Things we wish we had known before starting a serialisation program or project – Tip 4: Ensure a robust cross-organisation impact assessment is carried out and maintained

Things we wish we had known before starting a serialisation program or project – Tip 4: Ensure a robust cross-organisation impact assessment is carried out and maintained

To successfully implement serialisation solutions, pieces of capability need to be implemented across many functions and geographies in an organisation. More often than not, pharmaceutical companies also need to ensure that capabilities are implemented in many third party supply chain partners as well. Impacts on such aspects as products, countries, supply chain nodes, supply chain partners, supply chain processes, and IT systems all need to be considered.

Given the long lead-times and complex interdependencies between the different elements of the serialisation capabilities, we have found it essential to ensure that an early and comprehensive impact assessment is carried out and then acted upon.

Furthermore, serialisation requirements and typical pharmaceutical companies are constantly evolving, therefore there needs to be a mechanism in place to ensure that any impact assessment is reviewed regularly to ensure changes are adequately addressed in a timely manner. It is our experience that relying on established business processes, such as change control, do not provide a timely or robust mechanism to achieve this objective.

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.

Should you have any questions about this or any other of my blogs, please don’t hesitate to contact me at Stephen.McIndoe@be4ward.com.

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