Tuesday, December 29, 2020

EPCIS woes continue.....

Another day…another woefully non-compliant EPCIS message supported by some of the ‘biggest’ players in the space.  Most will say  “Hey Scott, lighten up, it gets the job done so who cares if a few things here-and-there are not compliant”     

So as a year-end message I’ll get back on my soapbox again-   The reality is most of these ‘infractions’ (except the last one discussed below) likely don’t have a material impact on how the EPCIS communicates the necessary information from point A to point B….  the real risk/concern is this is yet again just one small example in an absolute ocean of examples where the industry is not just lax in its attempts to strictly adhere to EPCIS but is fully welcoming of it.

I’m not some private investigator with special tools that can detect these issues- I’ve praised/linked to the FREE tool that will reveal most of the issues below in a matter of seconds (https://epcisworkbench.gs1.org/ui/home)….so this can’t be about it being too hard to root out non-compliance…its simply that:

1) To this point, there hasn’t been an overwhelming reason to be air-tight on EPCIS compliance-   No EPCIS police to come around and stop product from flowing and not nearly enough interconnectivity across the industry for these issues to start causing bigger issues.

2) It’s hard to push back when some of the ‘biggest’ players in the space are the ones openly generating non-compliant EPCIS and/or willing to accept non-compliant EPCIS

Previously I’ve raised the notion of one simple way that non-compliance with EPCIS directly impacts the industry:

Take the last issue highlighted below.  Its black-and-white- both entries are simply not compliant.   But it’s happening out there in the wild (which by the way I would be interested to know if either the sending or receiving vendors are ‘certified’ by an EPCIS conformance testing service) which means the system generating this EPCIS was built in such a way that allows that to happen and, even worse, the system receiving these messages either A) didn’t catch these as issues and/or B) was built (and even possibly ‘enhanced’) to support receiving these messages.   The development it takes to support not only compliant EPCIS but now also the ocean of non-compliant EPCIS costs money.  And do you think the vendors just eat those costs?  Of course not, it goes back on the industry through increased annual fees or baked into some new ‘module’ that will be marketed.  

Now extrapolate that out over the massive number of ‘connections’ that have to be put in place by 2023 for the US market to achieve compliance.    If every vendor can go off and define what they feel is acceptable use of EPCIS then it’s the pharma industry who ultimately feels the pain.

In this space, 2021 will be the year of collaboration (or non-collaboration depending on how it plays out).   The technical issues below are likely viewed by many (not me) as minor, but what needs to be in focus is whether the industry maintains the mindset that’s been attached to EPCIS compliance…. There should be no ‘minor’ or ‘major’ non-compliance- it needs to be black-and-white… you’re either compliant or you’re not….and unfortunately, we are long past the point where non-compliant practices have become the norm.

I wrote a blog post nearly a year and a half ago that pondered whether EPCIS had lost its value as a standard within pharma serialization….  Instances such as below would seem to indicate nothing has really changed….and I still think we are just at the tip of the iceberg when it comes to understanding the impact that these seemingly insignificant and incredibly detailed ‘misses’ will have when trying to accomplish end to end traceability in pharma.

My last few posts have focused on the need for the industry to do a reality-check on whether we are moving forward with serialization/traceability in pharma in the best way possible.  Non-compliance with EPCIS is yet another reason why this reality check is needed.


Note: X’s are mine- used to preserve confidentiality

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