GXP COMPLIANCE FOR THE LIFE SCIENCES

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

IT Compliance

GxP COMPLIANCE AND VALIDIERUNG

Companies in the life sciences must be able to meet a wide range of requirements. Apart from customer needs, these include laws, standards and directives, compliance with which can be very closely monitored and whose fulfilment is a condition for market entry in the first place. These include requirements for the implementation and operation of computerised systems (FDA 21 CFR Part 11, EU GMP Annex 11 and Annex 15). At the present time, topics such as data integrity and protection from counterfeit medicinal products now also have a key role to play.


Today, all activities for the implementation and fulfilment of regulatory requirements are referred to in general as ‘compliance’. In a software context, the related concept is therefore ‘IT compliance’. For companies working in the pharmaceuticals and medical technology industries, Computer System Validation (CSV) forms an integral part of IT compliance.


DHC – YOUR SPECIALISTS FOR GXP COMPLIANCE AND VALIDATION


Our firm has been offering consulting services in the life sciences and working in the field of IT compliance since 1996. Our first clients were SAP customers from the pharmaceuticals industry, who needed to validate their systems due to stringent regulatory requirements. Validation accordingly became one of our key consulting topics, and so we developed a process-oriented and risk-based DHC validation method. We orient ourselves naturally here on the lifecycle model (V-Model) according to the latest version of GAMP, the relevant ISO standards (e.g. ISO 13485) and the regulatory requirements of the FDA (e.g. 21 CFR Part 11) and European regulators (e.g. EU GMP Annex 11).


We offer you a full and comprehensive set of services focused on IT compliance. These services also include the standardisation and harmonisation of validation and qualification measures, so as to meet the widest possible range of regulatory requirements. These services aim to simplify your IT QM, thereby saving you both time and money.

Our specialised know-how related to validation and IT compliance is further complemented by our industry experience as well as our expertise in process and project management.


WHY CHOOSE DHC?

Use our experience as specialists for GxP Compliance::

  • Over 20 years of expertise in GxP compliance and computer system validation
  • Comprehensive experience in the design and implementation of QM systems in a regulated environment
  • Acknowledged sector expertise in pharmaceuticals/life sciences and medical technology
  • In-depth knowledge of sector-specific laws, standards and directives
  • High level of knowledge transfer
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
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Learn more about our consulting services for GxP Compliance!

CUSTOMERS

WEBINARS AND EVENTS

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 WEBINARS

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