This IT project is part of our digitalization and optimization of our customers’ IT landscape. Through targeted measures, we promote technological progress, optimize cross-system processes and create a sustainable basis for future developments. Our IT reference projects serve as a basis for orientation. They support the reusability of tried and tested concepts as part of project implementation.
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PRI Approval
Project duration: 6 months
Brief description
Quality assurance and approval of Potentially Reportable Incidents (PRIs) and Quarterly Complaint Check.
Supplement
Central release of PRIs and correspondence with relevant interfaces: ICC, First Level Investigation Unit (FLIU), Case Investigation and Resolution Unit (CIR), Vigilance, the responsible countries, local and global Salesforce support and quality teams.
Subject description
The Project is ensuring the complaint handling of Potentially Reportable Incidents (PRIs) within the organization (defined countries) in accordance with the legal and global Diabetes Care specifications, timelines and data quality.
IT project data
- Industries pharmaceutical industry
- Specialist tasks Audit, GxP/GMP, international communication systems, QM in the project, quality assurance
- DP tasks project management
- System environments Cloud Computing, Internet/Intranet, organizational consulting, standard software: CRM systems
- Procedure model Waterfall Model
- Standard software and BI Salesforce
Project period01.01.2019 - 30.06.2019
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