Qualification

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.


DHC CONSULTING SERVICES FOR THE QUALIFICATION OF IT INFRASTRUCTURE

Consulting
  • 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)

WHY CHOOSE DHC?

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
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!

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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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