Case Study: IDMP Data Governance for Global Regulatory Affairs, Production & Supply
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.
Celegence Solution & Approach:
QDOSSIER – a Celegence company supported following activities:
- 1Workshops to put IDMP in the context of company’s daily business
- 2Impact assessment of IDMP implementation guide and version updates
- 3Analysis of proposed enterprise-wide data model including an Enterprise Data Lake (EDL) and RIM to support IDMP and beyond
- 4Data collection, remediation and data entry into RIM using load sheets
- 5Collaboration 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
- 6Ensured data governance by defining data owners, data consumers and data standards, including controlled vocabularies mapped to externally used CVs through Reference Data Management
- 7Creation/editing of procedural documents and training materials
- 8Training on revised procedures
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.