The IT Compliance Framework is designed to ensure the implementation, validation and GxP-compliant operation of SAP S/4HANA from day one. It containsbest-practice validation processes, SOPs and templates that are optimally tailored to SAP projects with the aim of secure implementation and operation of the system. This is particularly important when planning, hosting, operating and supporting in the cloud or outsourcing to a service provider, e.g. Life Sciences Alliance. When using the IT Compliance Framework, the timely re-validation of the SAP system in case of changes is guaranteed (Managed Validation Services).
Processes and SOPs are consistent and logically coordinated and ensure efficient and cost-efficient operation over the entire life cycle.
- All mandatory activities and functions of the CSV are defined in the framework.
- Orientates itself to the GAMP®5 V model and GAMP®5 Operation GxP Systems.
- Focus on systems to support business processes.