industries

Kvinta is a powerful cross-industry software solution with a global reach. Its flexible architecture and cutting-edge technologies empower our customers to tailor their experience by selecting industry-specific features, and precisely align their business practice with the requirements. With Kvinta, businesses unlock a range of business benefits, ensure compliance and become Track & Trace ready.

Kvinta offers industry/market-specific features for a reason: T&T is influenced by business practices and has to align with existing processes that vary across industries. Kvinta tailors functionalities to best cover these variations and therefore eases integration, implementation, and rollouts to different markets.

The main differences are:

  • the complexity of regulations
  • the complexity of supply chains and business practices
  • companies' IT landscape variability
  • the export-import practices and regulations
  • the level of EDI and other services integration
  • the level of T&T application required (from basic serialization to full traceability)
The core of Kvinta functionality applies to any industry. Kvinta orchestrates the T&T data and supports T&T's function across a company and/or a chain of partners.
At the industry/market level, Kvinta is designed to support the specifics of a particular business case, emphasizing the functionalities required. From the complex requirements in a fully regulated environment with aggregation and full traceability to simpler serialization-only scenarios.

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INDUSTRY SELECTION
INDUSTRY
PERSPECTIVE
PHARMA
The pharmaceutical industry is one of the largest and most technologically advanced industries in the world. As medications can be life-critical, it is essential to strictly control the market to prevent counterfeit medications that may contain toxic or dangerous substances. Pharma has become a pioneer of Serialization and Track & Trace as a result. It is usually the first industry to introduce Serialization and Track & Trace regulations in any new country. The industry faces a range of challenging demands due to the high-speed production lines, the variety of consumer packages, contract manufacturing, and specific integrations between manufacturers, suppliers, and logistics providers. Meeting all these demands requires hardware and software that can seamlessly manage manufacturing and logistics processes. Additionally, the pharmaceutical industry with the highest standards and GxP (Good Practices) validations is strictly regulated. Traceability regulations as a rule establish not only validation of serialization codes but also control over batches, expiry dates and each operation including customer sale and withdrawal from circulation.
TOBACCO
The tobacco industry is the second largest industry in the world that has Serialization and Track & Trace regulations. The reason for this is the high prevalence of counterfeit goods circulating in the market. The illegal turnover of goods has a significant impact on the state's losses in taxes and excise, as well as on the health and safety of consumers. Compliance with these regulations is complex and requires close attention to detail. The best example of this is the EU TPD in Europe. Currently, numerous countries around the world have introduced regulations mandating the implementation of Serialization and Track & Trace in the tobacco industry. The tobacco industry faces extremely high production speeds and volumes, which set very challenging demands for both hardware and software to ensure seamless manufacturing and logistics processes.
BEER
Beer is a regulated alcoholic drink that is subject to laws in many countries worldwide, and in some cases, is even prohibited. However, while there are existing regulations governing the production and distribution of beer, Serialization and Track & Trace regulations have yet to be widely adopted in the industry. Nevertheless, an increasing number of countries are introducing these regulations. The beer industry faces several challenges when implementing Serialization and Track & Trace measures, even with low to medium levels of regulatory complexity. These challenges include large production volumes, ultra-high production line speeds, the use of various materials and consumer package form-factors, and complex distribution practices. To ensure compliance with regulations and protect their businesses, manufacturers and distributors must address these challenges and consider the most effective and efficient ways to implement Serialization and Track & Trace.
BOTTLED WATER
Bottled water is one of the most widely consumed consumer products worldwide, and its popularity makes it an easy target for counterfeit producers. In some countries, the share of counterfeit bottled water in the total market can be as high as 25%. Serialization and Track & Trace regulations are often introduced to combat this issue, but the number of countries implementing these measures remains low. Water production typically involves numerous contract manufacturing organizations (CMOs) with high-speed production lines for large volumes, and the use of various materials and consumer package form factors. This presents significant challenges for manufacturers and distributors when implementing Serialization and Track & Trace measures to ensure compliance and protect consumers.
APPAREL AND SHOES
Counterfeit products are rampant in the footwear and apparel markets, with millions of illegal sales taking place every year. This not only deprives the government of taxes but also negatively affects consumers in terms of quality and service, while damaging the brands themselves. Serialization and Track & Trace are key measures taken to combat these issues, driven not just by regulations but also by businesses seeking to protect their brands. While only a few countries have currently introduced Serialization and Track & Trace regulations, they tend to be relatively straightforward. As consumer-oriented markets with high importance placed on brand loyalty, the footwear and apparel industries are pioneers in leveraging the benefits of direct-to-consumer communication and marketing associated with Serialization and Track & Trace.
ALCOHOL
The alcohol market is typically highly regulated, and in some countries, it operates as a black market. According to the World Health Organization (WHO), 25% of alcohol in the global market today is counterfeit. Counterfeit alcohol harms producers, the national economy, and poses significant risks to the lives and health of consumers. Serialization has proven to be highly effective and appreciated in other industries, and its advantages in the alcohol industry cannot be overestimated. However, despite the mid to low complexity of Serialization and Track & Trace regulations, they are not widely adopted. Implementing Serialization and Track & Trace measures is crucial in combating counterfeit alcohol and protecting consumers. Manufacturers and distributors must consider the most effective and efficient ways to implement these measures to ensure compliance with regulations and safeguard their businesses and consumers.
DAIRY
Dairy products are widely available in retail outlets, ranging from small shops to hypermarkets. While regulations mandating Serialization and Track & Trace in this industry are less common than in Pharma and Tobacco, they serve the same purpose of protecting consumers and optimizing tax collection. Although less complex, the regulations can still present challenges due to the variety of different product types, consumer package form factors, and short product life cycles. This often requires the purchase of different equipment for serialization or package unification to reduce costs. The extensive logistics involved in the dairy industry, with numerous points of sale and perishable products, make the impact of Serialization and Track & Trace on business processes critical. Manufacturers and distributors must carefully consider how to integrate these measures into their operations to ensure compliance and protect their business interests.
HOME APPLIANCE
The global home appliance market is a highly competitive and rapidly evolving industry that includes a wide range of products, such as refrigerators, washing machines, dishwashers, ovens, and other household appliances. This market is driven by factors such as rising disposable income, increasing urbanization, and technological advancements, while also being affected by changing consumer preferences and demands for eco-friendly and energy-efficient appliances. Counterfeiting is a major concern in the industry, particularly with the growing dominance of online trade. Serialization and Track & Trace measures are designed to combat counterfeiting and increase transparency for consumers.
COUNTRY
PERSPECTIVE
EU
The EU is a critical player on the global scale in many ways. Economically, it is the third largest market in the world. To protect its consumers and fight counterfeit products, the European Commission has initiated Serialization and Track & Trace regulations for two industries: tobacco and pharmaceuticals. The main technical characteristic for both industries is the unique identifier (UI), which provides the possibility of verifying the authenticity of single folding boxes or cigarette packs. This unique identifier typically contains the GTIN, Serial Number (for pharma Batch Number and Expiry Date are added) in a Data Matrix code. With the introduction of a Digital Product Passport and other green initiatives, the number of industries engaged in Serialization and Track & Trace will continue to grow in the next decade.
USA
The US is the biggest and most competitive market in the world. Serialization and Track & Trace requirements were introduced almost a decade ago and have played a critical role in the pharmaceutical supply chain practices in the USA. These regulations affect prescription drugs, over-the-counter medications, medical devices, and biological products, including those that are manufactured in the US or imported from other countries. The US FDA has set specific deadlines for compliance, and failure to meet these requirements may result in penalties or legal consequences. The original FDA approach to Serialization and Track & Trace forces pharmaceutical companies to collaborate and involve supply chain partners in creating sustainable systems. The latest DSCSA regulation is a good example of that approach.
BRASIL
Brazil is an example of where Serialization and Track & Trace regulations have been postponed several times due to the inconsistency of the dialogue between the government and businesses. The first drafts of legal acts obliging the serialization of pharmaceutical products appeared in Brazil in 2019. The Serialized Drug Traceability program captures the activities from the manufacturing or import of drugs through the distribution of the drugs in the downstream supply chain until they reach the point of dispensing or supply to establishments authorized by the Brazilian Health Regulatory Agency (ANVISA), such as medical institutes and research labs. To achieve serialized drug traceability, a national-level reporting system called "SNCM" has been formed. Nevertheless, the regulations have not been implemented yet.
UZBEKISTAN
Uzbekistan is an important player in the CIS market. Serialization is an international project that has been implemented on the territory of the Eurasian Economic Union (EAEU), with best practices mostly taken from the Russian market. The main goal of this project is to decrease the share of counterfeit products. In less than two years, data matrix labeling of tobacco products, beer, alcohol, household appliances, and pharmaceutical products has been launched in Uzbekistan. The CRPT-Turon organization with ASL Belgisi national traceability system declares that Serialization is not only an effective tool to combat illegal imports and sales of low-quality products but also an important source of analytical information.
KAZAKHSTAN
The Republic of Kazakhstan is one of the largest economies in the CIS. Serialization is an international project that has been implemented on the territory of the Eurasian Economic Union (EAEU), with best practices mainly taken from the Russian market. The main goal of this project is to decrease the share of counterfeit products in the light industry market of Kazakhstan, which currently accounts for 63% of the total turnover, as well as in the footwear market (48.5%), alcohol market (25%), and pharmaceutical market (12%). Serialization has already begun with long-term experiments for pharmaceutical products and bottled water.
RUSSIA
Russia plays a major role in the CIS market. Its market is the most regulated and complicated in the context of Serialization and Track & Trace. The national traceability system, Chestniy ZNAK, controls the turnover of furs, tobacco, pharmaceuticals, milk products, bottled water, apparel, shoes, perfume, digital cameras, and tires. The list of product categories involved is continuously expanding, and final regulation acts are usually issued after completion of the pilot project for a new product group. The emission of serialization codes is provided by the CRPT operator on a paid basis and includes the generation of a verification code that is part of the DataMatrix. All supply chain members from the manufacturer or importer to retail are involved and must register in the Chestniy ZNAK system. The system also provides consumers with the ability to check the authenticity of products by scanning codes in a mobile application.
BAHREIN
The Kindom of Bahrain, with its well-developed economy and strong focus on the healthcare industry, has recognized the importance of Serialization and Track & Trace systems in ensuring patient safety and enhancing the efficiency of the supply chain. Traceability was first initiated for pharmaceutical products in 2017 by Legislative Decree No. 41. The track & trace regulation of the Kingdom of Bahrain closely follows those of other countries and is based on GS1 standards. Following the implementation of mandatory serialization for MAH/CMO invoicing, companies are required to report all traceability events (commissioning, shipment/receiving, dispensing and aggregation) to the NHRA-MVC Traceability Hub.
UAE
The UNITED ARAB EMIRATES imports the majority of pharmaceutical products and many other product groups. This, along with the country's important role in the world economy, has led to the introduction of Serialization and Track & Trace requirements in the UAE. The country is following the world's best practices, with a traceability decree that applies to all conventional medicines being announced in the UAE in June 2021. After a transitional period intended for the implementation of serialization, all operations must be reported to the Tatmeen traceability system by code owners. Distributors, dispensing centers, and medical centers report appropriate shipping events of drugs.
KSA
The Saudi Arabian economy heavily relies on imported pharmaceutical goods, but the government is actively diversifying the economy and investing in healthcare. The Serialization and Track & Trace regulations introduced in Saudi Arabia closely follow those of other countries and are based on GS1 standards. This standardization is intended to make it easier for global pharmaceutical manufacturers to comply with regulations in multiple countries and help to prevent counterfeit products from entering the global market. All products must be serialized in compliance with the Saudi Food and Drug Authority (SFDA) regulations. Stakeholders must report serial numbers (SNs) through the new authority platform called DTTS (Drug Track & Trace System), which was launched on January 7, 2019.