EMA PMS DATA ALIGNMENT
Automatically Compare and Align Your Data with the EMA PMS
Our solution provides an automated comparison engine and a guided workflow to find and fix discrepancies, ensuring your data is fully aligned and to EMA PMS in time for meeting the upcoming regulatory deadlines
Start with an Instant Quality Report on Your EMA Data
Get ready for EMA PMS Alignment in 5 minutes.
Download Your Data
Sync your data from EMA Data Leverage or EMA Connectors for SMS, PMS, OMS and RMS.
Get an Instant Quality Report
See all EMA data errors and warnings instantly (validated against pre-configured IDMP-O rules).
Review & Resolve Quality Issues
Leverage reporting and monitoring or cleanup progress.
Achieve Full, Continuous Alignment with Your Internal Data
Automated Comparison with Your Internal Systems
Once your IDMP Product Data Backbone is in place, the platform automatically compares your internal data (from Veeva, RIM, etc.) side-by-side with the validated EMA dataset, using AI-enabled proposals to Identify discrepancies across all products efficiently.
AI-enabled auto-generate mapping proposals for data stewards to confirm.
UI allows to compare data between EMA PMS and internal data.
Fixing Data Quality and Alignment Issues
A user-friendly workflow enables your data stewards to manage and coordinate the resolution of any discrepancies directly in a single interface, ensuring every change is traceable and audit-ready.
Capture assessment of alignment issues in ACCURIDS.
Track progress of issue resolution (in EMA PMS or RIM) with %.
Manage resolution coordination through ticket system.
Planned integration with EMA ticketing.
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Trusted by pharma leaders
"The automation and intelligent mapping capabilities made a huge difference. What used to take weeks of manual effort can now be completed in a fraction of the time — with higher accuracy and clear audit trails. It has truly elevated the way we work with product data.”
Senior Regulatory Information Manager at a Leading Global Pharmaceutical Company
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Our phased approach for EMA PMS Data Alignment
Phase 1
Data Quality Risk Assessment
Get first report of data quality issues of EMA PMS and internal data.
Duration
2 weeks
Key Value
Automated EMA PMS DQ Reporting
Outcomes
EMA PMS Knowledge Graph
EMA PMS Data Quality Report
Phase 2
Data Alignment of Key Products
Get first alignments of product data to inform creation of prioritized resolution roadmap.
Duration
4 weeks
Key Value
Onboard internal product data for comparison with EMA PMS
Outcomes
Internal Knowledge Graph
EMA-Pharma data alignment for selected products
Phase 3
Data Alignment of Full Portfolio
Full resolution of EMA PMS data alignment issues.
Duration
1–3 months
Key Value
Resolve data quality and alignment issues at EMA PMS or internal source systems
Outcomes
EMA PMS compliance
Continous monitoring of changes
Phase 4
Cross-functional harmonization
Leverage and expand the aligned product data to connect regulatory with clinical, supply chain, manufacturing and other functions.
Duration
6–12 months
Key Value
Integration with key systems
Outcomes
Use Case Roadmap
Business process improvements
Enabled by the IDMP Data Standardization Fabric
Our EMA PMS Data Alignment capabilities are a core feature of our IDMP Fabric. The Fabric creates the clean, unified, and standardized Product Data Backbone that makes this level of automated comparison and reliability possible in the first place.
Learn more about the IDMP Fabric
`Ready to Start Your` EMA PMS Alignment Journey?
Ready to see the purpose-built Fabric in action? Schedule a personal demo and we will show you how to eliminate the risk and complexity of your IDMP project.
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