From Global Compliance Mandate to Strategic Asset

The Challenge: Mastering Product Data in an Era of Global Compliance Mandates

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Health authorities worldwide are rolling out mandates based on the ISO IDMP standard. The EMA's PMS project is just the first wave of a global shift that demands more than just data reformatting; it requires life sciences companies to achieve true mastery over their product data integrity. For a top 10 global pharmaceutical company, this presented a familiar but daunting challenge: critical product information was locked away in disconnected Regulatory and CMC (Chemistry, Manufacturing, and Controls) systems, making it nearly impossible to ensure quality, consistency, and compliance.

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The company needed a solution that would not only prepare them for EMA PMS but also establish a scalable foundation to meet future IDMP requirements and, most importantly, transform their data into a queryable, enterprise-wide asset.

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The Solution: An Intelligent Data Fabric, Ready in 100 Days

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In an intensive sprint of less than 100 days, ACCURIDS integrated siloed product data from the client's disparate Regulatory and CMC systems into a unified, standards-based Knowledge Graph.

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By mapping this information to the PISTOIA IDMP Ontology, this process created a powerful, interconnected view of their product portfolio where one had never existed before. With this solid data fabric in place, the client was immediately enabled to tackle its most pressing challenge: the data alignment required for EMA PMS compliance, which became the first of many value-added use cases addressed by the platform.

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The ACCURIDS platform provides more than a static repository; it is an interactive data asset that empowers Subject Matter Experts. They can now interrogate complex product relationships using both natural language questions and structured queries. The Knowledge Graph is now ready for enterprise-wide adoption, serving as a trusted and centralized source for business applications that need to consume this high-quality product data.

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"Before ACCURIDS, finding a specific detail about a product's formulation across different regulatory filings could take days of chasing emails and reports. Now, I can ask a direct question and get a validated answer in seconds. It completely changes how we access and trust our own data, allowing us to focus on the science, not the data hunt."

— Senior Scientist, CMC

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The Results: Compliance, Clarity, and Long-Term Governance

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This rapid initiative did more than just address a looming deadline; it fundamentally changed how the company interacts with its product data, creating a lasting strategic advantage.

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• Accelerated Compliance Readiness: Established a validated data foundation that immediately enabled the client to begin their EMA PMS compliance journey, creating a robust framework for all future IDMP-related mandates.

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A Trusted, Centralized Data Hub: Created a single, reliable source of truth for product information, breaking down departmental silos and providing a consistent data backbone for other business applications to leverage.

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"We initially saw this as a project to solve our EMA PMS compliance challenge. It quickly became clear we were building something much more strategic. With this Knowledge Graph, we've laid the cornerstone for true end-to-end product data governance — from NME to divestment. This isn't just a regulatory solution; it's a foundational piece of our company's digital transformation."

— Digital Transformation Lead