Companies are spending hundreds of millions of dollars, euros, rupees and rubles getting ready to comply with serialization regulatory mandates around the world. Deadlines are fast approaching in the US and the EU and they are already passed in India, South Korea, Argentina and Turkey. What companies are looking for next is how to extract some value beyond just complying with government mandates. Just about every solution provider offering serialization components and solutions out there has at least one product or service that is aimed squarely at this type of need. What we need to do is get these people together: those who are looking, and those who have the solutions.
Cognizant, a management consulting company, has written a very nice 11-page white paper exploring value beyond compliance. Continue reading Sponsored: Extracting Value Beyond Compliance From Serialization
Last week the US Department of Health and Human Services (HHS) Office of Inspector General (OIG)
There are lots of impactful requirements in the Drug Supply Chain Security Act (DSCSA), but there are two whose impact will likely increase the safety of patients far more than all of the others. That is, they are the most helpful requirements. Do they include serialization? Verification? Transaction documentation? Wholesaler and 3PL licensing? Not even close.
The second—and longer—draft guidance document the FDA published on the day of the third DSCSA public meeting is a “catch-all” (see also “
As I mentioned last week, the FDA published two new draft DSCSA guidance documents on the day of the recent FDA DSCSA Public Meeting (see “
Last Wednesday the FDA held the third in a series of three Drug Supply Chain Security Act (DSCSA) public meetings (see “