Serialization will for sure bring benefits to the Pharma Industry, it will deliver brand protection and it will help combat against counterfeiting. Next to that, the entire supply chain (from manufacturer to pharmacist) will become fully tracked and traceable so that pharmacists can always verify the authenticity of the product before handing over to the end-consumers.
But the implementation of Serialisation is not a simple software update, it will be a major operation in the adaptation of software systems, manufacturing equipment, inspection equipment, communication networks, messaging with government bodies, endpoint devices at the pharmacist, etc.
This article will focus only on the so-called level 4 systems, the core ERP system in the company. All companies active in the production of medicinal products will have to decide how they will fit the Serialisation solution in their IT landscape. We will like to share with you what we have discovered during the selection process and hopefully, this is good input for those companies that have not decided yet.
The end-markets drive the speed and progress:
- Depending on the end markets where the company is active, Serialization is already or soon a legal requirement (e.g. Turkey, China, USA);
- These markets can only be served when the packaging is properly serialized, hence companies should already be fully prepared. EU is coming in 2019. But also new markets come up as Saudi Arabia, Ukraine, Russia, and Brazil with still not always clear requirements.
The existing IT landscape, business processes and IT strategy set the tone:
- Centralized landscape and processes: a solution to be found with the existing ERP system.
- Scattered landscape and non-harmonized processes: the cloud is a more appropriate solution.
- In any case, a solution must be found in combination with a network. This network is essential for the communication to customers, CMO’s, and the Medicine Verification Institutes.
- Network-to-Network is the future setup, irrelevant to the chosen solution. Not point-to-point because that will lead to an unmanageable and costly IT jungle.
The own system validation efforts depend fully on the chosen solution:
- If a solution is found in combination with the own ERP system, the validation effort is just the same as every new implementation or large change. But the advantage of having the Serialisation solution attached to the own ERP system is that the company continues mastering its own validation roadmap and speed.
- If a solution is found in the cloud due to a scattered IT landscape and/or business processes, the validation effort can be less, but the release calendar of the vendor must be strictly followed. The (Software as a Service-SAAS) provider will simply implement its next release and not wait for one customer that is not ready with the re-validation. QA/validation team must be able to cope with this calendar.
Do not forget the internal cost:
- To make the business case, the vendor(s) have of course to submit the quotation(s). But the sum of all quotations is only part of the input of the business case.
- Depending on the chosen solution, people are involved in running the serialization process. And for the one-time setup, significant work on interfaces must be included.
Timely engage your customers and CMO’s:
- As your own customers and CMO’s are simply struggling with the same, it is highly recommended to take the lead in Serialisation and market the leadership that you show as a competitive advantage.
Prepare for success:
- Start on time and as early as possible. There will be for sure setbacks and hurdles to take. And how ultimately the full solution end-to-end will look like is even unknown territory.
Conclusion
The success of Serialisation for your company is in the simplicity and practicality in which the recommendations as above can be applied.