Serialization & Track & Trace
Smart Pharmaceutical Serialization & Compliance Solutions
What Problems Do Serialization Systems Solve?
Serialization assigns a unique digital identity to every production unit via Barcode, DataMatrix, or QR Code carrying the batch number, expiry date, and manufacturer data, enabling precise tracking from production to the end consumer.
The Aggregation phase links each unit to its carton and pallet from Level 1 to Level 4, enabling immediate and accurate Recall when issues arise in a specific batch.
In pharmaceutical and food industries, serialization is a mandatory requirement under SFDA and GS1 standards to ensure product safety, prevent counterfeiting, and achieve full regulatory compliance.
Are Pharmaceutical Serialization Systems Mandatory or Necessary
Global
Compliance
Full compliance with SFDA, FDA, EU-FMD, and GS1 standards
Anti-Counterfeiting Protection
A unique digital identity for every unit protecting your product and market trust
Full Supply Chain Visibility
Complete tracking from production line to final market with zero gaps
Quality & Safety Assurance
Higher accuracy, fewer errors quality measured and proven at every stage
Our Three Core Solutions
Track & Trace System
A digital system that assigns a unique serial identity to every unit via Serial Numbers, DataMatrix, and GS1 Codes ensuring full compliance, anti-counterfeiting protection, and real-time supply chain visibility
Aggregation System
A smart hierarchical system linking each unit to its carton and pallet through automated Parent-Child operations improving logistics tracking, reducing errors, and supporting regulatory compliance
Level 4 Serialization System
A centralized platform managing all Serialization data with full integration across production lines, ERP, MES, and SFDA systems delivering real-time reporting and reduced operational complexity
Your Journey with Automera in 5 Steps
Current State Assessment
Analyzing production lines, existing systems, and compliance requirements
Solution Design
Selecting components and tracking architecture tailored to your factory environment
Implementation & Integration
Connecting the solution to all operational and regulatory systems
Testing & Qualification
Verifying full operational and regulatory readiness
Training & Support
Qualifying your teams and providing continuous post-launch support
Industries We Serve
Pharmaceutical
Manufacturing
Advanced serialization solutions supporting SFDA and GS1 compliance.
Food
Manufacturing
Improve batch traceability and supply chain visibility.
Medical
Devices
Enhance product tracking and regulatory compliance.
Cosmetics
Industry
Improve anti-counterfeiting and logistics traceability.
What Makes Automera Your Ideal Partner
Specialized Practical Expertise
Extensive experience in Serialization, Track & Trace, RSD, and Aggregation projects in compliance with SFDA standards
Full Integration with Production Lines
Our solutions operate seamlessly with existing packaging lines without disrupting production
Deep Understanding of the Pharmaceutical Sector
We understand the operational and compliance requirements of pharmaceutical and food factories from the inside
Continuous Post-Launch Support
Ongoing technical support, maintenance, and system updates to ensure the highest level of performance
Frequently Asked Questions
- What is Serialization?Serialization assigns a unique serial number to every product unit for full traceability.
- Is the system SFDA compliant?Yes. Our solutions are designed to support SFDA regulatory requirements.
- What is the difference between Serialization & Aggregation?Serialization identifies individual units, while Aggregation links units, cartons, and pallets together hierarchically.
- Can the system integrate with ERP & MES?Yes. The system integrates with most industrial and enterprise platforms.
Is your factory ready for full SFDA Serialization compliance?
