How a CMO links a Pharmaceutical Manufacturer that does not own any TraceLink serialization apps

You are a CMO onboarding a Pharmaceutical Manufacturer that does not own any TraceLink serialization apps.

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The CMO must perform the following tasks before onboarding a Pharmaceutical Manufacturer that does not own any 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.

    The standard EPCIS Shipment message with comm-agg-ship must be configured to send data to the Pharmaceutical Manufacturer's Enterprise Serialization Management (ESM) system.

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

  • A TraceLink Network Success Manager must set up any WSDLs or Configurable Workflows that are required for the integration.

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.

Enable Event Workflow

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 for a CMO to establish and configure a Link with a Pharmaceutical Manufacturer that does not own any TraceLink serialization apps.

Step 1: Add Partner Information

Add the CMO's company and location information 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 2: Add the Pharmaceutical Manufacturer to the Appropriate Apps

Invite the Pharmaceutical Manufacturer to link to Serial Number Manager and Serialized Operations Manager. Contact the Pharmaceutical Manufacturer's Network Success Manager (NSM) to see whether the Pharmaceutical Manufacturer should be added to each app at the company level or the location level. Let the NSM know when the Link invitations are sent.

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

Step 3: Accept the CMO's Link Invitations

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

  • Go to Application Settings > Link Invitations.

Step 4: Add a SOAP WSDL

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

  1. Go to Management > SOAP WSDLs.
  2. Select WSDL.

Step 5: Add Products

Add product master data for the products that the CMO manufactures on behalf of the Pharmaceutical Manufacturer.

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

Step 6: Create Serial Number Templates

Create a template that auto-replenishes serial numbers from the Pharmaceutical Manufacturer's ESM system. Set Request From to the Pharmaceutical Manufacturer company.

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

Assign numbers to the General Pool for maximum efficiency.

Step 7: Add Serial Number Templates to the Internal Locations

Add the auto-replenishment template for each packaging code that the Pharmaceutical Manufacturer'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.

Step 8: Request Configuration of the Pharmaceutical Manufacturer's Links

Email the Pharmaceutical Manufacturer's TraceLink Network Success Manager. TraceLink will configure the appropriate settings and identifiers for the Pharmaceutical Manufacturer's link to the CMO's apps.

Step 9: Configure the Pharmaceutical Manufacturer's Links

The Network Success Manager configures the Pharmaceutical Manufacturer's Links to Serial Number Manager and Serialized Operations Manager. The identifiers here must match the identifiers that the CMO's apps use.

  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 10: Test Serial Number Messages – Transfer Commissioned Serial Numbers

Request, commission, and transfer serial numbers to the Pharmaceutical Manufacturer 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 11: Test Serial Number Messages – Receive Transferred Serial Numbers

When the CMO sends the transfer shipment through Serialized Operations Manager, the shipment should prompt the configurable workflow that sends the serialization information to the Pharmaceutical Manufacturer's ESM system.