SNI’s Are Not Enough In a Plateau-Based Supply Chain Security Approach

I recently published an essay on RxTrace called “Plateaus of Pharma Supply Chain Security” in which I proposed that a better timeline for the introduction of technology to secure the U.S. pharmaceutical supply chain was one based on plateaus.  Each succeeding plateau would add the adoption of new technology and/or data communications among the participants … Continue reading SNI’s Are Not Enough In a Plateau-Based Supply Chain Security Approach

Attributes Of A Global Track & Trace Application

In this essay, I’m not going to discuss the attributes of a track & trace system from a regulator’s point of view.  I’m not going to discuss input into the FDA’s Track & Trace workshop that occurs this week and I’m not going to speculate on the outcome of that meeting.  Instead, I’m going to … Continue reading Attributes Of A Global Track & Trace Application

Pharma Serialization ROI

Over the last few years I’ve taken part in many conversations that touched on the question of how to achieve a Return On Investment (ROI) with serialization in the pharmaceutical supply chain.  It seems intuitive that there should be an ROI because serial numbers provide increased data granularity and accuracy, but those characteristics in themselves … Continue reading Pharma Serialization ROI

Writing Is Thinking. For Example, Ken Traub

Noted writer, editor, literary critic and teacher, William Zinsser, is known for the quote “writing is thinking on paper”.  Today I don’t think paper has much to do with it, but what I think he means is, the very process of writing something forces a person to think about the thing they are writing about, and … Continue reading Writing Is Thinking. For Example, Ken Traub

Terminology: Track and Trace, and Pedigree

I don’t get paid for endorsements.  I don’t sell my opinion.  No one has my thoughts under their control.  So when I tell you that the Healthcare Distribution Management Association’s HDMA Track and Trace Seminar is my favorite pharmaceutical industry serialization and pedigree seminar every year, you should know that’s my honest opinion.  This year, the … Continue reading Terminology: Track and Trace, and Pedigree

Masterpiece: GS1 Tag Data Standard 1.5

GS1 EPCglobal ratified and published the most recent version of the Tag Data Standard (TDS), 1.5.  I have always been a fan of TDS, but earlier versions served as much to expose embarassing disconnects in GS1 standards as they did to explain how to apply GS1 identifiers in an Radio Frequency IDentification (RFID) context.  Earlier versions of TDS tightly bound … Continue reading Masterpiece: GS1 Tag Data Standard 1.5

RxTrace, One Year Retrospective

RxTrace is now one year old.  There are 34 essays that together amount to a true liberal exploration of the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance…as promised. My personal favorite essays from the past year, in chronological sequence are: The Florida Pedigree Law (August 10, 2009) The California Pedigree Law … Continue reading RxTrace, One Year Retrospective

Will The Pharma Supply Chain Be Able To Use Inference? Maybe Not!

In an essay published in April, I explained my theory that “RFID is DEAD…at Unit-level in Pharma”, which, if true, would mean that most drugs in the U.S. supply chain would be serialized by manufacturers with 2D barcodes by 2015 for California.  In my last essay, “Inference in the Pharmaceutical Supply Chain”, I carried that … Continue reading Will The Pharma Supply Chain Be Able To Use Inference? Maybe Not!