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

Plateaus of Pharma Supply Chain Security

One of the most recent improvements that California made to their drug pedigree law was to spread out the compliance dates by supply chain segment.   Previously, all segments had to comply with the regulation by January 2011.   Now drug manufacturers will need to comply with half of the products (or sales) by January 2015 and … Continue reading Plateaus of Pharma Supply Chain Security

U.S. Pharma Supply Chain Complexity

The debate over pedigree regulatory models in the U.S. pharmaceutical supply chain often centers around how much data for each package of drugs needs to be moved between trading partners as those drugs move down the supply chain from the manufacturer to distributor(s) and ultimately to the pharmacy.  The ideal model would minimize the amount … Continue reading U.S. Pharma Supply Chain Complexity

The Viability of Global Track & Trace Models

At the end of my last essay I said I had recently concluded that the jump to a fully automated pharma supply chain upstream visibility system is too big and complex to be achievable by every company in the U.S. supply chain by the California dates.  I want to explain that statement in a future essay (soon), but … Continue reading The Viability of Global Track & Trace Models

Reliance on Trust in the U.S. Pharma Supply Chain

Trust plays a big role in today’s U.S. pharmaceutical supply chain.  Patients trust that their doctors know what they are doing when they prescribe a medicine and they trust their pharmacist to fill their prescriptions with real medicines that were: manufactured to tight quality specifications, are well within the expiration date, have not been tampered … Continue reading Reliance on Trust in the U.S. Pharma Supply Chain

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

Electronic Message Security and More on Certifications

Digital electronic messages can be transmitted from one party to another using a wide range of communications technologies.  Today, businesses that make use of the internet to transmit their business messages to and from their trading partners make use of standards-based Electronic Data Interchange (EDI) message formatting. EDI messages are typically transmitted point-to-point, from one … Continue reading Electronic Message Security and More on Certifications

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