For many years, there has been a great deal of uncertainty in the implementation timing of certain legislation requirements, and legislators have often delayed deadlines.
This has had a knock-on effect on the solution providers. Understandably, they have been reluctant to commit to expanding their businesses until they were confident that the customers would require the capacity.
To date, this has often meant that, particularly in the enterprise solution space, actual capacity and development activity has been limited. Indeed, whenever legislative deadlines have approached in the past, it has been clear that the vendors quickly became capacity constrained, with availability of key staff being highly restricted and noticeably extending delivery lead time.
At the time of writing in early 2015, the US and EU legislation has implementation dates of 2017 and
2018 respectively. Accordingly, vendors are reporting plans of significant expansion in 2015 to meet the anticipated demand. Whilst this is very good news in terms of the capacity it will create, there are two related issues that will likely spin out of this. Firstly, it is very challenging to rapidly expand any business without impacting the quality of products and or service. Secondly, the expansion is being carried out to meet an anticipated significant increase in demand and therefore, this new capacity is unlikely to do anything more than meet this additional demand.
Therefore, we recommend ensuring that any serialisation plan be built using conservative lead time estimates and that capability implementation be phased. Also, consider avoiding plans that call for significant capability implementation in the 2017/18 time period. We predict this period will be highly challenged, much like dealing with the Y2K issue was in 1999.
I hope you enjoyed this instalment on Things we wish we had known before starting a serialisation program or project. Please check back in next week for the continuation in this series.
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