Qualification

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

IT 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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CUSTOMERS

WEBINARS AND EVENTS

06. September
German Webinar

Datenintegrität und computergestützte Systeme

Vorstellung der Anforderungen an die Datenintegrität computergestützter Systeme gemäß ALCOA sowie deren Umsetzung in Validierung und Betrieb.

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17. September
English Webinar

From SAP ERP to SAP S/4HANA

How do changes in S/4HANA, SAP’s new ERP system, affect GMP compliance?

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08. November
German Webinar

Prüfmittelverwaltung und -überwachung mit SAP

Vorstellung der in SAP integrierten Prüfmittelverwaltung mit allen Funktionen für die unternehmensweite Verwaltung betrieblicher Prüfmittel

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12. November
English Seminar

SAP: Validation and GMP Compliance

Seminar with speakers from DHC GmbH, organized by Concept Heidelberg on behalf of the ECA Academy, Steigenberger Hotel Berlin

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22. November
German Webinar

Validierung von SAP S/4HANA Enterprise Management

Neue Compliance Aspekte und Wege zu SAP S/4HANA sowie Vorstellung der prozessorientierten, risikobasierten DHC Methode auf Basis von SAP Activate

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29. November
German Webinar

APQP, FMEA und PLP mit SAP QM

Vorstellung der verschiedenen SAP Werkzeuge zur Abbildung von APQP und Darstellung von SAP PPM, FMEA, Kontrollplan, Prüfplan und Qualitätsmeldung

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06. Dezember
Webinar

SAP QM als integriertes Laborinformations- und Managementsystem (LIMS) in der Life Sciences

Vorstellung von LIMS-Funktionen des SAP QM sowie Integrationsaspekte zu Einkauf, Lagerung, Produktion und Vertrieb

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