1. Deploying GMP Applications Scott Fry, Director of Professional Services

2. Overview  Server technology  Deployment process  Maintenance  Vendor partnership  Question and answers

3. Server Technology  Server technology –Client server –Failover clusters –Virtualization –Cloud

4. Server Technology  Internal infrastructure –Client servers –2-tier architectures –3-tier architectures

5. Server Technology Failover clusters

6. Server Technology  Failover clusters –High availability –Enterprise deployments and large sites

7. Server Technology Virtualization  Physical hardware – Processors, memory, chipset, I/O devices, etc. – Resources often grossly underutilized  Software – Tightly coupled to physical hardware – Single active OS instance – OS controls hardware

8. Server Technology  Software abstraction – Behaves like hardware – Encapsulates all OS and application state  Virtualization layer – Extra level of indirection – Decouples hardware, OS – Enforces isolation – Multiplexes physical hardware across VMs What is a virtual server?

9. Server Technology Public vs. Private Cloud

10. Server Technology  Cloud –Pay-per-usage Infrastructure-as-a-Service (IaaS) Platform-as-a-Service (PaaS) Software-as-a-Service (SaaS) –Availability, reliability & security –Hardware / IT staffing

11. Deployment Process  Application requirements  Dedicated environments  Server requirements  Platform requirements  Client requirements

12. Deployment Process  Application requirements –Hardware and network –Software licenses –Security policies –IT staff

13. Deployment Process  Dedicated environments –Development –Validation (Test/QA) –Production

14. Deployment Process  Server requirements –Performance –Storage –Availability –Support staff

15. Deployment Process  Platform requirements –Operating systems Microsoft Windows, Linux, Sun –Database’s Microsoft SQL, Oracle –Browsers Internet Explorer, Chrome, Firefox

16. Deployment Process  Client requirements –Operating systems Microsoft Windows –Vista, Windows 7 –Browsers Internet Explorer, Chrome, Firefox

17. Deployment Process Application Server 64-bit Database Server 64 – Bit Client 64 - Bit Processor Dual 2 (GHz) Core Duo Xenon compatible processor; 2.33 (GHz) or faster processor recommended. Quad 2 (GHz) Core Duo Xenon compatible processor; Quad 2.33 (GHz) or faster processor recommended 700 (MHz) Pentium III processor; 1.5 (GHz) or faster Core Duo processor recommended Operating System Windows Server 2008 R2 Enterprise Edition or Standard Edition. Windows Server 2008 R2 Enterprise Edition or Standard Edition. Microsoft SQL 2008 R2 Microsoft XP SP3, Vista, or Windows 7 Memory 4 gigabyte (GB) or more recommended 8 gigabyte (GB) or more recommended 512 GB of RAM or more; 2 GB or more recommended Hard Disk  Approximately 500 GB of available hard-disk space for the recommended installation of Microsoft SQL Reporting Services  Approximately 50 GB pre 10,000 Assets of hard-disk space recommended over a 10 year period. Other Requirements  Microsoft Internet Information Services 7.5  ASP.NET 4.0  Microsoft Internet Information Services 7.5  ASP.NET 2.0  Microsoft Internet Explorer 8.0(Native Mode) A A IE8 only supported for R3 Display Super VGA (1024X768) or higher-resolution video adapter and monitor Other DevicesMicrosoft Mouse or compatible pointing device

18. Deployment Process GAMP System Lifecycle

19. Deployment Process  User Requirements  Functional Requirements  Design / Configuration  Qualification –Server Qualification –Installation Qualification –Operational and/or Performance Qualification –Traceability Matrix

20. Deployment Process  User Requirements –What the system is supposed to do –Normally written by the user –May be sent to suppliers as part of the vendor selection process which should include All essential requirements (musts) If possible a prioritized set of desirable requirements (wants) –Requirements should be linked to Performance Qualification

21. Deployment Process  Functional Requirements –Normally written by the supplier –Describes the detailed functions of the system, i.e., what the system will do –An initial version of the FS may be produced as part of the supplier response –Further revisions of the FS are prepared in conjunction with the user –Links to Operation Qualification, which tests all the functions specified

22. Deployment Process  Design and configuration –Configure your system to closely match your current and ideal procedures –Amount of configuration will depend on the amount of flexibility in your selected system –A configuration document should be created

23. Deployment Process  Server Qualification –When implementing a calibration management software and validating it in a GxP compliant environment –Verify that your computer hardware and network can support the system you’re implementing –Understand where investments in computing hardware will have the greatest impact on the user end or on the network or server side

24. Deployment Process  Installation Qualification (IQ) –Documented verification that a system is installed according to written and pre-approved specifications

25. Deployment Process  Operational Qualification (OQ) –Documented verification that a system operates according to written and pre-approved specifications throughout all specified operating ranges

26. Deployment Process  Performance Qualification (PQ) –Documented verification that a system is capable of performing or controlling the activities of the processes it is required to perform or control, according to written and pre-approved specifications, while operating in its specified operating environment

27. Deployment Process  Traceability Matrix –Maps the user requirements to: User Requirements Functional Requirements Installation Qualification (IQ) Operational Qualification (OQ) Performance Qualification (PQ)

28. Deployment Process  Validation final report –The validation final report is a summary of the evidence leading to the conclusion that the system has been successfully validated

29. Maintenance  Backups  Updates and patches  Performance monitoring  Change management  Periodic review

30. Maintenance  Backups –Define backup schedule –Define what type of backups –Storage of backups –Test backups

31. Maintenance  Updates and patches –OS updates –Application updates

32. Maintenance  Performance monitoring –Determine your monitoring goals –Choose the appropriate tool for the type of monitoring you will perform –Identify the events to monitor –Determine the event data to capture

33. Maintenance  Change management –The goal is to enable change while ensuring compliance –The process should be well documented in an approved procedure

34. Maintenance  Change management –Follows the same lifecycle processes Planning Specification Configuration Verification Reporting –All of these activities should be well documented for each change

35. Maintenance  Periodic review –Maintaining the validated state involves:

36. Vendor Partnership  Why Blue Mountain Quality Resources –Over 1000 implementations of Calibration Manager. –Over 100 implementations of Blue Mountain RAM in the Life Sciences industries –Over 20 year of experience in Life Sciences industry

37. Vendor Partnership  Why Blue Mountain Quality Resources –Familiarity with regulations and technology means you get the most from your investment –Full range of services to supplement your resources, reduce costs and minimize risks

38. Vendor Partnership  Blue Mountain Professional Services –Services Solutions

39. Deploying GMP Applications Questions