How a Pharmaceutical Manufacturer and CMO that both own TraceLink serialization apps establish a Link when the Pharmaceutical Manufacturer generates the serial numbers

You are a Pharmaceutical Manufacturer onboarding a CMO that also owns TraceLink serialization apps, and you generate the serial numbers. See the CMO prerequisites.

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The Pharmaceutical Manufacturer must perform the following tasks before onboarding a CMO that also owns TraceLink serialization apps, when the Pharmaceutical Manufacturer generates serial numbers. Some of the tasks below must be completed by the Pharmaceutical Manufacturer's TraceLink Technical Consultant.

The Where sections demonstrate where to go to complete the task. Select the Help icon () on that screen for more information on individual fields.

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 a SOAP WSDL (conditionally required)

Pharmaceutical Manufacturers that do not use TraceLink as their SOR need a custom WSDL to auto-replenish serial numbers from their Enterprise Serialization Management (ESM) system.

When the WSDL is available, the Pharmaceutical Manufacturer or their Technical Consultant can add the WSDL to Serial Number Manager.

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

Enable Event Workflow (conditionally required)

Pharmaceutical Manufacturers that do not use TraceLink as their SOR need a custom shipment Configurable Workflow so that Serialized Operations Manager sends data to the ESM system in the correct format.

After a Technical Consultant adds the Configurable Workflow to Serialized Operations Manager, the Pharmaceutical Manufacturer must enable the workflow.

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

Add Products

Add product master data for the products manufactured by the Pharmaceutical Manufacturer. This product master data must match the product master data entered by the CMO.

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

Create Serial Number Templates

Create templates to generate serial numbers for the CMO. If the company replenishes serial numbers from the company's ESM system instead of generating them through TraceLink, create an Auto-Replenished By Other Serial Number Manager template with the Request From field set to the Pharmaceutical Manufacturer.

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

Assign numbers to the General Pool for maximum efficiency.

This flowchart displays the steps to successfully establish and configure a Link between a Pharmaceutical Manufacturer and a CMO that both own TraceLink serialization apps, when the Pharmaceutical Manufacturer generates the serial numbers.

This configuration is also called "service-to-service."

The Where sections demonstrate where to go to complete the task. Select the Help icon () on that screen for more information on individual fields.

Step 1: Add Partner Information

Add the CMO's company and location information to Master Data Exchange and Company Administration.

Where

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

    If the partner doesn't exist in the Manage Partners page, Add Partner Company adds the partner to the Manage Partners page. When you add an identifier for the partner in Partner Master Data, the partner finds the corresponding Company and adds it to the proper entry in the Manage Partners page.

Step 2: Add the CMO to the Appropriate Apps

Invite the CMO to link to Serial Number Exchange and Serialized Operations Manager at the company level. Contact the CMO's Technical Consultant to see whether the CMO should be added to each app at the company level or the location level.

Where

  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 Pharmaceutical Manufacturer's Link Invitations

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

Where

  • Go to Application Settings > Link Invitations.

Step 4: Add Serial Number Templates to the CMO

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

Where

  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 5: Configure Links to the Pharmaceutical Manufacturer's Apps

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

Where

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

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

Step 6: 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 Pharmaceutical Manufacturer.

Where

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

Step 7: Add Partner Information

Add the Pharmaceutical Manufacturer's company and location information to Master Data Exchange and Company Administration.

Where

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

    If the partner doesn't exist in the Manage Partners page, Add Partner Company adds the partner to the Manage Partners page. When you add an identifier for the partner in Partner Master Data, the partner finds the corresponding Company and adds it to the proper entry in the Manage Partners page.

Step 8: 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 Technical Consultant to see whether the Pharmaceutical Manufacturer should be added to each app at the company level or the location level.

Where

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

Step 9: Accept the CMO's Link Invitations

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

Where

  • Go to Application Settings > Link Invitations.

Step 10: Configure Links to the CMO's Apps

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

Where

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

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

Step 11: Add a SOAP WSDL

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."

Where

  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 12: Create Serial Number Templates

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

Where

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

Assign numbers to the General Pool for maximum efficiency.

Step 13: Add Serial Number Templates to the Internal Locations

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

Where

  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 14: 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.

Where

  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 15: Test Serial Number Messages – Receive Transferred Serial Numbers

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

Where

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