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.more
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.more
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.more
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.
MDR Rule 11 – influencing software identified as medical devices with full forcemore
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 Activatemore
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 Qualitätsmeldungmore
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 Vertriebmore
SAP consulting, quality management and GxP 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.
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
Steigenberger Hotel Berlin
10789 Berlin, Germany
This Education Course is directed at experienced employees from
who have to deal with SAP S/4HANA in a healthcare environment.
Our webinars are provided as a free service for DHC customers and potential customers.