The Enhanced Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA) is due to begin on November 27, 2023. That’s the first day that the US pharma supply chain is supposed to fully operate with serial numbers. Yes, serial numbers in human readable and encoded into 2D barcodes will be on every drug packaged after November of this year, but there is only limited use of those serial numbers in the supply chain until 2023. But when the EDDS starts, everything changes. From that point on, every Transaction Information (TI) document must include the full DSCSA Unique Identifiers—including the serial numbers for the first time—that are physically included in the shipment, the Transaction History (TH) no longer needs to be exchanged, and the data exchange requirements change. Let’s focus in on those data exchange changes. Continue reading EDDS: The New Data Exchange Requirements
Buried deep inside the complaint filed in federal court last month by TraceLink against the Healthcare Distribution Alliance (HDA) is the heart of the issue (see “Tracelink vs. HDA”). It’s about the sharing of product master data throughout the supply chain—that is, “Supply Chain Master Data” (SCMD) (see “Supply Chain Data Synchronization and Patient Safety”). According to TraceLink’s complaint, the closed nature of HDA’s Origin master data sharing service (see “Dawn of HDA’s Origin, The Key to DSCSA Compliance”) is causing problems for vendors of DSCSA compliance solutions, and that will cause end-user companies in the supply chain to pay more for their overall solution. Continue reading What The TraceLink v HDA Lawsuit Teaches Us About The Value of Supply Chain Master Data
What a surprise it was to learn yesterday from Phil Taylor of SecuringIndustry that Tracelink, a traceability software vendor, has filed a lawsuit against the Healthcare Distribution Alliance (HDA), a non-profit industry organization representing the larger wholesale distributors in the United States (see SecuringIndustry, “TraceLink sues HDA over control of pharma track-and-trace data”). I had to check the calendar to see if it was April 1st.
It wasn’t. Continue reading Tracelink vs. HDA
This week at the Healthcare Distribution Alliance (HDA) Distribution Management Conference and Expo (DMC) the HDA and ValueCentric will provide much more detail around the new master data sharing service they plan to make available in July. The new service—named “Origin”—is intended to provide members of the pharma supply chain with a single directory of master data for all prescription drugs marketed in the United States (see Origin website). That is, it is a database of master data wrapped within a cloud-based service.
Origin master data is composed Continue reading Dawn of HDA’s Origin, The Key to DSCSA Compliance
There is a not-so-secret situation that has been festering for years in the internal IT systems of many companies in the U.S. pharma supply chain. In the past, nobody liked to admit it, but most would, because the full extent of the problem was hidden away from public view. It was an internal problem mostly affecting only internal systems.
The problem was that the quality of the local master data was poor. Master data is the data that companies hold in internal databases to describe their trading partners (customers and suppliers), products (their own and those of other companies), contract parameters (pricing, authorization, terms and conditions, etc.), and facilities, etc.
Companies get lulled into thinking this data Continue reading DSCSA Deadline Represents A Crossed Threshold Into The SCMD Era
During the March 14, 2013 meeting of the Enforcement Committee of the California Board of Pharmacy, Joshua Room, Supervising Deputy Attorney General at California Department of Justice assigned to the California Board of Pharmacy distributed copies of draft text that he is looking for public comments on. The draft is for regulations covering pedigree “certification”, the use of “inference” and “inspection” of electronic pedigrees. Unfortunately the text is Continue reading Draft Regulations On Certifications Within California ePedigrees
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
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