The wide-scale use of “inference” in the pharmaceutical supply chain is essential to the successful operation of a track & track or ePedigree system. Companies cannot be expected to open every case they plan to ship, or that they receive, so that they can figure out exactly which package-level serial numbers are involved. The use of the serial number packaging hierarchy, or, “Aggregation information”, to “infer” which packages are being shipped or received is the only way to maintain a level of supply chain efficiency that is close to pre-serialization levels. On the other hand, regulator acceptance of the use of inference in the supply chain has the potential to complicate their investigation of criminals.
In recognition of its importance in maintaining efficiencies, the California legislature instructed the Board of Pharmacy to draw up rules that would allow companies to optionally make use of it (see my essay “Inference in the Pharmaceutical Supply Chain” for the exact text of the inference provisions of the California Business and Professions Code). It leaves the important question about who Continue reading How Should Inference Work?→
Who will own the data that supply chain trading partners store in some future cloud-based, semi-centralized Network Centric ePedigree (NCeP) data repository? I met one potential future repository service provider who seemed to think that they would own that data. Imagine their excitement. All the data about where drugs go throughout the supply chain! Think of the value they could mine from that.
Well, that’s never going to happen because companies in the supply chain won’t sign up for handing over all of their supply chain data to some third-party just so they can comply with regulations, especially when there exists an alternative approach that would allow them to avoid using a third-party and still comply (by using DPMS). And regulatory agencies are Continue reading Data Ownership In The Track & Trace Cloud→
As I indicated last week, I wanted to write about a specific dialog that occurred at the December 4, 2012 California Board of Pharmacy Enforcement Committee meeting. The important exchange came at the end of the meeting during the catchall agenda item called “General Discussions” when topics that are not on the agenda can be raised by Board members or the general public in attendance.
“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,
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
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