As validation is a vital and enduring matter for compliance in the Life Sciences Industry, we support you to achieve GxP compliance in the Cloud by offering extensive validation support as well as an automated qualification infrastructure for a smooth validation process of the UDI Platform.
Our UDI Platform is based on the SAP Business Technology Platform, which is constantly evolving and continuously being developed and enhanced by SAP, so that businesses can leverage these innovations and remain competitive in today’s fast paced digital economy. However, the continuous delivery of service updates poses a challenge to follow the traditional validation and qualification approach for Computer System Validation (CSV). Therefore, an adapted approach is required in order to verify that the intended use is constantly met.
Our UDI Platform is developed in accordance to the GAMP®5 Supplier Good Practice and designed to meet the specific requirements of the regulated industry in accordance to FDA 21 CFR Part 11. We provide release notes for business users and IT users with respect to the affected business processes within the UDI Platform. This is intended to help the identification of internal processes and to simplify the corresponding change management, thus reducing efforts in ensuring continuous compliance.
We also compiled a whitepaper that describes in detail how our software solutions can be operated as GxP-compliant applications on SAP Business Technology Platform. The whitepaper is available on request.
Bridge the gap between keeping the cloud pace and running software in a safe and reliable way with our GxP Compliance Service – an automated qualification infrastructure to ensure qualified operations of the UDI Platform by conducting testing in regular intervals in an automated and thus easily repeatable manner.
It integrates the shared responsibilities and other cloud-related specifics into the established GAMP®5 V-Model and supports the continuous verification of the UDI Platform as well as continuous qualification to provide evidence that leveraged SAP Business Technology Platform services always meet their intended use despite of underlying changes by SAP.
