As the leader of whole industry chain traceability system in China, Acctrue Technology signed a strategic cooperation agreement with the first drug whole chain traceability cloud service provider in the world in May 2018 and started deep cooperation in the field of drug digitalization supply chain and global compliance management in Asia-Pacific region.
In November of the same year, many executives such as Shabbir Dahod, CEO of TraceLink, visited the headquarters of Acctrue Technology and warmly welcomed by Xie Zhaohui, the President of Acctrue Technology.Both parties further reached a consensus on promoting the exported drug cooperation project construction of domestic pharmaceutical enterprises. The two enterprises will create a win-win Level1-Level5 all-round and one-stop drug safety and digital supply chain solution based on the deep localization technical strength, the industrial background of Acctrue and the influence of Tracelink in drug supply chain in the world, and provide advanced service that conform to the international industry norms and standards for the pharmaceutical enterprises in China.Tracelink hopes to provide a solution that not only conforms to the laws and regulations but also can increase income for pharmaceutical enterprises in China, and help them to deliver drug to the patients safely.
So far，Acctrue and Tracelink has provided customized technical solutions for nearly 30 domestic pharmaceutical enterprises such as Pfizer, Minsheng Binjiang, HANSOH, Hengrui, YILING PHARMACEUTICAL, Techdow Pharma, HUMANWELL HEALTHCARE and SINOPHARM ZHIJUNthe drug whole industry chain digital traceability system that conforms to the laws and regulations of many countries such as China,EU and the USA, implemented more than 40 production lines and provided vigorous technical support for guaranteeing the quality safety of exported drug and the international market competence of pharmaceutical enterprises in China.
Drug serialization is the key for meeting the regulatory compliance
Since drug have major influence on the public health due to its particularity, all links from market access to circulation of drug in the global standard market shall be strictly regulated.According to statistics, more than 40 countries in the world have promulgated the drug traceability laws so as to trace and manage drug in the full life cycle of supply chain. The United States promulgated the Drug Supply Chain Security Act (DSCSA) at the end of 2013, the core concept behind it is to develop and maintain a traceability system from drug production to sales terminal and ensure 100% accuracy.
The so-called serialization is a way to classify the single-packed independent individual identification codes, a process to convert the product status information into a storable or transmissible form and an only method to trace drug in the whole supply chain.
After the Drug Supply Chain Security Act (DSCSA) of the United States and the Falsified Medicines Directive (EU-FMD) of EU took into effect, guaranteeing the drug package serialization and traceability has gradually become a global industrial standard/mandatory law.For pharmaceutical enterprises involved in overseas market transactions, seeking for a suitable serialization infrastructure solution is the key to meet the regulatory compliance.
Powerful cooperation and mutual complementarity
Create the best serialization solution for exported drug
TraceLink--The first drug traceability platform in the world
TraceLink is a world-famous drug traceability solution provider.The drug traceability SaaS platform--Life Sciences Cloud traces the drug and obstructs the fake drug through the whole supply chain so as to protect consumers from fake and toxic drug. So far, TraceLink has covered nearly 300,000 partners dominated in the United States and EU market, owned over 270,000 supply chain terminals and become one of the most widely drug traceability platform in the world.
TraceLink has senior industrial experience since its development:
IPM experience:
Industry-leading SaaS software platform
Strong software development and management capacity
Rich experience in pharmacy or supply chain
TC experience:
1.Strong system solution capacity
2.Rich technical solution design experience and strong fault removal capacity
3.Solid knowledge reserve and strong configuration skills
Acctrue Technology--The first brand of pharmaceutical whole industry chain traceability in China
1.Flexible product architecture
Acctrue tagging system is applicable to various serialized tagging production lines and can realize seamless docking with different L4 system service providers.
2.Stable product performance
Acctrue Technology has rooted in the China drug electronic supervision code industry for more than 10 years, served over 3,000 customers and owned more than 10,000 production lines.
3.Rich experience in overseas projects
Acctrue Technology established the branch in San Francisco, USA in 2013, has successfully provided the whole industry chain traceability service for many foreign-funded pharmaceutical companies such as Pfizer, Bayer, AstraZeneca, Roche, Sanofi and Novartis, Astellas, CSL Behring, Octapharma and Grifolsas well as serialization construction service for domestic pharmaceutical companies such as Hengrui, CSPC, Techdow Pharma and Minsheng Pharm to export drug to the USA and EU.
4.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.
Acctrue and tracelink cooperate based on the deep understanding and research in domestic and foreign pharmaceutical traceability industrial policies and standards, give full play and complementary the advantages and put forward the serialization solution which is most suitable and the best choice for many pharmaceutical enterprises.
The solution is based on ESC production line tagging system. Every salable independent unit is sprayed with GS1 QR code so that the product can have functions such as tagging, data acquisition and package association establishment. According to the product data management (PDM) system, effectively collect production and in/out-stock data and upload the data to the global digital third-party cloud platform (such as SAP, Tracelink and Rfxcel). The solution is applicable to the traceability requirements and government regulations of many countries such as China, the United States, Korea and EU, fully meets the requirements of GMP/GSP, 21 CFR Part 11 and Annex 11 for information system, generate codes (code128, GS1, SGTIN and SSCC) according to different business demands and code system or customize the format to support QR code.
Case sharing
Techdow Pharmais a large-scale low molecular heparin pharmaceutical enterprise that integrates R&D, production and sale of drug into a whole, the raw materials of drug have obtained many international authoritative qualification, and Techdow has become the largest low molecular heparin preparation exporter in China. Enoxaparin sodium of Techdow Pharma is exported to EU, and the market share accounts for more than 60%.
Founded in 1970, Hengrui Medicineis the largest research and production base of antineoplastic drug and surgery drug in China, one of the most innovative large-scale pharmaceutical enterprises as well as the first domestic pharmaceutical enterprise that is approved to sell injection in European and the United State.
In recent years, Acctrue has undertaken the product serialization system projects of two companies to export EU and the United States. Both projects have the characteristics such as group platform control, more export varieties/multi-factory remote production and centralized and complicated product data information, so they shall be compatible with the laws and regulations of China, the United States and Europe. The projects of Techdow Pharma provide hundreds of product specifications and dozens of package sizes. In addition, Techdow Pharma has flexible production modes such as “QR code + three phases”, “Only three phases are printed but unassociated” and “Manual production shall be started when automatic packaging line is failed”.
Therefore, the system of Acctrue Technology is highly integrated with ERP, WMS, WCS and TrackLink and gives full play to the management value of drug serialization inside the enterprise and supply chain while meeting the requirements of FDA/CFDA drug serialization regulations.
The success of serialization system projects of many exported drug proves that Acctrue Technology has the serialization functions that conform to the laws and regulations of different countries and made outstanding achievements in implementing the system standardization, conforming to different business demands of enterprises and promoting the expandability and interoperability.
In the future, Accture will take “unique code for product” as the core continuously, focus on the fields such as pharmacy and fast consumption, committed to the construction of whole industry traceability ecosystem, help enterprises break through many barriers such as supply chain, channels and market, fully improve the digital management level of enterprise and promote the reforming of industry chain and improvement of value chain.