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

GxP Compliance

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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Learn more about our consulting services for GxP Compliance!



15. Oktober
Webinar (in German)

VxP, the cloud-based Validation Platform for the Life Sciences

With VxP, DHC offers a cloud-based validation platform to accelerate validation processes and digitalise documentation.

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.