IDMP mit SAP

Identification of Medicinal Products
to improve patients´ safety

SAP Life Sciences

Identification of Medicinal Products (IDMP) with SAP


In the future, the EU will require marketing authorisation holders (MAHs) to submit a wide range of structured data to regulators. One such category of data is the identification of medicinal products (IDMP) in the European market. The central idea behind IDMP is to add more detail to the information available for medicinal products on the market, with a special focus on their composition and pharmacovigilance. To implement this IDMP initiative, the EU is consolidating five ISO standards, and the initiative must be put into practice by affected pharmaceutical companies no later than the implementation deadline.


In a global context, other regulators will follow who will want to have similar kinds of data reported. Pharmaceutical companies therefore now face the challenge of being able to manage a growing volume of structured data efficiently, while also leveraging this data profitably to optimise their business processes (‘Big Data’).

With S/4HANA Product Data Submission Management (PDSM), SAP has developed an extremely flexible software package that can consolidate and prepare this data before submitting it electronically to regulators. Alongside IDMP, UDI requirements can also be implemented.

DHC CONSULTING SERVICES FOR IDMP WITH SAP

Consulting

Business Case
The business case sets out the arguments about the scope in which the module can be cost-effectively deployed. We also provide answers to the question of costs as well as the benefits achievable by a SAP rollout. To do so, we assess the compatibility of SAP PDSM functionality with your company’s marketing authorisation strategy and the appropriate business scope for deployment of the module.

Scoping
At the scoping stage, we work with you to assess the impact of a SAP PDSM implementation on the various business units and processes within your company. Our appraisal of the associated costs and risks is our most important contribution, since it provides you with the support you need to define your priority criteria and estimate the necessary time and effort required.

Working from the basis of your requirements, our SAP PDSM experts describe potential solution options and examine these for functional gaps and/or ascertain the degree of coverage in SAP PDSM. As a result, we can determine the optimum functional scope for the SAP PDSM module.

Proof of Concept (PoC)
In the proof of concept, we demonstrate the functional capabilities of SAP PDSM and how it can meet your day-to-day business needs. We work with you to determine the technical requirements, potential costs and the associated risks of the various scenarios available. We then provide you with a list of potential proposals that take into account your priorities and are based on our SAP PDSM know-how. Following this, we can then develop a preliminary timetable for implementation of the PDSM concept.

Implementation

We are SAP PDSM specialists and provide you with support for implementing your IDMP solution. We can handle all of the tasks involved – such as design, customising, testing and production cutover.

Our implementation work includes the following services:

  • Design and setup of the IDSM data model in SAP PDSM
  • Realisation of workflows for data processing
  • Implementation of rules for data consolidation
  • Setup of controlled vocabularies
  • Creation of reports
  • Configuration of the interface to SAP S/4HANA
  • Programming of interfaces to systems such as CTMS, RIMS, etc.
  • Implementing submission to regulatory authorities (FDA, EMA, etc.)
  • System validation
Services & Support

Even after your IDMP process in SAP goes live, we can provide second- and third-level support services as required. Regardless of whether you need remote service provision or direct, on-site support, our SAP specialists offer a mobile and flexible service. Our wealth of experience means we are familiar with the key questions asked by your users and can guarantee prompt support into the long term.

WHY CHOOSE DHC?

Use our experience as specialists for IDMP with SAP!

  • Over 20 years of expertise in the implementation and validation of SAP in the life sciences
  • In-depth master data know-how, drawn from comprehensive experience gained in a wide variety of SAP ERP implementation projects
  • Seasoned experts in SAP for pharmaceuticals
  • Incorporation of process-oriented and agile rollout strategies (BPMN 2.0, SCRUM, Design Thinking)
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 / Austria
Carsten Buri

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

Carsten Buri, DHC AG
Request Information!

Learn more about our consulting services for IDMP with SAP!

Customers

WEBINARS AND EVENTS

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08. August
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06. September
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08. November
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12. November
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22. November
German Webinar

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29. November
German Webinar

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

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06. Dezember
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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

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