UDI WITH SAP

Labelling of medical
devices for greater safety

Unique Device Identification (UDI) mit SAP

UNIQUE DEVICE IDENTIFICATION WITH SAP


The US Food and Drug Administration (FDA) final rule (released in 2013) requires the manufacturers of medical devices to label their products with a unique number – the Unique Device Identification (UDI). This UDI number contains important product or manufacturer information on the product or secondary packaging, while also linking to master data entries from the manufacturer in a central database. This unique device numbering system is used for the identification and tracing of products. The UDI applies to all medical devices as defined by the IMDRF (International Medical Device Regulators Forum).
The adoption of the new EU Medical Device Regulation (MDR) by the European Parliament on 5 April 2017 means that the European UDI regulations for the labelling and registration of medical devices – as set out by article 24 of the regulation – will also become law in Europe in the near future.


Following acceptance by the EU Parliament, the MDR was published in the Official Journal of the European Union. The MDR entered into force 20 days after publication and will become law from mid-2020 after a three-year transitional period. In light of the extensive new requirements for notified bodies and the new EUDAMED/UDI database system stipulated by article 24, however, this transitional period offers very little room to manoeuvre. As with the existing FDA regulations for Unique Device Identification (UDI), this kind of data must also be stored in Europe from now on, and the processes (labelling, data transfer, etc.) must be implemented accordingly.


DHC CONSULTING SERVICES FOR UDI WITH SAP

Consulting

Scoping
In a scoping workshop (which can also be booked as a separate entry-level workshop), we work with you to analyse the UDI requirements for your company, and consider potential approaches for implementation and validation. Typical workshop topics include the system environment, the structure of products and product groups, labelling and interfaces to existing applications, etc. We determine the work packages that need to be completed and consider potential responsibilities for implementation.

Blueprint
Starting with our solution as the basis, definitions are then needed for the mapping of the individual UDI attributes, the steps in the maintenance process and the transfer of data to the FDA or EUDAMED. Depending on data volume and the frequency of changes, the degree of automation also needs to be specified. In the same way, the respective authorisations also need to be defined. Additional requirements (attributes) for other regions may need to be accounted for here as well – although our model is so flexible that future requirements can also be added as needed at any time.

Implementation

We provide you with coaching to implement your Unique Device Identification in SAP or you can commission us to do this for you. In addition to Customising work, we can also handle any necessary SAP programming as well – such as making modifications to interfaces, for example. If required, we can develop specialised reports and extend data models. Our long experience with SAP ERP plus our network of partners also provides you with the help you need to solve any complex challenges (such as label printing).

Being able to truly meet the needs of safe and efficient validation requires an integrated approach to validation from the project outset. We offer you support for your validation plan, requirements definition, draft specification, test plan, tests and validation report using the DHC method that has proven its worth in a great many projects. The UDI solution validation must naturally be a good fit for your current validation methodology.

Services and Support

Our support doesn’t dry up when things get difficult. If necessary, we are happy to assist you with your first data transfers to the respective authorities. We can also handle initial operations for the entire UDI solution after your go-live date.

DHC – YOUR SPECIALISTS FOR UDI WITH SAP

With their wealth of project management experience and training (e.g. in PRINCE2), our consultants provide you with support for managing your UDI project while constantly monitoring progress and budget. We help to ensure the project stays UDI-focused, and work to facilitate collaboration between IT and the departments. Even for smaller-scale projects, the support we offer for the systematic completion of tasks is considered to be exceptionally efficient and valuable by many customers.

WHY CHOOSE DHC?

Make use of our experience and industry expertise

  • DHC is a long-standing specialist in the particular challenges facing the pharmaceutical and medical technology industries, and is a trusted partner for any and all issues that involve SAP and validation aspects.
  • The experience we offer is drawn from a wide variety of UDI projects involving medical device manufacturers – from project planning and technical implementation in SAP to the transfer of data to the corresponding databases (GUDID or EUDAMED), as well as validation.
  • Our tried and tested approach presents you with a reliable and efficient implementation for the various requirements, while remaining flexible enough to be modified to the circumstances in your particular company.
Germany
Matthias Bothe

Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0
email: matthias.bothe@dhc-gmbh.com

Matthias Bothe, DHC GmbH
Switzerland
Carsten Buri

Director Sales & Marketing
phone: +41 44 500 888 7
email: carsten.buri@dhc-ag.ch

Carsten Buri, DHC AG
Request information!

Learn mor about our consulting services for UDI with SAP!

WEBINARS AND EVENTS

06. September
German Webinar

Datenintegrität und computergestützte Systeme

Vorstellung der Anforderungen an die Datenintegrität computergestützter Systeme gemäß ALCOA sowie deren Umsetzung in Validierung und Betrieb.

more
17. September
English Webinar

From SAP ERP to SAP S/4HANA

How do changes in S/4HANA, SAP’s new ERP system, affect GMP compliance?

more
08. November
German Webinar

Prüfmittelverwaltung und -überwachung mit SAP

Vorstellung der in SAP integrierten Prüfmittelverwaltung mit allen Funktionen für die unternehmensweite Verwaltung betrieblicher Prüfmittel

more
12. November
English Seminar

SAP: Validation and GMP Compliance

Seminar with speakers from DHC GmbH, organized by Concept Heidelberg on behalf of the ECA Academy, Steigenberger Hotel Berlin

more
22. November
German Webinar

Validierung von SAP S/4HANA Enterprise Management

Neue Compliance Aspekte und Wege zu SAP S/4HANA sowie Vorstellung der prozessorientierten, risikobasierten DHC Methode auf Basis von SAP Activate

more
29. November
German Webinar

APQP, FMEA und PLP mit SAP QM

Vorstellung der verschiedenen SAP Werkzeuge zur Abbildung von APQP und Darstellung von SAP PPM, FMEA, Kontrollplan, Prüfplan und Qualitätsmeldung

more
06. Dezember
Webinar

SAP QM als integriertes Laborinformations- und Managementsystem (LIMS) in der Life Sciences

Vorstellung von LIMS-Funktionen des SAP QM sowie Integrationsaspekte zu Einkauf, Lagerung, Produktion und Vertrieb

more
DHC WEBINARS

Our webinars are provided as a free service for DHC customers and potential customers.