Deploying GMP Applications Scott Fry, Director of Professional

Report
Deploying GMP Applications
Scott Fry, Director of Professional Services
Overview
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Server technology
Deployment process
Maintenance
Vendor partnership
Question and answers
Server Technology
 Server technology
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Client server
Failover clusters
Virtualization
Cloud
Server Technology
 Internal infrastructure
– Client servers
– 2-tier architectures
– 3-tier architectures
Server Technology
Failover clusters
Server Technology
 Failover clusters
– High availability
– Enterprise deployments and large sites
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
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
Server Technology
Public vs. Private Cloud
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
Deployment Process
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Application requirements
Dedicated environments
Server requirements
Platform requirements
Client requirements
Deployment Process
 Application requirements
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–
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Hardware and network
Software licenses
Security policies
IT staff
Deployment Process
 Dedicated environments
– Development
– Validation (Test/QA)
– Production
Deployment Process
 Server requirements
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–
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Performance
Storage
Availability
Support staff
Deployment Process
 Platform requirements
– Operating systems
• Microsoft Windows, Linux, Sun
– Database’s
• Microsoft SQL, Oracle
– Browsers
• Internet Explorer, Chrome, Firefox
Deployment Process
 Client requirements
– Operating systems
• Microsoft Windows
– Vista, Windows 7
– Browsers
• Internet Explorer, Chrome, Firefox
Deployment Process
Application Server
64-bit
Processor
Database Server
64 – Bit
Client
64 - Bit
Dual 2 (GHz) Core Duo Xenon
Quad 2 (GHz) Core Duo Xenon
700 (MHz) Pentium III
compatible processor;
compatible processor;
processor;
2.33 (GHz) or faster processor
Quad 2.33 (GHz) or faster
1.5 (GHz) or faster Core
recommended.
processor recommended
Duo processor
recommended
Operating
Windows Server 2008 R2
Windows Server 2008 R2
Microsoft XP SP3, Vista, or
System
Enterprise Edition or Standard
Enterprise Edition or Standard
Windows 7
Edition.
Edition.
Microsoft SQL 2008 R2
Memory
4 gigabyte (GB) or more
8 gigabyte (GB) or more
512 GB of RAM or more;
recommended
recommended
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

Microsoft Internet
Information Services
7.5
ASP.NET 4.0

Microsoft Internet
Information Services
7.5
ASP.NET 2.0
Requirements

Display
Other Devices
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
A
Microsoft Internet
Explorer 8.0(Native
Mode)A
IE8 only supported for R3
Super VGA (1024X768) or
Super VGA (1024X768) or
Super VGA (1024X768) or
higher-resolution video adapter
higher-resolution video adapter
higher-resolution video
and monitor
and monitor
adapter and monitor
Microsoft Mouse or compatible
Microsoft Mouse or compatible
Microsoft Mouse or
pointing device
pointing device
compatible pointing device
Deployment Process
GAMP System Lifecycle
Deployment Process
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User Requirements
Functional Requirements
Design / Configuration
Qualification
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Server Qualification
Installation Qualification
Operational and/or Performance Qualification
Traceability Matrix
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
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
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
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
Deployment Process
 Installation Qualification (IQ)
– Documented verification that a system is installed
according to written and pre-approved specifications
Deployment Process
 Operational Qualification (OQ)
– Documented verification that a system operates
according to written and pre-approved specifications
throughout all specified operating ranges
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
Deployment Process
 Traceability Matrix
– Maps the user requirements to:
•
•
•
•
•
User Requirements
Functional Requirements
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
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
Maintenance
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Backups
Updates and patches
Performance monitoring
Change management
Periodic review
Maintenance
 Backups
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Define backup schedule
Define what type of backups
Storage of backups
Test backups
Maintenance
 Updates and patches
– OS updates
– Application updates
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
Maintenance
 Change management
– The goal is to enable change while ensuring
compliance
– The process should be well documented in an
approved procedure
Maintenance
 Change management
– Follows the same lifecycle processes
•
•
•
•
•
Planning
Specification
Configuration
Verification
Reporting
– All of these activities should be well documented for
each change
Maintenance
 Periodic review
– Maintaining the validated state involves:
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
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
Vendor Partnership
 Blue Mountain Professional Services
– Services Solutions
Deploying GMP Applications
Questions

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