Drug Supply Chain Security Act (DSCSA) of the USA
The United States formally promulgated a special traceability regulation "Drug Supply Chain Security Act " (DSCSA) at the end of 2013 and required that a traceability system of whole supply chain should be established throughout the country by the end of December 2023.
Falsified Medicines Directive (FMD) of EU
In July 2011, the European Parliament and EU Council approved the Falsified Medicines Directive (FMD) which explicitly required to establish a safety archive to verify the authenticity of drug sold in EU as well as a common database of EU countries to store the medicine safety information.
FMD was formally promulgated on February 9, 2016 and required that drug sold in EU countries should conform to FMD by February 9, 2019.
According to the ESC production line tagging system, spray GS1 QR code on each salable independent unit, so that all products can have the functions such as tagging, data acquisition and package association establishment.
According to the product data management (PDM) system, effectively collect the production and in/out-stock data, upload the data to the global digital third-party platform (such as Tracelink) and help pharmaceutical enterprises to meet the regulator’s requirements for drug serialization.
As an open global business language used in many links and fields, GS1 international code can provide a unique identification for trade items and logistics units in the world.
According to the GS1 unified coding standard, get through the whole supply chain of pharmaceutical industry through product serialization construction, eliminate obstacles of data circulation in all links, improve the management efficiency and transparency of supply chain and gradually realize the transformation and upgrading of supply chain digitalization in the pharmaceutical industry.
Product architecture
Acctrue tagging system is applicable to various serialized tagging production lines and can realize seamless docking with different L4 system service providers.
Product stability
The data accuracy of China Drug Administration reaches 100%. Acctrue tagging system has served the pharmaceutical electronic supervision code industry for more than 10 years and owns more than 3,000 customers, over 10,000 production lines and a large amount of cases of smoothly-operated high-speed packaging lines, and the system stability has been proved by a lot of practice.
Experience in overseas projects
Acctrue Technology established branches in San Francisco in 2013 and has successfully provided whole industry chain traceability service for many foreign-funded pharmaceutical enterprises such as Pfizer, Bayer, AstraZeneca, Roche, Sanofi and Novartis as well as serialization construction service for domestic pharmaceutical enterprises such as Hengrui, Minsheng Binjiang, CSPC and HANSOH to export drug to the USA and EU.
Excellent service
Acctrue Technology has more than 10 years of experience in whole industry traceability of drug and whole-process consulting solutions, occupies more than 85% drug supervision market and has rich implementation and service experience in the field of drug electronic supervision.
