General

  • Country Specific Labeling: Label added to the product packaging that contains information specific to a shipping destination that is not present on the primary product labels. May contain additional languages, product data or statements.
  • eIFU: Electronic version of Instructions for Use typically made available on the company product website for viewing / download.
  • Implant Card: Card completed by the physician for the patient that documents the detailed information related to implant used and its location.
  • Instructions for Use (IFU): Instructions provided with the product for safe and efficacious use of a product. Commonly used forms are booklets, maps and sheets.
  • Label: Material affixed to the product packaging with information concerning the product.
  • Label Validation: Confirmation that arrangement and format of a label conveys intended information.
  • Label Verification: Confirmation that label stays affixed and legible through rigors of distribution and storage.
  • Labeling: Any information printed on or affixed to the product packaging the partially or completely describes the product.
  • Literature: Any printed materials that partially or completely describes or promotes the product. May take the form of brochures, posters, quick reference guides, promotional items, etc.
  • Material Identification Label: Label for in-house use to identify manufacturing materials or subassemblies.

Materials

  • Continuous label stock: Uncut label stock typically used with online label printers. Label printers require a cutter installed to cut the labels as they are printed.
  • Continuous web stock: Uncut Tyvek® or pouch material used in the online label printing process. Requires a cutter to be installed on the label printer to cut the material between prints.
  • Die-cut label stock: Adhesive-backed label that is cut to specific dimensions. May include peel-away segments.
  • Label stock: Material used to create labels. May contain specific finishes or varnishes depending upon the printing process used.
  • Piggyback label stock: Triple-layer label stock consisting of two backing paper layers and one label stock layer. Typically used when a peel-away segment is placed on the edge of the label stock.

Barcodes

  • AIDC (Automatic Identification Data Capture): Refers to the methods of automatically identifying objects, collecting data about them, and entering them directly into computer systems, without human involvement. A very common form of AIDC is a barcode.
  • Alphanumeric: Describes a data string that can include letters, numbers and characters.
  • Application Identifier: GS1 numeric code included in the barcode string that indicates the specific information that follows it.
  • Auto discrimination: The ability of a barcode analyzer to detect the type of barcode symbology when scanned.
  • Barcode: A sequence of bars and spaces that translates data into a machine-readable format.
  • Barcode character: A group of bars and spaces that translate into a specific letter, number or character.
  • Barcode density: The number of characters present per characters per inch (CPI).
  • Barcode grader or verifier: A device that is used to verify the grade of a barcode based on ISO 15415, ISO 15416 and ISO 15417.
  • Barcode reader / scanner: Device that reads and translates a barcode into a human / machine-readable format.
  • Barcode symbology: Refers to the specific symbology used.
  • Check digit or Check sum: Character appearing at the end of a barcode string that confirms the code is correctly translated. Common check digits used are Mod 10 and Mod 43.
  • Code 128: Linear barcode symbology that can be used for either alphanumeric or numeric-only barcodes. Formerly known as UCC/EAN-128 and is used extensively worldwide for all packaging levels of the supply chain. Considered a high data density barcode.
  • Code 39 (3 of 9): Liner barcode symbology consisting of uppercase letters, numbers and a specific set of special characters. Utilizes start/stop characters “*”. Considered a low data density barcode.
  • Datamatrix or QR Codes: 2D barcode configuration.
  • EAN: European Article Numbering organization. Merged standards with UCC in 1990 to form GS1.
  • EAN-13: Symbology for specific retail product types.
  • EAN-8: Symbology derived from EAN-13 for use on small packages where EAN-13 would be too large. Applies to retail product types.
  • GS1: Organization that develops and maintains global barcode standards for business communication. Designed to improve the efficiency, safety and visibility of supply chains. Used for both retail and professional products.
  • GTIN: GS1 term used for Global Trade Item Number. Refers to the data string contained in a barcode that identifies the manufacturer, package level / configuration, product code and check digit.
  • HIBCC: Health Industry Bar Code Council.
  • Numeric: Describes a data string that is comprised only of numbers.
  • Primary barcode: Refers to a linear barcode that contains the product GTIN.
  • Secondary barcode: Refers to a linear barcode that contains the Use By Date (if applicable), Manufacturing Date, Lot or Serial Number and any other necessary data.
  • Start / Stop character: Characters used to denote the beginning and end of a barcode. “*” character is most commonly used.
  • UCC: Uniform Commercial Code organization. Merged standards with EAN in 1990 to form GS1.
  • UPC: Universal Product Numbering organization widely used for tracking retail products.

Printing Processes

  • Digital printing: Method of printing from a digital-based image directly to a variety of media. Digital printing is a higher cost per page than offset printing, but the price is usually offset by avoiding the cost of technical steps required to create printing plates and supports short turnaround times.
  • Flexographic printing: Printing process which utilizes a flexible relief plate. Considered a modern version of letterpress that is equipped with high speed rotary functionality which supports printing on almost any type of media including plastic, metallic films, cellophane and paper. Well-suited for printing large areas of solid color.
  • Offline printing: Refers to the practice of printing labels in a different location than the production line and issues labels for use.
  • Offset printing: Most commonly used printing technique in which the inked image is transferred from a plate to a rubber blanket, then to the printing surface. Employs a flat image carrier. Ink rollers transfer ink to the image areas of the carrier, while a water roller applies a water-based film to the non-image areas.
  • Online printing: Refers to the practice of printing labels on the production line.
  • Trigger printing: Refers to an online printing process that requires the scanning of a barcode(s) or other trigger to produce a single label correct label as opposed to utilizing a hand entry.

Systems

  • 21 CFR 21 Part 11: Ferderal Regulation for software systems to have electronic signatures, includes audit logs and versioning.
  • Artwork system: System used for desktop publishing. Usually comprised of illustration, page layout, image manipulation and PDF editing software.
  • Commercial Off-the-Shelf software (COTS): Software that is ready to use without customization. Can have configurable aspects.
  • Custom software: Software that is developed for internal use and not commercially available.
  • Label applicator: Automated hardware used to apply labels to packaging components.
  • Labeling system: System used for in-house printing on the production line. Typically comprised of a computer with label software installed and a label or desktop printer.
  • Labeling vault: Software system used for the controlled storage of label files. Document control systems are most often used for this purpose.
  • Software validation: Process used to test and document that the software performs as intended per a specific set of rules and / or testing methodology.
  • Vision inspection: Automated system used to verify a printed label to a pre-approved template.

Other

  • Anti-counterfeiting: Measures taken to prevent the theft, destruction or replacement of the original product, use in illegal transactions or to otherwise deceive the recipient. A variety of methods used include, but are not limited to holographic labels and / or data added to barcodes.
  • Artwork: Files created for the purposes of vendor-supplied printed materials.
  • Label printer: Specialty printer exclusively designed for printing labels. May be thermal transfer or direct thermal which requires a specific varnish to be applied to the label stock for consistent, permanent and reliable print quality.
  • Label reconciliation: Process used to ensure all labels issued have been used, destroyed or removed from the production line, and designed to prevent label mix-ups between product lots.

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