Applicability statement transfer for secure and payload exchange B2B docs.

Actor Module

Authorized Representative

Australian Regulatory Guidelines for Medical Devices

A collection of data sets so large and complex that it becomes difficult to process with standard database tools and techniques specifically linked to Master Data Management (MDM).

Business Process Improvement, a systematic approach to analyze and change underlying business processes to achieve more efficient results

Business-to-Business, interaction or relationship between two companies as opposed to involving consumers. In an information exchange context this typically involves integration between business applications from both companies.

Basic Unique Device Identification

Customer Master Data Management

Competent Authority

A catalog is a listing of products and or services that can be shared to obtain a global list of a company’s products.

A classification assigned to an item which groups related items together.

Categories which are placed into hierarchical structured groupings to facilitate the management of like items at various levels or groups.

Structured grouping of category levels used to organize and assign products

Coordinating Competent Authority

An approach to shifting/transitioning individuals, teams, and organizations from a current stated to a desired future state.

Designating Authority

Capturing data from multiple source systems and integrating them into a single persistent data store.

Provides a single virtual view of one or more source data files.

The replication of identical data through multiple systems.

Party who is officially recognized as the owner of the data in question. For a given item or party, the data source is responsible for maintaining the information that is under its responsibility in the Global Commerce Initiative.

A party which is authorized to view and make use of Master Data provided by a Data Source. Data Recipients are also known as “subscriber”

The process of checking for accuracy and integrity using accepted industry standards.

Data Dictionary

Digital Transmission – Data exchange module

Device Identifier

European Commission

Electronic Case Reporting

Electronic Data Interchange is the transfer of structured data, by standard messaging
standards, from one computer application to another.

Electronic trading is the process whereby all supply chain transactions – order, shipments, goods processing, sales, and payments—are all done electronically (paperless). Electronic procurement usually conducted via the internet, including auctions, catalog, request for quote, and more.

Electronic Product Code – a part of the Radio Frequency Identification (RFID) standards framework

Enterprise Resource Planning software

End User License Agreement

Electronic Workflow Management uses software tools to create a controlled and visible set of sequenced and concatenated steps within a defined process.

Secure internet platform used to deliver EDI messages, also known as Value Added Network (VAN).

A set of related programs, located at a network gateway server that protects the resources of a private network from users from other networks

Field Safety Corrective Action

Field Safety Notice

File Transfer Protocol used to easily exchange files over the internet using desktop software.

Good Automated Manufacturers Process 5

Global Commerce Initiative

The Global Individual Asset Identifier is the GS1 Identification Key used in a diverse range of business applications ranging from tracking to recording the life cycle of the history of aircraft parts. It is assigned by the owner of the of the asst and may be bar coded using Application Identifier (8004)

Global Location Number, a globally unique number assigned by companies based on their GS1 prefix for use in EDI, and for numbering legal, functional, and physical entities.

Gross Margin Return on Inventory Investment is a ratio in microeconomics that describes a seller’s income on every dollar spent (sales units divided by average inventory units equals gross margin divided by average inventory costs).

The GS1 Identification Keys include a variety of methods of identification. The GS1 ID keys are GTIN, GLN, SSCC, GIAI, GRAI, GSRN, and GDTI.

A prefix assigned by GS1 Member Organizations and used to create certain GS1 ID keys such as GTINs and GLNs.

Goods and Services Tax

Global Trade Item Number

Health Level 7 (International standard for transfer of clinical and admin data via software

Hypertext Transfer Protocol Secure is a widely used communications protocol for secure communication over the internet.

Industrial and Financial System 10 (usually a part of an ERP?)

Originally an acronym for Innovit’s Intelligent Catalog Engine, now it is the name used to describe Innovit’s family of data management tools including applications for product data, customer data and master data

In-Vitro Diagnostic Device

In-Vitro Diagnostic Regulations

Master Data is data about business entities such as customers or products about which there is an agreed-upon view across the organization.

Medical Device Consultation Group

Master Data Management, the management of all business reference information within an organization.

Medical Device Regulation

Metadata is a term used in data warehousing and data integration initiatives to refer to the data schema- that is, the structure and definitions of the types of data in a database.

Manufacturer Incident Report

Retailers require Material Safety Data Sheets to provide to customers and contain information regarding handling, using, and storing hazardous goods including toxicity.

National Medical Products Administration is the Chinese agency for regulating drugs and medical devices.

The data sourced, through its home data pool /solution provider, send an electronic notice to the subscriber when a valid event occurs. This is based on the subscription profile. (Neutral or price attribute changes).

Product Information Management is the management of all information related to a product. Also referred to as product data management and product catalog management.

Product Lifecycle Management

EDI EANcom product price catalog message used to communicate to EANnet

Periodic Summary Report

Periodic Safety Update Report

Regulatory Information Management

Supply Chain Management is the integrated management of the flow of physical
goods and associated information, from raw materials sourcing to delivery of finished
products to consumers. Part of ECR philosophy.

Single Identification Number

Serious Incident Report

Single Registration Number

Single Object Access Protocol for extensible markup language

System/Procedure Pack Producer

Therapeutic Goods Administration (an Australian Regulatory Authority)

Trend Report

Uniform Code Council currently known as GS1 US, based in the U.S. is a membership organization of GS1 Global.

Unique Device Identification

Unique Device Identification-Device Identifier

Universal Standard Products and Services Classification code is an open global standard for classifying products and services.

A series of value-added process activities that incorporate demand creation & management. An extension of supply chain management philosophy.

Vendor Master Data Management

A sequence of concatenated steps with a defined process

Extensible Markup Language

Schema Definition for XML