Our answer for an optimal UDI solution in SAP
The basis for our solution is the UDI SAP module from our company for the maintenance of UDI master data. All FDA relevant UDI attributes are maintained and managed in the UDI module for SAP.
During development, the database tables and the UDI module were designed so flexibly that the master data maintenance of the EUDAMED (European Database for Medical Devices) attributes can also be maintained without major adjustments.
Basic functions are already delivered in the basic version:
- Change monitoring of UDI data
- Lock/Unlock GTIN Trigger Fields
- UDI data validation of the collected data
- UDI Data Excel Download
- Release management of UDI data
- UDI code lists like GMDN Codes, MRI Safety, FDA Listing No, FDA Product Code, Issuing Agency etc.
- Preparation for data transfer in HL7 XML formatTransfer of HL7 files via WebTrader to GUDID.
Another highlight is the preparation of the UDI modules for the administration of other authorities that have other attributes like the FDA.
A successful UDI implementation requires more than just the pure master data maintenance in SAP. For this reason, we offer a concept for the holistic UDI implementation in SAP.
We offer you a complete package for the implementation of UDI requirements.
The following elements belong to it:
- Customer workshop (fit gap analysis)
- UDI concept development & consulting
- UDI data maintenance in SAP
- UDI data transmission
Customer workshop (fit gap analysis)
In our workshop we examine the exact requirements and the initial state of your ERP system together with the specialist personnel of your company. With our catalogue of questions specially designed for the UDI requirements, we can create an optimal basis for an initial cost estimate based on the answers.
UDI Concept Development & Consulting
We create a concept for you that exactly fits your company. Subsequently, we support you in the implementation of the regulatory requirements and solution implementation.
- We will support you in identifying existing UDI attributes in your ERP system,
- Evaluate labels and printing systems,
- support you in the correct selection of a GS1 barcode generator or present our SAP barcode generator,
- in the area of UDI Attribute Change Management,
- Realization of an audit trail log for each UDI relevant material to show
Implementation of our UDI solution for SAP
NEW: Watch a short presentation video for our UDI module
We have made it our task to enable the data maintenance of the UDI attributes exactly where they belong: in your SAP ERP system. In principle, UDI attributes are material master data and some of them already exist in the SAP material master. The ideal solution is therefore obvious: data maintenance directly from the SAP material master transaction.
For the settings and jump to the transactions of the UDI module, a customizing section was created in the SPRO.
To provide users with a familiar screen for master data maintenance, we have created a branch from MM01/Mm02/MM03 specifically for this purpose.
After maintaining the familiar SAP master data, you can now maintain all other attributes in the UDI Add-On.
Our UDI data maintenance generates an additional subscreen in the material master via SAP Standard Customizing, in which you can determine whether a material is UDI relevant or not. From this subscreen, you can then branch to our UDI data maintenance transaction.
We offer additional SAP Addon Tools for the release of UDI data, evaluation, UDI data download to Excel and generation of a PDF protocol.
UDI data maintenance is now more than just classic master data maintenance. In addition to the known UDI data, you can now also see the GUDID status and the current GUDID transfer status of our UDI service.
UDI Data transfer to GUDID database and EUDAMED
with us as your partner
There are several possibilities for data transmission to the FDA’s GUDID. The transfer of data by manual input on the GUDID website can still be realized for a few products ( < 100 ) with manageable effort.
Another possibility is the implementation of a fully automated interface using software such as SAP PI or TIBCO. For this purpose, complex interface protocols such as AS/2, EDIFAKT and SSL must be correctly implemented. Our experience in projects and observations shows that such a highly complex solution has always been very time-consuming and expensive.
For this reason, we offer a cost-effective service for UDI data transmission. The experiences of our customers are very positive. With pleasure we can let you come an individual offer.
You can learn more about our data transmission to GUDID and EUDAMED (in preparation) under “UDI data transmission”.
We will be happy to assist you in uploading larger amounts of data.
Are you interested?