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Part 1: Making Use of Serialization Data

An information expert from Merck shares advice on how data can be used, challenges to overcome, and what may be in store in the future.

Michele D'Alessandro, Vice President and CIO for the Manufacturing Division at Merck.
Michele D'Alessandro, Vice President and CIO for the Manufacturing Division at Merck.

Like any pharmaceutical manufacturer, Merck & Co., Inc.’s serialization approach is driven by the Drug Supply Chain Security Act (DSCSA) in the US, Falsified Medicines Directive (FMD) in the European Union, and similar country-specific regulations around the globe. But the company is also deriving value from serialization data, and sees potential uses for the data further in the future.

“We serialize our product in accordance with all of the DSCSA, FMD and other similar regulations, so obviously there's a compulsory aspect of the work that we do,” says Michele D'Alessandro, Vice President and CIO for the Manufacturing Division at Merck. But she explains that there’s more to be gained. “We believe that through the collection of all of this serialized product data, there's a wealth of information in the context of big data, insights and descriptive/predictive analytics. I think it's actually untapped potential, meaning I don't think we do enough with the power behind that data today.”

Beyond regulations

D'Alessandro notes that knowing the product genealogy, or history of the product, as it flows through the supply chain is very valuable in answering questions, like:

  • What is the path the product follows? Is it as expected?

  • Does product get stalled in any part of the supply chain and what are the patterns to the latency?

  • How can we use these insights to proactively shorten the lead time of our supply chain the next time?

Merck can also compare what might be happening with distribution in one country versus another, because, while the requirements are all called “serialization,” countries have implemented their rules differently. “We actually get to compare the differences that exist, and that gives us the ability to either standardize or point out the variations that might be adding to complexity, to cost, to efficiency, etc.,” she says.

LAST CHANCE TO SAVE! New Tech for Life Sciences at PACK EXPO Southeast
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LAST CHANCE TO SAVE! New Tech for Life Sciences at PACK EXPO Southeast