Articles tagged with “serialization”

DSCSA EPCIS Exception Handling: Failure Modes and Fixes

A 2026 analyst report on DSCSA EPCIS exception handling: PDG's five exception categories, GS1 EPCIS 2.0 ErrorDeclaration mechanics, FDA stabilization survey data, and Cardinal Health's historical sampled pilot findings.

43 min read

8/5/2026

dscsa epcis exception handling gs1 epcis pdg guideline hda exceptions handling serialization drug supply chain security act transaction information pharmaceutical traceability

Pharma Labeling Operations: A 6-Month Pre-Approval Checklist

Get a 6-month checklist for pharmaceutical labeling operations. Updated for 2026 with DSCSA enforcement deadlines, FDA PMI rule status, EU ePI developments, and current recall data.

40 min read

11/23/2025

labeling operations pharmaceutical labeling regulatory approval fda labeling requirements gmp product launch checklist serialization 21 cfr 201.56

Evaluating ERP Systems for Pharmaceutical Compliance

An analysis of top ERP systems for the pharmaceutical sector, evaluated on regulatory compliance (21 CFR Part 11), batch traceability, and serialization. Updated for 2025–2026 with DSCSA enforcement timelines, AI/Copilot capabilities, and latest platform releases.

90 min read

8/25/2025

erp systems pharmaceutical manufacturing regulatory compliance 21 cfr part 11 batch traceability serialization gmp quality assurance