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Serial number management, certifications, and pedigree reporting

Serial number management is a set of functions that will allow you to securely and accurately control and keep track of the serial numbers you apply to your pharmaceutical or biologic products.

Again, flexibility is crucial.  You will need a single, centralized place where serial numbers of all types will be allocated and then distributed to the remote facilities where the actual commissioning (associating the serial number with the physical product) occurs. 

In GS1 parlance, this includes SGTINs (Serialized Global Trade Item Numbers), SSCCs (Serial Shipping Container Codes), GIAIs (Global Individual Asset Identifiers), and GRAIs (Global Returnable Asset Identifiers). 

All of these standard identifiers need to be managed by the specific serial number management module of your track-and-trace solution.

Some countries define and provide serial numbers to you.  These can come in data form (as is the case with China) or as preprinted labels (Italy).  Because these numbers may not conform to GS1 standards, your solution will need the flexibility to deal with non-GS1 identifiers and serial numbers.

A certification is nothing more than a corporate assertion of truthfulness of the track-and-trace data, incorporated into the e-pedigree information itself.  This feature is intended to make it easier to prosecute criminals—one of the important components of track-and-trace regulations.

Not all country regulations require you to include this within your track-and-trace data, but your track-and-trace solution must be able to include this assertion if you expect to meet future e-pedigree requirements.

Some people tend to confuse a digital certificate with what California requires, which is simply that you provide information on the certifier, which is the person or company that certifies that the pedigree is true. There’s no actual certificate per se.

Pedigree reporting
If a country or state regulation requires e-pedigree reporting, your solution needs to supply it.  The problem here is that many of the global requirements are not well defined.  You or your technology partner must monitor all government agencies in order to be alerted early to new requirements so that you have enough time to work on a compliant implementation. Layering pedigree onto serial number management allows new requirements to be met without substantial changes to the underlying serial number management system.

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