SlideShare una empresa de Scribd logo

Controlled Cloud in Pharma

•
•
G
gazdagf

This document summarizes the IT infrastructure and cloud strategy of a large pharmaceutical company. It describes the company's physical and virtual infrastructure across multiple sites. It then discusses how the virtual infrastructure was qualified and validated, including qualification of virtual templates, servers, and applications. Finally, it notes that while an external cloud could provide disaster recovery benefits, moving GxP systems to the cloud is currently not allowed by quality assurance standards due to lack of infrastructure control and documentation from cloud providers.

1 de 31
200 8 . 06 .2 5 .
The Madness of Clouds a controlled, qualified cloud in pharma GAZDAG, Ferenc EGIS Pharmaceuticals Plc, Head of IT Infrastructure 08-09. Sept. 2011 IT Governance, Risk and Compliance
Content ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
EGIS Plc. ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Geography
Physical infrastructure TGY (HQ, plant) 30 Hosts, 358 VMs 1800 PCs KÖR (plant) 5 Hosts, 24 VMs, 500 PCs BÖK (plant) 6 Hosts, 82 VMs, 500 PCs KER (sales office) 6 VMware Hosts, 16 VMs, 400 PC MGY (storehouse) 6 PCs 1 Gbps leased line (optical) 10 Mbps leased line (micro) CWDM darkfiber (2x1Gbps) 10 Mbps leased line (optical) CWDM darkfiber (4x1Gbps) 100 Mbps micro 2 Mpbs optika 100 Mbps (optical) 10 Mbps micro Internet 17 offices (MPLS vpn) 38 Hosts, 60 VMs, 1100 PCs
What is the Cloud? ,[object Object],[object Object],[object Object]
Virtual infrastructure EGIS HU cloud SAP sub-cloud EGIS Intl cloud QA system Sub-cloud
Application running virtualized (part) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Licensing 1 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Licensing 2 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Qualification and validation ,[object Object],[object Object],[object Object],[object Object]
V modell for computerized system validation User Requirements specification (URS) Functional specification (FS) Design Specification HW/SW (DS) Implementation Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Checks
Application validation – Infrastructure qualification Storage Network Virtualisation layer (Hypervisor) Hardware units HA DR Mentés Qualification Validation Application Operating system Virtual hardware Application Operating system Virtual hardware Application Operating system Virtual hardware Application Operating system Virtual hardware
QA in virtual systems Virtual infrastructure Qualification of virtual template(s) Qualification of virtual platform Validation of application Virtual machine Application OS Virtual machine Application OS Virtual machine Application OS Virtual machine Application OS Virtual machine Application OS Virtual machine Application OS Virtual template OS Virtual machine Application OS
Results of virtualization ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
„ Nice to have” for the auditor ,[object Object],[object Object],Server1 router switch Server2 SAN /NAS router switch
The reality ,[object Object],[object Object],Server1 routing switch Server2 SAN/NAS routing switch Cloud vSwitch VM VM Server VLAN managementVLAN iSCSI PC VLAN Printer VLAN Local vm, Virtual application, Remote desktop / VDI, „BYOPC” External Cloud VM VM
Preparing the documentation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Server qualification (retrospective) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],application OS (Infra software) Virtual layer Physical server Backup Storage Environment
Server results x279
Network qualification (retrospective) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Network results ,[object Object]
Security ,[object Object],[object Object],[object Object],[object Object],[object Object]
Others ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],x~50
Stuff ,[object Object],[object Object],[object Object],[object Object],[object Object]
Standard Operationg Procedures ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Results of FDA inspection Passed
External Cloud ,[object Object],[object Object],[object Object],[object Object],[object Object]
Summarization ,[object Object],[object Object],[object Object],[object Object]
Thank you! Any questions? [email_address]

Recomendados

ChadKillinger2016
ChadKillinger2016ChadKillinger2016
ChadKillinger2016Chad Killinger
 
VMworld 2013: VMware Compliance Reference Architecture Framework Overview
VMworld 2013: VMware Compliance Reference Architecture Framework Overview VMworld 2013: VMware Compliance Reference Architecture Framework Overview
VMworld 2013: VMware Compliance Reference Architecture Framework Overview VMworld
 
AV/DF Advanced Security Option
AV/DF Advanced Security OptionAV/DF Advanced Security Option
AV/DF Advanced Security OptionDLT Solutions
 
CISCO ACS 5.6 Migration Guide
CISCO ACS 5.6 Migration GuideCISCO ACS 5.6 Migration Guide
CISCO ACS 5.6 Migration GuidePCCW GLOBAL
 
Software Defined Substation Intelligence, Automation and Control
Software Defined Substation Intelligence, Automation and ControlSoftware Defined Substation Intelligence, Automation and Control
Software Defined Substation Intelligence, Automation and ControlBastian Fischer
 
040711 webcast securing vmachine
040711 webcast securing vmachine 040711 webcast securing vmachine
040711 webcast securing vmachine Erin Banks
 
From Cisco ACS to ISE
From Cisco ACS to ISE From Cisco ACS to ISE
From Cisco ACS to ISE Mahzad Zahedi
 
Introducing Oracle Audit Vault and Database Firewall
Introducing Oracle Audit Vault and Database FirewallIntroducing Oracle Audit Vault and Database Firewall
Introducing Oracle Audit Vault and Database FirewallTroy Kitch
 

Recomendados

ChadKillinger2016
ChadKillinger2016ChadKillinger2016
ChadKillinger2016Chad Killinger
 
VMworld 2013: VMware Compliance Reference Architecture Framework Overview
VMworld 2013: VMware Compliance Reference Architecture Framework Overview VMworld 2013: VMware Compliance Reference Architecture Framework Overview
VMworld 2013: VMware Compliance Reference Architecture Framework Overview VMworld
 
AV/DF Advanced Security Option
AV/DF Advanced Security OptionAV/DF Advanced Security Option
AV/DF Advanced Security OptionDLT Solutions
 
CISCO ACS 5.6 Migration Guide
CISCO ACS 5.6 Migration GuideCISCO ACS 5.6 Migration Guide
CISCO ACS 5.6 Migration GuidePCCW GLOBAL
 
Software Defined Substation Intelligence, Automation and Control
Software Defined Substation Intelligence, Automation and ControlSoftware Defined Substation Intelligence, Automation and Control
Software Defined Substation Intelligence, Automation and ControlBastian Fischer
 
040711 webcast securing vmachine
040711 webcast securing vmachine 040711 webcast securing vmachine
040711 webcast securing vmachine Erin Banks
 
From Cisco ACS to ISE
From Cisco ACS to ISE From Cisco ACS to ISE
From Cisco ACS to ISE Mahzad Zahedi
 
Introducing Oracle Audit Vault and Database Firewall
Introducing Oracle Audit Vault and Database FirewallIntroducing Oracle Audit Vault and Database Firewall
Introducing Oracle Audit Vault and Database FirewallTroy Kitch
 
SSL VPN Evaluation Guide
SSL VPN Evaluation GuideSSL VPN Evaluation Guide
SSL VPN Evaluation Guide Array Networks
 
Cisco Study: State of Web Security
Cisco Study: State of Web Security Cisco Study: State of Web Security
Cisco Study: State of Web Security Cisco Canada
 
At8000 s configurando_8021x
At8000 s configurando_8021xAt8000 s configurando_8021x
At8000 s configurando_8021xNetPlus
 
Protect Your End-of-Life Windows Server 2003 Operating System
Protect Your End-of-Life Windows Server 2003 Operating SystemProtect Your End-of-Life Windows Server 2003 Operating System
Protect Your End-of-Life Windows Server 2003 Operating SystemSymantec
 
LF_OVS_17_OvS-CD: Optimizing Flow Classification for OvS using the DPDK Membe...
LF_OVS_17_OvS-CD: Optimizing Flow Classification for OvS using the DPDK Membe...LF_OVS_17_OvS-CD: Optimizing Flow Classification for OvS using the DPDK Membe...
LF_OVS_17_OvS-CD: Optimizing Flow Classification for OvS using the DPDK Membe...LF_OpenvSwitch
 
Sem cis ise
Sem cis iseSem cis ise
Sem cis iseLino Quivén
 
ISE_Pub
ISE_PubISE_Pub
ISE_PubWill Hatcher
 
DataPower Restful API Security
DataPower Restful API SecurityDataPower Restful API Security
DataPower Restful API SecurityJagadish Vemugunta
 
Cisco Trustsec & Security Group Tagging
Cisco Trustsec & Security Group TaggingCisco Trustsec & Security Group Tagging
Cisco Trustsec & Security Group TaggingCisco Canada
 
EAP-TLS
EAP-TLSEAP-TLS
EAP-TLSKarri Huhtanen
 
ESM_Express_InstallGuide_6.9.0.pdf
ESM_Express_InstallGuide_6.9.0.pdfESM_Express_InstallGuide_6.9.0.pdf
ESM_Express_InstallGuide_6.9.0.pdfProtect724v2
 
Intorduction to Datapower
Intorduction to DatapowerIntorduction to Datapower
Intorduction to DatapowerShilpin Pvt. Ltd.
 
TLS and Certificates
TLS and CertificatesTLS and Certificates
TLS and CertificatesKarri Huhtanen
 
Running Kubernetes on OpenStack
Running Kubernetes on OpenStackRunning Kubernetes on OpenStack
Running Kubernetes on OpenStackLiz Warner
 
Platform Observability and Infrastructure Closed Loops
Platform Observability and Infrastructure Closed LoopsPlatform Observability and Infrastructure Closed Loops
Platform Observability and Infrastructure Closed LoopsLiz Warner
 
Intel® Select Solutions for the Network
Intel® Select Solutions for the NetworkIntel® Select Solutions for the Network
Intel® Select Solutions for the NetworkLiz Warner
 
Brand positioning-1231961903820264-3
Brand positioning-1231961903820264-3Brand positioning-1231961903820264-3
Brand positioning-1231961903820264-3Aastha Munjal
 
Virtualizáció az EGISben
Virtualizáció az EGISbenVirtualizáció az EGISben
Virtualizáció az EGISbengazdagf
 
Model Approach for Infrastructure Quality of Primary Education Facilities. Im...
Model Approach for Infrastructure Quality of Primary Education Facilities. Im...Model Approach for Infrastructure Quality of Primary Education Facilities. Im...
Model Approach for Infrastructure Quality of Primary Education Facilities. Im...SSA KPI
 
Computer System Validation Then and Now — Learning Management in the Cloud
Computer System Validation Then and Now — Learning Management in the CloudComputer System Validation Then and Now — Learning Management in the Cloud
Computer System Validation Then and Now — Learning Management in the CloudInstitute of Validation Technology
 
Virtual infrastructure qualification
Virtual infrastructure qualificationVirtual infrastructure qualification
Virtual infrastructure qualificationUS Data Management LLC
 
Regulatory Considerations for use of Cloud Computing and SaaS Environments
Regulatory Considerations for use of Cloud Computing and SaaS EnvironmentsRegulatory Considerations for use of Cloud Computing and SaaS Environments
Regulatory Considerations for use of Cloud Computing and SaaS EnvironmentsInstitute of Validation Technology
 

Más contenido relacionado

La actualidad más candente

SSL VPN Evaluation Guide
SSL VPN Evaluation GuideSSL VPN Evaluation Guide
SSL VPN Evaluation Guide Array Networks
 
Cisco Study: State of Web Security
Cisco Study: State of Web Security Cisco Study: State of Web Security
Cisco Study: State of Web Security Cisco Canada
 
At8000 s configurando_8021x
At8000 s configurando_8021xAt8000 s configurando_8021x
At8000 s configurando_8021xNetPlus
 
Protect Your End-of-Life Windows Server 2003 Operating System
Protect Your End-of-Life Windows Server 2003 Operating SystemProtect Your End-of-Life Windows Server 2003 Operating System
Protect Your End-of-Life Windows Server 2003 Operating SystemSymantec
 
LF_OVS_17_OvS-CD: Optimizing Flow Classification for OvS using the DPDK Membe...
LF_OVS_17_OvS-CD: Optimizing Flow Classification for OvS using the DPDK Membe...LF_OVS_17_OvS-CD: Optimizing Flow Classification for OvS using the DPDK Membe...
LF_OVS_17_OvS-CD: Optimizing Flow Classification for OvS using the DPDK Membe...LF_OpenvSwitch
 
DataPower Restful API Security
DataPower Restful API SecurityDataPower Restful API Security
DataPower Restful API SecurityJagadish Vemugunta
 
Cisco Trustsec & Security Group Tagging
Cisco Trustsec & Security Group TaggingCisco Trustsec & Security Group Tagging
Cisco Trustsec & Security Group TaggingCisco Canada
 
ESM_Express_InstallGuide_6.9.0.pdf
ESM_Express_InstallGuide_6.9.0.pdfESM_Express_InstallGuide_6.9.0.pdf
ESM_Express_InstallGuide_6.9.0.pdfProtect724v2
 
Running Kubernetes on OpenStack
Running Kubernetes on OpenStackRunning Kubernetes on OpenStack
Running Kubernetes on OpenStackLiz Warner
 
Platform Observability and Infrastructure Closed Loops
Platform Observability and Infrastructure Closed LoopsPlatform Observability and Infrastructure Closed Loops
Platform Observability and Infrastructure Closed LoopsLiz Warner
 
Intel® Select Solutions for the Network
Intel® Select Solutions for the NetworkIntel® Select Solutions for the Network
Intel® Select Solutions for the NetworkLiz Warner
 

La actualidad más candente (16)

SSL VPN Evaluation Guide
SSL VPN Evaluation GuideSSL VPN Evaluation Guide
SSL VPN Evaluation Guide
 
Cisco Study: State of Web Security
Cisco Study: State of Web Security Cisco Study: State of Web Security
Cisco Study: State of Web Security
 
At8000 s configurando_8021x
At8000 s configurando_8021xAt8000 s configurando_8021x
At8000 s configurando_8021x
 
Protect Your End-of-Life Windows Server 2003 Operating System
Protect Your End-of-Life Windows Server 2003 Operating SystemProtect Your End-of-Life Windows Server 2003 Operating System
Protect Your End-of-Life Windows Server 2003 Operating System
 
LF_OVS_17_OvS-CD: Optimizing Flow Classification for OvS using the DPDK Membe...
LF_OVS_17_OvS-CD: Optimizing Flow Classification for OvS using the DPDK Membe...LF_OVS_17_OvS-CD: Optimizing Flow Classification for OvS using the DPDK Membe...
LF_OVS_17_OvS-CD: Optimizing Flow Classification for OvS using the DPDK Membe...
 
Sem cis ise
Sem cis iseSem cis ise
Sem cis ise
 
ISE_Pub
ISE_PubISE_Pub
ISE_Pub
 
DataPower Restful API Security
DataPower Restful API SecurityDataPower Restful API Security
DataPower Restful API Security
 
Cisco Trustsec & Security Group Tagging
Cisco Trustsec & Security Group TaggingCisco Trustsec & Security Group Tagging
Cisco Trustsec & Security Group Tagging
 
EAP-TLS
EAP-TLSEAP-TLS
EAP-TLS
 
ESM_Express_InstallGuide_6.9.0.pdf
ESM_Express_InstallGuide_6.9.0.pdfESM_Express_InstallGuide_6.9.0.pdf
ESM_Express_InstallGuide_6.9.0.pdf
 
Intorduction to Datapower
Intorduction to DatapowerIntorduction to Datapower
Intorduction to Datapower
 
TLS and Certificates
TLS and CertificatesTLS and Certificates
TLS and Certificates
 
Running Kubernetes on OpenStack
Running Kubernetes on OpenStackRunning Kubernetes on OpenStack
Running Kubernetes on OpenStack
 
Platform Observability and Infrastructure Closed Loops
Platform Observability and Infrastructure Closed LoopsPlatform Observability and Infrastructure Closed Loops
Platform Observability and Infrastructure Closed Loops
 
Intel® Select Solutions for the Network
Intel® Select Solutions for the NetworkIntel® Select Solutions for the Network
Intel® Select Solutions for the Network
 

Destacado

Brand positioning-1231961903820264-3
Brand positioning-1231961903820264-3Brand positioning-1231961903820264-3
Brand positioning-1231961903820264-3Aastha Munjal
 
Virtualizáció az EGISben
Virtualizáció az EGISbenVirtualizáció az EGISben
Virtualizáció az EGISbengazdagf
 
Model Approach for Infrastructure Quality of Primary Education Facilities. Im...
Model Approach for Infrastructure Quality of Primary Education Facilities. Im...Model Approach for Infrastructure Quality of Primary Education Facilities. Im...
Model Approach for Infrastructure Quality of Primary Education Facilities. Im...SSA KPI
 
Computer System Validation Then and Now — Learning Management in the Cloud
Computer System Validation Then and Now — Learning Management in the CloudComputer System Validation Then and Now — Learning Management in the Cloud
Computer System Validation Then and Now — Learning Management in the CloudInstitute of Validation Technology
 
Regulatory Considerations for use of Cloud Computing and SaaS Environments
Regulatory Considerations for use of Cloud Computing and SaaS EnvironmentsRegulatory Considerations for use of Cloud Computing and SaaS Environments
Regulatory Considerations for use of Cloud Computing and SaaS EnvironmentsInstitute of Validation Technology
 
Computer System Validation
Computer System ValidationComputer System Validation
Computer System ValidationEric Silva
 

Destacado (7)

Brand positioning-1231961903820264-3
Brand positioning-1231961903820264-3Brand positioning-1231961903820264-3
Brand positioning-1231961903820264-3
 
Virtualizáció az EGISben
Virtualizáció az EGISbenVirtualizáció az EGISben
Virtualizáció az EGISben
 
Model Approach for Infrastructure Quality of Primary Education Facilities. Im...
Model Approach for Infrastructure Quality of Primary Education Facilities. Im...Model Approach for Infrastructure Quality of Primary Education Facilities. Im...
Model Approach for Infrastructure Quality of Primary Education Facilities. Im...
 
Computer System Validation Then and Now — Learning Management in the Cloud
Computer System Validation Then and Now — Learning Management in the CloudComputer System Validation Then and Now — Learning Management in the Cloud
Computer System Validation Then and Now — Learning Management in the Cloud
 
Virtual infrastructure qualification
Virtual infrastructure qualificationVirtual infrastructure qualification
Virtual infrastructure qualification
 
Regulatory Considerations for use of Cloud Computing and SaaS Environments
Regulatory Considerations for use of Cloud Computing and SaaS EnvironmentsRegulatory Considerations for use of Cloud Computing and SaaS Environments
Regulatory Considerations for use of Cloud Computing and SaaS Environments
 
Computer System Validation
Computer System ValidationComputer System Validation
Computer System Validation
 

Similar a Controlled Cloud in Pharma

Hannover Messe 2017 - Systems Federation in industrie 4.0
Hannover Messe 2017 - Systems Federation in industrie 4.0Hannover Messe 2017 - Systems Federation in industrie 4.0
Hannover Messe 2017 - Systems Federation in industrie 4.0Clemens Vasters
 
Nozomi Networks SCADAguardian - Data-Sheet
Nozomi Networks SCADAguardian - Data-SheetNozomi Networks SCADAguardian - Data-Sheet
Nozomi Networks SCADAguardian - Data-SheetNozomi Networks
 
Java in the Air: A Case Study for Java-based Environment Monitoring Stations
Java in the Air: A Case Study for Java-based Environment Monitoring StationsJava in the Air: A Case Study for Java-based Environment Monitoring Stations
Java in the Air: A Case Study for Java-based Environment Monitoring StationsEurotech
 
People Counting: Internet of Things in Motion at JavaOne 2013
People Counting: Internet of Things in Motion at JavaOne 2013People Counting: Internet of Things in Motion at JavaOne 2013
People Counting: Internet of Things in Motion at JavaOne 2013Eurotech
 
Air Quality Data Acquisition and Management Systems
Air Quality Data Acquisition and Management SystemsAir Quality Data Acquisition and Management Systems
Air Quality Data Acquisition and Management SystemsAgilaire LLC
 
Energy Oil Gas Presentation
Energy Oil Gas PresentationEnergy Oil Gas Presentation
Energy Oil Gas Presentationjlai
 
Virtual firewall framework
Virtual firewall frameworkVirtual firewall framework
Virtual firewall frameworkNithin Babu
 
Cloud to hybrid edge cloud evolution Jun112020.pptx
Cloud to hybrid edge cloud evolution Jun112020.pptxCloud to hybrid edge cloud evolution Jun112020.pptx
Cloud to hybrid edge cloud evolution Jun112020.pptxMichel Burger
 
Enterprise Cyber-Physical Edge Virtualization Engine (EVE) Project.pdf
Enterprise Cyber-Physical Edge Virtualization Engine (EVE) Project.pdfEnterprise Cyber-Physical Edge Virtualization Engine (EVE) Project.pdf
Enterprise Cyber-Physical Edge Virtualization Engine (EVE) Project.pdfDmitri Shiryaev
 
Managing Avionics Safety Certification for Unmanned Aircraft
Managing Avionics Safety Certification for Unmanned AircraftManaging Avionics Safety Certification for Unmanned Aircraft
Managing Avionics Safety Certification for Unmanned AircraftReal-Time Innovations (RTI)
 

Similar a Controlled Cloud in Pharma (20)

Introduction To Cloud Computing
Introduction To Cloud ComputingIntroduction To Cloud Computing
Introduction To Cloud Computing
 
Hannover Messe 2017 - Systems Federation in industrie 4.0
Hannover Messe 2017 - Systems Federation in industrie 4.0Hannover Messe 2017 - Systems Federation in industrie 4.0
Hannover Messe 2017 - Systems Federation in industrie 4.0
 
gesa_sol.ppt
gesa_sol.pptgesa_sol.ppt
gesa_sol.ppt
 
Sql Azure
Sql AzureSql Azure
Sql Azure
 
Nozomi Networks SCADAguardian - Data-Sheet
Nozomi Networks SCADAguardian - Data-SheetNozomi Networks SCADAguardian - Data-Sheet
Nozomi Networks SCADAguardian - Data-Sheet
 
Java in the Air: A Case Study for Java-based Environment Monitoring Stations
Java in the Air: A Case Study for Java-based Environment Monitoring StationsJava in the Air: A Case Study for Java-based Environment Monitoring Stations
Java in the Air: A Case Study for Java-based Environment Monitoring Stations
 
People Counting: Internet of Things in Motion at JavaOne 2013
People Counting: Internet of Things in Motion at JavaOne 2013People Counting: Internet of Things in Motion at JavaOne 2013
People Counting: Internet of Things in Motion at JavaOne 2013
 
Air Quality Data Acquisition and Management Systems
Air Quality Data Acquisition and Management SystemsAir Quality Data Acquisition and Management Systems
Air Quality Data Acquisition and Management Systems
 
TeraVM_overview_021115
TeraVM_overview_021115TeraVM_overview_021115
TeraVM_overview_021115
 
TeraVM_overview
TeraVM_overviewTeraVM_overview
TeraVM_overview
 
Energy Oil Gas Presentation
Energy Oil Gas PresentationEnergy Oil Gas Presentation
Energy Oil Gas Presentation
 
Prasad_Meduri
Prasad_MeduriPrasad_Meduri
Prasad_Meduri
 
Ikon Managed Services
Ikon Managed ServicesIkon Managed Services
Ikon Managed Services
 
Ikon Managed Services
Ikon Managed ServicesIkon Managed Services
Ikon Managed Services
 
NodeGrid Bold
NodeGrid BoldNodeGrid Bold
NodeGrid Bold
 
Embrace network
Embrace networkEmbrace network
Embrace network
 
Virtual firewall framework
Virtual firewall frameworkVirtual firewall framework
Virtual firewall framework
 
Cloud to hybrid edge cloud evolution Jun112020.pptx
Cloud to hybrid edge cloud evolution Jun112020.pptxCloud to hybrid edge cloud evolution Jun112020.pptx
Cloud to hybrid edge cloud evolution Jun112020.pptx
 
Enterprise Cyber-Physical Edge Virtualization Engine (EVE) Project.pdf
Enterprise Cyber-Physical Edge Virtualization Engine (EVE) Project.pdfEnterprise Cyber-Physical Edge Virtualization Engine (EVE) Project.pdf
Enterprise Cyber-Physical Edge Virtualization Engine (EVE) Project.pdf
 
Managing Avionics Safety Certification for Unmanned Aircraft
Managing Avionics Safety Certification for Unmanned AircraftManaging Avionics Safety Certification for Unmanned Aircraft
Managing Avionics Safety Certification for Unmanned Aircraft
 

Más de gazdagf

Orvosság a fizikai token ellen
Orvosság a fizikai token ellenOrvosság a fizikai token ellen
Orvosság a fizikai token ellengazdagf
 
Helyi hálózatok evolúciója: a következő lépcső
Helyi hálózatok evolúciója: a következő lépcsőHelyi hálózatok evolúciója: a következő lépcső
Helyi hálózatok evolúciója: a következő lépcsőgazdagf
 
Net App At Egis English
Net App At Egis EnglishNet App At Egis English
Net App At Egis Englishgazdagf
 
Net App At Egis Magyar
Net App At Egis MagyarNet App At Egis Magyar
Net App At Egis Magyargazdagf
 
Virtuális Platformváltás validált környezetben
Virtuális Platformváltás validált környezetbenVirtuális Platformváltás validált környezetben
Virtuális Platformváltás validált környezetbengazdagf
 
Virtualized Platform Migration On A Validated System
Virtualized Platform Migration On A Validated SystemVirtualized Platform Migration On A Validated System
Virtualized Platform Migration On A Validated Systemgazdagf
 

Más de gazdagf (6)

Orvosság a fizikai token ellen
Orvosság a fizikai token ellenOrvosság a fizikai token ellen
Orvosság a fizikai token ellen
 
Helyi hálózatok evolúciója: a következő lépcső
Helyi hálózatok evolúciója: a következő lépcsőHelyi hálózatok evolúciója: a következő lépcső
Helyi hálózatok evolúciója: a következő lépcső
 
Net App At Egis English
Net App At Egis EnglishNet App At Egis English
Net App At Egis English
 
Net App At Egis Magyar
Net App At Egis MagyarNet App At Egis Magyar
Net App At Egis Magyar
 
Virtuális Platformváltás validált környezetben
Virtuális Platformváltás validált környezetbenVirtuális Platformváltás validált környezetben
Virtuális Platformváltás validált környezetben
 
Virtualized Platform Migration On A Validated System
Virtualized Platform Migration On A Validated SystemVirtualized Platform Migration On A Validated System
Virtualized Platform Migration On A Validated System
 

Controlled Cloud in Pharma

  • 1. 200 8 . 06 .2 5 .
  • 2. The Madness of Clouds a controlled, qualified cloud in pharma GAZDAG, Ferenc EGIS Pharmaceuticals Plc, Head of IT Infrastructure 08-09. Sept. 2011 IT Governance, Risk and Compliance
  • 3.
  • 4.
  • 6. Physical infrastructure TGY (HQ, plant) 30 Hosts, 358 VMs 1800 PCs KÖR (plant) 5 Hosts, 24 VMs, 500 PCs BÖK (plant) 6 Hosts, 82 VMs, 500 PCs KER (sales office) 6 VMware Hosts, 16 VMs, 400 PC MGY (storehouse) 6 PCs 1 Gbps leased line (optical) 10 Mbps leased line (micro) CWDM darkfiber (2x1Gbps) 10 Mbps leased line (optical) CWDM darkfiber (4x1Gbps) 100 Mbps micro 2 Mpbs optika 100 Mbps (optical) 10 Mbps micro Internet 17 offices (MPLS vpn) 38 Hosts, 60 VMs, 1100 PCs
  • 7.
  • 8. Virtual infrastructure EGIS HU cloud SAP sub-cloud EGIS Intl cloud QA system Sub-cloud
  • 9.
  • 10.
  • 11.
  • 12.
  • 13. V modell for computerized system validation User Requirements specification (URS) Functional specification (FS) Design Specification HW/SW (DS) Implementation Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ) Checks
  • 14. Application validation – Infrastructure qualification Storage Network Virtualisation layer (Hypervisor) Hardware units HA DR Mentés Qualification Validation Application Operating system Virtual hardware Application Operating system Virtual hardware Application Operating system Virtual hardware Application Operating system Virtual hardware
  • 15. QA in virtual systems Virtual infrastructure Qualification of virtual template(s) Qualification of virtual platform Validation of application Virtual machine Application OS Virtual machine Application OS Virtual machine Application OS Virtual machine Application OS Virtual machine Application OS Virtual machine Application OS Virtual template OS Virtual machine Application OS
  • 16.
  • 17.
  • 18.
  • 19.
  • 20.
  • 22.
  • 23.
  • 24.
  • 25.
  • 26.
  • 27.
  • 28. Results of FDA inspection Passed
  • 29.
  • 30.
  • 31. Thank you! Any questions? [email_address]

Notas del editor

  1. Mert minden diasornak ezzel kell kezdődnie, ez kötelező 
  2. Röviden összefoglalva a Virtual rendszerek minőségbiztosítását, az mondható, hogy ebben a részben is jelentős áttérést ért el a virtualizáció. A fizikai világban az alapinfrastruktúrát, az egyedi szervereket és Operating systemeket kell kvailfikálni. Virtualan sem ússzuk meg a rendszer-kvalifikációt, azonban ezt csak egyszer kell megcsinálni minden rajta lévő rendszerrel. Ugyanígy az alap sablonokat is csak egyszer kell kvalifikálni, s az egyediesítést követően akutalizálni. Az Applicationokat mindkét esetben ugyanolyan erőforrás felhasználással validálni kell, de Applicationt talán kevesebbszer cserél az ember mint vasat
  3. A minőségbiztosítás és a dokumentáció nem az informatikai üzemeltetők kedvenc témája. Azonban a virtualizációval ez a teher is jelentősen csökkenthető. Míg a fizikai világban egy rendszer virtualizációja nagyjából két hétig tartott, amit egy – Applicationtól függő idejű– validáció követett, addig a Virtual világban egyszer kell a kéthetes alapkvalifikációt megcsinálni, amit a Virtual sablonok (nálunk ebből kb 7 darab van) követ. A sablonokból készítünk machineeket, ezek egyediesítése utáni ellenőrzésére 1 napot még szánnunk kell. S természetesen itt is validálni kell, ami Applicationtól függ. Elképzelhető, hogy egy gyógyszergyár esetén ez mekkora időnyereséget okoz, mivel legalább 30 validált rendszerünk van, aminek az infrastruktúra részét kvalifikálni kell. Az SAP esetében ez 132 munkanap helyett 34 munkanapot vesz igénybe.