IDMP Data Governance for Global Regulatory Affairs, Production & Supply

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

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