Case Study: 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.

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:

  • 1
    Workshops to put IDMP in the context of company’s daily business
  • 2
    Impact assessment of IDMP implementation guide and version updates
  • 3
    Analysis of proposed enterprise-wide data model including an Enterprise Data Lake (EDL) and RIM to support IDMP and beyond
  • 4
    Data collection, remediation and data entry into RIM using load sheets
  • 5
    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
  • 6
    Ensured data governance by defining data owners, data consumers and data standards, including controlled vocabularies mapped to externally used CVs through Reference Data Management
  • 7
    Creation/editing of procedural documents and training materials
  • 8
    Training on revised procedures

Highlights:

  • Data collection for 30+ loadsheets
  • 20+ impacted products (CAPs and non-CAPs)
  • Collaboration with 120+ external and internal manufacturing sites for IDMP data compliance
  • Module 3 templates change from narrative to tabular formats
  • Harmonized processes across merged entities
  • >150 user stories addressed to facilitate GPS data management

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.

Get in touch today to discuss your regulatory needs by reaching out to info@celegence.com or contact us online.

Learn More