GS1 recently released a PSA (Public Service Announcement) noting a specific practice which is currently widespread in pharma serialization implementations and is decidedly non-compliant with GS1's EPCIS standard. In addition to being non-compliant the practice also infringes upon GS1's property. See GS1's PSA at the end of this post.
Following GS1's lead I will help bring attention to these types of data compliance and quality issues through this blog.
What is the root issue? In simplistic terms many serialization vendors are communicating ’where' traceability events occur in a non-compliant fashion by populating the GS1 GLN (Global Location Number) incorrectly in EPCIS events.
How widespread is this issue? Considering multiple 'top' L4/L5 serialization vendors support this non-compliant practice this is a highly widespread issue. Numerous sources brought this to the attention of GS1 leading to the PSA. Additionally, proper use of GLN/SGLN has been part of the EPCIS standard since its inception over 10 years ago- So this particular item is alarming not only because of its pervasiveness, but also because of how basic and longstanding the underlying concept is.
How does this impact me?
- Non-compliant EPCIS, in any form, leads to challenges
in sharing traceability data with downstream partners (Distribution, 3PL,
- Not addressing data quality items, such as this,
immediately will end up costing the industry more time and money to
correct these issues as the volume of live, serialization data increases
(often paying the same vendors to fix their own mistakes)
- Widespread issues such as this introduces contractual
concerns for those responsible for providing compliant EPCIS integrations
- Tolerating non-compliant data in your serialization
implementation significantly reduces your ability to harness emerging
technologies such as AI and blockchain which demand good quality data
How can I determine if my implementation suffers from this issue? The key here is don't just take my word for it- you must check your data for yourself.
I know for some that's easier-said-than-done but fortunately there is no lack of services and tools to quickly find standards compliance issues such as this:
- The late Ken Traub developed an immensely helpful, FREE
tool which will instantly tell you whether an EPCIS message is compliant,
as well as provide a summary breakdown of its content. (Link)
- I have offered a FREE service to analyze serialization
data and provide compliance feedback (Link)
- The Jennason Serialization Test Tool provides automated
serialization test data generation which can be used to ensure your L4/L5
solution properly supports the standards and can also detect
If the options above are still too much effort ask your L4/L5 provider if any of your data is non-compliant per this PSA. Then let me know their response- I'm eager to hear!!
The message to the industry is simple- take responsibility for your implementations by leveraging the tools readily available to support you. Otherwise the 6.6% compliance rate we saw with DSCSA barcodes will seem pretty good by comparison.
I appreciate the work being done by Ralph Troger (GS1 Germany) and Craig Alan Repec (GS1 Global) to educate the industry on the proper use of standards by highlighting these non-compliant practices at both a global and country level. A second 'thank you' to GS1 Brasil for their efforts in making this PSA visible to their members.
I look forward to GS1 US taking the same vigor in protecting their property and standards.