VALIDATION OF CLOUD SYSTEMS

Special challenges are faced when
validating cloud computing systems!

IT Compliance

VALIDATION OF CLOUD COMPUTING SYSTEMS

Cloud computing is a general term for the supply, use and billing of IT services over a network that can be adjusted dynamically to meet demand.

Section 7 of the EU GMP Guide also applies to the use of cloud services:

  • Audits must be used to confirm provider suitability
  • Service provision must be set out in a contract
  • Quality must be controlled using appropriate measures (monitoring)

A special case here is the need to consider the entire supply chain, since many providers themselves source services from the cloud.

DHC CONSULTING SERVICES FOR CLOUD VALIDATION

Consulting

In consideration of the lifecycle of a (valid) cloud computing system, which is slightly different to that of a conventional IT variant for a computerised system, the following must be observed – and DHC consultants will be happy to advise you on these topics:

  • System and provider selection, and vendor qualification for the provider, taking into account:
    • Quality management – especially measures to maintain (valid) operation of the system (communication, change management, CAPA, business continuity)
      • Data protection
      • Service level agreements (SLAs)
      • Migration strategy (in and out)
  • Routine SLA monitoring

  • For IaaS (Infrastructure as a Service) and PaaS (Platform as a Service):
    • (Conventional) qualification of IaaS before commissioning
    • Measures for decommissioning or resource release: Data destruction/archiving
    • For the validation of software that runs on these services, additional risks must be addressed (e.g. by encrypting data) that arise from virtualisation and multi-user operation.
  • For SaaS (Software as a Service, such as S/4HANA)
  • Validation of the application as GAMP category 3 or 4 software

WHY CHOOSE DHC?

Make use of our experience and industry expertise as a validation specialist

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
Swtzerland
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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08. November
German Webinar

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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
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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

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