Solutions
ePedigreeRX Level 5 for DSCSA
Why Use ePedigreeRX - Level 5 for DSCSA?
In the context of the Drug Supply Chain Security Act (DSCSA) compliance, an L5 system refers to systems that operate at the business network or inter-enterprise level, integrating multiple organizations and systems in the supply chain, focusing on interoperability, data sharing, and external communication between different stakeholders.
Under the DSCSA, pharmaceutical companies must meet specific requirements related to tracking and tracing prescription drugs in the U.S. This includes product verification, serialization, and maintaining transaction histories. DCAA Solutions’ ePedigreeRX L5 system facilitates compliance and secure data exchange across the entire drug supply chain.
Why ePedigreeRX L5 System is Crucial for DSCSA:
Encrypted: secure transactions in ONE environment
One Database: All Supply Chain data is in one, central, secure database
Privacy: ePedigreeRX does not send your Supply Chain data to 3rd party track-and-trace vendors, along with all other vendors opening your data and comingling in the same database with other distributors!
Secure Cloud Environment: ePedigreeRX is managed by Acumatica because it is Acumatica in the most secure cloud environment!
Traceability: ePedigreeRX L5 system ensures that the pharmaceutical supply chain is transparent from the manufacturer to the end dispenser, making it easy to trace any drug at any point.
Regulatory Compliance: ePedigreeRX L5 system automates much of the compliance process, ensuring that pharmaceutical companies meet DSCSA requirements for verification, serialization, and reporting.
Why ePedigreeRX L5 system is crucial for dscsa:
End-to-End Traceability
Collaboration Across Entities
Regulatory Compliance
key functions of
ePedigreeRX L5 system for
dscsa compliance
Interoperability and Data Exchange:
L5 systems are used to enable the secure and standardized exchange of data between various trading partners (e.g., manufacturers, wholesalers, distributors, and dispensers) in the supply chain.This includes sharing Transaction Information (TI), Transaction History (TH), and Transaction Statements (TS) to track and trace drugs as they move through the supply chain.
Cloud-Based and Decentralized Solutions:
These systems often use cloud-based platforms to facilitate real-time data sharing. Pharmaceutical companies, logistics providers, and regulators can access information instantly to confirm that products are legitimate and comply with DSCSA regulations. An L5 system also enables global data sharing since drugs may pass through various regulatory environments, and a centralized view of the supply chain is essential.
Serialization and Aggregation Data Management:
The L5 system maintains global serialization repositories, which store and manage the unique serial numbers assigned to each product unit, along with aggregation data (which links individual units to larger packaging or pallets). This allows seamless product verification at any point in the supply chain, ensuring that all drugs have valid serial numbers and haven’t been tampered with or counterfeited.
Regulatory Compliance Reporting:
L5 systems often include reporting tools that automatically generate compliance reports and alerts based on the transaction data, allowing pharmaceutical companies to meet DSCSA’s stringent reporting requirements. They also facilitate quick recall management by making it easy to trace where a product has been distributed, enhancing patient safety.
Integration with Lower-Level Systems:
L5 systems integrate with L4 systems (ERPs) like Acumatica, SAP, or Oracle, and also with L3 systems (MES, WMS) for warehouse management. This enables companies to track the movement of serialized products across both internal and external entities. For example, when a product is shipped from one company to another, the L5 system ensures that the TI/TH/TS data is exchanged properly between each entity’s ERP systems, ensuring compliance at each step.
Why ePedigreeRX with Acumatica for Drug Distribution?
ePedigreeRX is built on Acumatica’s robust system, known for its cloud-based, scalable platform, which allows pharmaceutical companies to manage complex distribution networks, improve visibility into supply chain processes and ensure compliance with industry regulations-all functions crucial to drug distribution.
ePedigreeRX built on Acumatica’s system plays a crucial role in integrating data and processes from lower-level systems (like WMS or MES), enabling companies to make strategic decisions at the enterprise level. In the drug distribution context, a system like ePedigreeRX built on Acumatica is responsible for high-level management of the following activities:
Inventory and Supply Chain Management
ePedigreeRX built on Acumatica handles procurement, replenishment, and distribution of pharmaceutical products across various locations. The system ensures that stock levels are adequate, including managing batches, lot tracking and expiration dates for drugs.
Financial Management
ePedigreeRX built on Acumatica manages all the financial aspects of drug distribution, including billing, payments, and cost tracking. This helps in pricing the drugs appropriately while accounting for various costs like manufacturing, storage and transportation.
Warehouse and Distribution Logistics
ePedigreeRX and Acumatica integrate with warehouse management systems (WMS) and manages shipping and logistics, ensuring that drugs are delivered efficiently and in compliance with regulatory standards, such as temperature control for sensitive pharmaceuticals.
Regulatory Compliance
ePedigreeRX and Acumatica provides tools for ensuring compliance with regulatory requirements, such as those set by the FDA, particularly for tracking and traceability (DSCSA requirements in the U.S.). The system maintains record of drug transactions, ensuring full traceability from manufacturer to end customer.
Sales and Customer Management
Sales orders, invoicing and customer relationship management (CRM) features in ePedigreeRX on Acumatica allow distributors to manage their pharmaceutical client relationships, track order histories and forecast demand.
Production Planning and Control
While production planning (L3 activity) would typically be in the domain of Manufacturing Execution Systems (MES), ePedigreeRX on Acumatica can interface with these systems to provide an overview of drug manufacturing processes and ensure that production aligns with inventory and sales needs.
DCAA Solutions’ ePedigreeRX™ L5 System offers a seamless solution for Pharmaceutical Distribution
Acumatica’s cloud-based platform, combined with ePedigreeRX™ specialization in drug tracking and traceability, creates an efficient, scalable, and compliant solution for the modern pharmaceutical landscape.
In an industry where safety, efficiency, and compliance are paramount, this combination delivers an unparalleled advantage.