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 Cloud 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 an SAP Cloud Platform-based UDI governance solution that fits seamlessly into heterogenous IT landscapes (SAP and non-SAP) and provides the complete data governance and submission processes of UDI related Product Master Data.
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Its unique Content Package Concept enables you to cover the requirements of different regulatory authorities and thus achieve global UDI Compliance. We monitor the market requirements and implement upcoming changes of existing authorities timely into your cloud solution account for Continuous Compliance.
We help you to achieve GxP Compliance in the Cloud with our Continuous Compliance Platform, a GAMP®5-based adaptive Test-Framework designed specifically for the Life Sciences.
It supports both, Continuous Verification for applications running on SAP Cloud Platform as well as Continuous Qualification to provide evidence that leveraged SAP Cloud Platform services always meet their intended use.
Generally available soon, contact us 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.
