EU MDR Compliant Templates for a Multinational Pharmaceutical Company
IDMP Data Governance for Global Regulatory Affairs, Production & Supply
Project Summary
Consulted on efficient right-first-time data management for Regulatory Affairs (RA) and Global Production and Supply chain (GPS) to support EU IDMP for a big pharmaceutical company.
Project Deliverables
IDMP awareness creation
Data remediation and data entry
IDMP ready Module 3 templates
Business process definitions
Veeva RIM data model analysis
Change management
Procedural documents and trainings
Hypercare
Celegence Solution & Approach:
QDOSSIER – a Celegence company supported following activities:
Highlights:
Workshops to put IDMP in the context of company’s daily business
Impact assessment of IDMP implementation guide and version updates
Analysis of proposed enterprise-wide data model including an Enterprise Data Lake (EDL) and RIM to support IDMP and beyond
Data collection, remediation and data entry into RIM using load sheets
Collaboration with enterprise-wide stakeholders including IT, GPS, QA, CMC Authors, RA and Procurement to build business processes for data creation, maintenance and repurposing, incl. IDMP
Ensured data governance by defining data owners, data consumers and data standards, including controlled vocabularies mapped to externally used CVs through Reference Data Management
Creation/editing of procedural documents and training materials
Training on revised procedures
Project Achievements
Recognition of areas of improvement, resulting in engaged team members
Identification of data source, data suppliers and definition of data flow processes
Successful collaboration with key stakeholders for RIM implementation
Successful implementation of processes, effective engagement and training of data roles
Timely completion of agreed deliverables
Project Success
Key to the success of this project was effective communication with all the involved stakeholders/departments. With a deep understanding of regulations, data governance, IT solutions and business processes within RA and GPS, it became possible to provide them with a clear picture of their roles in fulfilling IDMP requirements.
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24 Dec, 2025
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