How Product Track Manages Serialization Data

TraceLink generates serialized event exchange data to support trade partner business requirements and integration of serialization data into warehouse shipping and receiving operations. The exchange of serialized event data is the final phase of the DSCSA compliance requirements. The final phase begins in November of 2023.

EPCIS Data Exchange

To distinguish between compliance data (Lot level ASNs / Transaction Histories) and serialization business data exchange, the data is sent in separate messages.

In addition to tracking lot level Transaction History data, Product Track sends outbound serialization event data and receives inbound serialization data (using EPCIS messages). If you are an Owner (publisher) of Serialized Operations Manager (SOM), you can aggregate, disaggregate, ship, and receive the serialized products.

Note: In order to view serialized data transactions in Product Track US, you must be an Owner (publisher) or linked to (a subscriber of) Serialized Operations Manager.

Registering Serial Numbers without EPCIS Data Exchange

As a repackager, wholesale distributor, or pharmacy (dispenser) you may want to keep track of the serial numbers on the products you receive from suppliers before the 2023 deadline for electronic serialized data exchange. TraceLink allows you to do this in the system if you own both Product Track and Serialized Operations Manager (SOM).

A Company Administrator at your company enables a workflow that tells the system to generate a SOM inbound receipt when you receive an ASN in Product Track and to update Product Track Transaction Exchanges when you complete the receipt in SOM.

When you receive the ASN in Product Track, Product Track creates an "unconfirmed" transaction exchange. In addition, it creates an unsubmitted SOM receipt from the data in the ASN. You add the serial numbers to the unsubmitted SOM receipt when you scan them during the physical receipt process. When you submit the receipt, the transaction exchange is marked as "confirmed," since scanning the physical product confirms that a serial number has been applied to the product. Additionally, when you receive the products in SOM you have the option to register these unknown serial numbers in the system. Registering the serial numbers in the system records the serial number, lot, and expiration date of the serial number. Once registered in the system, you can perform actions on the serial numbers, such as shipping and destroying. Likewise, when you view the transaction exchange in Product Track, you can view and download the serial numbers from the corresponding SOM receipt.