Generate EU Active - Update Product Pack State Report

Overview

Access this screen from the left panel under Event Workflow.

Manually generate an Active - Update Product Pack State report to send information to the EU Hub about serialized items whose status has been changed back to available. For example, the items might have been:

  • Proven to be suitable after being under investigation.
  • Reserved by government authorities for a quality check, but not tested.
  • Exported, supplied for distribution, or supplied as a free sample within the EU in a shipment that has been voided.

Compliance reports capture information about regulated activities, helping companies comply with requirements in the EU. They can be configured to generate automatically when certain events occur in TraceLink (e.g. commissioning serial numbers, updating a serial number's status, raising shipments), but may need to be generated manually if certain reports are incomplete or inaccurate.

Serialized Operations Manager generates this report only if the serial numbers specified were not already reported with this state.

Getting Started

When scanning, entering, or uploading a file to populate serial numbers, each number must be:

  • On a separate row.
  • Without any special characters.
  • In one of the formats below:

Used for:

  • Items
  • Innerpacks
  • Bundles
  • Cases and Shippers

The format is the AI(01)(21) serial number in barcode format:

  1. First is the 01 Application Identifier
  2. Followed by the GTIN-14 number
  3. Followed by the 21 Application Identifier
  4. Followed by the serial number

    Example: 010088202401033921725368249416

Used for:

  • Pallets
  • Mixed cases

The format is the AI(00) serial number in barcode format:

  1. First is the 00 Application Identifier
  2. Followed by the SSCC-18 code

    Example: 00008820200000050254

Used for:

  • Items
  • Innerpacks
  • Bundles
  • Cases and Shippers

The format is the full 20-digit China serial number, as in this example: 81102302020117515452

Watch how to preserve leading zeros!

Option 1: Specify Item Code and Lot Number

For Sampled and Locked Serial Numbers.

  • Item Code - Country Drug Codes and/or Internal Material Numbers for products in Master Data. Format of each option is:
    • [Packaging Code Type] [Packaging Code] for China
    • [Item Code Type] [Item Code] for EU and India
  • Lot Number - The number associated with the Packaging Item Code, Country Drug Code, or Internal Material Number, which identifies the serial numbers for the report.

Option 2: Specify Serial Numbers

For Sampled and Locked Serial Numbers.

  • Serial Numbers - The serial numbers of the product included in the report.
    • Scan Serial Numbers – Scan or type the serial numbers in the text box.

      Maximum of 30,000 characters.

    • Upload Serial Numbers From File – Upload a file with the serial numbers.

      The file must include only the serial numbers, no headings. Limit of one file per session. File size limit is 50 MB.

Specify Delivery Number

For Supplied, Exported, and Free Sample Serial Numbers.

  • Delivery Number - Number that uniquely identifies the shipment. For all manually triggered reports, ensure that the Delivery Number is unique for every delivery.

Available Actions

    The Show Data From drop-down does not impact the reports generated under Event Workflow Management.

  1. Select either Sampled or Locked from the State to Undo drop-down.

  2. Enter an Item Code in the type-ahead field.

    The product description displays under the field.

  3. Enter a Lot Number in the text field.
  4. Select the Submit button.

    The Event Workflow Management screen displays with the confirmation message "When the Locked - Product Pack Data report finishes generating, it will display in the EU Compliance Application."

    The report displays in the Compliance app once complete. Depending on the size of the report, processing may require a few minutes. Processing errors display in Info Exchange.

    The Show Data From drop-down does not impact the reports generated under Event Workflow Management.

  1. Select either Sampled or Locked from the State to Undo drop-down.
  2. Select the Option 2 - Specify Serial Numbers radio button.
  3. Enter the Serial Numbers by selecting one of the following:

    • Select Upload Serial Numbers from File:
      1. Select the Choose File button.
      2. Browse for and select the desired CSV file.

        The CSV file cannot contain headers.

    • Select Scan Serial Numbers:
      • Enter the serial numbers in the text field.

        or

      • Scan the serial numbers in the text field with an Edge device.

  4. Select the Submit button.

    The Event Workflow Management screen displays with the confirmation message "When the Locked - Product Pack Data report finishes generating, it will display in the EU Compliance Application."

    The report displays in the Compliance app once complete. Depending on the size of the report, processing may require a few minutes. Processing errors display in Info Exchange.

    The Show Data From drop-down does not impact the reports generated under Event Workflow Management.

  1. Select either Supplied, Exported, or Free Sample from the State to Undo drop-down.

  2. Enter the Delivery Number in the text field.
  3. Select the Submit button.

    The screen refreshes with the confirmation message "When the EU Export - Update Product Pack State Report report finishes generating, it will display in the EU Compliance Application."

    The report displays in the Compliance app once complete. Depending on the size of the report, processing may require a few minutes. Processing errors display in Info Exchange.

Error Messages

Errors either display at the top of the screen or are found in Info Exchange (may vary):

Error Message Description
Lot <lotnumber> for item <item code type> <item code value> does not exist. TraceLink cannot find a matching lot number.