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  • Writer's pictureJohn Hannan

Aligning your ERP Design for Drug Supply Chain Security Act (DSCSA) Compliance

Passed by the US Congress in 2013, the Drug Supply Chain Security Act (DSCSA) was intended to promote a safer and more reliable drug distribution chain within the US. With its vision of an electronically interoperable system, the DSCSA endeavors to halt the circulation of illegitimate medications, like counterfeit and potentially hazardous drugs. The outcome of this Act is that the general public is shielded from the hazards of such drugs by obstructing them from infiltrating the authentic drug supply system.

The DSCSA includes rules for manufacturers, repackagers, wholesale distributors, and dispensers. Generally, these rules are intended to improve the traceability of pharmaceuticals in the drug supply chain. This includes requirements for maintaining serial number information on all products and verifying product identifiers transmitted between trading partners when products are exchanged in the supply chain.

By aligning your ERP systems with DSCSA requirements, you can ensure that your business meets all legal requirements while taking proactive steps to ensure product safety and integrity within your organization.

Understanding Serialization & Traceability Requirements

The Drug Supply Chain Security Act (DSCSA) requires manufacturers and distributors of pharmaceuticals to trace and monitor all drugs. This is achieved through serialization and traceability systems, which assign a unique identifier to each package of drugs handed off between parties in the supply chain. This means that all parties must be able to capture, store, and share serialized product data throughout the process.

This requirement presents obvious IT challenges for businesses involved in the supply chain. How can businesses ensure that their ERP system is tracking the serial data of each product accurately? And how can they ensure this data is being shared with other participants in the supply chain?

The good news is that software solutions and services are available specifically for DSCSA compliance, including pre-configured ERP systems. By partnering with one of these providers, businesses can ensure that their ERP design is properly aligned for DSCSA compliance. This allows them to capture, store, share efficiently, and track product information throughout the supply chain.

ERP Design Factors for DSCSA Compliance

What are the major design considerations for ERP systems that need to comply with DSCSA? As it turns out, there are quite a few.

Automated Processes

The DSCSA requires businesses in the drug supply chain to automate processes and transactions. This means that an ERP system has to be able to handle large volumes of data, as well as support EDI (electronic data interchange) transactions with business partners.

Track and Trace

Manufacturers, wholesale distributors, and repackagers must be able to track and trace products throughout the entire supply chain at all times. An ERP system should have accurate information on product movements and stock levels and a secure platform to store relevant transaction documents such as invoices and packing slips.

Enhanced Compliance Cost Management

Accurately tracking changes in product prices is key for compliance cost management. An ERP system should provide accurate pricing information regarding price differences across channels and exchanges. It should also be able to track payment terms for easy reconciliation management.

These are the most important considerations when designing an ERP system for DSCSA compliance. There are many smaller details your team needs to take into account to ensure full compliance with DSCSA regulations.

ERP System Considerations for DSCSA Compliance

To ensure your ERP design meets the Drug Supply Chain Security Act (DSCSA) requirements, you'll need to consider several factors. Here are some of the most important considerations when it comes to ensuring your ERP system is DSCSA-compliant:

Product Identification

Each product must be assigned a unique identifier (GTIN) to ensure full traceability. This helps regulators track and trace when products cross state lines and different organizations in the supply chain. This should be part of your ERP design to comply with DSCSA regulations.

Authentication Processes

Your ERP should also support authentication processes to help prove that products haven't been tampered with or falsified during any distribution stage. To comply with DSCSA, this authentication data needs to be available for review and stored in a secure database.

Shipping Platforms

Your ERP should also include a secure shipping platform that supports tracking, tracing, and monitoring products throughout their lifecycle—from production to shipment and delivery. This will help ensure that products are not lost or stolen in transit.

By considering these factors when designing an ERP system for your organization, you'll have better peace of mind knowing that your business complies with DSCSA regulations.

Benefits of Aligning ERP Design for DSCSA Compliance

Aligning your ERP design with the Drug Supply Chain Security Act (DSCSA) compliance is something that many companies are doing these days for a good reason. Not only does it help your business stay compliant with the law, but it also provides a host of benefits.

Increased Safety

By aligning ERP design with DSCSA compliance, you improve safety for distributing prescription drugs throughout the supply chain. This is because different processes are in place to ensure that the right drugs are going to the right patients without being tampered with or replaced at any point in the supply chain.

Reduced Risk

In addition to providing increased safety, aligning your ERP design with DSCSA compliance reduces risk. This is because having an automated system to track and trace prescription drugs minimizes the chance of a mistake or oversight occurring that could lead to costly fines due to noncompliance.

Cost Savings

Finally, by automating certain processes related to DSCSA compliance, you can reduce costs associated with manual tracking and tracing of prescription drugs throughout the supply chain. These cost savings can be reinvested into other business areas for increased efficiency and productivity.

Bottom Line

You must tailor your ERP system accordingly to ensure a smooth transition and full compliance with the DSCSA. Take time to assess the current system and contemplate any possible changes in the model to keep your business in accordance with the DSCSA regulations. The successful and timely adoption of a suitable ERP will provide many benefits, including improved operations, enhanced data accuracy and traceability, and complete protection against potential issues with the DSCSA.

Follow John Hannan LLC on LinkedIn for valuable updates and insight into ensuring a compliant ERP system.


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