How a Pharmaceutical Manufacturer, Virtual CMO, and CMO that all own TraceLink serialization apps establish Links to each other

You are a CMO onboarding a Virtual CMO that also owns TraceLink serialization apps. See the Pharmaceutical Manufacturer or Virtual CMO prerequisites.

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The CMO must perform the following tasks before onboarding a Virtual CMO that also owns TraceLink serialization apps. Some of the tasks below must be completed by the CMO's TraceLink Technical Consultant.

Configure Integration

  • A Technical Consultant must set up and test the B2B connection for message exchanges between the companies before any of the following steps can be taken.

    Create a Support ticket in the Customer Success Portal or email case@tracelink.com to update a map after going to production.

  • A Technical Consultant must set up any WSDLs or Configurable Workflows that are required for the integration if the Pharmaceutical Manufacturer is not using TraceLink as its System of Record (SOR).

Add Internal Location Information

Add master data and identifiers for the company's internal locations to Master Data Exchange and Company Administration.

  1. Go to Master Data Exchange > Company.
  2. Select the Add Location link in the Actions column.

    Add a GLN identifier for the company and an SGLN identifier for each location to ship product in Serialized Operations Manager.

and

  1. Go to Company Administration > Partners.
  2. Select the Set Identifiers link in the Actions column for the company.
  3. Add the identifiers for the locations.
  4. Go to Company Administration > Locations.
  5. Select Can participate in TraceLink applications for each location.

Add Internal Locations to Serial Number Exchange

Add internal locations as Partners to the company's Serial Number Exchange app so that the locations can send commissioning and aggregation data.

  1. Go to Management > Applications.
  2. Select the Partners icon () in the Actions column for the correct app.
  3. Select Partner.

Add Products

Add product master data for the products that the CMO manufactures on behalf of the Pharmaceutical Manufacturer.This product master data must match the product master data entered by the Virtual CMO.

  1. Go to Master Data Exchange > Products.
  2. Select the Add Product button.

Ensure the following in the "Target Markets" tab:

  • Manufactured By is set to CMO.
  • The MAH ID is the Pharmaceutical Manufacturer's company identifier.
  • The Manufacturing CMO ID is the CMO's company identifier.
  • The Virtual CMO ID is the Virtual CMO's company identifier.

Enable Event Workflows

Enable Serialized Operations Manager event workflows to prompt TraceLink to send commissioning, aggregation, and shipping information to the Pharmaceutical Manufacturer when a shipment occurs.

  1. Go to Company Administration > Workflow.
  2. Enable the following workflow:
    • Event – Transfer Shipment
    • Event Source – [CMO] Serialized Operations Manager
    • Resulting Action – Generate SOM Shipment EPCIS Messages
    • System Type – CMO workflow

This flowchart displays the steps to successfully establish and configure a Link between a Virtual CMO and a CMO that both own TraceLink serialization apps. See the steps that the Virtual CMO must complete to Link the Pharmaceutical Manufacturer.

Step 1: Add the CMO to the Appropriate Apps

Invite the CMO to link to Serial Number Exchange and Serialized Operations Manager at the company level.

  1. Go to Management > Applications.
  2. Select the Partners icon () in the Actions column for the correct app.
  3. Select Partner.

Step 2: Accept the Virtual CMO's Link Invitations

Accept the Virtual CMO's Serial Number Exchange and Serialized Operations Manager Link invitations.

  • Go to Application Settings > Link Invitations.

Step 3: Add Serial Number Templates to the CMO

Add the serial number template for each packaging code that the CMO needs.

  1. Go to Serial Number Exchange > Manage Profiles.
  2. Select the [Company Name] - [Location Name] link in the ServiceLink column for the CMO location.
  3. Select the Add Packaging Codes button.

Step 4: Configure Links to the Virtual CMO's Apps

The identifiers in the Virtual CMO's Links to Serial Number Exchange and Serialized Operations Manager must match the identifiers that the Pharmaceutical Manufacturer uses in those apps.

  1. Go to Company Administration > Services.
  2. Select the Configure Subscription link in the Actions column for the correct Link.

    Make sure that the Shipment Event on the "Transaction Delivery Rules" tab is enabled to automatically deliver messages.

Step 5: Add Partner Information

Add the company and location information for the Pharmaceutical Manufacturer and the Virtual CMO to Master Data Exchange and Company Administration.

  1. Go to Master Data Exchange > Partner.
  2. Select the Add Partner Company button.

and

  1. Go to Company Administration > Partners.
  2. Select the Add Partner button.

    Identifiers added here must match Partner Master Data, and must be added at the same level as the Link (i.e. if the Pharmaceutical Manufacturer is linked at the company level, all identifiers are added at the company level). A GLN identifier should be added for the company and an SGLN identifier should be added for each location, if necessary.

Step 6: Add the Virtual CMO to the Appropriate Apps

Invite the Virtual CMO to link to Serial Number Manager and Serialized Operations Manager.

Linking the Virtual CMO to Serial Number Manager at the company level allows the CMO to auto-replenish serial numbers from the Pharmaceutical Manufacturer's Enterprise Serialization Management (ESM) system. The CMO needs to link the Virtual CMO to Serialized Operations Manager to transfer product, typically at the company level as well.

  1. Go to Management > Applications.
  2. Select the Partners icon () in the Actions column for the correct app.
  3. Select Partner.

Step 7: Accept CMO's Link Invitations

Accept the CMO's Serial Number Manager and Serialized Operations Manager Link invitations.

  • Go to Application Settings > Link Invitations.

Step 8: Configure Links to the CMO's Apps

The identifiers in the Virtual CMO's Links to Serial Number Exchange and Serialized Operations Manager must match the identifiers that the CMO uses in those apps.

  1. Go to Company Administration > Services.
  2. Select the Configure Subscription link in the Actions column for the correct Link.

    Make sure that the Shipment Event on the "Transaction Delivery Rules" tab is enabled to automatically deliver messages.

Step 9: Add a SOAP WSDL

CMOs need the Virtual CMO's custom SOAP WSDL to auto-replenish serial numbers from the Pharmaceutical Manufacturer's ESM system.When the WSDL is available, the CMO or their Technical Consultant can add the WSDL to Serial Number Manager.The Soap Class must be "ServiceToService."

  1. Go to Management > SOAP WSDLs.
  2. Select the Manage SOAP WSDLs link in the Actions column for the Serial Number Manager app.
  3. Select WSDL.

Step 10: Create Serial Number Templates

Create a template that auto-replenishes serial numbers from the Virtual CMO by setting the Request From to the Virtual CMO company.

  1. Go to Serial Number Manager.
  2. Select the Add New Template button.

Step 11: Add Serial Number Templates to the Internal Locations

Add the auto-replenishment template for each packaging code that the CMO's internal locations need.

  1. Go to Serial Number Exchange > Manage Profiles.
  2. Select the [Company Name] - [Location Name] link in the ServiceLink column for the CMO location.
  3. Select the Add Packaging Codes button.

Next Steps

After the Virtual CMO establishes and configures the Link with the Pharmaceutical Manufacturer and the CMO, all three companies can test that the Links are configured correctly.

After the Links are established between the Pharmaceutical Manufacturer and the Virtual CMO and between the Virtual CMO and the CMO, all three companies can test that the Links are configured correctly by following the steps below.

Step 1: Test Serial Number Messages – Transfer Product to Virtual CMO

Request, commission, and transfer serial numbers to the Virtual CMO to make sure that the Link is configured correctly.

  1. Go to Serial Number Exchange > Request Numbers to request serial numbers from the Pharmaceutical Manufacturer.
  2. Go to Serial Number Exchange > Commission Numbers to commission serial numbers for finished product.
  3. Go to Serialized Operations Manager > Outbound Movement and select the Create Delivery link to transfer the serial numbers to the Pharmaceutical Manufacturer.

    Ensure the following:

    • The delivery has a Sale Type of Transfer - In Country or Transfer - Export.
    • The following fields have the correct identifiers:
      • The From Business should be the Pharmaceutical Manufacturer's GLN.
      • The Ship From Location should be the CMO location's SGLN.
      • The To Business should be the Pharmaceutical Manufacturer's GLN.
      • The Ship To Location should be the Pharmaceutical Manufacturer location's SGLN.

Step 2: Test Serial Number Messages – Receive Transferred Product from CMO

Receive the transfer delivery from the CMO to make sure that the Link is configured correctly. The event workflow automatically sends the transfer shipment on to the Pharmaceutical Manufacturer after the Virtual CMO receives it.

  1. Go to Serialized Operations Manager > Inbound Movement.
  2. Select the Create Receipt link.

Step 3: Test Serial Number Messages – Receive Transferred Product from CMO

Receive the transfer delivery from the Virtual CMO to make sure that the Link is configured correctly.

  1. Go to Serialized Operations Manager > Inbound Movement.
  2. Select the Create Receipt link.