Utilisation

MAHs that own Russia Health Products Compliance can generate a Utilisation report to capture the serial numbers that are used on the saleable products in Russia. The reports are submitted to the Order Management Station (OMS).

Configure the report

The report for a product is generated when its product type is set to the corresponding product group in Product Master Data:

  • Product type as Food Supplement for BAFS

  • Product type as Medical Device for Medical Products

The event triggers (i.e. workflow subscriptions) for the report can be set in Administer for Russia Health Products Compliance. Make sure one of the following event triggers are enabled:

Source Application Event Action Description
Serialized Operations Manager Released Generate OMS Utilisation and Aggregation Reports from Core Integration TraceLink generates Utilisation and Aggregation reports for products that are quality released when they are submitted via core integration or the Web UI, as long as all of the event trigger conditions are met.
Serialized Operations Manager Released Generate OMS Utilisation and Aggregation Reports from Event Exchange Integration TraceLink generates Utilisation and Aggregation reports for products that are quality released when they are submitted via event exchange integration, as long as all of the event trigger conditions are met.

For more information on how to enable the event triggers, see the Administer Help Center.

Russia Health Products Compliance generates the Utilisation report when TraceLink processes a Product Release or Product Release Inbound and the following conditions are met:

  • The product's MAH, which is identified by the MAH ID for the RU Target Market in Product Master Data, exists in Company Master Data at the company or location level.
  • The products have a Packaging Code Type of GTIN-14 with a Packaging UOM (unit of measure) of Each.
  • In Product Master Data, the serialized item is associated with an Item Code and Lot Number that has a Target Market as Russia.
  • In Product Master Data, the Product Type of the serialized item is Food Supplement for Biologically Active Food Supplements or Medical Devices for Medical Products.
  • The commission event occurred outside Russia. Use the serial number (SN) to look up the lot aggregate and determine the commission location.

Generate the report

To generate the Utilisation report automatically, enable the appropriate event triggers and ensure that the relevant event trigger conditions are met. When configured, Russia Health Products Compliance generates the Utilisation report automatically when product release event occurs in one of the following interfaces:

Use the following Serialized Operations Manager API message to trigger the Utilisation report:

Product Release (XML)

Complete the elements required for the message. See the Serialized Operations Manager Core Integration API Guide for more information.

Element Values
cmn:LocationId Specify the company or location performing the product release for the serial numbers matching the specified item code and lot number.
cmn:InternalMaterialCode Specify the internal material number configured in the Product Master Data.
cmn:LotNumber Specify the lot number associated with the cmn:InternalMaterialCode.
cmn:QualityControlEntityId Specify the company or location where the product is tested for quality.

Use Serialized Operations Manager to trigger the Utilisation report from the Web UI. See the Serialized Operations Manager Online Help for more information.

  1. In Track & Trace Services (TTS), hover over Modules, and then select Serialized Operations Manager.
  2. Expand the Status Update drop-down and then select Set Product Release Status.
  3. Select the manufacturing location that provisioned the serial numbers from the Show Data From drop-down in the upper right.
  4. Complete the fields required for the report as follows:
    FieldValues
    Item CodeThe Internal Material Number or country drug code from Product Master Data.
    Lot NumberThe number associated with the packaging code.
    Quality Control Entity The company or location where the product is tested for quality.
    Transaction IDs

    The following fields are mandatory when the lot's commissioning location and target market are Russia:

    • Identifier Type – The type of identifier for the transaction.
    • Identifier Value – The value of the identifier for the transaction.
    • Document Date – The date printed on the corresponding transaction document.
  5. Complete any other fields that are required in the UI or that your company uses for a specific purpose.
  6. Select Submit.

    The Set Product Release Status screen displays, and Russia Health Products Compliance begins automatically generating the report from the event trigger.

To generate the Utilisation report manually, use the Russia Health Products Compliance Web UI. This option is useful if a report fails to generate automatically and the information must still be submitted to the Order Management Station (OMS).

  1. Select the Main Menu icon .
  2. Select Russia Health Products Compliance.

    A new tab opens and displays information for the Russia Health Products Compliance app.

  3. Select the Generate Report icon.
  4. Fill in the following fields:
    • Report Type drop-down – Required. Select Utilisation & Aggregation as Report Type.
    • Packaging Code field – Required. The packaging code of the product to generate the report for.
    • Lot Number field – Required. The lot number associated with the packaging code to determine the serial numbers to report.

  5. Select Generate.

    The panel closes, and TraceLink begins generating the report. Filter to find the new report.

Report details

Field Description Sourced From OMS Report Element
Report Type Displays as Utilisation. The type of report. Not reported
Status

The status of the report:

  • Generated – The report is generated in TraceLink but not yet submitted to the OMS.
  • Generation Failed – The report failed to generate in TraceLink.
  • Submitted – The report is generated and successfully submitted to the OMS.
  • Submission Failed – The report is generated but was not successfully submitted to the OMS.
  • Failed – The OMS received the report successfully but failed to provide a response.
  • Accepted – The OMS received the report successfully and accepted the information.
  • Partially Accepted – The event has multiple reports, and all of them are successfully submitted to the OMS, but the OMS did not accept all of the reports.
  • Rejected – The OMS received the report successfully but rejected the information.

The status of the report.

Not reported
Date Reported The date and time that the report is generated. The system date and time when the report is generated. Not reported
Product Group

The product group:

  • Biologically Active Food Supplements

  • Medical Products

The product group. productGroup
OMS ID The associated GUID. TraceLink obtains this value from the OMS. Order Management Station Identifier. omsId
UsageType Displays as Verified. The usage type. Not reported
Event Type

The event type:

  • Product Release
  • Product Release Inbound
The type of event. Not reported
Field Description Sourced From OMS Report Element
Packaging Code The packaging code for the product. The Packaging Code of the serialized item in the shipment.

Not reported
Product Description The name of the product. The description associated with the Packaging Code in Product Master Data.

Not reported
Quantity The quantity of serial numbers for the Packaging Code and Lot Number. The quantity of serial numbers in the shipment for the Packaging Code and Lot Number.

Not reported
Lot Number The lot number associated with the packaging code used to report the serial numbers. The lot number associated with the Packaging Code in Serialized Operations Manager for this product's serialized items. seriesNumber

 
Manufacturing Date The manufacturing date for the serialized items. The manufacturing date associated with the Lot Number in Serialized Operations Manager for this product's serialized items. If the product manufacturing date (production date) does not exist in Product Master Data, the Commissioning Date is considered for the report. productionDate

 
Expiration Date The expiration date for the serialized items. The expiration date in Serialized Operations Manager for the serial numbers in this lot. expirationDate

 

Tips

  • Select the Export icon to export the serial numbers for a Packaging Code and Lot Number to a CSV file.

Response information when using the message status query service:

  • Status – The status returned by the OMS for the submitted compliance report.
  • Report Name – The name of the compliance report submitted to the OMS.
  • Status Code – The HTTPS code returned by the OMS for the submitted compliance report.
  • Report ID – The unique ID returned by the OMS for the submitted compliance report.
  • Description – The description returned by the OMS for the submitted compliance report.
  • Response Date – The date the response is received from the OMS.

Tips

  • Select the Action icon, and then select Export Report File to export the report file generated for the OMS.
  • Select the Action icon, and then select Export Response File to export the response file received from the OMS.