As I mentioned in my HDMA wrap-up post, most attendees indicated that they are well on their way to serialization at the packaging line, and in turn, the start of compliance with the 2015 Drug Supply Chain Security Act (DSCSA) mandates.
So what’s next? Serialization and compliance with the 2017 requirements of the DCSCA. When we surveyed some of the HDMA attendees to find out their readiness for this next phase of serialization, we found that many have not begun the process.
Applying serialization numbers at packaging is only the first step. True compliance takes place when you actually ship serialized product and can track it through your entire supply network. You need to be able track serial numbers through the broader supply chain – from packaging through to your “serialized warehouse” and beyond – and then integrate that serialized data with the business systems you use every day (ERP, EPCIS, etc.).
The supply chain network itself is ever more diffuse, whether across geographies, multiple parties or both. Just when you begin to get a handle on how, where and what to serialize, you lose visibility as those items move across your supply chain. And that’s where the visibility is most important.
With visibility of where, exactly, serialized product was, is, and is headed next, you can efficiently process returns of expired, damaged or unused product. And with the ability to integrate warranty, shelf life, expiration date and unit price data into your ERP system, you can analyze the impact on inventory and profitability.
Real-time, in-depth visibility of product as it moves through the supply network is never more important than it is during a recall. Your reputation, compliance and revenue are all at stake if you don’t have the exact location and status of products in the field that will allow you to take immediate action.
With traceability comes the chance to gain ROI from your serialization investment. Since you don’t have a choice on whether or not you are going to serialize, why not take advantage of a solution that also provides full traceability to manage two of the areas that can provide significant ROI – product returns and recalls?