GXP COMPLIANCE FOR THE LIFE SCIENCES

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

GxP Compliance

GxP COMPLIANCE AND VALIDATION

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.


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 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.


Credentials

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.”

WHY CHOOSE DHC?

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
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
Request information!

Learn more about our consulting services for GxP Compliance!

CUSTOMERS

WEBINARS AND EVENTS

28. Januar
Web session (in German)

Validation of SAP S/4HANA on-premise and Private Cloud Edition

The webinar looks at the validation requirements for SAP S/4HANA on-premise vs. cloud systems.

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04. Februar
Web session (in German)

UDI: Implementing global requirements with the right strategy and software

Implementation of the UDI requirements based on the SAP Cloud Platform with the UDI Platform of p36

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10. Februar
Web session (in German)

Your journey to the secure Microsoft Cloud for Pharma, Medical Technology and Biotech

Overview of the key success factors for security on the path of regulated companies to the Microsoft Cloud

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11. Februar
Web session (in German)

New ISPE GAMP® Good Practice Guide: Enabling Innovation

What does the new ISPE Guide mean for Computer System Validation (CSV) or Computer Software Assurance (CSA)?

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18. Februar
Web session (in German)

QM in S/4HANA – Example of an integrated LIMS in a Customer Project

Presentation of the quality-relevant processes of a LIMS in a customer project with the help of SAP QM as an integrated overall solution.

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10. März
Web session (in German)

SAP S/4HANA Implementation and Validation in Life Sciences

Find out what benefits the LSA approach offers you for the optimal, validated deployment of S/4HANA.

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DHC WEBINARS

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