KevSecure: Your Ultimate Authenticity Checker

In an age where counterfeits flood the market, the need for genuine product validation has never been more crucial. The battle against imitation doesn’t stop with simply affixing QR codes or 2D codes to packages; that’s merely the beginning. Real victory lies in ensuring every product in a consumer’s hand is genuine.

Enter KevSecure Mobile Authentication Application.

Why KevSecure?

• Cutting-Edge Technology: At Kevision, innovation is our forte. We’ve channelled our expertise into creating the KevSecure App—a modern-day solution for product verification, designed with tomorrow in mind. Simple, user-friendly, yet incredibly effective.

• More than Just a Scanner: In the pharmaceutical realm, ensuring the legitimacy of a product isn’t limited to its origin. It’s about verifying details like batch numbers, expiry dates, and serial numbers. Plus, delving deeper into the composition, uses, side-effects, and more. KevSecure does it all.

• On-the-Go Validation: Easy to download. Easy to use. Whether you’re a supply chain specialist, brand guardian, or a law enforcement official, the KevSecure App lets you swiftly validate a product’s genuineness. Spot a counterfeit? You’ll know in seconds.

• Scale That Suits You: From start-ups to conglomerates, irrespective of your business size or the volume of products you deal with, KevSecure scales to meet your needs, ensuring every product aligns with authenticity standards.

• Empowering Enforcement: For authorities on the frontline against fraudulent products, KevSecure isn’t just a tool—it’s a weapon. Instant validation paves the way for decisive action against counterfeiters, safeguarding consumers and markets.

• Universal Compatibility: Every product bearing the unique identifier from our KevSecure Server can be scrutinized with our app. The result? Enhanced transparency across the supply chain, fortified security, and invaluable insights for continuous improvement.

Choose KevSecure. Because genuine matters.

Drug Supply Chain Security Act (DSCSA) was first enacted in 2013 by the US Food and Drug Administration (FDA) to boost the ability to increase patient safety. DSCSA outlines the necessary steps to build an electronic, interoperable system to identify and trace prescription drugs through the supply chain to eliminate drug counterfeiting. This enabled the government to identify any stolen, diverted, or counterfeit medicine and remove it from the market before the patients consumed it. Also, it is made sure that drugs and medicines subject to DSCSA are safely stored and transported to avoid any entry of harmful products.

Under the DSCSA, trading partners – primarily manufacturers, wholesale distributors, dispensers, and repackagers – are subject to certain requirements for enhanced drug distribution security.

The DSCSA, enacted in 2013, outlines steps to achieve interoperable, electronic tracing of products to identify and trace certain prescription drugs as they are distributed throughout the U.S. The DSCSA requires trading partners to provide, receive and maintain documentation about prescription drugs and their chain of ownership from manufacturer to dispenser as the drugs are distributed in the U.S. supply chain. Currently, these entities can choose to provide such information either electronically or in     paper format.

Those DSCSA requirements are scheduled to change on November 27, 2023, and will include requiring trading partners to provide, receive and maintain documentation about products and ownership only electronically. The stabilization period will accommodate an additional year, until November 27, 2024, to allow trading partners to implement, troubleshoot and mature their electronic interoperable systems. The stabilization period is intended to avoid disruption to the supply chain and ensure continued patient access to drug products as trading partners work to fully implement the enhanced drug security requirements.

With that, on 25th August 2023, the FDA extended the guidelines enforcement from November 27, 2023 to November 27, 2024.

The FDA issued two different draft guidelines and announced that “these documents are critical steps toward implementing the DSCSA enhanced drug distribution security requirements that will go into effect on.”

The first one “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs” describes the use of electronic standards for tracing products throughout the pharmaceutical supply chain. It is an update of the version issued in 2014. The guidance is primarily for manufacturers, wholesale distributors, dispensers, and repackagers; delayed enforcement pertains to product identifiers at the package level; saleable returns; interoperable, electronic product tracing; and investigating suspect and illegitimate products

To provide and maintain the data associated with the transaction information and transaction statements, the FDA strongly recommends trading partners use the Electronic Product Code Information Services (EPCIS) standard. EPCIS is a global GS1 standard that allows trading partners to capture and share information about products as they are transacted through the supply chain. FDA firmly believes that EPCIS is an appropriate globally recognized standard and there is considerable agreement amongst the stakeholders.

The second one “Identifying Trading Partners Under the Drug Supply Chain Security Act” will help industry, state, and local governments categorize the entities in the drug supply chain in accordance with the DSCSA. It is a revised version of the guidance issued in 2017. FDA announced that in the revised draft, it has added or revised its current thinking on the status of certain entities as trading partners, such as private label distributors, salvagers, returns processors, and reverse logistics providers.

The draft also includes clarification on how trading partners in the supply chain can be categorized. A clarification is also given on some drug distribution scenarios which include distribution for emergency medical use, office use, non-human research purposes, and research in humans under an investigational new drug application.
FDA also announced that until some rules are finalized and issued regarding the licensing standards for 3PL providers, these providers will be considered licensed trading partners if they are certified by the state.

Kevision Systems, part of the Kevin group, is a leading provider of complete solutions and services to protect your products and supplies. We are also a leading Solutions Provider for Vision-Based Inspection Systems for products, especially in the Healthcare, Food & Beverage as well as Automobile Industries. With Global Trade becoming seamless, the need for increased security & traceability of products is imperative for product authenticity. Kevision partners with clients to provide a robust & secure solution to meet product & client safety as well as regulatory compliance.

Drug Supply Chain Security Act (DSCSA) was first enacted in 2013 by the US Food and Drug Administration (FDA) to boost the ability to increase patient safety. DSCSA outlines the necessary steps to build an electronic, interoperable system to identify and trace prescription drugs through the supply chain to eliminate drug counterfeiting. This enabled the government to identify any stolen, diverted, or counterfeit medicine and remove it from the market before the patients consumed it. Also, it is made sure that drugs and medicines subject to DSCSA are safely stored and transported to avoid any entry of harmful products.

Recently, on 5th July, the FDA issued two different draft guidelines and announced that “these documents are critical steps toward implementing the DSCSA enhanced drug distribution security requirements that will go into effect on November 27, 2023.”

The first one “DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs” describes the use of electronic standards for tracing products throughout the pharmaceutical supply chain. It is an update of the version issued in 2014. The guidance suggests changes including a restriction on paper-based tracing of medicines and verification of products at the package level will be required unless a waiver, exception, or exemption applies.

To provide and maintain the data associated with the transaction information and transaction statements, the FDA strongly recommends trading partners use the Electronic Product Code Information Services (EPCIS) standard. EPCIS is a global GS1 standard that allows trading partners to capture and share information about products as they are transacted through the supply chain. FDA firmly believes that EPCIS is an appropriate globally recognized standard and there is considerable agreement amongst the stakeholders.

The second one “Identifying Trading Partners Under the Drug Supply Chain Security Act” will help industry, state, and local governments categorize the entities in the drug supply chain in accordance with the DSCSA. It is a revised version of the guidance issued in 2017. FDA announced that in the revised draft, it has added or revised its current thinking on the status of certain entities as trading partners, such as private label distributors, salvagers, returns processors, and reverse logistics providers.

The draft also includes clarification on how trading partners in the supply chain can be categorized. A clarification is also given on some drug distribution scenarios which include distribution for emergency medical use, office use, non-human research purposes, and research in humans under an investigational new drug application.

FDA also announced that until some rules are finalized and issued regarding the licensing standards for 3PL providers, these providers will be considered licensed trading partners if they are certified by the state.

Kevision Systems, part of the Kevin group, is a leading provider of complete solutions and services to protect your products and supplies. We are also a leading Solutions Provider for Vision-Based Inspection Systems for products, especially in the Healthcare, Food & Beverage as well as Automobile Industries. With Global Trade becoming seamless, the need for increased security & traceability of products is imperative for product authenticity. Kevision partners with clients to provide a robust & secure solution to meet product & client safety as well as regulatory compliance.

With global trade now becoming a norm, it is imperative for brand owners, manufacturers, consumers, supply chain companies, and governments to track their products & protect their brands from the menace of counterfeit products. In the case of medicines, it also means protecting patients from substandard & counterfeit medicines, which can be a significant health risk. 

To implement the Track and Trace systems, manufacturers usually expect robust and automated solutions that do not affect their production capacity and speed, are reliable and are compliant with the international & their local country regulations as well as standards.

Serialization and T&T systems are complex systems to implement. Expert & in-depth knowledge is what is required on the part of the partner who is responsible for installing & help maintain such systems. Hence, it is crucial to choose the right partner who understands your business needs and objectives, guides you during the implementation, and provides support after it.

Kevision Systems is a leading company providing Serialization Systems, including tightly integrated Hardware & Software, especially in Healthcare and Food & Beverage industries. Following are the critical evaluative factors that suggest Kevision Systems is the perfect partner for your T&T system implementation:

1. Expertise: Every business is unique, and so are its requirements. Addressing business requirements and providing unique solutions for them is crucial to achieving a successful implementation. With the help of our experts, we offer complete end-to-end Track and Trace systems which are fully integrated for traceability for pharmaceutical products. 
2. Responsible and Continuous Innovation: Kevision Systems is a pioneer in introducing Track and Trace systems with the latest in software & hardware technologies in India. With KevSecure, our Cloud Platform for Level 4, we can provide gateways to global government portals for seamless data transfer. We are constantly leveraging and working towards innovation in products & processes that will help businesses achieve their goals.We have developed our products and software in such a way that they cater to the changing needs of the businesses. You will easily be able to update the systems as per the changing regulations.
3. In-house Development: All our products, be it software or hardware, are developed in-house. We believe in providing an uncompromised quality of software and hardware to our customers.
4. Experience:With over a combined experience of over 50 years in the Pharmaceutical industry, we have the right credentials to support any needs that come your way.
5. 24×7 Support:With our formidable support system, we are able to provide 24×7 active support to our clients globally. Our support has been the cornerstone for our customers. We are available on call, on site, by mail, and online.

Kevision Systems provides leading solutions for end-to-end Serialization and Track & Trace of Pharmaceutical products. We are very keen to help you start your journey of serialization and protect your brands. For any queries, contact us at info@kevision.in.