Pharma Serialization Post-Implementation Challenges

What are the most problematic serialization post-implementation challenges?

Serialization post-implementation challenges in the pharma industry are very real yet are seldom talked about. We usually focus on issues that relate to getting drugs serialized in the first place. However, once that is over, there still remain some (and sometimes many) problems to be dealt with. These are what we call post-implementation challenges.

Serialization post-implementation challenges are best seen firsthand. That is why this article will primarily be based on our personal experience. This way, you will be getting information straight from the primary source (duly supplemented by supporting material, of course).

Over the years, we have helped many pharmaceutical companies successfully implement various serialization models. Time and time again we see the same problems popping up and otherwise reputable companies struggling to deal with these serialization post-implementation challenges. From issues with knowledge transfer to vendor lock, many roadblocks appear only after serialization has been implemented. Take this article as a cautionary tale so you can know what you can expect to be a problem. That way, you can prevent them from arising in the first place or, at the very least, have an easier time dealing with them when they do crop up.

We are dividing these problems into four broad categories which we will then explore in detail using our own experience for reference combined with supplementary research.

       1. A lack of clear responsibility

The first of our serialization post-implementation challenges has to do with responsibility. More specifically, the lack of a clear understanding as to who is responsible for dealing with and maintaining the serialization systems after implementation.

This problem has its roots in the serialization process itself. We have seen companies time and time again fail to appoint a clear leader or head of a serialization project. After implementation, when the team disbands, there is no person to make a decision. Important issues cannot be resolved because nobody knows whose responsibility it is in the first place to oversee serialization processes in the company.

For any other business-critical process, this would be unacceptable, and yet it is allowed to happen with serialization. This leads to several issues down the line:

  • New projects and updates take a lot of time
  • Decisions can’t be reached because who would make them?
  • Budgets do not get assigned or at least not in a timely manner
  • Departments clash over whose responsibility it is to take care of serialization issues
  • Communication silos get created and shut down healthy cross-company communication

All of these smaller serialization post-implementation challenges tend to arise when companies do not observe serialization as an integral and business-critical process but rather as something that has to be done for the sake of regulations. We have written in previous articles about the opportunities that serialization can provide, but that only works if it is done properly. In the future, make sure to have a clear idea of who is responsible for serialization in your company and who is to oversee it both during and after implementation. It will help you avoid these quite crippling issues and open up new pathways to utilizing serialization in a meaningful way within the company.

       2. Problems with knowledge transfer 

So you have a team, however disorganized, to take care of implementing a serialization system into your company. Great. However, you need to think about the future, too. The next in line of our serialization post-implementation challenges is the issue of knowledge transfer. What does this mean? Put simply, it is the problems which arise when one team has to pass on knowledge to another, usually freshly-hired team. It is an issue most pharma companies need to deal with sooner or later, and serialization is a category in which it tends to crop up a lot.

Managing a serialization system takes a lot of knowledge and, unfortunately, the team who handled the implementation may not be around forever. New hires will eventually need to take over and they have to be taught how to handle the serialization process. The issue comes when this is not anticipated, and people leave the company without leaving clear instructions.

Furthermore, there are many things that can prevent successful knowledge transfer even when the parties are able and willing:

  • Limited resources
  • Lack of leadership and support from management
  • Lack of a consistent, formalized or structured approach
  • Bad information storage and sharing practices (to be discussed further later)

However, things are not all bleak. The good news is that you can avoid having your serialization process breaking down post-implementation by following some knowledge transfer guidelines:

  • Facilitate team and peer-to-peer training, including coaching, shadowing, and pair work
  • Develop a formalized knowledge transfer strategy and integrate it into daily operations
  • Deliver information and training in a variety of methods
  • Improve (and simplify) how you archive and share important information
  • Continuously review your knowledge transfer practices to gauge their effectiveness
  • Provide good leadership
  • Ensure support from management

       3. Vendor lock (or lack thereof?) 

Vendor lock is an important issue on its own, but it can be particularly problematic in the context of serialization post-implementation challenges. What happens is that during the serialization process companies are advised to stick to one vendor. This is at first advantageous because you can usually get many things for a cheaper price. However, after implementation, either when issues arise or when certain additions are necessary, companies find themselves needing other resources that their chosen vendor may not necessarily be able to provide. Worse yet, getting it from somewhere else would mean having to pay full price.

There is also another way in which vendor lock becomes a problem and it is oddly enough the opposite of what we have just described. Essentially, before serialization companies may have a mishmash of outdated equipment acquired from a variety of sources. After the serialization process, however, it is beneficial to try and standardize where you acquire pharmaceutical equipment. The reason for this is the same as the one we have described earlier: it is cheaper to do business with only one or two vendors, but then you run the risk of vendor lock.

As with other serialization post-implementation challenges, however, several solutions to this exist. For one, vendor lock can be easily overcome by more careful planning. If you know what you are going to need you can select an appropriate vendor to partner with—one that will have what you need. Furthermore, you can lock yourself in with more than one vendor. It is not that difficult to find two or three trustworthy vendors that can provide you with everything you need. That way, you can straddle the line between being locked in with only one vendor and spreading yourself too thin.

       4. Bad archiving/storage of information (master data management) 

This and knowledge transfer are closely related serialization post-implementation challenges. After all, a large part of knowledge transfer has to do with efficiently storing and sharing information. However, bad archiving and data storage is also an issue of its own that deserves to be explored in some greater detail.

For the pharma industry, the most important thing to talk about would be master data management. According to gartner.com, master data management refers to:  a technology-enabled discipline in which business and IT work together to ensure the uniformity, accuracy, stewardship, semantic consistency and accountability of the enterprise’s official shared master data assets. Master data is the consistent and uniform set of identifiers and extended attributes that describes the core entities of the enterprise including customers, prospects, citizens, suppliers, sites, hierarchies and chart of accounts.

Managing a serialization process after implementation heavily depends on good master data systems and management. Having a simple, organized way to access the many disparate parts of the serialization process can make or break a company’s ability to maintain it.

Providing accurate information is not only important to internal affairs, however. Vendors will need to know many details about your serialization system if you want to minimize misunderstandings that could potentially arise. Your clients as well as your pertners will demand easy access to different categories of information. For this reason, we strongly advise investing in master data management. Cleaning, standardizing, and matching up data is well worth it in the long run. Although doing grunt work like normalizing date formats or standardizing values may not sound appealing, it is a necessary step to having a truly flourishing serialization system as well as company.

Conclusion

To summarize, then, pharma post-implementation challenges can be broken down into four broad categories:

  1. A lack of clear responsibility that arises when nobody is appointed to be the definitive overseer of serialization operations.
  2. Problems with knowledge transfer which arise when there is no clearly developed system for passing down knowledge to new hires.
  3. Vendor lock issues which can manifest as both being locked in with only one vendor as well as not having any vendor partners and spreading yourself too thin
  4. Bad archiving/storage of information practices which make it more difficult to access key data about your serialization system after implementation

Remember: a lot of this information comes firsthand and is as such additionally useful. After reading this article, you should have a clearer idea as to how these problems manifest exactly as well as how to avoid them in the future.

In the pharma industry, serialization post-implementation challenges are certainly a problem, but there are many other hot topics which can cause problems for businesses. Serialization is not always easy to implement in the first place, especially without the right advice. How to best navigate this? Well, we at Nubinno have written many blog articles on precisely these topics. In the pharma industry, knowing where to get the right information can mean the difference between growth and floundering. You can either get in touch with us on this website or even check out our network of pharma companies and vendors called Nubinno Connect.

We wish you the best of luck in keeping the world a healthier place.

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