Polaris at Klosterfrau: How SAP Technology transforms IDMP Compliance
The regulatory requirements for pharmaceutical companies continue to grow, especially in the context of the EU initiative for “Efficient Identification of Medicinal Products” (IDMP). How these complex requirements can be efficiently implemented was impressively demonstrated in the online discussion round of the SAP Expert Series for Life Sciences. The focus was on the Cologne-based traditional company Klosterfrau, which is the first in the world to introduce the Polaris solution for IDMP-compliant product data management as a cloud application.
A panel discussion combining practical insights and in-depth analysis
The session was moderated by Károly Földesi, Senior Director Digital Business at SAP Deutschland. Joining were high-caliber experts from the fields of Regulatory Affairs, IT, and Compliance: Dr. Ruth Wippern from Klosterfrau, Sebastian Pleister from the Gramont Group, and Matthias Bothe from DHC.
Dr. Wippern, responsible for electronic data management in Regulatory Affairs at Klosterfrau, emphasized her particular role as the interface between Regulatory Affairs and IT. The goal: to create a unified system for all regulatory product information, without breaks, without Excel spreadsheets, without isolated solutions. Sebastian Pleister, as the developer of Polaris, provided insights into the technical architecture, while Matthias Bothe contributed the regulatory and validation perspective.
From the world of Excel to an integrated platform
The starting situation at Klosterfrau is familiar to many pharmaceutical companies: product information is scattered across various systems and files and requires significant manual maintenance effort. While a functioning system already exists for XEVMPD submissions, it is insufficient for the more complex requirements of IDMP. The decision was therefore deliberately made against a separate RIMS solution and in favor of a platform connected to SAP.
With Polaris, a cloud-native SaaS solution on the SAP Business Technology Platform (BTP), Klosterfrau chose a system that not only processes IDMP-relevant data but can also map additional information such as brand names, dosage data, or data for non-EU markets. The potential connection to SAP S/4HANA was a decisive factor.
Agile Implementation under GxP Conditions
The implementation of the solution took place under strictly validated conditions, no easy balancing act between regulatory safety and agile implementation. Already in the planning phase, an interdisciplinary project team was formed, consisting of specialists from Regulatory Affairs, IT, external consultants, and validation experts. In parallel, a classical GxP validation approach was pursued: three separate cloud systems (development, test, and production) were set up, user requirements defined, risk analyses conducted, and test scripts created.
The Polaris introduction then proceeded step by step in the form of agile sprints. Even though different technical languages, for example between IT and Regulatory, were noticeable in daily work, all participants praised the productive and solution-oriented collaboration. The decision to start data entry into the production system with the so-called “blockbusters,” i.e., the most important products, proved to be effective. The data entry was manual and labor-intensive, but it laid the foundation for a reliable, central product database.
Polaris: Technological flexibility meets regulatory depth
SAP partner Gramont has developed SAP Cloud Application Polaris, a software that can very flexibly consolidate, prepare, and electronically submit this data to authorities, fully integrated into their SAP landscape with the same Fiori look and feel. What makes Polaris special is its configurable architecture. The solution is not only developed for IDMP but deliberately kept open for evolving regulatory requirements. New data fields, processes, and content can be added with minimal effort. User-friendliness also played a central role in development: Polaris offers a modern interface, integrated workflows, visualizations, and a complete audit log, all in an environment designed for validatability.
Particularly noteworthy is the ability to integrate additional areas such as medical devices or cosmetics into the system, which Klosterfrau already plans to implement for medical devices. This makes Polaris more than just an IDMP tool: it is a holistic product data platform for regulated companies.
Organizational Change Management as the Key to Success
A central learning from the project: The transition to an IDMP-compliant system is not only a technological challenge but above all an organizational change process. At Klosterfrau, structured training, tandem models, and accompanying documentation are implemented early on. The project introduction follows the ADKAR model of organizational change management, a structured approach that creates awareness, promotes acceptance, and enables sustainable adoption.
Polaris also remains dynamic during ongoing operations: monthly maintenance releases regularly bring new features and bug fixes, albeit accompanied by renewed validation effort, an aspect that was also factored into the project planning.
Outlook: Polaris continues to grow
The Polaris roadmap is ambitious: two releases with additional features are delivered per year. Klosterfrau and other pilot customers are invited to actively participate in the further development.
Conclusion: IDMP Compliance – Cross-system, Scalable, Future-proof
The discussion around the Polaris implementation at Klosterfrau impressively demonstrated that regulatory requirements like IDMP can not only be met but actively embedded into a company’s digital transformation strategy. The close integration of Regulatory Affairs, IT, and Compliance, along with the technological openness of the SAP BTP, create a solution that goes far beyond the minimum and can serve as a blueprint for other companies.
IDMP with SAP
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