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Manufacture Standards & Regulation, Technology and Equipment, Business Practice, Packaging, Trends & Forecasts

Serialization Blind Spots

Serialization used to be a very technical, internal problem, mainly focused on packaging lines. Over time, the focus shifted to managing the impact on business operations in warehousing and distribution, with increasing oversight by quality and compliance organizations. While some companies are still focused on getting their packaging lines serialized, others are now dealing with the external dimension of serialization – facing government reporting and data sharing challenges. This is especially true for large global companies with very diverse business operations and a complex supply chain. Though today’s challenge may still seem packaging line-focused, tomorrow’s challenge will be based on data management and the ability to derive business intelligence from billions or even trillions of data points.


One aspect of serialization that some companies overlook is the fact that it’s a complex data management problem (or opportunity) that impacts multiple departments within their organization. Serialization needs to be handled as a corporate-level program, led by a program manager and a team of experts who are able to analyze the impacts, as well as identify and communicate the long-term vision and opportunities.

Points of failure

A lot of companies will also soon face issues with operational sustainability. As more and more products are serialized and the number of the externally facing transactions increases, the number of failures to be dealt with will increase as well. Companies that focused on a “happy path” scenario and did not invest sufficient time in failure management will find themselves out of capacity, and having to deal with the mounting weight of failed transactions that need to be investigated and corrected. It is important to carefully consider all possible failure points inside and outside the walls of the company, and then ensure that the business processes, as well as technical solutions, are capable of supporting the rectification process in an efficient way.

Business process

There is a lot of focus on packaging and specific technology, while problems could often be downstream from packaging and related to a business process failure or lack of business process altogether. It is important to initially consider the impact on operations across the wide spectrum of affected departments, and then design the new business processes while taking into account the possible technical challenges. When this is done and agreed upon by stakeholders, it is crucial to communicate with the affected areas within the company so they are prepared to absorb the new process and technology.


This isn’t really an oversight, but I think it’s worth mentioning that serialization will not completely stop counterfeiting, but it will certainly make the legitimate supply chain more secure, at least for some time. Counterfeiting is a very profitable business and criminals will continue looking for ways around it. As for those online pharmacies that pretend to be legal but instead are illicit drug outlets, they will continue to sell fake drugs to unsuspecting consumers. The fight against counterfeit medicine needs to include continual consumer education and roll-out of technology that will allow consumers to verify drug authenticity themselves.

If implemented right, serialization will allow companies to put mechanisms in place to prevent product diversion and parallel importation, improve supply chain visibility, provide direct links to the patient, and offer vast amount of business intelligence data. Serialization certainly remains relevant today and will continue to be relevant for many years to come. Companies that understand this and plan for it by investing in the right technology will see that future – while others may cease to exist.

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About the Author
Pavel Lotkov

Pavel Lotkov is the Product Director at Adents.


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