The New Year brings with it new US federal serialization mandates (FDA: DQSA/DSCSA) which in turn starts the journey of implementing a more robust track and trace solution for the players in the life sciences industry. Even though the current regulations require tracking at the batch level, the need for end-to-end serialization is not far behind.
Meeting this new regulation can be looked at in two ways: 1) Only implementing a solution to meet compliance or 2) Implementing a solution that allows your company to extract valuable information from all of this new serialization data. The second option truly leverages the investment to one’s advantage. John DiPalo, CSO of Acsis Inc., notes "Government mandates calling for unit-level serialization are not optional. A byproduct of these mandates is the ability to better protect your brands as well as improve operational efficiencies by using this data at the operational level.”
Below is John’s list of seven benefits that serialization can afford your organization: