Articles tagged with “traceability”

Git Version Control for FDA and IEC 62304 Compliance

Examines how to apply Git version control workflows to satisfy FDA compliance under the 2026 QMSR, covering traceability, audit trails, CSA guidance, SBOM requirements, and standards like 21 CFR Part 11 & IEC 62304.

50 min read

8/26/2025

git fda compliance version control iec 62304 21 cfr part 11 medical device software regulatory submission traceability

Pharmaceutical Serialization Software and Regulatory Compliance

This article explains pharmaceutical serialization software, its critical role in securing the drug supply chain, and adherence to regulations like DSCSA and FMD. Updated with 2025-2026 enforcement deadlines and vendor developments.

65 min read

7/21/2025

pharmaceutical serialization supply chain security dscsa fmd traceability regulatory compliance anti-counterfeiting