Status Quo – October 2017 – Episode 1: The easy way through serialization‘s jungle
The „Status Quo“ series of our blog regularly puts the spotlight on current issues around the topic of serialization. We write about challenges of serialization we encounter with industry representatives and our clients and discuss existing solutions.
The deadlines for serialization are approaching and many pharma companies are asking themselves how to integrate serialization duties (easily) into daily production routines. As of today, only a few MAHs and CMOs are ready to serialize. Various consequences that results from questions regarding the implementation like: “How can we exchange data between production partners?” are not yet predictable.
Serialization seems like an impervious jungle, with the path through it yet unclear. Marked trails are missing due to sparse practical experience. Therefore, teamwork and open communication between external partners and internal departments is vital.
Everything can be easy
Take software for example: a complex task gets easier, if the software is dedicated to solution orientation and user-friendliness. That means the software must adapt to the tasks and processes at hand, not vice versa. In workshops with industry experts of several pharma companies, we recognized the many similarities mid-sized companies in Europe have written on their serialization to-do lists. These similarities can be summarized in standard processes. Little by little, these processes then lead to the definition of best practices. And the impervious jungle becomes a safe path towards the goal of serialization.
Only a few steps towards serialization
Standard processes reduce the tasks to a few key features. Companies then just have to decide on the responsible person(s) for the respective task and on which best practice is used. In the daily use, serialization can be completed in a few clicks. To remain a few-click-task, the software must be flexible to adapt to new processes or regulatory changes. It is equally essential to figure out potential improvements from practical experiences by talking about the current state. The experience of the future users, the pharma companies, is therefore also needed for software development. All these steps illuminate the way through the jungle, making it easier and faster to reach the goal.
tracekey solutions makes serialization simple and helps illuminating the path. Our task is to transform the scary serialization jungle trip into a pleasant woodland walk.