Articles tagged with “serialization”

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

Get a 6-month checklist for pharmaceutical labeling operations. This guide covers key steps for regulatory approval, FDA/GMP compliance, and avoiding costly del

35 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