EPCIS files play a vital role in ensuring traceability throughout the supply chain under the Drug Supply Chain Security Act. In this post, we'll take a quick look at what they are, the challenges of processing them, and the dangers of overlooking the importance of exceptions management — the ability to easily detect errors that may be invisible to the human eye.
Files in GS1's EPCIS (Electronic Product Code Information Services) standard serve as the backbone of DSCSA compliance. These files contain exact information about a product's journey throughout the supply chain, from manufacture to final sale. Essentially, EPCIS files track the movement and history of each individual product, ensuring transparency and accountability.
While the event-based nature of EPCIS files is straightforward, he sheer volume of data involved, combined with the need for accuracy and speed, presents significant challenges to supply chain operations. Each transaction event must be recorded accurately, and any discrepancies or errors can have far-reaching consequences.
Manually processing these files is time-consuming and error-prone; were it even viable to handle without systems built to process these huge files, the process would leave ample room for mistakes that can lead to non-compliance issues and disruptions in the supply chain, especially as file exchange volumes rise in the months leading to full DSCSA enforcement.
Here's where the importance of a robust exceptions management system comes into play. Exceptions occur when there are discrepancies or errors in the data accompanying the product or when the data doesn't match the physical product as delivered. Identifying and resolving these exceptions promptly is crucial to maintaining a smooth and compliant supply chain. Failing to do so can have serious consequences.
Unresolved exceptions can lead to delays in product movement. When an exception arises, the affected product is typically quarantined until the issue is resolved, resulting in potential delays in reaching patients in need. This not only affects patient care but also impacts business operations, as time and resources are wasted in resolving the exception manually.
Moreover, overlooking exceptions can put your organization at risk of non-compliance and regulatory penalties. DSCSA mandates that all trading partners maintain accurate and consistent records of their product transactions. Ignoring or mishandling exceptions can lead to inaccuracies in these records, jeopardizing your compliance status and inviting unwanted scrutiny from regulatory authorities.
To mitigate the challenges posed by EPCIS files and ensure compliance, a robust exceptions management system is crucial. Tools like LSPedia's Investigator for EPCIS act as both a safety net and a warning system, helping you proactively identify, address, and resolve exceptions in a timely manner. By leveraging automation, hundreds of preset rules, and advanced algorithms, the system can quickly detect errors and discrepancies within EPCIS files, allowing you to take swift corrective action.
Investigator not only saves time and effort but also minimizes the risks associated with non-compliance. It provides visibility into the supply chain, empowering you to track exceptions and their resolution status effectively. With a proactive approach, you can prevent exceptions from snowballing into larger issues that disrupt your operations and impact your reputation.