inConversation With Mr Marco Baietti, Antares Vision Group.
The pharmaceutical industry faces increasing pressure to ensure the safety, authenticity, and traceability of medicines, vaccines, and other vital products. Given their critical nature, it is essential for consumers and regulators to have complete visibility into each product’s journey—where it has been, what ingredients it contains, who was involved in its production, and how it moved through the supply chain. Implementing modern, end-to-end Track & Trace systems enables companies to not only meet these demands but also respond swiftly to recalls, outbreaks, and regulatory changes.
As the demand for such technology grows, particularly within the pharmaceutical industry, the focus is increasingly on comprehensive solutions that span from production to distribution.
These solutions ensure regulatory compliance at every level and provide a robust framework for serialization and data management across the entire supply chain.
Marco Baietti, L1-L4 Solution Director from Antares Vision Group, offers his insights into the future of Track & Trace technology within the pharmaceutical sector. He emphasizes how evolving technologies will help manufacturers navigate regulatory complexities while improving operational efficiency. According to Baietti, Track & Trace systems will continue to advance, offering greater transparency and control, and ensuring that pharmaceutical products remain safe, authentic, and traceable throughout their lifecycle.
How does a Track & Trace solution handle significant data volume growth and diverse tracking needs in the future, and how well does it integrate with existing and potentially new tracking systems used by partners?
Developing a high-volume Track & Trace solution that can meet multiple (often unknown) future requirements can be challenging. For example, Antares Vision Groups solution tracks a diverse range of products, from medicines to cosmetics, and from wine to berries, across a global supply chain. In terms of volume, approximately 30% of US pharmaceuticals are tracked by our systems.
To meet the high-volume requirements of our customers, the software must be built with highly efficient code, using a distributed architecture—meaning it must be fast and capable of running on multiple computers. Anticipating new, unknown future requirements necessitates configurable designs that are based on abstracted frameworks, rather than specific industry requirements.
Historically, Track & Trace solutions, especially those from global suppliers, were designed as closed systems with proprietary protocols, making end users reluctant to adopt mixed T&T technologies. However, as Track & Trace evolved and the need for interoperability grew, solution providers collaborated to implement common industry-based standards. Most T&T implementations now leverage serialized standards from GS1, the originator of EDI (Electronic Data Interchange) standards, which has become the leader in serialized T&T standards. For
instance, a Track & Trace solution developed for medicines in the Middle East using GS1 standards reduced integration time by more than 60%, allowing supply chain partners to reuse existing, well-tested integrations that were already in place.
How does Track & Trace technology address evolving security threats and data privacy regulations, specifically ensuring secure, accurate, and traceable data while adhering to regulations like GDPR and HIPAA?
In the pharmaceutical industry, Track & Trace systems are used to monitor drugs from manufacturing to dispensing along the supply chain, without tracking the end user (patient) or utilizing personal data. The scope of current regulations is limited to ensuring that the medicines purchased through authorized channels are not counterfeit or falsified and are legally sold within the specific market.
HIPAA regulations apply to most Track & Trace solutions for medicines. Since pharmaceutical T&T systems do not track patient information, HIPAA compliance is straightforward. However, GDPR requires T&T data to be anonymized, omitted, or subject to removal at the user’s request. In terms of security, T&T is similar to other solutions that use continuous monitoring, active updates, layered security, secure coding processes, and more.
Can you elaborate on how Track & Trace technology can improve anomaly detection, predict disruptions, or optimize logistics?
Track & Trace systems allow organizations to associate detailed information with a product as it moves through the supply chain. While this may seem routine, it can be best understood through a practical example. A global berry grower uses unique IDs to track 2 billion boxes of berries across the supply chain. When consumers provide feedback on a specific box, the grower can identify where the berry was harvested, its growing conditions, and most importantly, the specific berry variety (e.g., “Vibrant,” “Honeye,” or “Florence” strawberries).
This level of traceability enables the grower to focus on their most popular berry varieties and optimize growing conditions.
Additionally, because each box has a unique ID, the grower can engage consumers with targeted messages or videos, create interactive games and lotteries using the ID as a game token, and gain valuable insights into how their products are transported through the supply chain.
Is there potential for integrating blockchain technology with a Track & Trace solution, and how would such integration enhance transparency and trust within the supply chain network?
The use of blockchain in Track & Trace systems has been limited, particularly in industries that handle high-volume data and require high-performance tracking. Blockchain’s inherent characteristics—such as its decentralized structure and immutable ledger—make it well-suited for secure and tamper-proof record-keeping. However, its current scalability challenges and slower processing times have made it less practical for industries that need to track vast amounts of data quickly and efficiently, such as pharmaceuticals or consumer goods.
A more effective approach is to use traditional Track & Trace solutions for high-volume tracking, where speed and efficiency are critical, and integrate blockchain technology for specific functions that require highly secure and immutable processing. This combination allows organizations to leverage the strengths of both technologies: Track & Trace for handling large-scale data in real-time, and blockchain for adding an extra layer of security and trust in areas where data integrity and transparency are paramount.
How does Track & Trace go beyond tracking to provide end-to-end visibility into product conditions and actively mitigate counterfeit products from entering the legitimate supply chain?
In the pharmaceutical industry, the end user (patient or consumer) is not authorized to directly verify the authenticity of the product by checking the code on the packaging. The only entity with the authority to perform this verification is the pharmacist at the point of sale. When the pharmacist checks the code, the system queries a regulatory database to confirm the product’s authenticity. If the verification is successful, the code is “decommissioned,” meaning it can no longer be used for future sales. This decommissioning process helps prevent the resale of legitimate codes and ensures that products cannot be falsely authenticated multiple times.
Additionally, a randomization process is employed at a ratio of 1:10,000, meaning that the probability of a counterfeit product being mistakenly recognized as genuine is extremely low. This system greatly reduces the risk of counterfeit products entering the legitimate supply chain.
However, it is important to note that full end-to-end visibility, where every stage of the supply chain is transparent to all stakeholders, is not currently allowed in the Life Sciences market. The regulatory framework limits visibility to authorized entities, such as manufacturers, distributors, and pharmacists, to ensure that sensitive data and processes remain secure and comply with legal and privacy requirements.
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