We deliver highly innovative Software-as-a-Service (SaaS) solutions for the life sciences industry by combining outstanding SAP technology know-how with special expertise in regulatory topics in the life sciences.
Our SAP Business Technology Platform-based SaaS solutions are built on intelligent design to optimize UDI related processes and ensure GxP compliance in the cloud – implemented with large technological expertise and high quality focus.
About usOur core product, the UDI Platform, is the strategic UDI governance solution for medical device manufacturers based on SAP Business Technology Platform. It provides the complete data governance and submission processes of UDI related product master data and fits seamlessly into heterogenous IT landscapes (SAP and non-SAP).
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Our unique Content Package concept enables you to cover the requirements of different regulatory authorities across the world and achieve global UDI compliance. We monitor the market requirements and implement new requirements of different authorities as a service to ensure your continuous UDI compliance.
We help you to achieve GxP compliance in the cloud with our unique Service Qualification Platform. The approach of continuous service qualification enables regulated companies in the Life Sciences to run software applications on SAP Business Technology Platform (BTP) through compliance automation on platform service level.
The Service Qualification Platform is currently running in multiple pilot projects in the large enterprise segment – contact us now to attend in the pilot phase!
Since the emergence of UDI in 2012, through various practical experiences in implementation and pilot projects for various regulatory authorities, we have gained a high level of expertise in relation to business and technical requirements for Unique Device Identification (UDI). Deep insights into legislations, available software capabilities on the market and ongoing change implementation efforts ultimately led us to combine our strong UDI background with our technological expertise in SAP Cloud technologies to create the UDI Platform and furthermore, to focus our “SaaS-Solutions” business area entirely on the Life Sciences.
We are aware of the importance of quality management in business and software processes within the regulated industry and therefore attach great importance to it.
