“Delivering the difference in pharma” – that is our commitment to our customers, especially in the current situation that we all are facing since more than a year. The Covid-19 pandemic changed so much and is affecting each of us, be it in our private or working life where we need to get used to the “new normal”.
However, what’s the “new normal” for our customers and MES consultants, used to be on-site, travelling around the world and supporting pharma and biotech companies in the implementation and operation of Werum PAS-X MES?
Software consultants at Körber Business Area Pharma usually support PAS-X implementations from the beginning to the end, guiding the customers aiming for a smooth and successful project. One of the most important roles is analyzing customers’ business processes and user requirements and to map them according to PAS-X functionality. The task is to develop the solution with our customers, ensuring that the business process and requirements are covered using the full potential and all benefits of PAS-X following our established best practices.
This activity is normally performed in intensive full-day workshops over a few weeks with different topics, such as QA processes, equipment management, material handling, and of course, the production process itself where the related experts and stakeholders are providing their input for a proper assessment and evaluation.
To transfer these face-to-face activities into a remote approach for the benefits of our customers has been a challenge, but nothing that prevented our consultants to achieve the target of high-quality solutions for our pharma and biotech customers, scattered around the world. For a remote approach, we are using online platforms and tools to communicate and document the progress, having full traceability and transparency of the progress and outcome for the customers. Additionally, we use interactive tools to engage with our customers to get their valuable and needed feedback and make it a memorable and fun experience. This way, we also ensure that the material stays ingrained in their minds.
In a remote “Sandbox” system, demonstrations and MBR prototyping are executed simultaneously for proof of concept solutions even without having a system installed on customer site. Online whiteboards as well as applying a flexible schedule with, for instance, half-day sessions are completing the setup for successful remote workshops. Moreover, due to the high focus of the customers´ workshop participants during online meetings, we find that conducting workshops to dedicated topics can be as productive in virtual meeting rooms as being in a meeting room on-site. Hence, one of the key success factors to a smooth project implementation, i.e. delivering our best practice PAS-X content packages including the related consultancy, is still ensured.
Another challenging task is the MBR design: creation of the product batch records (recipes) in Werum PAS-X MES is much more than just a transfer of the paper specification 1:1 into the system. This is because it’s not a simple “paper on glass” concept – it’s about optimizing and improving the manufacturing processes for the operators on the shop floor, while having a strong user guidance via clear electronic work instructions and workflow enforcement to achieve “Right First Time”. To design the workflow and instructions including all process parameters and values, a close collaboration with the process owners, subject matter experts and operators is required to get a good understanding of the production process to identify the improvement possibilities, which can be automation of work steps and their documentation.
The big advantage for our customers especially during remote sessions where the consultants cannot see the business process and visit the manufacturing site is that our consultants have an excellent process knowledge and experience of MBR design within the pharma industry. This makes it easier to design an MBR from hundreds or even thousands kilometers away. Additionally to our design guidelines, which guarantee an effective design structure, we use our PAS-X process libraries content packages. These are already predefined recipe building blocks representing the entire process and its sub processes, and designed based on our extensive industry expertise and experience, hence speeding up the recipe creation process for our customers. As a result, this enables seamless manufacturing and fast delivery of life-saving medicines to the market.
Overall, we tackled the challenges coming with the “new normal”, developing, adjusting and improving ourselves, working together with our customers to ensure a smooth implementation and operation of Werum PAS-X MES at their production sites. We are delivering the difference in pharma – no matter if on-site or remote.
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