Serialization: Why you should rethink
Changing the paradigm of drug serialization: bottom-up vs top-down. Why you should rethink where you start analyzing your needs.
CMO or pharmaceutical company, serialization will, depending on the markets you cater for, be mandatory for you very soon. And it will impact your business at every level. To what degree certainly depends on the solution you choose and on your vendor’s and project management team’s skills. But where do you start implementing?
Where to start implementing serialization
When analyzing your business’ serialization needs and planning your implementation schedule, you can either start on line-level and work your way up or start with the big picture to ensure your serialization solution meets everyone’s needs.
There are two approaches to implementing serialization at a pharma plant level:
- A bottom-up approach, driven by packaging machine stakeholders
- A top-down approach, driven by Information Technology stakeholders
The bottom-up approach is a straightforward solution that most Mark&Verify Modules vendors provide. Which is why, until now, it has been the most commonly applied one. However, this paradigm is changing.
The second approach relies on a top-down analysis of corporate IT requirements, taking into consideration the features of in-line marking devices and cameras. This requires corporate input and therefore all serialization projects should start with the establishment of an executive serialization team.
Pros and cons of a bottom-up methodology
The main feature of the bottom-up approach is the local database at line level, each packaging line having its own database. The data used and generated at line-level will then be made available to the level above, which has to then be defined.
On the one hand, this approach is interesting because the URS (User requirement Specifications) is simple to prepare, the validation work is quite straightforward and the initial installation is fast. On the other hand, interfacing such solutions with existing ERP systems requires additional software development. This leads to customized solutions with major disadvantages: time (and often money) -consuming software upgrades, long (re)qualification processes, downtimes and data storage and exchange issues.
Software upgrades are fastidious because each line has to be upgraded individually. This process stops production altogether on each line concerned. Furthermore, each line has to be re-qualified individually before production can recommence. Serialized batch data is stored locally and is therefore at risk if there is no back up on a global server. Moreover, with the amount of data growing over time, storage capacity will eventually become saturated at line level.
Pros and cons of a top-down approach to serialization
A top-down angle looks at a serialization solution from a global architectural perspective. This approach starts with analyzing data exchange and storage requirements and an architecture that can actually pilot the whole serialization solution before looking at specific line-level installations.
When involving global corporate IT requirements and multiple departments, it is clear that the development and approval even of the User Requirement Specification (URS) will take longer than just specifying the needs on line level. However, even if the URS in this case is more complex and time consuming to establish, this approach definitely has its advantages.
While a top-down approach to serialization implementation requires more time and capital investment for the first pilot line, the Total Delivered Value (or Total Value of Ownership) is far superior. How so?
Why a top-down approach is better in the long run
So far, few suppliers, among them Adents, offer a sufficiently standardized serialization platform that can be deployed on the majority of in-line marking devices and cameras on the market. However, he benefits of such a supplier-agnostic platform are evident. You can use the same system on all your packaging plants. Data is stored on a site level server and not on a server on each line. Upgrades are easier because they are centralized. And so forth. For pharmaceutical companies, it goes without saying that the upgrade process should be considered seriously given that regulations will evolve in the future. Or you might want to conquer new markets with different regulatory requirements. This point is just as important for CMOs though! What happens if one of your clients wants to export to a new market…?
The limits of first generation serialization systems
Today many pharmaceutical companies have already invested in serialization equipment, some even having implemented multilevel aggregation. They have gained experience thanks to which they can now measure the limits of current solutions and better assess new ones. As existing regulations are evolving and new ones are being prepared, users’ requirements are getting more accurate and demanding and may well lead them to overhaul their existing solutions.