A lot has been written about the concept of “verification”, here in RxTrace and elsewhere. It’s all good, but I still don’t think the critical point has been made yet by anyone—including me (see “What’s So Hard About Unique Identifier Verification?”)—and until it is, companies are going to do it wrong. Less than an hour after I posted my essay last Wednesday (see “GS1’s Messaging Standard For Verification Of Product Identifiers”) I received an email from a subscriber who had questions about it, the essay was referenced in a post on LinkedIn by a reader in Europe, and I found a great link to a brand new essay about verification by Scott Pugh that had just been posted about the same time. So here is my new take on why most companies are going to get it wrong.
Continue reading Most Companies Will Do DSCSA Verification Wrong →
Verification is an important part of the operation of the Drug Supply Chain Security Act (DSCSA), and from my observation, it isn’t understood very well. People new to the DSCSA always think “verification” means something beyond what the actual definition is in the law. Late last week the FDA published new draft guidance describing their current thinking about the “verification systems” that members of the supply chain are required by the DSCSA to have in place. It’s an important draft because I suspect not many companies have “verification systems” that have the kind of capabilities spelled out by the FDA. Of course, as usual, it’s only a draft, not for implementation but for comment only. You have until December 24, 2018 to submit comments for consideration by the FDA as they someday make this guidance final. Continue reading DSCSA: Verification Systems Draft Guidance →
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