Qualification of IT infrastructure according
to EU GMP Guide Annex 11 and GAMP

Qualification of IT infrastructure

The risk-based qualification of buildings, premises, systems, equipment and IT infrastructure forms an integral part of quality assurance in a regulated environment, and is also required by law (EU guidance on good manufacturing practice).

A planned and documented process must be used to demonstrate that the equipment and premises are suitable for their intended purpose, and actually function reliably under the real-world conditions applicable on site.

The execution of this process must be set down in written standard operating procedures (SOPs) and work instructions (WIs). The SOPs must describe all operations in a clear and structured manner, and be informed by risk-based principles.

An appropriately integrated qualification strategy can be used to avoid the duplication of work in departments that access shared IT services, so as to ensure the availability of consistent and qualified IT platforms. Another important aspect here is the integration of these measures into a company-wide Quality Assurance system.

DHC utilises the V-Model as its validation and qualification strategy. To this end, both the chronological sequence as well as the phases and documents relevant for risk-based publication are depicted:

  • Design Qualification: Specification of the requirements for the equipment or the system. These include user requirements, as well as functional and design specifications.
  • Installation Qualification: Documents the installation and commissioning of the system or machine, and demonstrates compliance with applicable regulations and required performance data as well as specifications.
  • Operational Qualification: Equipment test or inspection process that assesses whether a system or piece of equipment is operating correctly.
  • Performance Qualification: Field test that documents the deployment of the equipment in routine operations.


  • Strategies and specification documents for qualification
  • Creation of a qualification plan
  • Risk-based infrastructure analysis
  • Creation of test specifications (IQ/OQ)
  • Support for the execution and documentation of the tests
  • Incident and Problem Management (ITIL)
  • Process design and creation of corresponding process descriptions (SOPs)


Make use of our experience and industry expertise as qualification specialists

  • Over 20 years of expertise in computer system validation and qualification
  • A wealth of expertise in regulatory requirements
  • Broad-based experience with a very wide range of IT systems
  • Integrative approach adopted for existing QM systems
  • High level of knowledge transfer
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
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With VxP, DHC offers a cloud-based validation platform to accelerate validation processes and digitalise documentation.

22. April
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On the topic of “Integrated QMS”, the SAP partners, DHC and SSE, will present current concepts and use cases at the online info day on 28 April 2021.

23. April
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28. April
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In this CSV online info day, we explain the characteristics, possibilities and challenges of digital validation.

30. April
Webinar (in German)

Using SAP Fiori Apps for QM in ECC 6.0

This webinar will introduce SAP Fiori Apps for QM and how they can be integrated into an SAP system that has not yet been converted to S/4HANA.

06. Mai
Webinar (in German)

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Implementation of the UDI requirements based on the SAP Cloud Platform with the UDI Platform of projektraum36

07. Mai
Webinar (in German)

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Presentation of the structure and essential contents of the IT Compliance Framework and description of the possibilities of use.

11. Juni
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Learn how we have optimised important core QM processes in the course of digitising production and introduced them on the basis of SAP QM.

25. Juni
German Webinar

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Free webinar about the standardized DHC method for software evaluation using the example of QM in S/4HANA.

09. Juli
Webinar (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.

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.