Speaker's blog: Tips for developing a serialization strategy

by Stephen McIndoe

Stephen McIndoe is an award-winning serialization specialist and has worked with many companies to develop serialization strategies, design solutions and manage implementation programs. He heads the serialization team at Be4ward and will bring a global serialization update at the Pharma Serialization online conference.

What are the things you wish you had known before starting a serialization program or project? Look at some of Stephen's tips for developing a serialization strategy:


Tip 1: Identify and interpret the emerging and evolving legislation

Serialization legislation, particularly in its early iterations, tends to be somewhat vague, in­complete and sometimes contradictory. Interpreting the legislation and predicting its im­pacts can present significant challenges, requiring specific serialization knowledge as well as new legislative relationships with local legislators.

This is further compounded when considering the timelines allowed in the legislation. His­tory has shown that timelines are often vague and subject to change. However, when im­plementation dates are finally set, they often do not allow enough time for robust imple­mentation.

Given the uncertainties in requirements and timing, organizations need to ensure there is a clear way of communicating their considered view of the legislative requirements at any particular moment. Failing to do this will potentially result in individual functions or groups creating their own interpretations, which at minimum is wasteful of resources, but at worst results in capabilities being implemented which do not meet the eventual requirements of the legislation.


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Tip 2: Understand the full impact of these multiple pieces of legislation on the company and product supply chain

Serialization presents a potentially broad impact on a typical organization. It is important to engage all of the potentially impacted parties early in the impact assessment phase to ensure that comprehensive solutions can be defined.

A further challenge is that multiple pieces of evolving legislation will often impact many of the same capabilities. Understanding these potential impacts and their likely evolution over time is key to ensuring effective solutions are defined and implemented in a timely manner.


Tip 3: Define solutions and implementation plans which strike the optimal balance between ensuring product supply and the caution that is prudent with this evolving legislation


There are often a number of supply chain configurations and technical options that can be brought to bear with particular serialization legislative requirements. Short-term tactical options have to be weighed against longer-term strategic solutions. Some of the challenges that need to be addressed when defining optimal solutions include:

  • Differing serialization models being called for in differing pieces of legislation
  • Uncertainty in the detailed technical requirements as legislation evolves
  • Evolving and competing serialization standards being developed by standards bodies and industry groups
  • The requirement for many supply chain nodes and assets to be able to handle multi­ple legislative requirements simultaneously
  • Deciding on the optimal degree of integration of serialization capabilities with exist­ing capabilities e.g. production control systems and ERP systems
  • Uncertainty in the timing of legislation
  • Striking the optimal balance between providing new equipment versus retrofitting existing equipment
  • Agreeing interfaces and implementation timeliness with third parties

Defining the timing of implementation plans, to a large extent, needs to be considered hand-in-hand with the solutions themselves. One risk that also needs to be considered is that of the ‘last minute rush’, or ‘Y2K effect’. By this we mean the risk that, as is so often the case with this type of legislation, everyone waits until the last minute to implement solutions, only to find that the supply base cannot cope with the peak in demand, driving up cost and forcing companies into non-compliance. This is a particular concern in the 2017 timeframe as the USA, Europe and others all have legislation which becomes effec­tive around this time.


For more tips for developing a serialization strategy please visit Stephen McIndoe's blog.

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