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Deploying GMP Applications Scott Fry, Director of Professional Services

Deploying GMP Applications Scott Fry, Director of Professional Services. Overview. Server technology Deployment process Maintenance Vendor partnership Question and answers. Server Technology. Server technology Client server Failover clusters Virtualization Cloud. Server Technology.

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Deploying GMP Applications Scott Fry, Director of Professional Services

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  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 • 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 Virtualization

  8. Server Technology What is a virtual server? • 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

  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

  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 GxPcompliant 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

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