Serialization Tracking and Tracing

Serialization Tracking and Tracing

Life sciences industry is going through a global surge with serialization requirements, and that too, at a fast pace.  By the Drug Supply Chain Security Act (DSCSA), U.S. manufactures are required to serialize their products at the unit level by November, 2017, with repackager deadlines beginning in 2018, and serialization deadline for distributors beginning in 2019.  The full completion of US requirements is laid out from 2015 to 2023.

With the Falsified Medicines Directive, manufactures serving the EU have until February 2019 to comply with new tracking and tracing requirements.  These tracking and tracing includes serialization requirements (tracking, and tracing), verification,and government reporting.

With more countries following tracking, and tracing of pharmaceutical products, 75% of the world’s prescription drug supply is expected to be covered under these laws.  With many companies adopting these regulations, it is highly likely that your company in the field will get affected, too.

Pharmaceutical companies need to set their attention to full drug serialization.  Drug Chain Security Act (DSCSA) requires the manufactures to mark their packages with Product Identifier, Serial Number, Lot Number, and Expiration date by November 2017.  This requires pharmaceutical companies to alter their highly regulated packaging.  Manufacturing companies will also need to perform end-to-end serialization testing with wholesale distributors, and other supply chain companies to comply with the requirements, and to make sure that product tracing, verification, and serialization works.

Since these regulations come with a lot of new, and confusing terminology, and with a complicated set of rules to be followed involving multiples parties, there is a need for the experts, who completely understand the new set of rules, and can help with compliance.

How we can help:

The goal of Insolate Technologies is to provide, develop, execute, and maintain your EPCIS Serialization application.  This can either for a long term, or for a short period of time, on demand basis.  We are here to help.

Our experts can help you with:

Help selecting the vendor (if you are still in the process of selecting one).

Maintain your project plan with the given time frame.

Understand GS1 regulations, and updates.

Be a point of contact, and work with your EPCIS provider.

Write business requirements, validate master plan, test plan, and test cases.

Maintain release updates.

Execute test cases.

If you would like to hear more about our services, please feel free to drop us an email at info@insolatetech.com

We look forward to working with you.

Thank you.