07 Jun GS1’s DSCSA Guide Urges Adoption of Latest Version of EPCIS
GS1 US recently published a 42-page document, “Frequently Asked Questions (FAQs) by the Pharmaceutical Industry in Preparing for the U.S. DSCSA” to help pharma organizations understand how to use GS1 standards to meet the upcoming Drug Supply Chain Security Act.
Verify Brand has always been a major supporter of GS1’s EPCIS, which was built into our platform from the very beginning and continues to feature the most up-to-date EPCIS standard.
While the entire GS1 document is worth a read, we want to underscore a few key points. Namely, that using a standards-based, well-architected serialization software ensures a smooth implementation process as well as the extensibility and scalability of the serialization data you capture.
4.1.4 Why should I use EPCIS to meet the data requirements of DSCSA?
EPCIS is designed to support full track and trace of products for many different purposes. By using EPCIS to meet the requirements of DSCSA, you lay the foundation not only for DSCSA compliance, but also for using supply chain data for a myriad of purposes including tracking and tracing recalled product, new product introduction, anti-counterfeiting, product authentication at point of use, optimization of supply chain routes, and more. EPCIS lays the foundation for knowing where your products are at any time, any place in the supply chain, and the possible uses of this data for business benefit are limitless. In this respect, EPCIS is far superior to siloed approaches such as devising a single-purpose data model exclusively for DSCSA compliance. The EPCIS approach allows all companies to maximize the return on the investment made in gathering the data in the first place.
Many of the leading companies in the U.S. pharmaceutical market have stated their desire to standardize on EPCIS and the GS1 US Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability, Release 1.2 as the preferred means to meet DSCSA data requirements. Using EPCIS helps assure that you are using a best practice for DSCSA data reporting and you will have the greatest degree of interoperability with other trading partners.
4.1.6 What version of EPCIS (1.0, 1.1, or 1.2) do I need?
To meet the requirements of DSCSA and achieve interoperability with trading partners, you should use Release 1.2 of the GS1 US Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability. This in turn makes reference to EPCIS Version 1.2 and the Core Business Vocabulary (CBV) 1.2. Each of these documents has its own series of version numbers, so it is a coincidence that the latest version of all three is 1.2 (though this makes it easier to remember!).
It is important to recognize that the EPCIS standard by itself is not enough. You must follow the specifications in the GS1 US Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability, Release 1.2 in order to create data that meets DSCSA requirements and that will be interoperable with other trading partners in the U.S. pharmaceutical supply chain. Therefore, when speaking with trading partners or solution providers, you should always verify that they are using Release 1.2 of the GS1 US implementation guideline. Merely complying with Release 1.2 of EPCIS, without making use of the GS1 US implementation guideline is not sufficient.
4.1.7 My trading partner or solution provider only supports Release 1.1 of the guideline. What do I do?
Release 1.2 of the GS1 US Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability has been available since November 2016. It is the only version that is capable of meeting all data requirements of DSCSA, including both lot management and serialized traceability. Earlier versions do not. For example, Release 1.1 of the GS1 US implementation guideline specifies data for serialized traceability that almost meets DSCSA requirements, but it lacks the transaction statement and a few other necessary ingredients.
As Release 1.2 of the GS1 US implementation guideline has only been available to the public since November 2016, not all trading partners or solution providers have fully implemented this version. If your trading partner or solution provider only supports Release 1.1, find out from them what their plan is for supporting Release 1.2.
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