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Case Study 2: IDMP Readiness & Master Data Foundation (Pharmaceutical Manufacturer)

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Project Overview

This initiative focused on preparing a pharmaceutical manufacturer for IDMP compliance by establishing a robust Product, Substance, Organisation, and Referential (SPOR) master data foundation. The project addressed fragmented product and regulatory data across departments and laid the groundwork for structured submissions and ongoing regulatory alignment.

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IDMP Readiness & Master Data Foundation

 Transforming Life Science Data Integrity & Efficiency

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Business ObjectivesFeatures & FunctionalityData Governance & ComplianceData Quality & StandardisationData Integration & ConsolidationMaster Data Lifecycle Management

Business Objectives

  • Establish a single source of truth for IDMP-relevant data
  • Improve data accuracy, consistency, and completeness
  • Eliminate duplicate product and substance records
  • Strengthen regulatory compliance and audit readiness
  • Enable scalable IDMP submission processes

Features & Functionality

  • IDMP Data Model Alignment (ISO 11615, 11616, 11238, 11239)
  • Product & Substance Data Cleansing and Deduplication
  • Controlled Vocabularies and Referential Data Mapping
  • Automated Validation Rules for Regulatory Consistency
  • Integration with Regulatory Affairs and Quality Systems

Data Governance & Compliance

  • Defined data ownership across Regulatory, Quality, and Manufacturing
  • Role-based access controls
  • Alignment with GDPR, POPI, and EMA IDMP requirements
  • Ongoing audit and stewardship framework

Data Quality & Standardisation

  • Standardised product naming conventions
  • Mandatory attribute enforcement
  • Automated completeness and consistency checks

 

Data Integration & Consolidation

  • Consolidation of ERP, RIMS, and legacy product datasets
  • Harmonised product identifiers across systems

Master Data Lifecycle Management

  • Workflow-based creation, update, and retirement of IDMP entities
  • Version control and audit trails
  • Continuous monitoring dashboards

Project Timeline

1

Months 1-2

Data audit and IDMP gap assessment

2

Months 3-6

Data cleansing, standardisation, and mapping

3

Months 7-12

IDMP model configuration and system integration

4

Months 13-18

Validation, testing, training, and deployment

Project Highlights

Milestones and Deliverables


  • Cleaned and IDMP-aligned product master dataset.
  • Data governance framework for long-term accuracy and compliance.
  • Regulatory-ready data model.
  • Integrated Regulatory and Quality data flows.
Post-launch support & training. Integrity checks & updates.
Measurable Success Metrics


  • 60% reduction in duplicate product records.
  • Improved regulatory submission readiness.
  • Increased data accuracy for reporting and analytics.
  • Faster response to authority data requests
 Ensuring trusted data without compromise.
Expected Sustainable Key Outcomes


  • Long-term IDMP compliance foundation
  • Enhanced decision-making with high-quality, structured data.
  • Scalable platform for partner engagement and automation.
  • Improved regulatory confidence
Enhanced digital processes, supporting future initiatives. 

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