Tag Archives: supply chain master data

Should GS1 Continue Developing ePedigree Standards?

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Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.For the first time since GS1 produced the Drug Pedigree Messaging Standard (DPMS) standard in 2005, GS1 has just published a call-to-action for the formation of a new standards development group to focus on a new pedigree-related standard.  The new group will be called the “Pedigree Security, Choreography and Checking Service (PSCCS) Mission Specific Work Group (MSWG)”.  According to the call-to-action:

“This group will develop standards to allow pharmaceutical supply chain parties striving to meet pedigree regulation requirements, by gathering and checking pedigree event data.  Standards will also address data confidentiality and security.  This MSWG will create

        A) standard for security framework applicable to EPCIS and,

        B) pedigree checking services.”

This group’s output will not be a self-contained pedigree standard, per se, but Continue reading Should GS1 Continue Developing ePedigree Standards?

Before You Sign Up For GDSN, Get Your Data In Order With A Data Quality Program

Last week I published an essay that gave GS1 some advice on how to trigger interest in adoption of their Global Data Synchronization Network (GDSN).  Those of you who read that essay in the first two days read my snarky comments about GS1 seemingly attempting to commandeer the term “Data Quality” to include the need for GDSN.  That was based on a mis-interpretation of their marketing materials for their “Data Quality Framework” and as soon as I discovered my mistake I removed that part of the essay, leaving the core point of the essay intact (see “An Open Letter to GS1, RE: GDSN Marketing”).

In fact, GS1 is saying exactly the opposite of what I originally thought regarding Data Quality and GDSN.  That is, before you start publishing your supply chain master data (SCMD) through GDSN you should ensure that the quality of your data is high.  As GS1 points out, “Good quality data is foundational to collaborative commerce and global data synchronisation.”  I couldn’t agree more.

The GS1 Data Quality program is centered on the “Data Quality Framework”, which is Continue reading Before You Sign Up For GDSN, Get Your Data In Order With A Data Quality Program

An Open Letter to GS1, RE: GDSN Marketing

Dear GS1,

How have you been?  I’ve been fine, done a bit of writing since we last met and gotten a little greyer.  How are the kids?  My two kids are doing great but I have to admit, after raising two I don’t know how you do it with 125 kids, or whatever the number of M.O.s there are today.

The reason I’m writing to you today is to offer you my thoughts on your Global Data Synchronization Network (GDSN) Marketing campaign.  That campaign would be more effective if it focused on demonstrating the distinction between internal master data (and programs associated with improving its quality), and externally shared master data (and the significantly different kinds of programs needed to improve its quality).  And especially to show that many (most?) of company master data is, in reality, externally shared master data, either incoming or outgoing.  That’s the step that I see missing from your campaign.

Companies who are already familiar with the kind of programs that are designed to improve their internal master data need to be taught to see the special characteristics of Continue reading An Open Letter to GS1, RE: GDSN Marketing

GS1 Standards – Betcha Can’t Use Just One!

The title is a paraphrase of a TV commercial from the 1960’s, ’70’s and ’80’s for Lay’s Potato Chips but the sentiment is the same.  You really can’t get away with using only a single GS1 standard.  That’s why they are sometimes referred to as “The GS1 System of Standards“.  It’s a “system” of standards.  Multiple standards that are designed to work for you together in concert; as a whole; not independently.

So when your customer demands that you make use of Global Location Numbers (GLN) and/or Global Trade Item Number (GTIN), they are starting you down the path of adoption of much more than just those two “entry-level” standards (see my essay “So a customer demands that you use GLN’s and GTIN’s. What next?”).  Here is a partial list of other GS1 standards that you may benefit from adopting once you fully embrace GLN and GTIN: Continue reading GS1 Standards – Betcha Can’t Use Just One!

Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 1

Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.For the application of unique serial numbers, or Standard Numerical Identifiers (SNIs), to packages as part of compliance with the California Pedigree Law in 2015-2017 , GS1’s Electronic Product Code (EPC), particularly in barcode form, is the clear winning standard.  But there seems to be a very common misconception going around that for pedigree data management, all you need to do to comply with that law is to deploy a system that is based solely on the GS1 Electronic Product Code Information Services (EPCIS) standard.  The  misconception assumes that there is a formula that can be followed to achieve compliance and that EPCIS is the whole formula.

In truth, EPCIS will almost certainly be an important component in the compliance formula but exactly how it fits, and whether there are other necessary components, has not yet been determined.

There are probably several reasons that this misconception persists.  First, GS1 US continues to promote their 2015 “Readiness” Program as if it is that formula.  The program documentation strongly implies that, if you simply follow their program, you will “be ready” to comply with the law; but it stops short of actually saying that you will be compliant.

Second, it seems like people are either able to understand the law well but not the technical standards, or they are able to understand the technical standards well but not the law.  The legal folks are left to trust what the technical people say about EPCIS, and the technical people assume that as long as the data elements identified in the law are present somewhere then EPCIS must comply.

Now I am not a legal expert but I’ve been looking at the text of the California Pedigree Law for a few years now and I think I understand it at a level that allows me to estimate how various technical approaches might fill its requirements.  Let me show you how Continue reading Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 1

California Board of Pharmacy Re-awaken

Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.For the first time in over two years the topic of pedigree appears on the agenda of the California Board of Pharmacy for their upcoming meeting on September 7.  Earlier this year in a presentation at the FDA Track & Trace Workshop Board Executive Office Virginia Herald mentioned that the Board would take up the topics of inference, drop shipments, decommissioning and linkage between shipping orders and invoices at a future meeting in 2011.  It’s hard to tell if those will be the actual topics discussed in next week’s meeting because they aren’t called out explicitly.  Here is the item as it actually appears on the agenda: Continue reading California Board of Pharmacy Re-awaken

So a customer demands that you use GLN’s and GTIN’s. What next?

In the healthcare supply chain a significant number of hospital group purchasing organizations (GPO’s) have stipulated, to varying degrees, that their suppliers begin making use of GS1 Global Location Numbers (GLN’s) in all of their trade with their member hospitals by the end of 2010 (Sunrise 2010) and GS1 Global Trade Item Numbers (GTIN’s) by the end of 2012 (Sunrise 2012).  Here are the announcements from Novation, Premier, MedAssets and Amerinet.  From the wording of their announcements it appears that Continue reading So a customer demands that you use GLN’s and GTIN’s. What next?

Use of GLN and GTIN for Pedigree Regulatory Compliance

I am fortunate to have so many friends and colleagues who work in end-user and solution provider companies and who are impacted by the issues I cover in my blog. After each post I often exchange emails and phone calls with some of them and we discuss/debate what I’ve written about. These are great conversations because they sometimes confirm my opinions and sometimes challenge them, but I almost always come away with a more refined understanding of the technology or regulation we discussed. That is, I learn something.

This is exactly what has been happening with my recent series on Supply Chain Master Data (SCMD). As I’ve defined it, SCMD is just like regular old Master Data (MD) except that the identifier and the full data set behind each instance of SCMD has a single owner, and all parties in the supply chain who may encounter the identifier must have a way of obtaining the full set of data from the owner so they know what the identifier means. But this assumes that only the identifier will be used in supply chain data communications in place of the full data set that the ID refers to.

GLN’s On Electronic Invoices

Let’s take GS1’s GLN (Global Location Number), for example. You can use GLN’s in two ways: as true SCMD, or in a non-SCMD way.

An example of using GLN’s as SCMD in an invoice application would result in an electronic invoice that did not have any explicit addresses in it–no customer billing address, no customer shipping address and no “remit payment to” address. Instead, it would simply include the customer’s billing GLN, the customer’s shipping GLN and the “remit payment to” GLN. Each party in this example would have already obtained the full addresses from their respective owners in some way, either through a registry (like GS1 U.S.’s GLN Registry for Healthcare), or directly from the owner, so there is no need to include that data on each invoice between these parties.

The non-SCMD use of GLN’s occurs when a company uses a GLN identifier as a way of obtaining their trading partner’s full address, and then they would put the full address on each of their invoices for that partner. This approach makes use of GLN’s to “synchronize” the address master data that each trading partner keeps locally. Continue reading Use of GLN and GTIN for Pedigree Regulatory Compliance