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

GxP Compliance


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 “GxP compliance”. For companies working in the pharmaceuticals and medical technology industries, Computerized System Validation (CSV, software validation) forms an integral part of GxP compliance.


Our firm has been offering consulting services in the life sciences and working in the field of GxP 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 GxP 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 GxP compliance is further complemented by our industry experience as well as our expertise in process and project management.


Mohammad Anwar Hossain, Project Manager, SAP project ‘UTTORON’, Deputy General Manager, IT, Incepta Pharmaceuticals Ltd., Dhaka

“DHC made the most effective job in our project. Many of their activities not only assured the goal of a prospective validation of SAP ERP ECC 6.0, but also reduced the project risk. Due to the structured approach with SAP processes and business scenarios and defining the business requirements in URS documents, we were pretty sure, that the new ERP system will cover the daily business of Incepta.”


Use our experience as specialists for GxP Compliance::

  • More than 20 years of expertise in computerized system validation in pharmaceuticals/life sciences and medical technology
  • Numerous successfully completed prospective and retrospective validation projects
  • Scalable DHC Best Practice Validation Method / Validation Content
  • High audit reliability
  • Strong team of CSV managers with profound knowledge of regulatory requirements (GAMP, FDA, GxP, ISO 13485, …)
  • Long-term and trusting cooperation with our customers
  • Ensuring the transfer of knowledge to you as a customer
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
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 GxP Compliance!



22. Oktober
Webinar (in German)

Test equipment management and monitoring

Presentation of the test equipment management integrated in SAP with all functions for the company-wide management of operational test equipment.

04. November
Webinar (in German)

SAP S/4HANA Transformation and Validation in Life Sciences

Learn everything about phases for the system transformation (system conversion) of an SAP ECC to S/4HANA with integrated validation.

26. November
Webinar (in german)

APQP, FMEA and PLP with QM solutions from SAP (SAP QM)

Presentation of the various SAP tools for mapping APQP and presentation of SAP PPM, FMEA, control plan, inspection plan and quality notification

09. November
Life Online Training

SAP: Validation and GMP Compliance (Live Online Training der ECA Academy)

Online training with speakers from DHC GmbH, organised by Concept Heidelberg on behalf of the ECA Academy,


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