Qualification of IT infrastructure and cloud-based infrastructure

The web session will be held in German. If you only speak English, please contact us via email for a personal online appointment (consulting@dhc-gmbh.com). We are looking forward to meeting you!

Computerised systems are indispensable and an integral part of the day-to-day operations of companies in the GxP-regulated sector. The GxP compliance of IT systems in this environment depends critically on the underlying IT infrastructure. Numerous regulations address the integrity of these systems.

EU GMP Annex 11 “Computerised Systems” explicitly states: “The application should be validated, the infrastructure should be qualified.” Detailed requirements for qualification are contained in EU GMP Annex 15 “Qualification and Validation”. An interpretation of these requirements from the inspectors’ point of view can be found in the ZLG Aide-mémoire “Monitoring of computerised systems”, published in 2013 by the ZLG Expert Group 11 Computerised Systems.

The web session deals with the implementation of requirements for GxP-compliant operation of the IT infrastructure. The basis for this are the processes defined in ITIL (IT Infrastructure Library) and the GAMP Good Practice Guide “IT Infrastructure Control and Compliance”, which describes an approach to meet the current regulatory requirements for the operation of an IT infrastructure in the regulated sector. The basic prerequisite is an effective quality management system in which the quality-relevant processes are defined, controlled and monitored. This QMS is implemented based on a risk-based approach. During the web session, we will show you how the efforts can be scaled depending on the risk and how the effectiveness of the QMS can be guaranteed.

More and more companies are using cloud-based infrastructures. This offers many advantages, but it by no means means means the elimination of qualification and validation for GxP-relevant processes. The use of system-based virtual machines can also be a good alternative to running operating systems directly on the computer. In this web session, we will explain the challenges that companies face in the regulated environment.

Date

Friday, 6 October 2023, 10:00 – 10:45 a.m.
No time on this date? Then simply register anyway and secure your access data for the free podcast! You will receive them automatically shortly after the web session.

Target group of the web session

This web session is aimed at specialists and managers from the areas of IT, CSV and quality management who are responsible for the operation and commissioning of IT infrastructure.

Content of the web session

• Regulatory requirements
• Requirements GxP compliant operation of an IT infrastructure
  • Quality management system
  • Risk management
  • Qualification of the infrastructure
  • Processes for qualified operation of the infrastructure
• Procedure for implementing a quality management system for qualified operation of the IT infrastructure
• What is Cloud Computing?
• Application to service models
• Qualification of the IaaS provider
• Qualification of virtualisation platforms

Your benefit

• Over 25 years of industry know-how in the validation of computer-based systems
• Over 25 years of consulting know-how in risk management
• Lessons learned from many successfully implemented validation projects in the GxP environment
• Lessons learned from many successfully implemented projects in the field of quality management for IT infrastructure
• Interactive exchange with our experienced consultant and other web session participants

Technical requirements

The web sessions are online seminars. To participate, all you need is a PC with an Internet connection and loudspeakers. Alternatively, audio can be transmitted via telephone, while you can follow the image presentation via your browser. The web sessions are interactive, i.e. you can ask questions at any time.

Participation and registration

The web session will be held in German. If you only speak English, please contact us via email for a personal online appointment (consulting@dhc-gmbh.com). We are looking forward to meeting you!

Our web sessions are a free service for customers and interested parties of DHC.
IT service providers and consultants are excluded from participation.
The number of participants is limited.

Register now free of charge: https://attendee.gotowebinar.com/register/8315109893730341727