Research of SolMan 7.2 topics including but not limited to: document creation, signature schemes, process modelling, change request management, 21 CFR Part 11 compliance, integration between ChaRM and test management, Focused Build, running of demo system, authorization, customization .

Drafting, training and implementation of major update in change request management process. Drafting of boundary conditions for revalidation project. CSV&C consultancy supporting for the VM function – especially supporting/organizing the compliant handling of the high volume of changes to the running system. Review, approval and closeout of changes in the running change request management process.

Review, approval and closeout of changes in the running change request management process. CSV&C consultancy supporting for the VM function in updating SLC documentation.

Review, approval and closeout of changes in the running change request management process. CSV&C consultancy supporting several VM functions in details of the change request management process.

Support of CSV&C function for deployment of SAP-ERP system to four international company sites. Duties included but not limited to: driving and supporting update of SOP and validation documentation, supporting facilitation of risk-mitigation measures through training team and serving as a deputy in review, approval and closeout of changes in the running change request management process.

Modelling of IT Change Request Management Processes. Creation of Process Training Material. Performance of Functional Risk Analysis and creation of related documentation.