Time is running out
Accessibility of infrastructure and speed to deployment have become paramount as U.S. regulatory deadlines loom. The next milestone for manufacturers to comply with 2013’s Drug Supply Chain Security Act is Nov. 27, 2017, by which date pharmaceutical manufacturers are required to print a unique product identification code on all Rx units of sale and homogenous cases distributed domestically.
The Quick Compliance Programme
The looming deadline makes the Antares Vision Quick Compliance Program particularly prescient, as Antares guarantees a fully integrated, validated, and complete serialization program in such a short timeframe. The program is based on preconfigured modules in concert with a standardized package of software, documentation and services, minimizing the need for Project Management Office (PMO) efforts. All units, which also offer post-implementation flexibility and scalability, are preconfigured in Antares Vision’s new Moorestown, NJ, warehouse space, and are ready-to-ship.
Featured hardware in the Antares Vision Quick Compliance Program includes:
- P&C EVO Ready: A version of the P&C EVO (details below) preconfigured for the Nov. DSCSA compliance guidelines. Ideal to print on one side of the carton.
- Reel 2 Reel module: An off-line labeling printing station. This produces reels of serialized labels suitable for bottle labeling,
- Manual station: Manages printing of serialized labels on cases (both bottles and cartons) according to the DSCSA requirement.
Data storage and Level 4
The program’s software is Antares’ GTS Plant Manager, which generates or imports serialization numbers and stores all data while interfacing with Level 4 repositories. GTS Plant Manager comes preconfigured and ready to manage line serialization. As needs evolve, the scalable software can be expanded to manage additional lines and other communication layers.
Source: Serialization Countdown