Cloud-based solution delivers complete DSCSA adherence
ME NewsWire/Business Wire
CRANBURY, N.J. - Friday, October 31st 2014
Systech International, a global leader in brand protection technologies, today announced that Citadel – Systech’s cloud-based enterprise serialization platform – seamlessly fulfills global regulatory requirements, including the Drug Supply Chain Security Act (DSCSA) lot traceability requirements that will take effect in January 2015. The law requires manufacturers to send Transaction Information, Transaction History, and Transaction Statement (TI/TH/TS) in the form of an advance shipping notices (ASNs) to their wholesalers. Manufacturers using Systech Citadel will be automatically compliant with upcoming FDA requirements and safeguarded against additional adherence deadlines through 2023.
Systech enhanced Citadel’s ASN 856 capabilities to ensure alignment with the Healthcare Distribution Management Association’s (HDMA) Electronic Data Interchange (EDI) Guidelines for the 856 Advance Ship Notice to Support Implementation of DSCSA, published in July of this year.
Systech Citadel’s unique plug-in frame work and extensible infrastructure allows rapid development for new and changing regulations. This is a critical differentiator for Citadel, as it is able to meet the compliance needs of both global and domestic providers while addressing the long-term needs of each region’s phased-in implementation plans with minimal rework and change over time.
“We are proud to be one of the only truly global solution providers actively committed to the shifting compliance needs and goals of the pharmaceutical landscape,” said Robert DeJean, CEO, Systech. “Demonstrating that Citadel satisfies regulations in markets worldwide proves that Systech is again ahead of the competition in offering solutions that will enable manufacturers to meet global regulations and DSCSA compliance in 2015 and beyond.”
Systech Citadel offers a full suite of features necessary to serialize product and track its movement through the supply chain — enabling regulatory reporting, product authentication, and brand-protection benefits which transcend the mere need for meeting compliance deadlines. All of this is delivered seamlessly through a world-class, cloud-based platform.
Systech Citadel can be used as a standalone solution, or deployed together with the proven Systech Enterprise Serialization® foundation to which it is fully integrated. Companies can also integrate Systech Citadel with existing infrastructure as the fourth layer in the serialization stack, allowing manufacturers to pick, pack and ship products as well as provide initial transaction and shipping information.
To find out more about Citadel, please visit http://www.systech-tips.com/track-and-trace.php.
About Systech International
Systech International is a global leader in brand protection technologies with solutions that address the needs of enterprise serialization, track and trace, and authentication, serving a wide variety of industries ranging from pharmaceutical and medical devices to food and beverage and consumer goods. To learn more about Systech, please visit www.systech-tips.com.
Jack Bunting / Trish DaCosta