You can set up the Serialized Manufacturing application to perform serialization and aggregation of the manufactured products.


You can manage the Serialized Manufacturing application through the main tabs below.


TABLE OF CONTENTS


Products


You can register products, product groups, and batches. Products can be associated with product groups.


For each product, you can:

  • Specify market-specific master data.
  • Manage serial numbers.
  • Manage aggregations: product to be aggregated and/or container packing levels. The configured aggregation settings are used when executing packaging orders on a Wipotec-OCS packaging line.
  • Configure country settings.


For the EU market, you can upload the product master data to the EU Hub as per the EMVS guidelines. If the Manufacturer for Pharma application is activated for your tenant, the product is also created in that application after uploading the master data to the EU Hub. The product in the Manufacturer for Pharma application will take the values and settings given in the Serialized Manufacturing application except for the fields that cannot be mapped between the two applications.


For the AF market, you can upload the product master data to TRVST.


For the USA market, you can meet the Drug Supply Chain Security Act (DSCSA) requirements as a manufacturer.

  • You can manage your products in the Verification Router Service (VRS) Lookup Directory (LD). You can activate being the VRS responder for the products
  • You can extend the expiration date of a batch after approval from the authorities.
  • You can recall a batch.
  • You can configure the response (providing no reason in case of product identifier mismatch and manufacturer policy).
  • You can configure the product verification endpoint for the VRS requests (inside Movilitas.Cloud or an external one).


SN/SSCC pool


You can manage the SSCC pool, monitor the serial number pool, and view the history of the packs and SSCCs.



Serial Number (SN) pool


The serial numbers are linked to product codes and each serial number belongs to an instance of the product.


The Serialized Manufacturing application brings full flexibility for serial number management. You can fill the serial number pool in the following ways:

  • Generate serial numbers in Movilitas.Cloud by using the Serial Number Management (SNM) source. A business channel is to be created with the Serial Number Management (SNM) source.
  • Establish a connection to SAP Advanced Track and Trace for Pharmaceuticals (SAP ATTP) system from where Movilitas.Cloud can fetch the serial numbers. The connection can be established by using a business channel with the SAP ATTP source.
  • Establish a connection to SAP Information Collaboration Hub for Life Sciences (SAP ICH) system from where Movilitas.Cloud can fetch the serial numbers. The connection can be established by using a business channel with the SAP ICH source.
  • Establish a connection to TraceLink from where Movilitas.Cloud can fetch the serial numbers. The connection can be established by using a business channel with the TraceLink Partner source.
  • Establish a connection to Novumgen from where Movilitas.Cloud can fetch the serial numbers. The connection can be established by using a business channel with the Novumgen source.
  • Commission the external, unique, and GS1-compliant serial numbers through Manufacturer V2 API after producing the packs on the shopfloor.


In all cases, the serial numbers per product are stored in a serial number pool in the Serialized Manufacturing application to ensure that all the serial numbers are unique in the system.


In the serial number pool, you can monitor the status of the serial numbers. However, you cannot monitor the external serials commissioned over Manufacturer V2 API in the pool. The pool is just updated with them in the background and you can check them under the Commissioning tab.


For markets that link a crypto code to a serial number:

  • You can request crypto codes from external systems (OMS Cloud - Kazakhstan, Code OMS - Uzbekistan).
  • You can obtain crypto codes and crypto keys while requesting the serial numbers (TraceLink and SAP ATTP).

The application stores the crypto code and crypto key next to the related serial number in the serial number pool. The crypto codes and crypto keys are not exposed to the users in the serial number pool view but they are provided in one of the following ways:

  • In response to serial number requests from SAP ATTP.
  • By releasing a packaging order to a packaging line.


SSCC pool


You can manage serial shipping container codes (SSCCs) that are used to group individual packs of products and to keep track of them during the packaging process. Manufacturers can create SSCC sequences that follow the GS1 standard so they can be used outside the company. All SSCCs - generated in Movilitas.Cloud, requested from external systems (TraceLink or SAP ATTP), or sent through Manufacturer V2 API after aggregation - are listed in the SSCC pool with their status.


SSCC history


You can request the historical activities connected to each container.


Pack history


You can request the historical activities connected to each pack.


In the USA market, you can set the authenticity of a pack (none - OK, suspect, or illegitimate). The setting is applied in the VRS response.


Site Management


While Marketing Authorization Holders (MAHs) hold the product license, the manufacturing activities can be outsourced to other companies, called Contract Manufacturing Organizations (CMOs). As an MAH, you can have contracted wholesalers. 


The Site management tab offers site data management and site activity control.


The MAH and the CMO can establish a partnership in Movilitas.Cloud. Due to the partnership, the MAH and the CMO are integrated within Movilitas.Cloud with their customized views and functions.


As a MAH:

  • You can register the CMOs that perform manufacturing on your behalf.
    • You can invite the CMO to be a partner in Movilitas.Cloud. The partnership enables the MAH and the CMO to exchange data in an efficient, controlled, and secure manner.
    • You can add products to these CMOs and assign the serial numbers to the CMOs that they need to use during their manufacturing activities.
    • For a CMO not being a partner in Movilitas.Cloud, you can export the assigned serials to a CSV file and give the file to the CMO.
  • You can register all your contracted wholesalers (Third-Party Logistics - 3PLs).
  • You can activate operators to scan items for commissioning by using the mobile application. This is a typical use case when you want to update Movilitas.Cloud with the output of the serialization activities, for example, by scanning the printed labels that are put on cartons. The scanned items are listed under the Commissioning tab and are ready for commissioning to the market.
  • If you perform manufacturing, you can register your manufacturing sites.


As a CMO, you can register your manufacturing sites and the MAHs that outsource the manufacturing activities to you.

  • You can invite the MAH to be a partner in Movilitas.Cloud. The partnership enables the MAH and the CMO to exchange data in an efficient, controlled, and secure manner.


Packaging


You can register packaging lines and packaging orders in Movilitas.Cloud and send packaging orders to the packaging lines.


Movilitas.Cloud offers two approaches:


ApproachDescriptionWhen to Use?
Establishing a connection from Movilitas.Cloud to a packaging machine on the shopfloor

You can establish a connection to systems on the shopfloor, for example, to a Wipotec-OCS machine, by creating a shopfloor channel with Wipotec-OCS-v2 source and then creating a packaging line using this shopfloor channel. In the article mapping of the Wipotec-OCS V2 channel settings, it is possible to create mappings and specify up to 4 aggregation levels for the product codes included in the mapping. For more information, see Configuring a Wipotec-OCS V2 channel and Specifying Aggregation Levels.


Once you have the packaging line, you can send packaging orders to it.


In a packaging order, you specify the number of packs that need to be serialized in production and you can specify the percentage of extra serial numbers.

  • The extra percentage ensures that there are enough serial numbers in case some packs are rejected at the line due to an error during production.
  • You can follow up on the progress of the packaging orders in the Packaging --> Packaging orders --> Packaging order history tab.
  • Once the packaging order is released, the involved serial numbers and SSCCs get the Assigned status in the pool and they are associated with the order number.
When you use Movilitas.Cloud to control the tasks on the shopfloor as well as to do the administration.
Controlling the shopfloor outside Movilitas.Cloud through middleware and using the Manufacturer V2 API to do the administration in Movilitas.Cloud.

You can use the Manufacturer V2 API to get the information from Movilitas.Cloud to perform tasks on the shopfloor and to update the Movilitas.Cloud with the results from the shopfloor.


You control the shopfloor by using a middleware software and you use this middleware to communicate with Movilitas.Cloud over Manufacturer V2 API.


You register the packaging order and optionally the packaging line in Movilitas.Cloud for administration purposes, but there is no control over the shopfloor from Movilitas.Cloud.


Once the production is finished, you update Movilitas.Cloud with the results, including the order status, the serial numbers, SSCCs, and aggregations.

When you use Movilitas.Cloud for administration purposes only and you isolate the control of shopfloor activities from Movilitas.Cloud by using middleware.



Commissioning


The Commissioning tab is populated with items in one of the following ways:

  • Over the Manufacturer V2 API.
  • Over Movilitas Mobile by scanning packs.
  • By uploading a CSV file that contains the data of produced packs.
  • By uploading an EPCIS file that contains the data of produced packs.
  • By sending a commissioning request from SAP ATTP.
  • By sending a generic report from SAP ATTP.
  • By receiving a SOM_SHIPMENT_EVENT file from a CMO through TraceLink.
  • From a Wipotec-OCS packaging line once the packaging order is finished on the line.


These items are ready for commissioning to a market.


When uploading a CSV file that contains the data of produced packs, the application processes the file line by line. It detects the mismatches found across the data set and saves the failed records to a downloadable CSV file.


When uploading an EPCIS file that contains the data of produced packs, the application processes the file. It detects the mismatches found across the data set and saves the errors into an XML file.


Under the Commissioning tab, view the commissioning requests per product, select the items, and commission them to the applicable market.


Note: Depending on the configuration in Movilitas.Cloud, items can be automatically released to the market and the items are not listed under the Commissioning tab. For example:

  • Commissioning directly from SAP ATTP to TraceLink.
  • Commissioning while shipping.
  • Executing a packaging order on a Wipotec-OCS packaging line and commissioning to SAP ATTP. 
    • Note: Decommissioned items are automatically reported to SAP ATTP. Automatic decommissioning to SAP ATTP is non-configurable by the user.


Labels


You can define ZPL printing templates, printing destinations, and printing orders.


You can register FTP servers, NiceLabel Label Cloud printers, and Zebra Cloud Connect printers, as printing destinations by creating the respective channel. Once the printing orders are created, you can execute the printing orders in the required label format on the assigned printing destination.


You can include the following pieces of information in a printing order:

  • Order ID
  • Product code schema
  • Product code
  • Batch
  • Expiration date
  • Amount of serial numbers
  • ZPL printing template - applicable to Zebra printers only
  • Printing destination


The serial numbers included in the printing order get the Assigned status in the serial number pool and they are associated with the order ID.


Settings


This tab allows you to configure the application-level settings.

  • You can manage market profiles and connect to external systems.
  • You can activate or deactivate the automatic release of packaging orders.
  • You can allow the creator to release batches or make it mandatory to involve another user in this procedure.
  • You can control the access to the Admin UI for users with the "User" or "Support" role.


For more information on typical use cases, see the Serialized Manufacturing Workflows.