SAP Life Sciences

Rely on the SAP S/4HANA specialists
for pharmaceuticals and medical technology!

SAP Life Sciences

SAP QM

The digital transformation and Industry 4.0
need new approaches to quality management.

SAP Qualitätsmanagement

GxP Compliance & CSV

With over 20 years of experience and a wealth of
sector-specific expertise – you can rely on DHC!

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SAP Life Sciences

As a SAP Silver Partner, we help you develop and complete the implementation strategy for your digital transformation with SAP S/4HANA by applying our best practices and over 20 years of experience in the life sciences sector.

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SAP Life Sciences

SAP Quality Management

The digital transformation and Industry 4.0 need new approaches to quality management. We are the specialists for IT solutions that focus on quality management, quality assurance and quality control based on SAP QM.

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SaP Qualitätsmanagement

GxP Compliance / CSV

Our experience in regulatory requirements for the life sciences sector dates back to 1996, and we offer process- and risk-based methods and best practices for IT compliance, and for the validation of computer-aided systems.

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IT Compliance

DHC DR. HERTERICH & CONSULTANTS

Since 1996, DHC has been enabling companies to implement SAP solutions and achieve software validation (CSV) in the life sciences. Thanks to our work in this regulated environment, we are now seasoned specialists in the fields of quality management and GxP compliance. As a result, our field-tested and pre-configured solutions for quality control and quality assurance are now no longer restricted to the pharmaceuticals and medical technology industries, but are also used in other sectors such as manufacturing and automotive.

The know-how possessed by our eminently qualified DHC consultants characteristically offers a combination of process and industry expertise combined with proficiency in IT that also fully accounts for compliance requirements.

As a SAP Partner, we implement enterprise processes by drawing on SAP technology, which we have used as a basis for developing best practice solutions and templates.
 

This helps to significantly accelerate projects while also improving their quality. The design and implementation of our projects is process-oriented, so as to be able to guarantee maximum gains in terms of economic benefits.

To meet the stringent requirements for core processes in the life sciences (e.g. in Quality/IT Management, as well as in pharmaceutical enterprise logistics) and the underlying IT systems, we have always proceeded by developing our own, innovative solution strategies. Today, we are successfully applying the insights and solution competencies gained in this work to other sectors such as manufacturing and automotive.

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Softwarevalidierung (CSV) und Sharing Economy

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Quo vadis Softwarevalidierung?

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Intelligent ERP: SAP S/4HANA

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DHC JOBS

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    City: Saarbruecken, Freiburg (i. Br.) , Quota: full-time
    Start: immediate start
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    City: Saarbrücken, Freiburg (i. Br.) , Quota: full-time
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DHC Jobs
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.

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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?

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08. November
German Webinar

Prüfmittelverwaltung und -überwachung mit SAP

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

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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

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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

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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

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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

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DHC DR. HERTERICH & CONSULTANTS

SAP consulting, quality management and GxP compliance

Seminar “SAP: Validation and GMP Compliance”

SAP S/4HANA has been launched in 2015 as the new intelligent ERP system. The software is available as cloud edition and as on-prem edition. SAP S/4HANA is being called the biggest update to its ERP system in over two decades. Together with the move to in-memory database SAP HANA a new user interface (SAP Fiori) was introduced. The mainstream maintenance for the predecessor products will end in 2025. Due to this time line a lot of SAP customers have already started the transformation journey to SAP S/4HANA or at minimum have initiated a pre-project.
How will all these technical and functional changes in the surrounding of SAP S/4HANA (user interface, in-memory database, different deployment types) impact the validation approach and the validation scope?
This ECA course will provide comprehensive knowledge about how to validate SAP S/4HANA for new SAP customers as well as for installed base customers who are planning a system conversion. Expect two days full of shared best practices for the validation of SAP S/4HANA considering recent regulatory requirements like EU GMP Guide Annex 11, GAMP 5 and 21 CFR Part 11.

Objectives

You will learn:

  • How to validate SAP S/4HANA in a GMP environment
  • Which specific requirements should be taken into consideration in the CSV process?
  • How to use SAP Solution Manager 7.2 as a validation platform?
  • What problems could arise during validation and how to solve them?
  • How to maintain the validated state of SAP with the least efforts?

Date:

Tuesday, 12 November 2019, 09.00 h – 18.00 h
(Registration and coffee 08.30 h – 09.00 h)
Wednesday, 13 November 2019, 08.30 h – 17.00 h

Venue:

Steigenberger Hotel Berlin
Los-Angeles-Platz 1
10789 Berlin, Germany

Target Group:

This Education Course is directed at experienced employees from

  • IT & IT Service Providers
  • Quality Assurance / Quality Control
  • Production / Engineering

who have to deal with SAP S/4HANA in a healthcare environment.

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