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  11. Setting up the ePedigree...

Setting up the ePedigree functionality (Pharma US)

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This document outlines the instructions for setting up the ePedigree functionality, which is applicable for US installations of DC1 Pharma, allowing you to report the Pedigree ID’s for Prescription drugs electronically for pedigree compliance.

File To do
Update pre-loaded application tables Run pre-load tables. This will pre-load the NDC types and the ND item cross reference type.
Work with AXIs The ePedigree AXI group is a file that is delivered with the system. Nothing needs to be set up here, but it is mentioned for informational purposes. The following AXI’s belong to this AXI group: BUSINESS PARTNER, ITEM, RECEIPTS, SHIPMENTS, and VALIDATE.

The following table depicts the values in the PLIST IN and PLIST OUT fields.

AXI PLIST IN PLIST OUT
BUSINESS PARTNER TPLPEDBPAA TPLPEDBPAB
ITEM TPLPEDITMA TPLPEDITMB
RECEIPTS TPLPEDRECA TPLPEDRECB
SHIPMENTS TPLPEDSHPA TPLPEDSHPB
VALIDATE TPLPEDVALA TPLPEDVALB
Work with additional products The rfXcelV4.2 for load sequence 996 is an entry delivered with the system. Nothing needs to be set up here, but it is mentioned for informational purposes. This additional product needs to be activated in the Work with companies file. See below.
Work with companies Activate the following applications for the applicable company:

    US (US modifications)
    PHA (DC1 Pharma)
    UPH (US Pharma)

    Note: You must deactivate any other country modifications that are active before activating the US application.

    Additional product needs to be activated for the company. Select the Add products option for the actual company. On the Work with companies, Additional products panel, activate the rfXcelV4.2 additional product via the Activate option.
Pharma control file Enter the following details:

    ePedigree active
    Set this field to YES to activate ePedigree tracking on company level, making all ePedigree related tracking fields visible.
    ePedigree adm email
    This field is optional. Enter the email address to which you would like the notification to be sent when the transmission of the rfXcel interface files have been sent to the authorities.
Work with warehouses Contact information for ePedigree receptions and shipments can be entered in this file. If entered, it will update the files to be sent to the authorities. If anything for the ePedigree transaction is in error, the contact defined in the fields will be notified.

Select the Pharma option for the applicable warehouse to access the Pharma information panel.

Enter the following details under ePedigree receptions:

    Contact person
    Enter the name of the contact person who will be responsible for receiving ePedigree items.
    Contact phone
    Enter the phone number of the person who will be responsible for receiving ePedigree items.
    Contact email
    Enter the email address of the person who will be responsible for receiving ePedigree items.

    Enter the following details under ePedigree shipments:

    Contact person
    Enter the name of the contact person who will be responsible for shipping ePedigree items.
    Contact phone
    Enter the phone number of the person who will be responsible for shipping ePedigree items.
    Contact email
    Enter the email address of the person who will be responsible for shipping ePedigree items.
Work with items Each applicable item must be a batch item with date handling to be able to activate an item for ePedigree tracking.

Inventory information panel:
Toggle to this panel and set the Batch field to YES. Click Next until you reach the last Inventory information panel and set the Date handling field to YES.

US Pharma panel:
Toggle to the Pharma information panel and complete the following fields:

    ePedigree tracking
    Set the ePedigree tracking field to YES for the item that you want to track for ePedigree compliance.
    Qty per pedigree lbl
    This field must be completed when ePedigree tracking is activated. Note: If the warehouse in which the item will be stored is known, you can override this value on Item/Warehouse level. Enter the number of labels that will be printed when receiving batches that are defined as pedigrees. If the batch quantity is supplied, the number of labels (copies) to print is determined by the batch quantity and what is entered in this field (or in the equivalent field on Item/Warehouse level).

    If you enter 0 or 99, one label will be printed.

    If you enter more than 0 but less than 99, the following formula will be used to calculate the number of labels that will be printed:

    Batch quantity/Qty per pedigree lbl, rounded up to the nearest whole number.

    Example:
    Batch quantity received = 8.
    This Qty per pedigree lbl value = 2.
    The result will be 4 labels (8 / 2 = 4)

    Labels, holding the Pedigree ID, batch and item number, are automatically printed during the reception. A re-print of the label can be performed via the ePedigree label enquiry.

    NDC type
    Select the applicable pre-loaded NDC (National Drug Code) type. Valid types include NDC442, NDC532, NDC541, and NDC542.

    The NDC type dictates the number of digits the NDC item code must contain. When moving data to the pedigree interface files, the system formats the NDC item code (i.e. it will insert two hyphens) based on the NDC type. For example, NDC type NDC542 would mean that the NDC item code would require 11 digits (5+4+2) and when the system formats the NDC item code, the result will be 11111-1111-11.

    NDC item code
    Enter the NDC item code with the number of digits that is dictated by the NDC type. When this is entered the system will create a cross reference type for the item. The cross reference type will be set to ND.

The remaining NDC related fields are used for reporting purposes. This information is retrieved to the rfXcel interface files. Either all must be entered, or all must be blank.

  • Manufacturer
  • Unit
  • Strength
  • Form
  • Package
  • Quantity

Warehouses panel:
If the warehouse in which the item will be stored is known, you can override the Qty per pedigree lbl value that was defined on Item/Pharma information level.

    Qty per pedigree lbl
    Enter the number of labels that will be printed when receiving batches that are defined as pedigrees. If the batch quantity is supplied, the number of labels (copies) to print is determined by the batch quantity and what is entered in this field (or in the equivalent field on Item/Pharma information level).

    If you enter 99, one label will be printed

    If you enter more than 0 but less than 99, the following formula will be used to calculate the number of labels that will be printed:

    Batch quantity/Qty per pedigree lbl, rounded up to the nearest whole number.

    If you enter 0, the quantity defined in the equivalent field on Item/Pharma information level will be used to determine the number of labels that will be printed.

    Example:
    Batch quantity received = 8.
    The Qty per pedigree lbl value = 2.
    The result will be 4 labels (8 / 2 = 4)

    Labels, holding the Pedigree ID, batch and item number, are automatically printed during the reception. A re-print of the label can be performed via the ePedigree label enquiry.

Supplier information panel:
Toggle to this panel. On this panel the Gen inbound ePedig field is used when the pedigree ID is generated for a reception of a batch- and date controlled item. If you set the field to YES or NO here, it will override the value on Business partner/Pharma information level for the supplier. If this field is set to blank, then the value on Business partner/Pharma information level for the supplier will be used.

Example of settings determining if ePedigree tracking occurs

Business partner/Pharma information level for the supplier Item/Pharma information level Item/Supplier information level Will there be tracking?
Tracking is set to YES ePedigree tracking is set to YES Gen inbound ePedig is set to Blank YES
Tracking is set to YES ePedigree tracking is set to YES Gen inbound ePedig is set to NO NO
Tracking is set to NO ePedigree tracking is set to YES Gen inbound ePedig is set to YES YES
Tracking is set to YES ePedigree tracking is set to NO Gen inbound ePedig is set to YES YES
Work with business partners The ePedigree information from this file for the supplier and customer will be retrieved and will update the files to be sent to the authorities. If anything for the transaction is in error, the contact defined in these fields will be notified.

For each applicable business partner, toggle to the Pharma information panel and enter the following details under ePedigree:

    Tracking
    Select this field to enable tracking of ePedigree items for the business partner.
    Contact person
    Enter the name of the contact person who will be responsible for receiving/shipping ePedigree items.
    Contact phone
    Enter the phone number of the person who will be responsible for receiving/shipping ePedigree items.
    Contact email
    Enter the email address of the person who will be responsible for receiving/shipping ePedigree items.
    Gen inbound ePed
    Set this field if you would like to generate ePedigree numbers for items when the items are received into stock. This must be set to YES if the Tracking field is set to YES.
    Always genout ePedi
    This field is used when dispatching sales orders without pick lists. Set this field to YES to be able to create ePedigree transaction logs for these type of dispatches.

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