projektraum36
Delivering Native SAP Cloud-based Solutions for the Life Sciences Industry

In the highly regulated life sciences industry, there are numerous regulations and legislation that companies need to comply with in order to offer a product in their targeted marketplace. The companies are thus in dire need for solutions that can help them stay compliant, without impacting their delivery methodology at the same time. That’s where projektraum36 comes into the picture. Through its UDI-Platform, the company enables the life sciences industry to meet the requirements on Unique Device Identification (UDI) of regulatory agencies around the world in a faster, flexible and seamless manner. Natively based on the SAP Cloud Platform, the solution focuses on providing a managed service for data maintenance, validation and exchange with regulatory authorities in the context of UDI. “We deliver a solution that contains the concretedata models of the authorities, flexible and configurable maintenance and approval workflows as well as the respective interfaces to exchange UDI-relevant product data with regulatory authorities. For this, we follow a multi-agency approach to ensure a consistent and compliant way of handling UDI-requirements worldwide.” mentions Robin Wennemuth, co-founder of projektraum36.

The UDI-Platform integrates seamlessly into an organization’s existing hybrid SAP-landscape and contains preconfigured content for data exchange with the FDA and EUDAMED database for a short time-to-value phase. The platform allows enrichment of product master data based on the different data models of regulatory authorities. Further, it validates the data according to the particular requirements of the UDI databases and also provides comprehensive reporting of UDI submissions status. “Our solution is capable of validating the corporate device and regulatory data against the rules from the different regulatory authorities to ensure that only complete and accurate data is sent to the authorities,” mentions Patrick Pfau, co-founder of projektraum36.

p36.labs as the Cloud business unit of projektraum36 builds content packages for each regulatory authority and provides them as solution extensions on top of the UDI platform core. This allows the clients to use the UDI Platform as a central system for all UDI related maintenance and submission processes of multiple regulatory authorities.

Due to its intelligent design and integration with SAP, life sciences companies receive a comprehensive and integrated suite to ensure better product quality and stay compliant to regulatory requirements. p36.labs works closely together with SAP´s solution management for the life sciences industry and therefore plans to offer a standardized Integration of its UDI platform into SAP´s Product Data Submission Management (PDSM). SAP PDSM handles data collection from different sources—SAP and non-SAP systems—for their cleansing and submission preparation. This is especially interesting for life sciences companies affected by both IDMP for medicinal products and UDI for medical devices, in order to manage all their product data in one master data system as a single source of truth. “Through this, life sciences companies receive a comprehensive and integrated suite to ensure better product quality and stay compliant to regulatory requirements,” states Pfau.

Wennemuth mentions that as a start-up within the SAP-Ecosystem, projektraum36 has been delivering to the client’s requirements and will be focusing on the Life Sciences space for the next years. “We are coming up with a new product that will enhance the automation element within our platform and provide customers with a framework that will support in providing and operating compliant and validated solutions in the cloud,” concludes Pfau.