CAPTIS™: MDD to MDR CER Remediation of a Standalone Software
IDMP Data Migration & Integration for a Global Pharmaceutical Company
Project Summary
Celegence was tasked with expanding a client’s RIM platform to incorporate IDMP fields, collecting and remediating data from various source systems and documents, and migrating it into VEEVA Vault. Additionally, the team incorporated Sporify functionality to translate IDMP terms.
Project Deliverables
Configuration changes to VEEVA Vault
Loader sheets preparation
Error log resolution
Test environment setup and QC
Controlled vocabulary recommendations
Change management and user training
Celegence Solution & Approach:
Celegence collaborated with the VEEVA support team to align configuration changes with IDMP data. The team prepared more than 20 loader sheets, some containing approximately 10,000 rows, and resolved issues in the error log. Recommendations were made for setting up test environments and performing test runs, including the development of system testing in ALM. Celegence provided controlled vocabulary recommendations for SPORIFY mapping and managed change management, including user training and updating procedural documents.
Highlights:
Seamless configuration changes to VEEVA Vault
Detailed preparation and error resolution for loader sheets
Comprehensive change management and user training
Project Achievements
Celegence delivered the following value and business impact to the client:
Successfully prepped the system for future IDMP implementation
Accelerated process refinements, reducing upgrade time and risks
Configured and updated VEEVA implementation to reflect IDMP attributes
Project Success
Celegence’s meticulous approach to data migration and integration ensured the client’s RIM platform was fully prepared for IDMP implementation. The process refinements and comprehensive user training facilitated a smooth transition, setting the client up for continued success in regulatory compliance. Overall, the main win was that all IDMP data successfully migrated into the RIMS. .
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25 Mar, 2025
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