Cyrille Castelnau

Objectives:

• Redefinition of user processes toadapt the tool to the process

*Improvement of the End to End process(Upstream: automatic retrieval and analysis of sales forecasts / Downstream: automatic provision of Links to the tool for vaccine release and shipment: SBRS),

Achievements:

*Writingof all user requirements (**User Requirement Specifications**),*Change managementwith users to structurally and functionally validate the solution (graphical interface and processes),

• Writing of the user testing phase (**User Acceptance Tests / Acceptance**)
• Supervision of the UAT testing phase (**Test Leader**),

*Planning**, **monitoring**, and **communicationof all project tasks,*Rewritingof alldocumentation(Standard Operating Procedure, Operating Manual, Repository, Training Module),*Data migrationfrom the old system to the new one*Trainingof users on the new tool,*Point of contact as an expertfor all questions related to industrial or regulatory vaccine data and associated processes,*Hypercare managementpost-delivery.

Objectives:

*Create and maintain Linksto enable the company to secure therelease and shipment processof vaccines worldwide

• Implement alldocumentary structureassociated with good Link management practices

*Traininternal employees to ensure business continuity

Achievements:

*Writing and validationof the procedure (SOP) and operating manual,

• Rewriting of theRepository containing the rulesfor creating Links,
• Writing of the **training material**,

*Training of two internal employeesandcommunicationto all affected departments

Objectives:

*Implement processesandmanage changewith impacted users, enabling certain data to reach the quality level required forGxP classification*Increase the scopeof data integrated into the Repository by includingR&D datato improve the Product Logistic Flow

Achievements:

• Characterization of whatGxP datais
• Implementation of the process for all domains (**procedure adaptation**)
• Onboarding ofquality stakeholders(multi-site)

*GxP data migration*Adaptation of URSto add a role in data entry tools

• Writing and execution of user tests (**Test Leader**)
• Writing oftrainingmaterial and training of stakeholders

*Change managementfor employees in the concerned domains*Onboarding of R&D employees(governance implementation)

• Definition oftool evolutions

*Monitoring of tool modifications*Adaptation of processesfor R&D data*Monitoring of R&D data collection and migration*Trainingof employees on tool usage