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Companies in the U.S. are ramping up their Track & Trace capabilities to comply with the Drug Supply Chain Security Act.
By: Lisa Olivo
June 6, 2018
Companies in the U.S. are ramping up their Track & Trace capabilities to comply with the Drug Supply Chain Security Act (DSCSA) which outlines critical steps to build an electronic, interoperable system by November 27, 2023. This directive has made it vital for pharmaceutical organizations to find a market-ready implementation partner. Currently, ACG is the only market-ready Track & Trace solutions provider in the world that can help pharmaceutical companies comply with the DSCSA regulations. ACG, the leading global supplier of integrated manufacturing solutions for pharmaceutical and nutraceutical companies, has developed customizable solutions from line to repository levels through its Inspection business. Each solution meets the verification, data management, serialization, aggregation and government reporting requirements and can be tailored to meet the specific regulations outlined by the DSCSA. ACG Inspection’s Verishield offers Level 1 to Level 5 solutions that include: Level 5: Data Reporting to Government portals and Supply Chain Partners ACG can support country-specific data reporting functionality to the government portals as well as sharing of transactional information between supply chain partners (Manufacturers, re-packagers, wholesale distributors, dispensers and third-party logistics providers like trading partners). Level 4: Enterprise data management solution ACG can host enterprise server on the cloud platform for multiple Marketing Authorisation Holder (MAH) plants, contract manufacturing organizations (CMOs) and warehouses. ACG can also help in master and production data management to meet global Track &Trace regulations. Level 3: Plant solution, CMO solution and Advanced warehousing ACG can implement plant data management functionalities like data management, master data management, line registration and management, Centralized user management, LDAP Configuration. Level 2: Line-Level Serialization and Aggregation Machines Through our production-orders-based workflow support, ACG can support line-level machines with product-wise number management for global Track & Trace regulations. ACG can also execute serialization and aggregation functionalities for multiple packaging levels. Level 1: Unit-Level Devices Our systems are equipped with devices and sensors for performing actions and manipulating the physical processes on the production lines. These devices include sensors and actuators in the machines. Ettore Cucchetti, CEO of ACG Inspection, said, “ACG Inspection has been a Track & Trace platforms provider to pharmaceutical manufacturers for over a decade, offering end-to-end tailored engineering solutions. Our implementation experience spans the entire globe with serialization modular plugins, delivered to over 2000+ lines across the world. We are totally equipped for DSCSA requirements and are proud to be 5-step ahead, having developed a simple to customize T&T hardware and software building blocks.” ACG is a member of GS1 (Global Standards One), which is a not-for-profit organization that develops and maintains global standards for business communication. GS1 plays an important role in global pharmaceutical track & trace regulations. ACG Inspection is also a member of Open Serialization Communication Standard (Open SCS) group, which is a dedicated group of vendors and pharmaceutical manufacturers that have come together to standardize the packaging line serialization and aggregation data exchanges.
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