Serialization & Labeling Validation for Regulatory Compliance: 2D Codes, Aggregation, Software & Packaging Line Qualification How to Validate Serialization & Labeling Systems in Pharma: Compliance with DSCSA, EU FMD & Aggregation Controls Serialization and labeling validation in pharmaceuticals is crucial for regulatory compliance, supply chain integrity, and product traceability. Regulations such as the Drug Supply Chain Security Act (DSCSA) and the EU Falsified Medicines Directive (FMD) require validated systems for printing, verifying, recording, and reporting unique product identifiers. This article outlines a step-by-step approach for validating labeling and serialization systems including packaging line qualification, 2D code verification, aggregation, software validation,…