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IDMP EASI

Streamline IDMP compliance with pre-configured templates, data mapping, and real-time validation for EMA submissions.

Solution by Ennov
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Overview

Struggling with IDMP Data Extraction?

Discover the fastest method to prepare your regulatory data for IDMP without revamping your Regulatory Information Management (RIM) system.

What is EASI?

The EASI Connector by Ennov offers an agnostic, plug-and-play solution for IDMP. It efficiently extracts structured, validated data from any RIM system and converts it into an IDMP submission-ready format.

This solution also interfaces with the European Medicines Agency's (EMA) Product Management Service (PMS), enabling comparisons between your data and PMS data, facilitating preparation for submission to the EMA.

Why It Matters

  • Imminent IDMP Deadlines: EMA mandates the enrichment of PMS data, making delays costly.
  • No Manual Rework: Avoid data re-entry in the Product Lifecycle Management (PLM) portal. EASI automates the entire process.
  • Stay in Control: Verify and compare your data with PMS before submitting, allowing you to correct discrepancies at their origin.

How It Works

  • Agnostic Integration: Compatible with any RIM system.
  • Data Extraction and Transformation: Effortlessly converts product data into the IDMP format.
  • Validation and Readiness: Ensures data is fully validated and aligned with EMA's latest requirements, providing a future-proof and efficient solution.

Why Choose EASI?

  • Proven Expertise: Developed by IDMP specialists.
  • Flexible: Integrates with any RIM or master data system.
  • Fast Deployment: Submit IDMP data efficiently while maintaining your existing workflows.

The Result

  • Save Time
  • Ensure Full SPOR Compliance
  • Avoid Data Duplication
  • Be Prepared for PMS API Automation
  • Decrease Manual Errors
  • Partner with a Leader in IDMP Compliance

Ready to maximize your RIM's potential? Collaborate with Ennov to remain compliant and proactive.

Meta

Category
Regulatory & Quality Compliance
Field(s)
Quality & Compliance
Target user(s)
QA / Regulatory Affairs
Tag(s)
Quality & Compliance Management