FDA DSCSA Standards for Interoperable Exchange

Posted on December 2nd, by Gary Lerner in News, Pharmaceuticals, Regulations.

The FDA basically stated that currently used methods of information exchange from paper to electronic were suitable “interoperable” exchange methods and that trading partners should continue to use available methods.

New System to Improve US Drug Security?

Posted on December 1st, by Gary Lerner in Integrity Matters, News, Pharmaceuticals, Regulations.

Many in the industry had expected FDA to begin establishing the blueprint for drug product tracing transaction exchange. Instead of recommending exchange standards that facilitate the accurate and efficient interchange of information among trading partners, FDA chose to list known information-exchange methods currently in widespread use and declare them acceptable.

Using EPCIS to Attain Lot Level Traceability

Posted on October 16th, by Gary Lerner in Food & Beverage, Medical Devices, News, Pharmaceuticals.

EPCIS Implementation Guidelines are updated to support DSCSA compliance. Learn how GS1 Standards can best be applied to meet lot-level and item-level traceability requirements as stipulated in US FDA DSCSA regulation.