FDA Finalizes New Traceability Rules for High-Risk Foods

Fruits and Vegetables at a Market

After at least eight years in the making, the FDA announced the final rule to improve food traceability for domestic and foreign manufacturers who process, package, or hold foods included on the Food Traceability List (FTL) for U.S. consumption. This rule will require those manufacturers to maintain records containing Key Data Elements (KDE) associated with …

How Ready is Your ERP Software for the Drug Supply Chain Security Act?

Pharmaceutical manufacturing serialization requirements of the Drug Supply Chain Security Act

In complying with the U.S. Drug Supply Chain Security Act regulations, pharmaceutical manufacturers must ensure their ERP systems are up for the task. In late 2013 the Drug Supply Chain Security Act (DSCSA) was introduced and signed into law as a means to govern the management of pharmaceutical drugs manufactured and sold in the United …