Glossary
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An application utility that includes tools for configuring global company settings for use across all TraceLink applications. Users that have access to this utility are considered Administrators.
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A notification of pending deliveries, usually in an electronic format.
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The process of recording the serial number of a container along with the serial numbers of its contents; often referred to as a parent/child relationship, or a serialized container to content relationship.
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A multienterprise application that enables cross-enterprise teams to digitally execute, manage, and track shared processes to increase speed and improve effectiveness of the supply chain.
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Character set made up of digits and letters of the alphabet.
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The protocol used to securely transmit data over the internet in the preferred method for exchanging Electronic Data Interchange (EDI) transactions.
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An Opus enterprise app, provided by TraceLink, that supports the routing of event handlers and message handlers to the correct app.
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A member of a Network Company that has the permissions to perform administration functions, specific to an app. App Administrators can be members of app Owner companies to manage their apps and can also be members of app Partner companies to manage the partner side of the app, typically with limited capabilities.
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A GS1 term for numeric prefixes used in barcodes and Electronic Product Code (EPC)/Radio Frequency Identification (RFID) tags to define the meaning and format of encoded data elements.
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The master metadata store for all of the application metadata.
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Defines the metadata of an application or platform service. The goals of accelerating application development, facilitating the management of apps, and presenting a developer with a visual Solution Builder require that much of the behavior of an application be defined via metadata. See: Solution Builder
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The interface that allows other software programs to interact with applications. Members on the Network can generate a series of request and response messages corresponding to various TraceLink applications (whether synchronously or asynchronously).
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Defines where application images are stored so they can be deployed as running code.
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A product offering that includes one or more functions to fulfill customer/market needs. Applications are offered in various forms including, but not restricted to, web applications, mobile apps, APIs, and SDKs to appeal to different user needs.
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A member of APT with permissions to configure the app, data models, workflows, and Experiences in support of the company’s business processes. They also define Process Teams, create additional roles, assign process team admins, and add/remove user access to the APT app.
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An integration message (formerly known as transaction) is used as an interface to exchange data between two companies. Asynchronous messages do not fully process in real-time.
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One of the three primitive building blocks used to create the data model. (The others are object type and relationship.) An attribute is a characteristic or inherent part of an object type or relationship. The specific object instance of an attribute is known as a property. Example attributes include: Username, Serial Number, Product Identifier.
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The practice of checking a unique identifier against a set of captured serialized data to determine its authenticity.
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An Opus system app, provided by TraceLink, that governs what authenticated users are authorized to do within the context of an app through enforcement points and policies.
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A wholesale distributor that a manufacturer designates or authorizes to distribute its products.
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Method of automatically capturing data encoded on items and containers, and entering that data directly into computer systems without human involvement.
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A TraceLink compliance reporting app that searches, views, and generates reports required by the Bahrain National Health Regulatory Authority (NHRA).
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The solution created and released by the app developer, which serves as the default solution that is automatically applied to the network when a company licenses an app (e.g. TraceLink created and released the Supply Chain Work Management solution for the Agile Process Teams app).
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A group of products associated with a manufacturing or packaging operation. Synonymous with lot.
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A document issued by a carrier which details a shipment of merchandise and gives the shipment title to a specified party.
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A process in which the kernel is installed and made operational for the first time so that the rest of the system can be built using the TDE.
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A TraceLink compliance reporting app that searches, views, and generates reports required by ANVISA.
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The Brazilian Regulatory Agency responsible for the approval and supervision of food, cosmetics, tobacco, pharmaceuticals, health services, and medical devices.
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An approach to labeling and packaging operations in which products are produced in large batches, stored in unlabeled containers, and then labeled just prior to shipment.
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Defines a module's build and deploy processes in the TDE to enable continuous delivery.
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A group of items held together, usually by shrink wrap. Synonymous with Inner Pack.
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Interactions that support the transfer of standardized interchange files up to an enterprise’s EDI system. B2B interactions are not integrated with manufacturing, warehouse, or other backend business systems.
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An identification number issued to Brazilian companies by the Secretariat of the Federal Revenue of Brazil.
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How many instances of a type may exist on either the FROM or TO ends of a relationship. The cardinality key defines the relationship as one to one, one to many, many to one, or many to many.
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A container of product eaches (e.g. cartons, packages, bottles) which may or may not be bundled.
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An Opus system app used to manage global catalog items available to all companies on all environments.
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A TraceLink app that allows the users to manage and view supplier changes.
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Redundancy check used for error detection of identification numbers, used in National Drug Code (NDC) numbers, US Drug Enforcement Administration (DEA) numbers, Global Trade Item Number (GTIN-14) identifiers, and Serial Shipping Container Codes (SSCC).
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A TraceLink compliance reporting app that integrates with the National Medical Products Administration (NMPA) reporting system directly or through a local partner.
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The encoding format for serial numbers, issued by the Chinese government, used for products sold in China.
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Former organization in China responsible for ensuring pharmaceutical quality. Replaced by National Medical Products Administration in 2018. See NMPA.
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A logical grouping of containers that you can place tasks on. A cluster represents an instance of an AWS EKS controller.
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A group of objects.
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Process of associating a serial number to a particular object (product or container).
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A TraceLink app that allows companies within the TraceLink Network to connect and engage with each other. The Community Hub also allows non-TraceLink Members to search, verify, and track specific products.
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An Opus enterprise app, provided by TraceLink, that supports various administrative functions for System Administrators. These functions include user and role management across applications, network-level user and role management, partner management, location management, and maintaining company information.
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A member of a Network Company that has the permissions to perform system administration functions for apps to which the company has access.
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Each TraceLink product app that corresponds to a specific country, retains compliance data, and allows users to search and review the details of that data in compliance reports.
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Reports that display specific country compliance data.
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A visual element in the Design Studio that is used for building screens. A component is defined by its Properties. There are two types of components: UI components and Data components.
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A standardized unit of TraceLink code. A container is created from a Docker image at runtime.
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A section of the Foundation layer. Screens are displayed in the content area.
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A company providing manufacturing and sometimes packaging services for one or more pharmaceutical manufacturers based on contracts or service agreements.
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A third-party organization that manufacturers subcontract to package products.
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Vocabulary elements agreed upon by trading partners who will exchange data. See: http://www.gs1.org/epcis
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Improvements to an organization's processes taken to eliminate quality failures.
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An imitation usually created with the intent of fraudulently passing it off as genuine, often to take advantage of the established worth of the imitated product. The word counterfeit frequently describes the forgeries of currency and documents, and the imitations of clothing, software, pharmaceuticals, jeans, watches, electronics, and company logos and brands. In the case of goods, it results in patent or trademark infringement.
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Encrypted identification numbers generated by the Tsentr Razvitiya Perspektivnykh Tekhnologiy (CRPT) for use in Russia. Provides additional security and allows Russian pharmacies without internet access to verify products. A crypto code is associated to a serial number and consists of a key portion and a code portion.
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A GS1 term for the different kinds of media, such as barcodes, that can hold GS1 identification keys and application identifiers.
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A special type of a UI component in the XD Studio that has been preconfigured with an Opus Query. Included as part of a Screen Template section and configured to have specific behavior based on the Properties setting. To use a Data component, apps must be licensed so they can provide an API that responds to the Opus Query.
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An Opus system app, provided by TraceLink, that provides a set of standard processing steps as well as the ability for an application to define custom processing steps that can be used to transform, enrich, and combine data in various ways to create data products that can be used in applications for analytics and reporting purposes.
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The event interface for the schema store that allows authorized users to retrieve schemas. Kernel and platform developers create object types, relationships, and attribute definitions directly in the system. These items make up the Logical Data Model that an application manages.
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A part of the Solution Builder. Customers and Solution Partners use the data studio to configure data validations and actions.
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To disassociate a serial number from a product or container so that it is no longer tracked. In TraceLink, decommissioned serial numbers can be reused, whereas destroyed serial numbers cannot be reused.
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In TraceLink, a delivery is considered a sale, transfer, or return.
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A part of the Opus Solution Builder. Customers and Solution Partners use the Design Studio to create and modify experiences, create and modify screen/field layout, and configure data and actions.
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To disassociate a serial number from a product or container so that it is no longer tracked. In TraceLink, destroyed serial numbers cannot be reused, whereas decommissioned serial numbers can be reused.
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To remove products or containers from a parent container. The serial numbers of the contained product or container are no longer associated as children of the parent container.
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A retail pharmacy, hospital pharmacy, group of chain pharmacies, or any other person authorized by law to dispense or administer prescription drugs. Under DSCSA (United States), an entity is not considered a dispenser if it acts as a wholesale distributor or dispenses products only used for animals.
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The state of a serial number. TraceLink updates serial number disposition states after provisioning, encoding, commissioning, aggregating, decommissioning, and destroying serial numbers.
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A warehouse stocked with goods to be redistributed to retailers, wholesalers, or customers.
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A file that includes the code, runtime, tools, libraries, and settings needed to execute code for an app. A Docker image becomes a container at runtime.
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A character encoding that contains a large number of unique characters or symbols that is used to express languages such as Japanese, Korean, and Chinese.
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The direction of product flow, e.g. pharmaceuticals travel first through the manufacturers, then downstream to repackagers, then downstream to wholesaler distributors, and finally downstream to dispensers.
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US Federal Legislation passed in November 2013.
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An Act signed into law in 2013, which dictates the governance of pharmaceutical distribution and traceability in the US. See https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/ for details.
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The Saudi Arabia compliance reporting repository, which supports Saudi Food & Drug Authority serialization and traceability regulations.
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India’s web portal where manufacturers and exporters upload the compliance reports required for Indian pharmaceutical regulations.
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A company that publishes a business directory of other companies and assigns and maintains a unique identifier for each company within the directory.
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D&B's copyrighted, proprietary means of identifying business entities on a location-specific basis. Assigned and maintained solely by D&B, this unique nine-digit identification number has been assigned to over 100 million businesses worldwide.
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The DUNS Number plus a 4-digit extension (13-digit total) created by assignees when there is a need for more than one bank/Electronic Funds Transfer (EFT) account for a location. D&B does not create or maintain the +4 number.
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The smallest saleable unit of product, the secondary package level. Synonymous with item.
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A fully managed Docker container registry from AWS that makes it easy for developers to store, manage, and deploy Docker images.
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The electronic transfer of data between computer systems in a standardized message format.
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A unique identifier provided by the Chinese government for serialized product.
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A unique number that identifies a specific item in the supply chain. Also known as a serial number.
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See: www.gs1.org/epcis for the definition.
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The process of preprinting labels for serial numbers after they are provisioned. Once the labels are affixed to the products, the serial numbers enter the "commissioned state."
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An application used only by the owning company, much like their enterprise systems. Enterprise apps do not have linked partners, however they can be linked to the owning company and/or its locations to support integration with the company’s other enterprise systems. Examples of Enterprise Applications are Master Data, Administration, Audit Trail, Compliance Apps, TDE, and Opus Solution Builder.
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Business process management software used to manage and automate back-office operations.
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A term used for a serialization system that a customer may use as its System of Record (SOR) for serial numbers instead of TraceLink's serialization services. The ESM system provides serial numbers to TraceLink for serialization operations and global compliance reporting. Synonymous with External Serialization Manager.
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A namespace that contains a group of Kubernetes deployments.
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An organization sponsored by GS1. Develops the standards for Electronic Product Code (EPC) and for Radio-Frequency Identification (RFID) systems that store and manage EPCs.
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A code applied to transferred data for error control. The ECC provides redundancy and allows the receiver to recover the original data.
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A country-specific list of drugs that satisfies the healthcare needs of the population majority. In China, serial number file structures differentiate whether or not a drug is on or off the EDL and is known as Provincial Reimbursement Essential Drug List (PEDL).
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TraceLink app. Generates EU required reports regarding Serialization and Product Verification.
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A cloud-based gateway for EU compliance reporting. Provides interoperability between different national systems in the EU, and manages product status (e.g. decommissioning, recalls) and exceptions throughout the life cycle of a product. The hub does not store serialization data like a repository – instead it acts as a single point of entry.
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Pan-European system that implements the Falsified Medicines Directive (FMD). Verifies the authenticity of a medicinal product.
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Any action that is triggered in the TraceLink system becomes an "event" once processed in the system.
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An Opus system app, provided by TraceLink, that includes libraries for Route Manager. Event Gateway also includes GraphQL.
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A computer system designed to store serial number information and events relating to serialized products.
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A DSCSA term that describes the movement of a product where a change of ownership occurs.
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A wholesale distributor that purchases directly from a manufacturer and is the sole distributor of that manufacturer’s product.
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An Opus system app, provided by TraceLink, that provides APIs that enable the creation of experiences in Customize for companies that own Solution Builder.
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Experiences enable access to app functionality in a responsive web user interface (UI) accessible across devices (PC, mobile, etc). Experiences are defined using the Solution Builder Design Studio using low-code, UI-driven configuration. Experiences can include functionality within a single app or functionality that spans across apps. For example, an experience can be created that provides access to features of two different apps in an integrated user experience (when the customer has licensed both apps). Different Experiences can be created for different classes of users that may use the same app. For example, one app can contain a Dispenser Experience, a Manufacturer Experience, and a Partner Experience.
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Date of expiration or the last day an item should be used.
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A set of rules that allows documents to be readable by both humans and machines.
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A one-digit segment used to extend the serial reference segment of a Serial Shipping Container Code (SSCC) identifier. The SSCC format is: urn:epc:id:sscc:"[company prefix].[extension digit + serial number]."
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A standards-based product code, e.g. Global Trade Item Number (GTIN) or a market-specific product code, used to identify the product. Note that this is not a manufacturer Stock Keeping Unit (SKU), as SKUs are not regulated or standardized.
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A pan-European directive intended to protect patients from counterfeit medicines in the regulated pharmaceutical supply chain. The European Medicines Verification System (EMVS) was developed to implement the FMD.
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A law enacted in 2017 that dictates the governance of pharmaceutical distribution and traceability in Russia.
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An Opus app, provided by TraceLink, that supports the ability to import and export files to and from an app.
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A digit in the 0-9 range that is used in certain EPC and coding formats, as part of the RFID control information, to specify the packaging level associated with the serial number (e.g. each, case, pallet).
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Foundation layer of the platform. Experiences are built on top of the Foundation, which is always visible.
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An Opus enterprise app that allows authorized administrators to approve or reject requests to promote catalog items from a company's catalog into the global catalog. UI access to the Global Catalog Administration app is provided by the Global Catalog Administration solution.
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The Company Prefix of the GS1 Identification Key. The Company Prefix is used for any location (physical, operational, or legal) that needs to be identified for use in the supply chain.
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A unique reference number used to identify a legal entity (e.g. company, location) to support the secure exchange of business information.
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A unique 13-digit number containing a GS1 company prefix, a location reference, and a check digit, used to uniquely identify a physical location or legal entity in the supply chain. The GLN makes possible the unique and unambiguous identification of those locations and entities.
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A globally unique product identifier used by a company to identify its trade items at all item and package levels. To ensure the identifier is globally unique, GTINs contain the company's GS1 Company Prefix which is assigned by GS1.
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A general term, usually referring to quality and regulations, in which "x" serves as a variable (e.g. GMP is "Good Manufacturing Practice").
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A leading global organization dedicated to the design and implementation of global standards and solutions, to improve the efficiency and visibility of supply and demand chains globally. The GS1 system of standards is the most widely used supply chain standards system in the world (more at www.gs1.com).
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Formerly known as Code-128. A linear barcode used by organization members of GS1.
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A 4-12 digit globally unique company identifier assigned and administered by GS1 Global. A component of Global Location Number (GLN), Global Trade Item Number (GTIN), and Serial Shipping Container Code (SSCC) identifiers.
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A two-dimensional matrix barcode, also called a 2D matrix, consisting of black and white cells arranged in either a square or rectangular pattern. The information to be encoded can be text or raw data. Usage granted by the GS1 standards organization.
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A mechanism that executes one or more actions in response to an event. Handlers can be organized into modules.
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Headers comprise the prefixes used in Human Readable Interpretation of variable data. Common headers include GS1 Application Identifiers (AIs) or GS1 recommended field labels.
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In software development, a headless application architecture leverages an API-first approach that is focused on the data model, workflow, business logic, and APIs. The APIs are at the center for exposing information that can be consumed by user experiences and used for integration with other systems and applications. All Opus applications are headless apps built using the API-first paradigm.
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9-character alphanumeric unique identifier that is assigned to every facility, delivery location, and business activity in the healthcare supply chain.
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US National Association representing primary, full-service healthcare distributors. Formerly the Healthcare Distribution Management Alliance (HDMA).
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Defined under DSCSA as a sealed case containing only product that has a single National Drug Code number belonging to a single lot.
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Characters (e.g. letters, numbers) which can be read by persons and are encoded in data carriers. HRI is a one-to-one illustration of the encoded data.
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Defined under DSCSA as a product for which credible evidence shows that the product is counterfeit, diverted, or stolen; is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans; is the subject of a fraudulent transaction; or appears otherwise unfit for distribution such that the product would be reasonably likely to result in serious adverse health consequences or death to humans.
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A company that oversees the importation of product to a specific country.
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TraceLink app. Searches and views reports required by the Indian government.
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Defined under DSCSA as the smallest container of product introduced into commerce by the manufacturer or repackager that is intended by the manufacturer or repackager for individual sale to a dispenser.
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The digital transformation of manufacturing/production and related industries and value creation processes. It refers to the intelligent networking, automation, and data exchange of machines and processes, including cyber-physical systems, the Internet of Things, cloud computing, and cognitive computing.
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The recognition of the serial numbers within a sealed container based on previous observation, and not by directly reading each serial number. Inference is accomplished using data systems or documents and is controlled through validated procedures.
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A TraceLink B2B monitoring tool. Allows certain users to review data that is moving in and out of TraceLink. Monitors and logs file exchanges, errors, search details, and raw files.
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A TraceLink app that allows for B2B transaction exchanges between Trade Partners in custom formats.
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The process of reviewing an item, either manually or using automated systems.
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Demonstrates that a process or equipment meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place.
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A number assigned to a product for internal use and not for identifying the product externally.
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A location within the Owner Company that has been granted specified access to a TraceLink app.
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The ability of technology systems and software to communicate, exchange data and/or information, and make use of the information that has been exchanged.
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The smallest saleable unit of product, the secondary package level. Synonymous with each.
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Responsible for maintaining the verticle, which serves as the starting point of every app. The kernel developer maintains code that defines default behavior for every pod in the system.
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The South Korea compliance reporting repository, which supports serialization and traceability regulations.
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Enables dynamic deployment of a group of apps so they can be accessed at runtime. A Helm chart describes how Kubernetes deployments are grouped together in an environment.
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The 5 levels of serialization and information management, which include: L1 – Device, L2 – Packaging line software, L3 – Site-level serialization, L4 – Enterprise serialization system, and L5 – Network-level serialization system.
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An industry standard protocol for accessing and maintaining distributed directory information services.
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A system that manages a production line and interfaces with a company's Enterprise Resource Planning (ERP) system.
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The representation of the relationship between an Owner and a Partner within the context of an app. A Link creates the shared context within the app and defines the permissions for data exchange and access. A Link can be initiated by the app Owner or by a Member of the TraceLink Network, based on the app configuration. Links can be made at the company or location level, depending on what is appropriate for the given app.
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A company’s local storage for solution packages. Each company can maintain their collection of packages in their local library. In a future release, companies will be able to download solution packages and add to their local library, save their local solution customizations as packages to their local library, and use their local library to move packages between environments (i.e. from Validation to Production).
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Comprises the data and process of printing labels for use on all containers above the secondary packaging level (e.g. shipper and pallet labels).
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A group of products associated with a manufacturing or packaging operation. Synonymous with batch.
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An application utility that includes tools for managing application settings and Partners. Users that have access to this utility are considered Managers.
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An entity or organization responsible for producing a product.
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A control system for managing and monitoring work-in-process on a factory floor.
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The license holder (brand owner) of a pharmaceutical product.
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The Russia compliance reporting repository, which supports serialization and traceability regulations. MDLP is controlled by the Tsentr Razvitiya Perspektivnykh Tekhnologiy (CRPT).
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The collection of data representing a company's details, global identifiers, products, and trading partners. Particular types of data are required for serialization and global compliance reporting.
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TraceLink app for managing Company Master Data, Partner Master Data, and Product Master Data.
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An Opus multienterprise app, provided by TraceLink, that provides read-only access to Master Data Exchange (MDX) from Track & Trace Services.
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Any company, location, or person on the TraceLink Network.
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An integration message (formerly known as transaction) which is used as an interface to exchange data between two companies. Messages process in real-time.
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An Opus system app, provided by TraceLink, that enables notifications and inbox messages, based on the triggering of certain application events.
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An Opus infrastructure app, provided by TraceLink, that is used by app developers to define message processing flows and branching, which support asynchronous message processing via message handlers.
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Defines an app or platform service. The goals of accelerating app development, facilitating the management of apps, and presenting a developer with a visual development experience require that much of the behavior of an app be defined via metadata. The metadata repository contains object types, associations, and attributes.
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An Opus system app, provided by TraceLink, that is responsible for managing data models, which consist of object types, relationships, and attributes. This app generates the schema that apps use to persist the data and navigate the data model.
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A mobile instance of a customer's application run on a tablet or phone.
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Organizes a set of event handlers. Modules have their own Git repositories and their own build pipelines. In TDE, a developer selects which modules to include in the app they are building.
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An app used by the owning company that enables the company to share the app and data with supply chain partners on the TraceLink Network. Support for integrated supply chain partners is inherent to the app. Data can be exchanged via the user interface or message exchange with a linked Partner on the TraceLink Network. Examples of multienterprise apps are Agile Process Teams (APT), Serial Number Exchange (SNX), Product Track, and Product Information Manager (PIM).
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An app that allows companies to share financial information, product movement, serialized data, and production information about commercial activities with upstream and downstream supply chain partners.
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A term used by Kubernetes as a mechanism to support multiple virtual clusters backed by the same physical cluster. These virtual clusters are called namespaces and can be thought of as an abstract container or environment created to hold a logical grouping of apps and data stores.
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A nonprofit organization that promotes safe pharmacy practices.
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A unique three-segment numeric identifier assigned to each medication prepared for commercial distribution in the United States. The three segments of the NDC identify the labeler, the product, and the commercial package size. The NDC is used as the Item Code in Product Master Data for products distributed in the US.
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A list of drugs that a country specifies that satisfies the healthcare needs of the majority of the population.
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The organization in China responsible for ensuring pharmaceutical quality. Replaced China Food and Drug Administration (CFDA) in 2018.
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A country-specific product verification system that implements the Falsified Medicines Directive (FMD). NMVS systems verify the authenticity of a medicinal product by leveraging information sent through NMVS Compliance.
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A TraceLink app that generates searchable reports about pack verification and status update events across all European national systems.
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An information system set up and governed by national stakeholders to ensure a medicine’s authenticity by verifying its safety features. This prevents falsified products from entering the supply chain.
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A product identifier that adopts the structure of a Global Trade Item Number (GTIN) and is assigned by a third-party national agency. An NTIN contains a country-specific drug registration number.
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Provides access to app destinations as the side menu of the Design Studio. The navigation drawer allows a user to navigate content by selecting different objects to perform actions on.
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A business ecosystem is composed of networks. A single network is owned by a company and enables the execution of one or more processes. Networks can have linked entities, which can include Partner companies, Partner locations, and Owner locations based on the nature of the business processes the app supports and the requirements of the specific business context.
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An Opus system app, provided by TraceLink, which is responsible for arranging entities on the TraceLink Network, including companies, locations, users and roles, and their associations. Other end-user apps such as Network Operations, Company Administration, Application Administration, and User Administration all leverage this application's capabilities to facilitate the administration of their companies and networks.
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A member of a network that has the permissions to perform administration functions specific to a network (e.g. adding users at the network level, linking Partners and internal locations). Only apps that support multiple networks have Network Administrators.
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A Business-to-Business (B2B) connection between a company's ERP system and TraceLink that allows the company to exchange files with other companies from the TraceLink Network. Once a company is integrated to the Network, they can access TraceLink through an Applicability Statement 2 (AS2) mailbox, Secure File Transfer Protocol (SFTP) directories, or HTTP Post web upload location (in addition to the web browser application).
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Defining the company on the Network. TraceLink onboards a company once by adding a Company Profile to the TraceLink Network. The company’s Network profile defines the company so that TraceLink can always interact with it. The profile uniquely identifies each company on the Network to distinguish it from all other parties.
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An analytics-based application that will allow customers to plan and optimize demand and supply across the end-to-end supply chain.
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A server that hosts the platform for a consumer application. A node represents a physical location, a logical location, sub-location, organization, legal entity, or even specific system. Network nodes could be a plant, warehouse, or logical sub-division of a warehouse. For example, a 3PL facility that services multiple customers could have a different Network node representing a logical warehouse for each customer serviced at that location, a business unit or line of business, a geographic organization, a specific ERP system, or a corporate entity.
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Namespaces can be mapped to node pools to control the placement of pods on physical devices.
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One of the three primitive building blocks used to create the data model. (The others are attribute and relationship.) A reusable component for managing data in applications. Examples include: Purchase Order, Company, Project.
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A function that can be performed using an API. Referred to as an action in the platform data model.
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Formal testing of the TraceLink Life Sciences Cloud (TL-LSC) system performed by the TraceLink software quality assurance team. This formal testing is required by TraceLink's Software Development Lifecycle procedures for all changes to the system before a version is approved for release to customers. All OQ testing is documented and reviewed, with objective evidence filed with the test results.
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Within TraceLink, operational reporting allows TraceLink members to pull existing product data from the system into a CSV file.
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An Opus enterprise solution, provided by TraceLink, that provides the user interface for programmers, business analysts, professional services, customer IT staff, and third-party developers to build business process applications using the TraceLink Development Environment (TDE).
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A multi-tenant cloud environment for developing and hosting extensible mobile and web apps.
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A multienterprise app that coordinates the processes made up of various discrete orchestration tasks across supply stakeholders. Orchestration tracks the key dates, responsible parties, and other information for those tasks and can recalibrate the process based on defined contingencies. Orchestrated processes are created from templates and each orchestrated process has specific information defined.
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Evaluation of the effectiveness of a manufacturing operation.
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A TraceLink Member who has purchased a particular TraceLink application (a.k.a TraceLink Customer). Once purchased, the Owner establishes a Link to one or more Members, which makes that Member a Partner within that application's instance.
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Data and process for printing on primary and secondary product packaging.
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A portable version of a solution that preserves the functionality of the solution and the assets the solution uses (e.g. role or policy configurations, data model or workflow customizations, user experience tasks). Each package has a unique combination of package name and version number.
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Track and trace system that transfers serialization data between entities when products are sold in Saudi Arabia. A component of the Drug Track and Trace System (DTTS).
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Physical material, artwork, and printing used for all levels of product and logistics containers.
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A code that can be assigned at multiple levels of the packaging aggregation. The code type is chosen by the user. Packaging codes do not have to be the same code type between packaging levels.
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Largest of the TraceLink defined packaging levels. A flat transport structure that supports goods while being lifted by a forklift or other jacking device. Goods or shipping containers are often placed on a pallet secured with strapping, stretch wrap, or shrink wrap and shipped.
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An organization that buys a product on the open market with the intention to repackage or relabel, and then distributes the product to a different market.
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A practice for pausing the processing of a message if certain prerequisite conditions have not been met. If a prerequisite for a message has not been met, TraceLink stops processing that task, returns the task to the queue, and then tries to process the task again every 15 minutes for a predetermined amount of time (the default amount is two hours).
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A company on the TraceLink Network that is linked to an app controlled by another company for the purpose of collaborating with the app Owner in the context of a business process. A partner may or may not be a TraceLink customer for the app. When a Partner is also a TraceLink customer of the app, the information exchange is app to app.
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A collaborative forum and FDA public-private partnership dedicated to developing, advancing, and sustaining an effective and efficient model for interoperable tracing and verification of prescription pharmaceuticals in the US.
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A certified record that contains information about each distribution of a prescription drug. It records the sale of an item by a manufacturer, any acquisitions and sales by wholesalers or repackagers, and final sale to a pharmacy or other entity administering or dispensing the drug. The process generally begins with the serialization of a product, and then continues through the supply chain as the product is received by each trading partner.
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The documented evidence that the system, equipment, or process is capable of consistently producing a safe product of high quality.
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An entity or organization that is the license holder of the pharmaceutical product. This includes Brand Owners, Generics, MAHs, and other Specialty Companies.
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Process of collecting articles in a warehouse to fulfill a customer order.
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A group of TraceLink-developed technologies that are used as a base upon which other applications, processes, or technologies are developed.
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An Opus app, provided by TraceLink, that provides the basic UI framework for Opus Platform applications including the header, utilities menu, side menu, footer, and the content explorer. These major aspects of the UI framework are always present within any Opus app.
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A Kubernetes term for a group of containers deployed together.
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A policy defines the underlying expression that needs to be evaluated to determine whether the user with role X is permitted to perform the given action specified in role X (e.g. user can perform that action on that object in that environment). The policy expression is evaluated at the time the user initiates an action and responds in sub-millisecond time. The data model defines which attributes are available for policies to evaluate. TraceLink provides a set of policies with each app and Company Admins have permissions to update policies for apps they license. (See: Roles)
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TraceLink web application particularly for Trading Partners as opposed to TraceLink Customers.
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The packaging material in direct contact with a product's contents, usually the smallest unit of distribution or use (e.g. blisters, bottles).
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The three building blocks used to create the data model: object type, attribute, and association.
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A Process can be a base business object or custom business object. Solutions can only have a single instance of a specific object type. For example, if we have a base business object customized in 3 different ways, out of 4 variations of the base business object only one can be part of the solution.
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An organizing construct used by the Agile Process Teams (APT) app that provides the ability to configure team workspaces dedicated to specific groups of users and Partners that will use the solution to execute processes while maintaining separate data access and visibility within each Process Team. This enables a delegated usage model by multiple organizations or business units in the same company and their respective supply chain ecosystems. This enforces the same process across the enterprise while permitting each business unit to manage its partners, users, role assignments, and data visibility independently. See: Agile Process Teams (APT)
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A member of the APT app and one or more Process Teams with permissions to add/remove user access to the Process Team, link/unlink Partners to the Process Team, and assign the Process Team user roles to users and Partners.
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A TraceLink term that describes a one-to-one B2B relationship between a TraceLink customer and its Trade Partners.
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A collaborative workspace that includes all active product apps as a B2B toolset for a TraceLink customer and its Trade Partners.
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A prescription drug that is fully manufactured and is in its intended dosage. Synonomous with Medicine.
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A unique identifier assigned to each finished manufactured product that is ready to be marketed or sold. Synonymous with Universal Product Code.
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A TraceLink app that routes Consumer verification requests to Product Information Manager (Product Verification). This app also stores a history of verification requests and responses.
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A TraceLink app that allows users to exchange product master data with any of their supply chain partners.
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A TraceLink app that enables direct and indirect trading partners to manage product verification requests in real time across any party in the supply chain, without a need for preexisting relationships between the requesting and responding parties.
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Allows a user to verify the status of a serial number against a pharmaceutical manufacturer's data.
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Each region has one production cluster and one test cluster.
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A collaboration space for developers to create versions of a set of apps. A project is used to develop one or more versions of one or more apps. A company in a namespace creates a project. A client must address events to the TDE app to create a new project.
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The specific object instance of an attribute (i.e. the value of the attribute).
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A serial number state in which the serial number has been created and reserved for a product, but has not yet been commissioned.
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The storage or identification of a product, to prevent distribution or transfer of the product, in a physically separate area clearly identified for such use or through other procedures.
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The use of an object applied to or incorporated into a product, animal, or person for the purpose of identification and tracking using radio waves.
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The removal of a drug product from the market. In the US, recalls fall under three classifications: Class I is for drug products that can probably lead to adverse health effects or death; Class II is for drug products that can cause temporary or reversible health effects; and, Class III relates to instances where the drug product is not likely to cause adverse health effects.
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An inbound purchase, return, or transfer within TraceLink.
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The process of verifying that information in a digital system accurately reflects the state of objects in the real world (e.g. comparing a label on a package with the same label in TraceLink).
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Company data is stored in a data center in one of two regions: US East or EU Central. For data residency and privacy, a company can only have their data in one region. Companies can exchange data with companies in other regions, but a company cannot move data to another region. If a company needs to migrate data from one region to another, TraceLink creates a new company in the other region. Migration happens only on the production cluster.
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To assign a new serial number to a container (preserving existing aggregations) within TraceLink.
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One of the three primitive building blocks used to create the data model. (The others are object type and relationship.) A relationship is how business objects can be connected to each other; relationships represent "why" two objects are connected.
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Roles govern permissions to screens, functions, and data within an app, whether performed via the user interface or integration. Roles are managed by the Business Technology Specialists that configure and customize the app and by the Company Admins (users with Role Management access). An app can have many roles (to permit and restrict what different classes of members can do within the app). Roles are defined, named, and assigned to members of the app, including Partners. Every enterprise app must have roles for at least an Admin and a Member. Every multienterprise app must have roles for at least an Admin, Member, Partner Admin, and Partner Member. TraceLink will provide a set of default roles with each app that include the above, but may also include standard business use roles.
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Also known as the Federal Service for Surveillance in Healthcare. An executive body responsible for the control and supervision of the healthcare system in Russia. Part of the Ministry of Health. See http://www.roszdravnadzor.ru/en for more information.
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Currently placed under the metadata model.
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An Opus enterprise application that allows Marketing Authorization Holders (MAHs) who sell products in Russia to meet the reporting requirements of Federal Law No. 29-FZ of 2000 regarding the quality of food products and supplements and their safety for human health. Also refers to the Opus enterprise solution that provides the user interface for the Russia BAFS Compliance application.
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A TraceLink application that allows Marketing Authorization Holders (MAHs) who sell products in Russia to meet the reporting requirements of Federal Law No. 425-FZ.
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A TraceLink application that enables Marketing Authorization Holders (MAHs) and their CMOs to manage encrypted identification numbers with the Tsentr Razvitiya Perspektivnykh Tekhnologiy Order Management Station (CRPT OMS).
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Elements (e.g. anti-tampering devices, barcodes) carrying product and pack data, that are incorporated into a medicine product’s packaging and identification to facilitate verification. Under FMD, for instance, safety features contain a unique identifier encoded in a 2D barcode and anti-tampering technologies.
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A TraceLink application that enables Pharmaceutical Manufacturers and Wholesale Distributors to comply with Saudi Food & Drug Authority (SFDA) regulations.
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Saudi Arabia federal agency that oversees the regulation of food and health products within Saudi Arabia. See https://www.sfda.gov.sa/en/pages/default.aspx for more information.
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The physical database instantiation of the Logical Data Model that defines the detailed definition (i.e. attributes) of a particular object type or association, as opposed the metadata model, which is used when referencing the object types, associations, and attributes of the system.
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Divides the content area into sections that contain UI components and data components. The Screen template is based on the Flexbox (or "Flexible Box") layout mode, which provides a responsive, device-independent content flow.
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Defines physical and behavioral boundaries of a specific area in the UI, such as whether it spans across the entire screen or only part of the screen. A Screen template is composed in the XD Studio and can be reused across different devices.
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Defines a user's company-specific behavior. A script can insert pre-processing or post-processing steps to an event, or even override an event's defined behavior.
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An area within the XD Studio screen. A section contains UI components, Data components, or both.
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A network protocol that provides file access, transfer, and management over a secure channel.
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A section of a market or industry. The pharmaceutical supply chain includes segments such as Manufacturer, Wholesale Distributer, Dispenser, Contract Manufacturing Organization (CMO), Third-Party Logistics (3PL) companies, and Repackagers (also known as Third-Party Packagers or 3PPs).
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The distinctive portion or component of a Unique Identifier (UID), also known as a Serial Reference.
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The TraceLink app used to exchange and track serial numbers during the manufacturing and packaging stages of the product.
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The TraceLink app used to generate serial numbers. Manufacturers define the types and formats of the serial numbers and can assign them to packaging sites.
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The number used to identify shipping pieces such as pallets and cases. See the "GS1 Glossary" at http://gddold.gs1.org for more information.
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A unique identifier to a physical location (e.g. a specific building or bin within a warehouse). Where the Global Location Number (GLN) is a GS1 format, the SGLN is an Electronic Product Code (EPC) format, and is represented in Uniform Resource Identifier (URI) format (e.g. urn:epc:id:sgln:0030001.12345.400).
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The combination of a Global Trade Identification Number (GTIN) and serial number which uniquely identify an item.
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The accepted format of unique identifier as defined by the US Food and Drug Administration (FDA) for serialization of US marketed products. The sNDC is comprised of the National Drug Code (NDC) and a serial number.
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The TraceLink app that manages and reports on serial numbers and their corresponding products and containers.
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An application utility that configures app notification settings and TraceLink default settings.
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An Opus system app used to add, edit, and delete catalog items in a company’s catalog in a specific environment.
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A messaging protocol for exchanging structured (XML) information in the implementation of web services.
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A session and user authentication service that allows software system users to log in with a single username and password to access connected systems.
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A computer system responsible for a location-specific function. In traceability systems, site servers usually refer to local servers that allocate serial numbers to packaging control systems and manage serial number data before it is transmitted to an enterprise traceability event repository.
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A TraceLink app that serves as an event ledger to capture and record serial number observations on serialized objects (in whatever order they may occur) related to pharmacy, warehouse, and supply chain activities in an independent repository, without depending on full track and trace and serial number life cycle requirements.
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A TraceLink app that operates on a handheld device or smartphone that assists with warehouse and distribution functions.
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A TraceLink mobile app that allows Pharmacies and Hospitals in the European Union to meet verification and reporting requirements. Smart Rx Manager leverages Smart Event Manager to store all events and National Medicine Verification System (NMVS) Compliance to communicate with the appropriate European national system.
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Represents the state of metadata and code at a particular point in time. Developers can choose to take a snapshot at any time. Snapshots are identified by snapshot numbers. Test companies can be configured to use a specific snapshot number of an app's specific version, or to always use the latest snapshot. The latter is useful in development, as the developer makes changes without having to continually change the settings for their test company.
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A set of developer tools that allows other software programs to interact with the TraceLink Platform. Members on the Network can generate a series of request and response messages corresponding to various TraceLink applications (whether synchronously or asynchronously).
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An Opus enterprise app, provided by TraceLink, that allows TraceLink, Customers, and Solution Partners (SP) to create and customize solutions in a low-code environment. Design Studio, Workflow Studio, and Data Studio are all part of the Solution Builder.
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The global catalog where authorized solution providers can publish approved solution packages to be distributed to TraceLink customers. Companies can download packages from the catalog for the apps they have licensed, which they can then install as a solution and customize if needed.
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Once a bundle of applications (from a one or more Solution Areas) are chosen to meet a customer's needs, that customer's Solution is established.
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Solutions package configurations of data models, workflows, user experiences, and roles to create the functionality that a customer will use in support of a business requirement. The data model, workflow, and APIs come from the app. The user experiences and roles are associated in the context of the Solution. TraceLink offers default Solutions that can be used out of the box by customers. Configuring and managing solutions is done using the Solution Builder. Customers can also clone and customize solutions with the Solution Builder.
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TraceLink app. Searches and views reports required by the South Korean government.
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Code used to identify transportation companies.
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A standard identifier affixed to a prescription drug package.
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Within the US, a particular state’s license as a wholesale drug distributor, e.g. Indiana issues a wholesale drug distributor license number, in the format 4800XXXXA (including the “4800” prefix and the "A" suffix).
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Specifies a distinct type of item for sale. SKUs are not regulated or standardized and thus are not used for serialization.
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A network that provides access to consolidated, block level data storage.
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TraceLink app. Tracks external and internal supplier issues.
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A multienterprise collaboration solution for Tracelink’s Agile Process Teams (APT) app that allows capturing, analyzing, resolving, correcting, and preventing supply chain issues.
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A multienterprise work management Solution for digitalizing supply chain business processes and enabling structured execution cross-functionally and cross-company with supply chain partners.
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A product for which there is reason to believe that such product is potentially counterfeit, diverted, or stolen; potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to human; potentially the subject of a fraudulent transaction; or appears otherwise unfit for distribution such that the product would result in serious adverse health consequences or death to humans.
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An integration message (formerly known as transaction) is an interface where data exchanges between two or more entities. Synchronous messages fully process in real-time.
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Type of processing that provides an immediate response to a query. Simple Object Access Protocol (SOAP) and REST web services provide synchronous processing.
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A member of a company that has the permissions to perform system administration functions for apps to which the company has access (e.g. company configuration, adding users to the company).
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An application that enables fundamental capabilities of the Opus Platform and makes these available to end-user applications. Examples of System Applications are Metadata Manager, Application Manager, Workflow Manager, Message Processing Framework, and Application Version Manager.
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A data storage system that is the authoritative source for a particular data element when there are multiple sources of the same element.
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Under DSCSA, the combination of Transaction Information (TI), Transaction History (TH), and the Transaction Statement (TS) for a product as it moves through the drug supply chain.
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A team is composed of users from the company that owns the network and users from the linked entity who have access to the Link. Each Link within the network represents a single team.
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A member of an app or network that has permission to perform administration functions for that app or network (e.g. adding users at the network level, linking Partners and internal locations). Only apps that allow linking have Team Administrators.
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For rapid development work, platform developers can use Telepresence to allow code to be run on their local machine and proxied to the cloud.
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Using the Serial Number Manager (SNM) app, manufacturers define the formats of the serial numbers for particular products using serial number templates, which are defined presets for correlated serial number data.
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Contains the company namespace, QE, namespace, and other namespaces for QA/testing in a runtime environment for debugging. Each region has one production cluster and one test cluster.
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Defines the visual branding information and applies to all screens hosted in the XD Studio. A theme can be modified by companies and users. Examples: color, font, spacing, and other visual aspects not affecting functionality.
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A contracted company that provides distribution services of finished goods on behalf of another company. A 3PL provides distribution services, but never takes ownership of the product although the product is in its possession.
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A company contracted to manufacturer products for a pharmaceutical manufacturer.
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Term used to refer to any Third-Party Manufacturer (TPM), Third-Party Logistics (3PL), Contract Manufacturing Organization (CMO), or other externally contracted organization.
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An organization that is contracted to package product.
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An organization that is contracted to print serial numbers onto packaging containers.
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The set of implementations for the interface provided by the API package in the Opus SDK. It is part of the TL kernel verticle, and is shared by all subordinate verticles located in the container.
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A logical database built by TraceLink (based on RocksDB) to provide data persistence for Opus applications. An Opus application communicates with a TLDB instance through the Worldview data access layer.
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A TraceLink product offering which includes a fixed set of functions. For example, SNX is an app which includes provisioning, commissioning, and aggregation functions.
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The company or organization that enters into a commercial relationship with TraceLink, purchasing a TraceLink product offering, such as Product Track.
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An Opus enterprise app, provided by TraceLink, that enables programmers, business analysts, professional services, customer IT staff, and third-party developers to quickly build business process applications in a low-code, cloud-scale environment.
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The foundation of the TraceLink product offerings (i.e. TraceLink at the highest level). Members join the TraceLink Network and access applications either as Owners (if they purchased the application) or Partners (if Linked to the application).
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A responsive web experience that is accessed from http://opus.tracelink.com and will replace the tracelink.com website. The TraceLink Web Experience provides a Foundation layer of the platform UI that is always visible.
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A group of systems and processes used to determine the status and location (past and present) of a unique item.
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An on-going business-to-business relationship where a product transfer and change of ownership occurs (e.g. Customer, Supplier, 3PL).
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A Drug Supply Chain Security Act (DSCSA) term. A statement in paper or electronic form that includes the Transaction Information (TI) for each prior change of ownership, going back to the manufacturer of the product.
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A Drug Supply Chain Security Act (DSCSA) term. Information that documents the change in ownership of a product including drug product information, dates, and business party details.
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A DSCSA term that refers to a statement, in paper or electronic form, that provides a legal attestation that the entity transferring ownership complies with DSCSA requirements. The Transaction Statament is included with the Transaction Information and History.
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An Opus enterprise app, provided by TraceLink, which is responsible for transferring data from one format to another (e.g. JSON to CSV).
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The public-private organization in Russia responsible for generating crypto codes via their Order Management Station (OMS). See https://crpt.ru/ for more information.
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Included as part of a screen template section in the XD Studio and configured to have specific behavior based on the Properties setting.
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The US standard article number. A form of GTIN data carrier or barcode.
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A string of numbers and characters relating to a product that is unique within a given system.
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A unique identifier assigned to each finished manufactured product that is ready to be marketed or sold. Synonymous with Product Code.
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The opposite of the normal product flow in a supply chain (i.e. moving back up the supply chain). Generally speaking, the pharmaceutical product flows, and transactions occur, through the supply chain from manufacturers, to repackagers, to wholesaler distributors, to dispensers.
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An FDA Organization that regulates some products that are administered by veterinarians but can also be consumed by humans.
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Federal Agency which enforces federal drug laws within the US.
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A registration number assigned to an entity that has to be authorized by the US Drug Enforcement Administration (DEA) to manufacture, distribute, research, prescribe, or dispense a controlled substance for the purpose of tracking controlled substances. A valid DEA number consists of: 2 letters, 6 numbers, and 1 check digit. The first letter of the code identifies the type of registrant (P/R-Manufacturer/Distributor). The second letter is the first letter of the registrant's last name.
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US Federal Agency that oversees the regulation of food and health products within the US.
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TraceLink app. Tracks movement of products within the US supply chain.
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An individual associated with an entity or organization responsible for making use of product, process, or systems. A user must be an Owner or Partner (i.e. "Linked" within the context of an app).
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A set of apps that enable general functionality, such as receiving notifications and setting preferences. These apps are available to any registered user on TraceLink without the need to own or link to an app.
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TraceLink web application for TraceLink customers.
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The documented procedure for obtaining, recording, and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications.
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A hosted service that acts as an intermediary between business partners sharing standards based on proprietary data via shared business processes.
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Defined under DSCSA as a means of determining (i.e. verifying) whether the product identifier affixed to, or imprinted upon, a package or homogeneous case corresponds to the standardized numerical identifier or lot number and expiration date assigned to the product by the manufacturer or the repackager.
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An accreditation for pharmaceutical wholesale distribution facilities. Those wholesale distributors that achieve accreditation are in compliance with state and federal laws, and NABP's VAWD criteria.
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An open-source toolkit for building asynchronous apps on the JVM using reactive design patterns.
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A unit of deployment of code for one or more event handlers. Each Jar corresponds to a verticle. Jars can dynamically load multiple verticles when an app or microservice starts up.
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A company that outsources services to a Manufacturer/CMO.
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A software application that supports the day-to-day operations in a warehouse. Enables centralized management of tasks such as tracking inventory levels and stock locations.
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Web-based applications are accessed over a network connection and run inside of a web browser.
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An XML-based interface used to describe the functionality of a web service. In TraceLink, WSDLs are typically used to implement synchronous serial number requests and responses.
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The movement of a drug where the recipient is not a consumer/patient.
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A company that purchases products from manufacturers and then sells them to an entity other than a consumer or patient.
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Actions that are enabled in TraceLink based on particular events. For example, these events may trigger government reports (e.g. shipping, receipt).
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An Opus system app, provided by TraceLink, that executes base state transition conditions and transition actions as well as the custom transitions and actions for a given business object (e.g. Incidents).
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A part of the Solution Builder. Extends workflows and add business logic and conditions. Customers or Solution Partners use the Workflow Studio to extend workflows by adding business logic and conditions, and sub-states and transitions to the base workflow states and transitions to the base workflow states (e.g. Review step, Approval step) and add logic conditions and handlers.
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A collection of lightweight data access APIs that Opus apps can use to interact with data services, including S3, Dynamo, EBS, RDS, Memcache, Redis, and TLDB. The Worldview API is part of the TL Runtime, and is available to every Opus app.
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Describes the structure/schema of an XML document.
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