[["Role","Responsibilities","Name, function / company","Project","Operation"],["Process Owner","•\tWrites and/or reviews URS •\tWrites and/or reviews FS in relation to the URS •\tWrites and/or supports writing of qualifications protocols •\tSupports qualification tests execution •\tRunning tests for system changes •\tKey User Training","Cerebellis, Thomas Perraudin","x","x"],["Business Responsible","•\tCarries out project management •\tPerform CSV documentation maintenance or allocates resources to do so •\tUser Training","Cerebellis, Thomas Perraudin","x",""],["Key User","•\tTrained to use the system •\tExecute qualification tests protocols","","x",""],["Technical Unit","•\tTechnical support (installation and functionalities) if necessary •\tWrites or supports writing of FS •\tWrites and/or reviews qualification protocols •\tSupport during qualifications / reviews anomalies •\tEstablishment of infrastructure during the project and operational phases •\tAssistance with setting up the system during the project •\tRealization of system changes in accordance with the Functional Specifications •\tUser Training  •\tUser support during the production phase","Cerebellis, Laurent Noyon","x","x"],["CSV","•\tWriting Validation Plan and Report •\tSupport and review for most qualification documents including o\tURS and FS (regarding risk analysis and regulatory compliance) o\tIQ, OQ, PQ protocols (preparation and execution review)","Writee, Marie Euzen","x",""],["QA","•\tResponsible for Quality Assurance and regulatory support during the project phase •\tReview and approval of Procedure if any •\tReview and Approval of Validation Documents •\tReview validation anomalies if needed •\tReview and approval of changes during initial validation","Writee, Marie Euzen","x",""],["QA","•\tResponsible for Quality Assurance and regulatory support during the operational phase •\tReview and approval of Procedure if any •\tValidation anomalies review if needed","Cerebellis, Thomas Perraudin","","x"]]