serialization pharma industry

[Blog] Serialization: Expectations vs. Reality


What were the expectations of serialization? What did happen in reality?


We have discussed serialization`s challenges before and we could definitely say that because of their diverse nature and different level of difficulty, the individual supply chain participants adapt and deal with them in various ways. But what were their expectations for the process and more importantly what happened in reality – check below.

#1 Expectation – Label redesign

Reality – Redesign but not completely changed label design. The placement of data matrix and barcodes imposes the need for labeling changes. However, it`s a one-time event that will have an impact on the results of the company on different levels.

#2 Expectation – Difficult Compliance

Reality – With the right vendor (partner) the serialization could be not so difficult and achievable. Of course, the implementation of serialization is a complex process because your company has to comply with different regulatory requirements for the different markets. Here comes the role of your vendor – if your track and trace provider understands your real needs, the serialization will become plainly achievable process without production disruptions. Learn how to evaluate the vendor and make the compliance easy >>

#3 Expectation – Cost

Reality – Yes, the implementation of serialization in pharma manufacturing can be accompanied by a significant capital investment (updating existing equipment, IT architecture, software and hardware, training) if your vendor does not propose more flexible options since we are talking about generating, storing and processing millions of serial numbers for numerous supply chains.

But the costs for serialization are an initial investment in the future. The visibility and traceability of the serialized products will have an impact on the cost and loss reduction of the whole company.

Preventing and eliminating the distribution of counterfeit drugs and reducing the grey market will activity lead to sales volume.  As for the big IT investment, the company could only benefit from it after all because the data management would give the opportunity for real-time optimization of the business operations as well as the opportunity for various analyses for improving production efficiency.

#4 Expectation – Improvements in the communication between different participants across the supply chain

Reality – Definitely improved communication. Traceability systems provide transparent communication between the supply chain participants giving the opportunity for errors and issues detection on each level of the supply chain. Serialization makes the data exchange easy and the reporting simple.

#5 Expectation – Fast and accurate data capture at every point in the supply chain

Reality – In other words – visibility. Providing visibility is of great importance for the pharma industry. Serialization makes it possible and allows companies to accurately track each product (through unique codes assigned to them) at all times and places. The result is improved supply chain transparency and data accuracy.

#6 Expectation – Gaining inventory visibility

Reality – The tracking of individual units is already achievable using unique serial numbers. Serialized inventory allows the real-time status of items. It`s cost-effective for the pharma manufacture because they could streamline their operations.

As the next step of achieving inventory visibility pharma companies introduce to their production the aggregation. The aggregation in inventory management helps to minimize inventory costs and maximize production efficiency or customer experience.

#7 Expectation – Better product demand forecast

Reality – Product serialization gives the opportunity for better product forecasts. Having full visibility on market, the company could estimate the stocks of their products and regarding this to plan and organize the next manufacturing cycle. Also, this helps with the prevention of flooding the market with less-needed products on behalf of the lack of needed medications.

It`s always hard at first. The expectations are ominous because of the unknowns behind them. In reality, the advantages and benefits are more than you think. The key is the vendor – you need a partner during this process.


Schedule a meeting with SoftGroup and see how we can be not just a vendor, but your partner >>