Integrating with Global Label Management

Objective

After completing this lesson, you will be able to describe the integration of SAP Intelligent Clinical Supply Management with Global Label Management

Integration of SAP Intelligent Clinical Supply Management with Global Label Management

If you want to use Global Label Management together with SAP Intelligent Clinical Supply Management, some configurations need to be done in different areas of the system.

The subsequent sections provide you with an overview about these configurations.

Diagram showing SAP Intelligent Clinical Supply Management, with options including Printing of Inner- and Outer-Label Barcodes, Clinical Trial, GLM Label Types for Material Categories, and Barcode Profiles. An arrow labeled Specify points to a blue box labeled GLM.

Note the following prerequisites:

  • Windows Wordcompressor Integration Server (WWI-Server) needs to be set up and connected as described in the SAP Note568302 - Current version of EH&S WWI and EH&S Expert or OCC.
  • The Global Label Management basis configuration has been done as described in Global Label Management (EHS-SAF-GLM).
  • The master data objects must be created and linked. For example, study specification must have the CFG material assigned, at CFG material label view the CFG, PP, and Shelf Life Extension Generation. Variants must be maintained (note that there is a slight change compared to GLM standard maintenance), all underlying master data must exist, like label stock, layout templates, generation variants.
  • Barcode libraries can be connected. Please note that SAP does not deliver any barcode libraries. For demonstration purposes, several barcode types are provided, but they should not be used productively.

SAP Intelligent Clinical Supply Management Configuration

To integrate Global Label Management with SAP Intelligent Clinical Supply Management, the following Customizing has to be configured in SAP Intelligent Clinical Supply Management:

  • Specify Printing of Inner- And Outer-Label Barcodes Based on Control Key
  • Specify Clinical Trial-Specific Labeling Scenario for GLM
  • Specify GLM Label Types for Material Categories
  • Specify Barcode Profiles for Material Categories

Note

An example configuration can be found in the Configuration Document for SAP Intelligent Clinical Supply Management.
Icon of a manufacturing building with a screenshot of a software interface showing SAP Intelligent Clinical Supply Management settings. The highlighted options under Global Label Management include Specify Printing of Inner- and Outer-Label Barcodes Based on Control Key, Specify Clinical Trial-Specific Labeling Scenario for GLM, Specify GLM Label Types for Material Categories, and Specify Barcode Profiles for Material Categories.

Specify Printing of Inner- And Outer-Label Barcodes Based on Control Key

Description

You use this procedure to specify which control keys to use to generate or print an inner-label barcode (material category PP) or an outer-label barcode (material category CFG). 

This is necessary because a goods receipt is not possible for double-blinded treatment kits that only have one label or barcode but both require inner- and outer-label barcodes. 

In this case, different control keys are used to print or generate outer-label and inner-label barcodes when performing PI sheet-based printing with Global Label Management.

Procedure

  1. In the SAP Customizing Implementation Guide of Clinical Supply Management, go to Master DataGlobal Label ManagementSpecify Printing of Inner- and Outer-Label Barcodes Based on Control Key.
  2. Specify the label types for each material category.

Specify Clinical Trial-Specific Labeling Scenario for Global Label Management

Description

You use this procedure to enter the labeling scenario for clinical supply management if your organization uses Global Label Management. If you don't use Global Label Management, don't create an entry.

Procedure

  1. In the SAP Customizing Implementation Guide of Clinical Supply Management, go to Master DataGlobal Label ManagementSpecify Clinical Trial-Specific Labeling Scenario for GLM.
  2. Enter the labeling scenario that you want to use.

Specify Global Label Management Label Types for Material Categories

Description

You use this procedure to specify the label type to be used for each material category (CFG or primary pack material - PP) in Global Label Management. When a print request is created, the material category setting identifies which label type is meant for the PP material and which for the CFG.

Procedure

  1. In the SAP Customizing Implementation Guide of Clinical Supply Management, go to Master Data → Global Label Management → Specify GLM Label Types for Material Categories.
  2. Specify the label types for each material category.

Specify Barcode Profiles for Material Categories

Description

You use this procedure to specify the (EAN128) barcode profiles to be used for specific material categories in combination with the following properties:

  • Serialized
  • Multi-protocol
  • Open Label

Procedure

  1. In the SAP Customizing Implementation Guide of Clinical Supply Management, go to Master Data → Global Label Management → Specify Barcode Profiles for Material Categories.
  2. Specify the barcode profiles according to your business requirements.

Global Label Management

To integrate Global Label Management with SAP Intelligent Clinical Supply Management, there are a number of configurations necessary.

The SAP Intelligent Clinical Supply Management Administration Guide gives a good overview about what has to be done concretely.

Note

Visit the following link to find the guide: Configuration for Global Label Management.

Icon of a wrench with a screenshot of a software interface showing Product Safety and Stewardship settings. The options under Global Label Management include Prerequisites for Global Label Management, Set Basic Data and Tools for Global Label Management, Label Template, Label Determination, Specify Labeling Scenarios for Label Printing, Define Print Process, Transfer WWI Printer, Set Up Print Station, Specify Connections to Logistics Systems, Configure Function Workbench, and Business Add-Ins (BAdIs).

SAP Intelligent Clinical Supply Management-Specific Additions in Global Label Management

Clinical Reporting Symbols

The following SAP Intelligent Clinical Supply Management-specific clinical reporting symbols exist:

  • ICSM PCN/ blinded packaging batch
  • ICSM Protocol ID
  • ICSM Study
  • ICSM Medno
  • ICSM EAN/UPC for GTIN in PP
  • ICSM calculated UBD
  • ICSM ITF for GTIN in CFG
Screenshot displaying various parameters and labels with detailed information. The parameters listed include: - GCG_/I for PCN/UBD Group - GCG_/I1 for Protocol ID - GCG_/I2 for Study - GCG_/N for Med Number - GCG_/P for EAN/UPC - GCG_/U for Calculated Use-By Date - GCG_IFF for ITF Code Below, there are two label examples: 1. CFG Label: - Protocol ID: ski_4 - PCN ID: 1000001263 - Clinical SerNo: 02E-1YPQ-1037 - Expiry Date: 28.02.2026 - Barcode with information including GTIN, PCN, Clinical SerNo, and Protocol ID 2. PP Label: - Protocol ID: Protocol STB-12345 - PCN ID: 1000000001 - Clinical SerNo: 3027145727 - Barcode with information including PCN, Clinical SerNo, and Protocol ID

Clinical MtS Printing Scenario

In Global Label Management, a dedicated print scenario for SAP Intelligent Clinical Supply Management exists: ICSM Make-to-Stock /CTCO/ICSM_MTS.

Screenshot of SAP Labeling interface. The interface features tabs including ICSM Make-to-Stock, Make-to-Order, Delivery, Goods Receipt, Generic, and Sample. The form displayed shows the following fields and options: - Order: 1000022 - Material: MZ-LS-CFG0004 - Description: CFG 1mg / placebo / comparator - Packaging Unit: Carton - Number of Pack. Units: 1 - Hierarchy Explosion (checkbox, checked) There are buttons for: - Change Mode of Transport - Change Countries - Change Validity Area (with Add Countries option) At the bottom-right, there is a Label Tree button.

It allows the following:

  • Separation of processes from the commercial operations.
  • Quantity and data determination for dependent labels, such as CFG and PP labels with same blinded data and matching GTIN and ITIP in correct proportions as per manufacturing.
  • Buffer data for label scenario, in case reprinting of an ill-printed label is not desired or not possible.

POC for Different Label Types

In development POC and in customer POC, different clinical label designs were tested:

  • Single Panel Label
  • Dynamic data from process order
  • Bar codes GS1-128, DataMatrix, others
  • Human readable bar code string
  • Booklet Labels in PDF-A format
  • Multilingual LtR and RtL
  • One layout for all countries
  • Test auto-sizing
  • Country-based regulatory data
  • Master Label documents
  • Shelf Life Extension stickers
Screenshot showing multi-lingual booklet and labeling instructions for a product. The Booklet Multi-Lingual section lists languages with corresponding numbers: - English (EN) 2 - Deutsch (DE) 3 - עברית (HE) 4 - Русский (RU) 5 Product information is provided in different languages: 1. English: - Demo Product Name (blinded or open) 5 mg/ml - Instructions for use, dilution, storage temperature (36-46°F), and clinical trial use. - Contact information for Clinical Study Sponsor. 2. German: - Similar instructions as English but in German. 3. Russian: - Similar instructions as English but in Russian. 4. Hebrew: - Similar instructions as English but in Hebrew. Each label includes instructions for use, storage information, and Clinical Study Sponsor Contact Information.

GS1 Compliant Label

Following the GS1, the SAP Intelligent Clinical Supply Management Global Label Management data on the labels is tagged with standard (Application Identifiers. The SAP Intelligent Clinical Supply Management barcodes are generated according to GS1 guidelines.

This simplifies reading, tracking, and tracing of clinical product in the supply chain.

Diagram illustrating GS1 standards for identification and capture. The identification section shows codes like GLN (Global Location Number), GTIN (Global Trade Item Number), SSCC (Serial Shipping Container Code), GRAI (Global Returnable Asset Identifier), GIAI (Global Individual Asset Identifier), and GSRN (Global Service Relation Number) among different stages in the supply chain, including manufacturer, item, case, pallet, transport, distributor, distribution center, retailer healthcare provider operator, and consumer. The capture section features various GS1 barcodes and RFID types including EAN/UPC, GS1-128, ITF-14, GS1 Databar, GS1 DataMatrix, GS1 QR Code, GS1 Composite Barcode, EPC HF Gen 2, and EPC UHF Gen 2. Highlighted is a barcode example with details: - GTIN: (01) 16000000006133 - PCN: (10) 10000001263 - Clinical SerNo: (21) 02E-1YPQ-1037 - Protocol ID: (7240) ski_4 The barcode itself is labeled as Demo.

Example of Application Identifiers

01 Global Trade Item Number (GTIN)

10 Batch or lot number

21 Serial number

7240 Protocol ID

8006 Identification of pieces of a trade item (ITIP)

Example Bar Code String

]C10116000000006133#101000001263#21E2E-1YPQ-1037#7240ski_4

Note

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