, Eudralex, GAMP 5 standards
Tailor-made solution
SmartREG integrates naturally into your technological ecosystem
SmartReg eBR can be integrated into your existing infrastructure or deployed in our global solutions
SmartEMS
✔️ Combine voice batch file management with automated monitoring of environmental parameters
✔️ Centralize all critical data from your aseptic operations
✔️ Speed up your audits with comprehensive cross-reporting
SmartUnit
✔️ Integrated into our smart mobile or fixed production units
✔️ Continuous monitoring of critical parameters on-site or remotely
✔️ Ready to use, with secure infrastructure and easy validation
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