PMS Documentation for Software-Based Cardiovascular Imaging and Planning Tools – Audit & CE Marking Support
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:
Implemented recommendations from the gap analysis, minimizing regression testing time and costs.
Standardized mapping tools to reduce complexity and errors.
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.
Learn MoreOther Related Articles
10 Jul, 2025
Contact Us Today
From document publishing automation to eCTD submissions and beyond, Celegence is your trusted partner for regulatory affairs excellence. Contact us to learn how we can help you achieve your compliance goals efficiently and cost-effectively.
"*" indicates required fields