The DSCSA, enacted by the U.S. Food and Drug Administration (FDA), mandates an interoperable system for pharmaceutical traceability. Aggregation in the USA plays a key role in meeting these requirements, providing the following benefits:

1. Enhanced Traceability: Enables end-to-end tracking of pharmaceuticals, reducing the risk of counterfeiting and diversion.
2. Regulatory Compliance: Ensures adherence to DSCSA mandates, avoiding penalties and supply chain disruptions.
3. Operational Efficiency: Streamlines warehouse operations, inventory management, and product recalls.
4. Supply Chain Transparency: Strengthens trust among manufacturers, distributors, and consumers by improving visibility.

The Growing Importance of Aggregation in the USA for DSCSA Compliance

As of November 27, 2024, all trading partners must exchange aggregated product data electronically using EPCIS format, making compliance even more critical.

The pharmaceutical serialization and aggregation market is experiencing significant growth due to increasing regulatory demands. The global track-and-trace market was valued at approximately $2.8 billion in 2022 and is expected to surpass $6 billion by 2027, with North America leading due to DSCSA enforcement. The demand for high-performance aggregation solutions is rising as companies look for seamless integration options to meet compliance requirements.

In the U.S., pharmaceutical serialization and aggregation solutions are becoming standard across all major manufacturers, CMOs (Contract Manufacturing Organizations), and wholesalers, driving investments in hardware and software solutions for compliance.

Despite its advantages, aggregation presents several challenges for pharmaceutical companies, including:

• Integration with Existing Systems: Many businesses struggle to align aggregation with their current serialization infrastructure.
• Data Management: Handling vast amounts of serialized data requires advanced software solutions.
• Hardware Adaptation: Upgrading packaging lines to accommodate aggregation can be complex and costly.
• Regulatory Understanding: Navigating DSCSA requirements demands expertise in global serialization and compliance.

At VISIOTT-TPS, we offer state-of-the-art aggregation and serialization solutions tailored for pharmaceutical manufacturers and supply chain stakeholders. Our advanced systems ensure seamless compliance with DSCSA and global regulatory standards. Key features of our solutions include:

• Automated Aggregation Stations – High-speed aggregation of units, bundles, cases, and pallets with precision.
• Serialization-Integrated Software – Real-time data capture and compliance reporting with EPCIS support.
• Customizable Hardware Solutions – Flexible and modular aggregation stations that integrate with existing production lines.
• User-Friendly Interface – Intuitive software that simplifies aggregation management and reduces human error.
• End-to-End Compliance Support – Expert guidance to ensure DSCSA readiness before the 2024 deadline.

VISIOTT-TPS follows ISA-95 standards, ensuring that our aggregation solutions align with plant-wide operational and information systems. Our systems integrate seamlessly at multiple levels:

• Level 0: Physical devices such as printers, scanners, and conveyors.
• Level 1: PLCs (Programmable Logic Controllers) and other control equipment for automated aggregation.
• Level 2: SCADA (Supervisory Control and Data Acquisition) integration for real-time monitoring.
• Level 3: MES (Manufacturing Execution System) connectivity, ensuring accurate data flow between packaging lines and enterprise systems.
• Level 4: ERP (Enterprise Resource Planning) and business intelligence system connectivity for seamless reporting and compliance tracking.

Our aggregation solutions help plant managers maintain full control over serialization and aggregation processes while reducing manual intervention and ensuring compliance with ISA-95 structured levels.
Ensuring Data Integrity Title 21 CFR Part 11 is a key regulation under the U.S. FDA, ensuring electronic records and signatures are secure, traceable, and tamper-proof. VISIOTT-TPS aggregation and serialization software is fully compliant with CFR 21 Part 11, providing:

• Audit Trails: Comprehensive logging of user activities to ensure accountability.
• Electronic Signatures: Secure and verified user authentication for all actions.
• Data Encryption & Protection: Ensuring pharmaceutical serialization data remains protected.
• Access Controls: Role-based security to prevent unauthorized modifications.
• System Validation: Adherence to FDA requirements for software validation and documentation.

By integrating CFR 21 Part 11-compliant solutions, pharmaceutical companies can confidently meet FDA requirements while ensuring data integrity and security.

Aggregation is no longer an option but a necessity for pharmaceutical companies operating in the U.S. market. As the DSCSA deadline approaches, implementing an effective aggregation strategy will be crucial for regulatory compliance and supply chain optimization. VISIOTT-TPS is committed to providing innovative solutions that help businesses navigate these challenge as with ease.

Are you ready to enhance your aggregation and serialization capabilities? Contact VISIOTT-TPS today to learn more about our cutting-edge solutions for DSCSA compliance.