Automated Validation Manager automates the validation life cycle of the TraceLink Life Sciences Cloud using an automated, validated test harness to perform the Performance Qualification. Other deliverables include a Validation Plan, Functional Risk Assessment, User Requirements Specification, Requirements Traceability Matrix, and Certificate of Release.
TraceLink has long collaborated with GS1 Brazil and in-market industry associations around the development of regulatory and business requirements, and will continue to be closely involved. Brazil Compliance will be developed to address all final specifications. The application will use TraceLink’s existing capability including trade partner on-boarding and data exchange, managing serial number events and reporting events to the regulatory authority.
Change Management standardizes direct and indirect supplier change control processes and maintains them in a single repository. Suppliers can submit changes and change documentation and notify all stakeholders about the changes. Enables a standard process to communicate acknowledge and acceptance of a change or requests for additional information.
TraceLink’s China Compliance application manages China’s track and trace regulations. China’s Drug and Food Administration (CFDA) generates serial numbers and assigns them to manufacturers. TraceLink serialization application owners import the serial numbers, and, using an encoding format unique to China, they apply the serial numbers to their products. The China Compliance application creates the required reports, including complex file splitting, sequencing, and naming and makes them available for upload to the designated CFDA system.
Delivery Tracking provides pharmaceutical manufacturers with visibility into when raw materials and APIs arrive at their contract partners and when finished goods are shipped. The application also provides visibility into when product is received at 3PLs and when 3PLs ship product to customers. In addition to visibility, transactional information can be sent from contract partners and 3PLs to properly record inventory and product movement within the ERP system for proper financial reporting.
Edge Track provides seamless integration of serialization and fulfillment operations in the warehouse. With a single scan, warehouse operators verify the inventory data expected by their Warehouse Management System (WMS) or ERP, as well as the serialization data expected by TraceLink’s Serialized Operations Management application. By meeting business and compliance requirements in a single scan, Edge Track improves efficiencies in the warehouse.
End-to-End Administration is a TraceLink service designed to minimize the resource investment required to manage a compliance solution. Every Product Track subscription includes end-to-end administration services, providing a team of TraceLink compliance experts to manage all DSCSA compliance tasks.
European Union Compliance
European Union Compliance helps companies across the pharmaceutical supply chain meet the existing and developing requirements of the European Union Falsified Medicines Directive (EU FMD).
India Compliance generates and stores the reports of serialized product events required by India’s Directorate General of Foreign Trade. The application creates compliance reports for product that is exported from India to India’s Drugs Authentication and Verification Application (DAVA) system.
Inventory Monitoring provides pharmaceutical manufacturers with visibility into their inventory positions at their contract manufacturers. Inventory is typically reported daily and includes inventory categories such as Quantity On Hand, Quantity On Hold, Quantity Inspection, and Quantity On Order. In addition to total amounts, inventory reporting is provided at the lot level and lot history balances are captured and available to show which lots are being consumed.
Issue Tracking facilitates the exchange and tracking of supplier issues and complaints between the pharmaceutical company and their direct and indirect partners. Issue lifecycles are tracked from submission, investigation, and resolution through to closure. Issues are categorized so that detailed analysis can be performed supporting 8D (8 Disciplines) and Six Sigma DMAIC methods for root cause analysis and problem solving.
Master Data Exchange is a central repository for master data required for serialization, track and trace, and compliance applications. Master data consists of information related to the Company and its locations, Partners and their locations, and Product. Master data is used by TraceLink’s applications as part of executing advanced business logic that drive workflow.
Patient Engagement Software Development Kit (SDK)
TraceLink’s Patient Engagement SDK provides pharmaceutical companies with the ability to incorporate medicine verification capabilities and the distribution of product information into their own mobile and web properties. In addition, with the permission of the participating pharmaceutical company, the medicine verification experience can be integrated into third-party digital solutions where patients are already engaged, thereby creating new, secure communication channels between pharmaceutical companies and consumers.
TraceLink’s Pharmacy Application provides hospitals and pharmacies with comprehensive tablet and smartphone-based applications to interact with serialized medicines for regulatory compliance and value-based business benefit. As serialized product volumes continue to rapidly increase across the globe, the ability of pharmacists and dispensing doctors to verify the authenticity of unique medicines, to gain real-time access to product master data and notifications, and to engage with interactive medicine content within their existing dispensing process becomes possible for the first time.
Product Information Manager
TraceLink’s Product Information Manager provides a global network application for enabling permissioned sharing and consumption of serialized medicine information, interactive digital content, product disposition status, and other critical product data to direct business partners, indirect trading partners, and patients.
Product Track US manages your compliance data across the pharmaceutical supply chain to ensure that you meet your regulatory requirements as the Drug Supply Chain Security Act (DSCSA) is phased in. Product Track traces your product as it moves through the supply chain and generates the Transaction Histories required for lot-level compliance. Product Track also manages serialization data for those companies implementing package-level traceability to prepare the 2023 DSCSA requirements.
Production Tracking provides pharmaceutical manufacturers with visibility into manufacturing and packaging processes at their contract manufacturers. Production Tracking also uses TraceLink’s Integrate Once, Interoperate with Everyone™ network architecture eliminating the need to establish point-to-point integrations with each contact manufacturer. The pharmaceutical manufacturer has full visibility into the production process from material acquisition through to delivery allowing them to manage their contract manufacturers as an extension of their manufacturing processes.
Quality Review provides pharmaceutical manufacturers and contract manufacturers with a secure, collaborative workspace to exchange reviews and commentary on quality documents including batch records, change controls, and deviations. With the appropriate permissions, users can see the commentary captured as part of the review cycle and receive notifications when documents have been commented on or moved to another stage in the review cycle.
Russia Compliance is built on the same network tenant platform providing it with the core serialization, integration, and compliance functionality available in our other applications. Our configurable workflows and application logic are designed to meet the complex data choreography requirements needed to meet Russia compliance.
SecureChain provides pharmaceutical companies with a mobile application that prevents drug diversion, protects revenue, and enforces trade partner policies. Through the mobile application, field personnel can discreetly capture information regarding the product and its identity and review its supply chain history.
Serial Number Exchange manages the allocation of serial numbers from Serial Number Manager to the line management systems. Business logic works to verify serial number requests, commissioning, and aggregation information. Includes out of the box integrations with leading line management systems simplifying site onboarding and reducing risk.
Serial Number Manager provides serial number generation including randomization and sequential algorithms for different packaging levels. Serial number inventories are maintained by setting configurable parameters on when to generate more serial numbers. Configuration parameters are defined through serial number templates that are associated with each product.
TraceLink’s Serialized Operations Manager (SOM) application provides an EPCIS repository to manage events associated with serialization data. In addition, Serialized Operations Manager enables supply chain and distribution processes so that serialization does not need to be embedded into ERP and WMS systems. Serialized Operations Manager also provides pre-built business logic and workflow designed to monitor transaction flow and events in order to trigger actions in other applications such as Product Track or EU Compliance.
Smart Inventory Tracker is a mobile application—natively connected to the cloud—that combines serialization and fulfillment operations in the warehouse to meet both business and regulatory compliance needs. The application manages your warehouse data where the product is handled, enabling rapid response. Smart Inventory Tracker verifies and updates the status of the serialized product in your TraceLink serialization repository, Warehouse Management System (WMS), and Enterprise Resource Planning (ERP), with compliance reporting triggered based on configurable workflows.
South Korea Compliance
South Korea Compliance manages the creation and exchange of compliance reports and monitors TraceLink’s Serialized Operations Manager application for reportable events. For example, if a delivery is created in SOM, South Korea Compliance generates a report and sends it to the South Korea Pharmaceutical Information Service (KPIS).
TraceLink MyMeds application provides pharmaceutical companies, patients, pharmacists, and other caregivers the opportunity to securely opt in to a digital information sharing experience, all tailored around serialized medicines.