As part of the S/4HANA migration, many companies are planning to consolidate their existing MES landscape, as it has grown over many years. In order to leverage the anticipated efficiencies and at the same time securely and sustainably run their production processes in the highly regulated pharmaceutical and medical technology environment, organisations must pay special attention to the global harmonisation of their processes.

Established MES and IT landscapes with diverse systems from different vendors and a multitude of interfaces are among the biggest efficiency killers in the networks of pharmaceutical and medical technology manufacturers. On the one hand, they require an extensive amount of personnel for the operation and maintenance of the respective systems as well as forcing the IT organisation to maintain experts for various systems. On the other hand, costs and deployment times increase because, for example, interfaces to other systems have to be configured and customised not just once, but several times. And finally, heterogeneous MES landscapes often lead to a deterioration in the quality of master data, which makes it more difficult to utilise data across the board.

„In light of the shortage of skilled labour, it will in future no longer be possible to provide enough experts for a company to operate several MES systems worldwide 24/7.“

 

Despite these known weaknesses, many companies have often shied away from a comprehensive consolidation of their MES landscape in the past due to the complexity and time involved in implementing such programs. Now, with the migration to S/4HANA, many organisations see a suitable time to reduce the number of local solutions and replace them with a global MES system. By doing so, they hope to transfer products more easily with all recipes and parameters globally, as they will be using the same system across different sites and areas. In addition, employees can be more easily deployed across locations and disruptions can be avoided, as changes can be rolled out globally by the core organisation instead of by local rollout teams.

Synergy potential through global process harmonization

In order to realise this potential, the consolidation of the MES landscape must start at the process level. A paradigm shift is currently emerging: Whereas in the past, companies usually customized their IT systems using scripts or individual programming to map their own company processes 1:1, processes in the MES environment are now increasingly being adapted to the supplier's standard with the aim of minimising configuration, implementation and maintenance costs.

„In future, MES consolidation will be less and less of a technology problem,
because the processes will be adapted to meet the suppliers' standards.“

 

To achieve this, processes must be harmonised across all sites and the resulting requirements have to be aligned with the MES providers. The extent of possible standardisation, where individual process steps are still required and at which points proprietary systems make sense also depends on the strategic orientation of the respective production system. For instance, in cost-sensitive environments, the aim is to achieve the highest possible degree of standardisation with minimal adjustments to supplier templates, whereas in other scenarios, the focus may be on the robustness of the processes or the expandability of the systems and require a different approach to process design.

This balancing of the degree of consolidation and standardisation of processes, taking into account both the respective corporate strategy and the regulatory and other industry-specific requirements, is a key success factor for a future-oriented consolidation of the MES landscape.

Requirements definition based on harmonized processes

In order to ensure that these aspects are sufficiently taken into account, a basic process library should be created prior to defining the requirements. This involves analysing the current processes at the respective locations and deriving a target landscape from this. To determine the optimum degree of process harmonization across all plants, the processes are broken down into individual process elements or sub-processes. The more granular the analysis is, the more precisely it can be determined to what degree harmonisation would add value in the production process. The findings can then be used to develop requirements, e.g. in the form of user stories, in order to define the target system. These are then submitted to the system supplier or incorporated into the vendor selection and evaluation process.

Consider quality compliance as a framework condition 

In addition to efficiency and profitability aspects, validation, compliance, and documentation requirements must also be taken into account when harmonising processes in the MES environment of pharmaceutical and medical technology manufacturers. This is where a consolidation of the MES landscape offers particular opportunities for increased efficiency, as new components do not have to be tested, validated and documented multiple times in various MES systems, but can be tested globally and delivered to the sites in a pre-validated form. To realise this potential, the Quality Compliance requirements, e.g. with regard to electronic signatures, audit trails or traceability of documentation, must be detailed and implemented in close cooperation with the system supplier.

Ensuring that process harmonisation is firmly anchored in the organisation 

Alongside process harmonisation, governance bodies and structures, such as a Business Process Harmonisation (BPH) Community or a Design Authority should be set up to provide long-term support for governance and maintenance activities at the system, process and harmonisation level once implementation has been completed. Otherwise, there is a risk that the processes and the core systems at the various locations will drift apart again over time, thereby cancelling out the anticipated synergy benefits.

To ensure that the changed processes are sustainably anchored in the organisation, these governance structures should be accompanied by systematic organisational change management as well as training and enablement. This applies in particular to the training of operators on site-specific processes, as these cannot be covered by the MES providers, as opposed to administrators or user training in the system.

Efficient implementation requires orchestration 

The consolidation of the MES landscape requires a great deal of harmonisation and coordination between global program management, the individual plants and the MES supplier. In general, none of the parties has the complete picture to manage this process holistically. For this reason, an orchestrator is essential to bring these different worlds together and bridge the gap between the IT system with its technical requirements and the process level in the pharmaceutical compliance environment.

msg industry advisors are experts in the harmonisation of business processes in the pharmaceutical and medical technology industry and are well acquainted with the way MES providers work as well as the industry and company-specific requirements of our customers and can therefore provide expert support in answering these and other questions:

• How can an optimal balance be found between standardising the MES on a global level while maintaining the necessary flexibility to adapt to the specific requirements of individual plants?
• Which interfaces are required and how can data consistency and security be guaranteed?
• What are the roles and responsibilities of the MES supplier, global programme management and the individual plants during implementation and after go-live?
• How are support and maintenance of the system organised, especially for globally distributed plants?

Would you like to find out more? Contact us and find out how you can successfully consolidate your MES landscape and increase synergy potentials.