Fragmented batch, material, and product version data across MES, ERP, and RIM systems continues to drive manual reconciliation, inefficiencies, and compliance risk across supply chain and regulatory functions. This webinar presents a practical IDMP Ontology (IDMP-O)–based integration use case that demonstrates how a shared semantic backbone can automate batch-level data management and align product information across CMC and Regulatory domains.
The session will showcase how IDMP-O enables consistent batch tracking, end-to-end genealogy, and traceability across product versions and clinical studies. We will highlight recent progress, including the establishment of core semantics, expansion of batch-tracking capabilities to meet broader regulatory requirements, development of competency questions and reference architectures, and early collaboration with pharmaceutical companies to validate and test the approach.
Attendees will learn how this approach delivers a single, queryable view of batch genealogy, supports faster and more reliable impact assessments and change control, and improves compliance readiness and data quality across regulatory submissions. This webinar is relevant for professionals working at the intersection of supply chain, CMC, regulatory affairs, and data standards seeking scalable, standards-based solutions for IDMP implementation.
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