Life Sciences division Tackling Virtualization and Validation of a Monitoring System

Transcription

1 Life Sciences division Tackling Virtualization and Validation of a Monitoring System Process Automation 11/10/2011 Presentation title slide 1 version 1.0

2 Why Virtualization Low infrastructure utilization Increase physical infrastructure costs Increasing IT management costs Insufficient failover and disaster protection High maintenance end-user desktops Presentation title slide 2 version 1.0

3 What is Virtualization» Reduce underutilization of resources» Run multiple virtual machines on a single physical machine, with each virtual machine sharing the resources of that one physical computer across multiple environments.» Different virtual machines can run different operating systems and multiple applications on the same physical computer. Presentation title slide 3 version 1.0

4 Virtualization benefits» Compatibilty: Virtual machines are compatible with all standard x86 computers» Isolation: Virtual machines are isolated from each other as if physically separated» Encapsulation: Virtual machines encapsulte a complete computing environment» Hardware independence: Virtual machines run independently of underlying hardware Presentation title slide 4 version 1.0

5 Virtualization results» 60-80% utilization rates for x86 servers (up from 5-15% in non-virtualized PCs)» Cost savings of more than $3,000 annually for every workload virtualized» Ability to provision new applications in minutes instead of days or weeks» 85% improvement in recovery time from unplanned downtime Presentation title slide 5 version 1.0

6 Example [before] Presentation title slide 6 version 1.0

7 Example [after] Presentation title slide 7 version 1.0

8 & Validation Presentation title slide 8 version 1.0

9 Validation benefits» Reduce Hardware complexity: Multiple applications on one hardware server Easy to setup development, validation and production environment» Reduce security risks If managed correctly system functionalities and security settings complexity are reduced» Reduce Hardware maintenance (lifecycle) Hardware issues no longer force re-validation or change of software. Presentation title slide 9 version 1.0

10 Validation considerations» New technology new competence new training Impact on existing procedures (ex. Back-up & restore) Impact on existing processes (ex. security & configuration) Risk assessment Impact assessment Regression analysis» Maintenance tasks are moved from hardware to software» One hardware server down multiple applications down Clustering redundancy - mirroring Presentation title slide 10 version 1.0

11 Validation considerations» Controlling failure modes of virtualization software Reconsider likelihood and detectability» Patching management of virtualization software» Interaction between virtual servers» Human risks (more complex environment)» Version control of virtual servers (usage of master file)» Process Control Security» Presentation title slide 11 version 1.0

12 Validation pre-requisites» Identify scope of virtualization Not all applications can/must be virtualized Build or acquire know-how» Identify risk impacts Group applications together (if possible) Highest impact defines criticality level of environment» Identify the effects of virtualization (ex: performance)» Use vendor experience and know-how Identify your minimum realistic expectations» Cooperation between network experts and virtualization experts Presentation title slide 12 version 1.0

13 Validation approach» Control/update SOP related to Installation guidelines Security management Patch management Qualification management Control of change Management Presentation title slide 13 version 1.0

14 Validation approach» Qualify the physical layer (Hardware server)» Install/Qualify virtual platform Functional testing Installation Qualification Operation Qualification Failure scenario s Availability Performance» Validate cgmp application» Validate e-records Presentation title slide 14 version 1.0

15 Validation approach Tom Verhaegen Validation consultant Luc Timmerman Project Manager process automation Presentation title slide 15 version 1.0