Serialization: Compliance by Design at Line Speed
End-to-end serialization systems that generate, print, verify, and manage unique identifiers for pharmaceutical, food, and consumer goods—ensuring global regulatory compliance without slowing production.
Generate, print, and verify in one seamless process
Real-World Use Cases
How manufacturers achieve serialization compliance with Unicus Vision systems
DSCSA Unit-Level Serialization
A pharma manufacturer needed to serialize millions of saleable units monthly while maintaining line speeds of 500 units/minute and meeting DSCSA verification requirements.
- GS1-compliant SGTIN generation with cryptographic signing
- High-resolution inkjet/laser printing on diverse substrates
- Real-time 2D code verification (ISO 15415 Grade A)
- Automatic database sync with repository systems
Batch Traceability for Recall Management
A food producer required unique batch serialization on flexible packaging to enable precise, rapid recalls while meeting FDA FSMA requirements.
- Dynamic code generation linked to batch/lot data
- Flexible material printing (film, foil, paper)
- OCR verification of human-readable batch codes
- Integration with quality management systems
Luxury Brand Protection via Serialization
A premium cosmetics brand needed secure serialization to combat counterfeiting while maintaining elegant packaging aesthetics.
- Discreet, high-density DataMatrix codes on luxury packaging
- Consumer-facing authentication via mobile app
- Blockchain-integrated serial number registry
- Real-time alerts for suspicious verification attempts
Technical Specifications
Engineered for regulatory compliance and production efficiency
ID Generation
GS1-compliant SGTIN/SSCC generation; cryptographic signing; sequential/random algorithms; multi-format output (DataMatrix, QR, RFID)
Printing Solutions
High-resolution inkjet (CIJ, TIJ), laser, thermal transfer; adaptive print head control; substrate-agnostic ink/toner selection
Verification System
Real-time 2D code grading (ISO 15415/15416); OCR/OCV validation; automatic reject of non-compliant units; audit trail with image capture
Data Management
SQL/NoSQL database support; REST/GraphQL APIs; EPCIS event generation; electronic signatures; FDA 21 CFR Part 11 compliance
Regulatory Compliance Features
- • Electronic signatures (21 CFR Part 11)
- • Audit trail with timestamped images
- • Role-based access control
- • Data encryption at rest & in transit
- • Automated compliance reports (PDF/CSV)
- • Real-time SPC dashboards
- • Exception management workflows
- • Regulatory submission templates
- • Pre-validated IQ/OQ/PQ documentation
- • Change control management
- • Periodic review workflows
- • Supplier qualification support
Why Manufacturers Choose Unicus Vision Serialization
Zero Compliance Gaps
Pre-built regulatory templates for 30+ countries with automatic updates—eliminate custom development and ensure audit readiness.
Line-Speed Performance
Serialize up to 1,000 units/minute with sub-50ms print-verify cycle time—no production bottlenecks, no compromises.
Seamless SKU Changeover
Switch product codes, packaging formats, and regulatory templates in <60 seconds with recipe management—no downtime.
Real-Time Quality Analytics
Monitor serialization yield, defect trends, and compliance metrics with live dashboards to drive continuous improvement.
End-to-End System Integration
Pre-built connectors for SAP, Oracle, and major MES/ERP systems—deploy in weeks with minimal IT overhead.
Fast, Measurable ROI
Typical payback in 12-18 months through reduced compliance penalties, lower manual labor, and avoided recall costs.
Seamless Enterprise Integration
Connect with your existing business systems and regulatory repositories
S/4HANA, EWM, GTS
Cloud SCM, ERP
EMVS, NMVS, VRS
GEPIR, GDSN, Digital Link
Achieve Serialization Compliance Without Slowing Production
Get a free compliance assessment and line-speed analysis. See how Unicus Vision can deliver regulatory-ready serialization at your production pace.