Elisa De Leo
Migration and Cutover Strategy for Central Label Management in Clinical Trial Supply Chain.
Rel. Eliana Pastor, Heldin Lee Höhener. Politecnico di Torino, Corso di laurea magistrale in Ingegneria Gestionale, 2025
Abstract
The clinical trial supply chain relies on highly regulated data and processes. This thesis provides a methodology for quality control in complex, high-risk, zero-defects, and human-driven data migration projects. This work concerns the Good Manufacturing Practices (GMP) regulated data migration of Investigational Medicinal Product (IMP) labels from a legacy Enterprise Resource Planning (ERP) system to the new Central Label Management (CLM) software. The upcoming retirement of the old ERP system presented two threats: failing to migrate the label data and the potential for data integrity loss of the migrated data. The objective was to develop a robust migration and cutover strategy to ensure 100% data correctness and correspondence against the IMP data.
Failure Modes and Effects Analysis (FMEA) was conducted to predict and mitigate threats to the migration process
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