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Madness of the Clouds

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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.

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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]

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Madness of the Clouds

  • 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]

Notes de l'éditeur

  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.