Case Study: IDMP Data Analysis & Remediation for a Global Pharmaceutical Company

Project Summary

Celegence was engaged to support an organization’s transition to using VEEVA as their IDMP central repository. The project involved data analysis and remediation to ensure data from various source systems was properly formatted and ready for integration into VEEVA Vault.

Project Deliverables

  • Comprehensive data analysis

  • Gap analysis against EU master lists

  • Recommendations for missing substances, manufacturers, and updates to vocabularies

  • Standardized data mapping tools

  • Complete and properly formatted data for IDMP implementation

  • Identified data sources and mapping to RIMS

Celegence Solution & Approach:

Celegence provided a team of Subject Matter Experts (SMEs), including multiple data analysts. The team conducted a thorough data analysis to ensure the data from all source systems was complete and in an acceptable format.

A gap analysis against EU master lists was performed, and recommendations were made for missing substances, manufacturers, vocabulary updates, and compliance with IDMP requirements. The team standardized mapping tools and resolved mapping errors to minimize regression testing time and costs.

Highlights:

  • Detailed data analysis and remediation

  • Standardized and matched differences in source and target data contents

  • Improved data quality in preparation for IDMP implementation

Project Achievements

Celegence delivered the following value and business impact to the client:

  • 1

    Implemented recommendations from the gap analysis, minimizing regression testing time and costs.

  • 2

    Standardized mapping tools to reduce complexity and errors.

  • 3

    Enhanced data quality, ensuring readiness for the next phase of IDMP implementation.

Project Success

Celegence’s expertise in data analysis and remediation ensured the client’s data was accurately formatted and compliant with IDMP standards. The improved data quality and standardized processes reduced project time and costs, setting the stage for successful IDMP implementation.

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