Hicof's DPP Track and Trace Solutions

In today’s evolving regulatory landscape, businesses must ensure product authenticity, safety, and traceability across the entire supply chain to meet EU Digital Product Passport (DPP) requirements. A robust DPP Track and Trace system is essential—not only for complying with DPP regulations but also to enhance supply chain transparency, prevent counterfeiting, and build consumer trust. Hicof’s high-performance machines and software, integrated with the innovative AMACENA Software, deliver a cloud-based solution that ensures real-time product tracking, reduces human error, and supports sustainable practices by providing essential product data for the DPP.

Businesses today carry the critical responsibility of managing the entire lifecycle of products—from manufacturing and packaging to distribution and retail. As global supply chains become more complex and regulations evolve, companies must adopt advanced technologies to ensure product integrity and compliance with the Ecodesign for Sustainable Products Regulation (ESPR) and EU Digital Product Passport (DPP)

DPP Track and Trace systems offer end-to-end visibility across the supply chain, supporting the DPP’s transparency and traceability requirements. Hicof’s solution, built on high-performance machines and software, integrates seamlessly into every aspect of product tracking without the complexity of managing separate components. This streamlined system not only meets but exceeds the requirements of the DPP, ensuring comprehensive product data throughout its lifecycle

Why DPP Track and Trace

Regulatory Compliance

Global regulations demand robust traceability and compliance for various industries. A compliant DPP Track & Trace solution ensures:

  • Complete Traceability: Each product is assigned a unique identifier, ensuring precise tracking throughout its lifecycle.

  • Audit Readiness: Automated reporting and immutable audit trails support inspections and regulatory submissions.

  • Risk Mitigation: Early detection of anomalies helps prevent counterfeit or unauthorized products from entering the market.

Supply Chain Security

A comprehensive DPP Track and Trace system protects against counterfeit products and unauthorized distribution. With real-time monitoring and data integration, businesses gain:

  • Full Visibility: Transparent insights into the movement of every product from origin to end user.

  • Quick Response: Immediate alerts and rapid issue resolution reduce the impact of deviations.

  • Enhanced Control: Ongoing monitoring ensures the smooth operation of all supply chain processes.

Operational Efficiency

A DPP Track & Trace system also boosts operational performance beyond compliance and security:

  • Automation: Automated data capture reduces errors and accelerates processing.

  • Cost Savings: Streamlined operations and reduced downtime lead to significant cost efficiencies.

  • Scalability: Cloud-based technology easily adapts to increasing production volumes and evolving business needs.

AMACENA STRUCTURE

HOW TO GET SUPERIOR CODING QUALITY OUT OF TRACK AND TRACE MACHINES

The Amacoder delivers a very high coding quality as shown in the image.

The reason for this high coding quality is as follows:

  • As the boxes are touching each other, the transport speed of the boxes is much lower than with conventional conveyor machines where a space between boxes is required
  • Very controlled movement of the boxes as they are guided from all sides during the flow through the machine
  • The servo controlled pusher is extremely precise in reproducing positions, speed and acceleration
  • A long distance between the print heads and the camera ensure complete drying of the ink, a prerequisite for correct barcode grading according ISO 15415 grading by the inspection camera
amacoder prin3

Hicof’s High-Performance Machines and Software

Hicof is renowned for its advanced solutions in product serialization and traceability. Our high-performance machines and integrated software are designed to work together seamlessly, providing businesses with unmatched reliability and efficiency in implementing Digital Product Passports (DPP). This comprehensive approach ensures precise tracking and compliance across the entire product lifecycle, supporting industries in meeting regulatory requirements and enhancing supply chain transparency.

Fully Integrated Design

Unlike solutions that rely on disparate systems, Hicof’s machines and software are developed in-house. This integrated approach means:

  • Elimination of Interface Issues: There’s no need for separate setups between printers, cameras, or data interfaces. Everything is pre‑configured to work in perfect synchrony.
  • Faster Deployment: The plug‑and‑play design allows for rapid implementation, minimizing production downtime.
  • Consistent Quality: With every component engineered together, the system consistently delivers precise and accurate results.

Swiss Engineering Excellence

Every element of our system is 100% designed and built in Switzerland—a country renowned for its precision engineering and rigorous quality standards. This commitment to Swiss manufacturing ensures that:

  • Reliability is Paramount: Our machines are built to last and perform flawlessly under demanding conditions.
  • Precision is Guaranteed: High‑resolution printing and state‑of‑the‑art verification processes ensure that every label is correct and compliant.
  • Long‑Term Value: The robust construction and advanced technology provide a future‑proof solution that grows with your business.

ONE SYSTEM

At the core of our DPP Track & Trace solution is the innovative AMACENA Software — a cloud‑based platform designed to revolutionize how serialization data is managed and utilized.

Cloud Design with Seamless Interfaces

AMACENA is built from the ground up for the cloud, offering a host of benefits:

  • Scalability and Flexibility: Easily adapts to growing data volumes and changing operational needs.
  • Regulatory Integration: Interfaces natively with all industry‑relevant regulatory databases, ensuring real‑time compliance.
  • Third‑Party Compatibility: Designed to work effortlessly with common third‑party track & trace systems, providing a unified view of your supply chain.

Four-Eye Principle Change Processes

One of AMACENA’s standout features is its robust 4‑eye principle change process. This critical security measure requires any changes to serialization‑relevant data to be reviewed and approved by two authorized users. Benefits include:

  • Enhanced Data Integrity: Dual approval minimizes the risk of unauthorized modifications.
  • Improved Accountability: Every change is logged and traceable, supporting regulatory audits.
  • Stronger Compliance: Meets the highest standards for data accuracy and security.
FUNCTIONALITIES Transparent

Easy-to-Use

User experience is a top priority for AMACENA:

  • Intuitive Dashboards: Clear, user‑friendly dashboards display key performance indicators, compliance metrics, and operational data in real time.
  • Simplified Navigation: Minimal training is required as the software is designed for ease of use.
  • Real-Time Alerts: Automated notifications help users quickly address any issues that arise.

Key Benefits of Digital Product Passports (DPP) for Businesses

Implementing a comprehensive Pharma MAH Track & Trace solution like Hicof’s brings a multitude of advantages for MAHs:

Regulatory Excellence

  • Automated Reporting: Seamless integration with compliance databases for effortless reporting.

  • Immutable Audit Trails: Every update is securely logged, ensuring full traceability.

  • Global Standards: Keeps pace with evolving regulatory frameworks.

Supply Chain Transparency

  • End-to-End Traceability: Unique product identifiers track goods throughout their lifecycle.

  • Counterfeit Prevention: Authentication mechanisms safeguard against fraud.

  • Real-Time Alerts: Swift identification and resolution of supply chain issues.

Operational Efficiency

  • Optimized Workflows: Reduces downtime and simplifies data integration.

  • Cost Savings: Automation minimizes manual interventions and errors.

  • Scalability: Cloud-based systems adapt to business growth.

Stock image of Digital Product Passport DPP Track and Trace

Brand Integrity & Consumer Trust

  • Sustainability Assurance: DPPs showcase eco-friendly credentials.

  • Enhanced Transparency: Detailed product information fosters trust.

  • Data Security: Encryption and access controls protect sensitive information.

THE LABEL CREATOR

Hicof AMACENA features a build-in web based label creator to create and adjust all print layouts for AMACODERS, and all connected tertiary label printers. The label creator allows GMP compliant change control of all label parameters across the enterprise. 

Implementation Strategy

To fully leverage the benefits of Hicof’s DPP Track & Trace solution, a structured implementation process is key. Here’s a step‑by‑step guide to ensure successful deployment:

Comprehensive Needs Assessment

  • Evaluate Existing Systems: Begin by analyzing current serialization, packaging, and data management processes.
  • Identify Gaps: Pinpoint areas where current systems fall short in meeting regulatory or operational needs.
  • Define Objectives: Clearly outline your goals for enhanced traceability, compliance, and operational efficiency.

Customized System Configuration

  • Tailor the Solution: Customize AMACENA’s cloud capabilities to align with your specific production workflows.
  • Integrate with Legacy Systems: Ensure smooth data flow between Hicof’s solution and your existing ERP, MES, and WMS systems using flexible APIs.
  • Develop Label Templates: Use the built‑in label design software to create templates that meet both regulatory requirements and your brand standards.

Pilot Testing and Validation

  • Conduct Pilot Runs: Test the system in a controlled environment to validate performance and data integrity.
  • Gather Feedback: Use pilot feedback to refine configurations and resolve any issues.
  • Ensure Quality Assurance: Rigorously validate that all components meet operational and regulatory benchmarks before full‑scale deployment.

Training and Change Management

  • Comprehensive Training: Provide hands‑on training sessions for operators, IT staff, and quality assurance teams.
  • Documentation and Support: Supply user manuals, video tutorials, and on‑site assistance to ease the transition.
  • Implement Change Management: Develop strategies to help staff adapt to new workflows, ensuring minimal disruption during the switch.

Full Deployment and Continuous Improvement

  • Go-Live Support: Offer dedicated support during the transition to full‑scale operation, ensuring that the system runs smoothly from day one.
  • Monitor System Performance: Continuously track key performance metrics using real‑time dashboards.
  • Regular Updates: Keep the system updated with the latest features, regulatory adjustments, and performance enhancements.

SUPPORT

The HICOF Machines offer in combination with AMACENA  an integrated IT-backbone, starting at machine level from the devices as printers, cameras and sensors up to data interfaces of governmental servers. In case of an issue, our experts have instantaneously access through remote access to all relevant parameters across all IT-servers down to the PLC, allowing a seamless and immediate support. This is the opposite of the conventional ISA-95 environment with several software and machine suppliers in which each service engineer has only access to his fraction of data, making a comprehensive root cause analysis extremely cumbersome as he has to synchronize with other involved vendors. 

Hicof solves the issue by offering 

One System, One Supplier, One Responsibility!

Our Highly skilled team is always ready to answer your serialization and packaging questions