// Webinar Ensure On-Time Drug Shipments: How to Quickly Replace Your Serialization System with the Leading Track-and-Trace Platform In 2019, Help Pharmaceuticals implemented a new serialization solution from another provider to comply with the EU Falsified Medicines Directive. However, the solution’s closed architecture required complex and difficult-to-manage interfaces which complicated the process of onboarding new packaging lines and trading partners. In 2022, Help Pharmaceuticals remedied the situation by migrating to a joint solution from Vimachem and Tracelink. The Vimachem Pharma 4.0 platform enabled Help Pharmaceuticals to implement a best-of-breed serialization solution from Seidenader / Optel (L1-2) , Vimachem (L3) and Tracelink (L4-5) while taking advantage of additional Vimachem Pharma 4.0 applications like Manufacturing Digitization and OEE. Watch this quick highlight video from a recent Vimachem and Tracelink webinar to learn how Help Pharmaceuticals was able to rapidly implement this future-proof serialization solution with no production downtime in less than 3 months. Giannis Fotopoulos QA Manager/Serialization Project Lead, Help Pharmaceuticals Alex Vidras Executive Director, Vimachem Benoit Eymard Vice President EMEA Sales, TraceLink Click to enlarge FILL OUT THE FORM TO SEE THE FULL WEBINAR
// Webinar Serialization Compliance in Russia with Medice and Wipotec The specifics of the Russian system and how to meet the requirements In cooperation with our customer Medice and our L1-2 partner Wipotec, our experts explain the special challenges of serialization in the Russian system. Producers from all industries must meet strict requirements when using crypto codes. In a live demonstration of the interaction of Vimachem software and Wipotec hardware, we show you our solutions for these special challenges. FILL OUT THE FORM TO SEE THE FULL WEBINAR
// FRESENIUS KABI Case Study SERIALIZATION DRIVING INNOVATION & CHANGE WITH RFID Fresenius Kabi to optimally support the US healthcare system, decided to implement RFID (Radio Frequency Identification) inventory tracking systems for pharmaceutical products sold in US hospitals. Without RFID, the process of identifying what products are in the hospital and how many, is very manual, repetitive and time consuming. With RFID tagging, the process of identifying and counting Fresenius Kabi products in US hospitals, is automated and compliant allowing Fresenius Kabi to optimally support its healthcare customers. Challenge: Manual tagging is time-consuming, labor-intensive, and possible errors. Benefit: Accurate/ ready-to-read, compliant and interoperable. Fresenius Kabi Products with RFID tags Ready-to-read, interoperable, RFID-embedded Label/tag specific to the product and batch Standardized format to enable interoperability (GS1) Direct-read or cloud-compatible Rain RFID Axia-Lab tested Key Learnings RFID and data matrix GS1 codes, complement each other and are used in different ways in various clinical workflows. RFID provides additional benefits of minimal handling and wireless identification. Required patient documentation at the point of dispense can be automated (e.g., in case of controlled substances handling). Manufacturer’s RFID solutions should be based on open standards to enable interoperability (e.g., GS1, RAIN). During the design and implementation phase new (and surprising) obstacles may be faced. Range of RFID enabled products is growing. Fill out the form to watch the FRESENIUS KABI Case Study
// ASPEN Case Study SERIALIAZATION FOR GLOBAL MEDICINES TRACEBILITY Aspen Australia, one of the largest pharmaceutical companies in Australia, needed to face the ever-changing regulatory requirements that European Commission (EU) created by developing the Falsified Medicines Directive (FMD) which requires serial numbers to be printed onto pharmaceutical products and for product serialization data to be transferred from the manufacturer to the regulator. To meet the anti-counterfeiting requirements of their target markets, in late 2018 Aspen embarked on the journey toward implementing a traditional serialization model of Level 4, Level 3, and Level 2 systems. Vimachem SSM (Level 3) was best aligned with Aspen’s selection criteria, as it seamlessly integrates with Tracelink (Level 4) while having a universal (non-proprietary) interface with the Wipotec-OCS (Level 2) serialization and aggregation equipment. The successful implementation was led by our SSM project team who remotely managed the complete implementation, provided all qualification documentation, and executed in collaboration with the Aspen team, the validation of both Test and Production environments. The serialization system’s commercial introduction took place in July 2020. Using GS1 DataMatrix and EPCIS standards, the implementation has effectively allowed Aspen to supply serialized products into export markets that are entirely compliant with their regulatory requirements. The challenge of counterfeit medications on international markets is addressed by using worldwide standards for serialization, which also facilitates tracking. The benefits of this implementation were: One best-of-breed (Wipotec-Vimachem- Tracelink) solution for ten different export markets Fully compliant with FDA CFR 21 part 11 Implementing global standards enables traceability Combats counterfeit products Fill out the form to Download the ASPEN Case Study
// IBERFAR Case Study PHARMA TRACKTS 2021 | Serialization Driving Change and Innovation Iberfar a global pharma contract manufacturer (CMO) needed an open and flexible serialization software solution to be able to support global customer serialization requirements including installation of aggregation equipment and exports to the Russian market. As a result, the Vimachem Level 3 SSM system was installed and validated within 2 months, and connected to 4 Seavision lines and the Tracelink Life Sciences Cloud. The newly installed solution allows real-time monitoring of the shop-floor serialization operations, integration of vendor-agnostic aggregation equipment and compliance with Russian serialization requirements. In this presentation from Pharma TRACKTS! 2021 see how Iberfar: Installed and validated an open and flexible Level 3 solution in less than 8 weeks Ensured compliance with the Russian regulatory requirements Has a Pharma 4.0 platform ready for further shop-floor digitization Join our hosts: Luis Monteiro Project and Digital Transformation Manager George Avramis Product Manager Track & Trace FILL OUT THE FORM TO SEE THE FULL VIDEO OF THE PRESENTATION












