With the Falsified Medicines Directive (EU FMD), a major digitization project was legally imposed on the entire pharmaceutical industry. From manufacturers, contract packagers, marking systems, and line producers to pharmacies – everyone was involved and had to integrate new processes, systems and hardware into their work within a few years. At the same time, a new need was created: Software had to be developed that was able to meet the legal requirements as soon as the regulations came into force and at the same time remain flexible enough to react quickly and effectively to short-term changes, new legislation, and customer requirements.
As a comprehensive and legally required digitization project for an entire industry, the EU-FMD is unique in Europe to date. From the very beginning, tracekey has therefore relied on agile working strategies, which is ideally suited to the large-scale serialization project of the pharmaceutical industry. It has enabled us to quickly provide our customers with software that enables them to comply with the regulations and allows us to
- always react to short-term adjustments and
- to quickly implement the requirements of other markets
- while at the same time to keep adapting the software to the real needs of our customers.
What is agile working?
Agile working is based primarily on three pillars: high flexibility, efficiency, and fast results, or high output. A fixed team works together on a task. Decisions are made in the team and small goals are set together that can be achieved within a clearly defined period, called a sprint. The decisions on which goals to choose and which tasks to work on are made by the employees, not by the management as in conservatively organized companies.
A large project, such as the development of serialization software for the pharmaceutical industry, is broken down into numerous small projects, each with a specific goal. The team focuses on creating the first functional version of the final product at the very beginning of the project. This can be serialization software, a new service, or an innovative POS system. In this way, the client can quickly work with something concrete and gradually develop and adapt the product together with the development team. The active participation of the customer is also an important cornerstone of agile working.
What are the advantages of agile as opposed to classic project management?
Agile working puts the customer and his real needs in the foreground. This method makes it more difficult to simply bypass the customer’s wishes since the exchange takes place at every completed project step and is based on a usable product. In classic project management, the customer usually only gets to see the final result. This often causes difficulties, because requirements and problems usually only become apparent when the product is used. With the agile approach, changed framework conditions, ideas, and new findings can be implemented without any problems and without more effort from the development team. Whereas in the classic project process, they can only be recognized afterward and implemented retrospectively. This in turn leads to additional work, higher costs, and less satisfaction on both sides.
The project also takes on a completely different form within the team. In hierarchically organized project management, the strategy, process, required resources, and goal are defined from the top. Hierarchical structures and predefined processes leave little room for manoeuvre. An agile team, on the other hand, is dynamic, flexible, and adaptable. Resources can be reallocated depending on the project status, goals readjusted, and strategies adapted. The team knows exactly which skills are best used when and what they can achieve in a certain period of time. This leaves room for innovative approaches to solutions, and the focus is on goal-oriented communication. Instead of having to have an important strategy or product change approved at three levels, agile teams take responsibility for and plan their projects together and can thus react more flexibly and quickly.
Why we chose agile project management for the pharmaceutical industry
The entire organizational structure of tracekey solutions has been designed according to the principle of agile working since its foundation. But why does a solution provider of a, to a large extent, very classically organized industry decide on an agile project approach? The initial situation of the pharmaceutical industry, when it became clear that it needed a serialization solution, was also the basis for our decision for an agilely organized SaaS company.
Although the pharmaceutical industry in Europe also consists of multinationals, the majority are small and medium-sized companies that employ fewer than 500 people. Regardless of the size and the human and financial resources of a company, they all have to comply to the same requirements. In addition, before the implementation of the EU FMD, the industry was not digitized across the board. This means that costs, software handling, and implementation effort were crucial aspects in the planning of our SaaS offering. With this starting position, it was important for us to develop software including a service which
- has neither high implementation costs
- nor a high implementation effort
- and is geared towards exactly what SMEs need.
Developing a large and bulky software that covers all eventualities and possible needs, but may be difficult to use or be confusing, was out of the question, as this would require a lot of time and cost-intensive implementation.
Agile project management enabled us to develop a serialization solution in a short time that could meet all the basic requirements of the pharmaceutical industry and the EU FMD and was always user-friendly and easy to implement. At the same time, it was designed from the outset to continue to grow, adapt and flexibly map new requirements.
With this approach, we have been able to convince numerous customers over the past nine years and develop many new features and additional solutions. We have built a company that can always flexibly adapt to market and customer requirements.
Tackling large-scale digitization projects
The large-scale digitization project in the pharmaceutical industry is a special case. The industry is highly regulated due to its high impact on people’s health and the associated risk. If we want to take stock of the past decade, the lessons learned can nevertheless be applied to other industries.
- Standards help. They help to define and establish new processes. But we have also learned that over-standardization hinders the establishment of processes.
- (Legal) requirements are not static. Even in the pharmaceutical sector, there were significant changes after the first implementation phase. The same can happen in classic customer projects. So that the software or the SaaS solution is also subject to a continuous adaptation process. Standardization also helps in this case. Especially in the case of software that requires validation, the standardization of processes and documents can simplify the process for development, support, and customers.
- The requirements define the toolset and not the other way around. If everyone is currently working on blockchain solutions, this does not necessarily mean that it is also useful for the upcoming digitization project. Cloud systems, for example, are well suited for digital supply chains and the integration of different actors, whereas production-related systems are often operated on-premises.
- The task, goal, and scope of an IT system should always be clearly defined. It often does harm if, for example, an ERP system suddenly has to manage mass data from production. A clear demarcation of the systems is achieved by classifying them into levels. The five levels go from device level (level 1) to the external network (level 5).
A positive example from the implementation of the EU FMD is the stakeholder model. Instead of specifying across countries how exactly the law should be established, a stakeholder model was introduced. The scope for manoeuvre has led to the establishment of separate organizations within the countries that have driven the implementation of the EU FMD forward at the same time. In Germany, for example, securPharm assumes responsibility as the first official body and provides the system for verifying medicines in pharmacies.
It can be said that agile working can provide more satisfaction on both sides. Self-organized teams approach projects on their own responsibility. Resources, goals, and output can be planned much better than would be possible in a hierarchically organized company. In addition, the team remains more motivated due to the continuous development and early sense of achievement. The client-side also benefits. They can work with a product more quickly, test in everyday life which functions are necessary, and pass these findings on to the teams. In this way, customer wishes and product development merge directly.