You have decided to implement and prospectively validate SAP S/4 HANA. You would like to outsource the tasks and activities for initial validation and maintaining the valid state of the system after Go Live.
Mediation of all tasks for the initial validation of the SAP system during the implementation, training or mediation of the validation method and definition of the requirements for the implementation team from a validation perspective, provision of all required documents (validation plan, SOPs for SAP validation, digital process landscape, templates for URS, FS, DS, customizing documentation, risk analysis, test plan, test cases, validation report, business processes, detailed processes, partially user requirements – all content specifically tailored to the Life Science Industry).
Providing the PQM, creating all validation documents as part of the implementation project, performing the risk analyses, creating the test plans and test cases, performing the tests (optional), creating the validation report, supporting the system release, keeping the system in a valid state after go-live, i.e. adapting the URS + FS documents, performing the risk analysis, adapting the SOPs if needed in the Hyper Care phase.
In the System Life Cycle:
After the Hyper Care Phase, DHC performs all IT QA tasks in the context of changes and release upgrades as well as upcoming authority and customer audits, e.g. risk analysis, document changes, provision of test plans, review and monitoring of tests, review and monitoring of formal requirements (including signature regulations).
Tests, transports, etc. are performed by the customer and controlled by DHC.