CAPTIS™: MDD to MDR CER Remediation of a Standalone Software
Implementation of Veeva Vault IDMP Functionality for a Global Pharmaceutical Company
Project Summary
Celegence was engaged to implement VEEVA Vault IDMP functionality for a client needing to comply with EU regulations. The project involved reformatting and closing data gaps to align with VEEVA’s new product capabilities.
Project Deliverables
VEEVA RIM Vault configuration changes
Data extraction and remediation
Loader sheets preparation
Data migration dry runs
Vendor management and mentoring
Celegence Solution & Approach:
Celegence provided expert knowledge of IDMP data and VEEVA RIM Vault architecture. The team offered business and data analysis support, managed 3rd-party vendors, and ensured VEEVA configuration changes were made correctly. Data was extracted through backend queries, and a gap analysis, data mapping, and remediation were performed. Celegence prepared loader sheets for data import and mentored vendor staff, conducting data migration dry runs to ensure a smooth transition.
Highlights:
Expert management of VEEVA RIM Vault configuration changes
Thorough data extraction, mapping, and remediation
Successful data migration dry runs
Project Achievements
Celegence delivered the following value and business impact to the client:
Maintained the client’s presence in the EU market, safeguarding $30 billion in revenue.
Simplified future upgrades by eliminating customizations.
Leveraged standard reports and analytics in new VEEVA functionality to quickly identify data issues.
Project Success
Celegence’s comprehensive implementation of VEEVA Vault IDMP functionality ensured the client met EU regulatory requirements and maintained market presence. The elimination of customizations and improved data quality reduced compliance risks and facilitated future upgrades, underscoring Celegence’s commitment to excellence in regulatory compliance solutions. .
Get in touch today
To discuss your regulatory needs by reaching out to info@celegence.com or contact us online.
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25 Mar, 2025
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