Deploying GMP Applications

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31 Οκτ 2013 (πριν από 3 χρόνια και 10 μήνες)

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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


Internal infrastructure


Client servers


2
-
tier architectures


3
-
tier architectures





Server Technology

Failover c
lusters


Server Technology


Failover c
lusters


High
a
vailability


Enterprise
d
eployments
and
large
s
ites


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


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?


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


Application
r
equirements


Dedicated
e
nvironments


Server
r
equirements


Platform
r
equirements


Client requirements



Deployment Process


Application requirements


Hardware and network


Software licenses


Security policies


IT
staff


Deployment Process


Dedicated
e
nvironments


Development


Validation (Test/QA)


Production

Deployment Process


Server
r
equirements


Performance


Storage


Availability


Support staff


Deployment Process


Platform requirements


Operating
s
ystems


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

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

Super VGA (1024X768) or
higher
-
resolution video adapter
and monitor

Super VGA (1024X768) or
higher
-
resolution video
adapter and monitor

Other Devices

Microsoft Mouse or compatible
pointing device

Microsoft Mouse or compatible
pointing device

Microsoft Mouse or
compatible pointing device

Deployment Process

GAMP System Lifecycle



Deployment Process


User Requirements


Functional
R
equirements


Design / Configuration


Qualification


Server
Q
ualification


Installation
Q
ualification


Operational and/or Performance
Q
ualification


Traceability Matrix

Deployment Process


User
R
equirements


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


A
ll
essential requirements (
musts
)


I
f
possible a prioritized set of desirable requirements
(
wants
)


Requirements should be linked to P
erformance
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 Q
ualification
(IQ)


Operational
Qualification
(OQ)


Performance
Qualification
(PQ
)

Deployment Process


Validation final
r
eport


The validation final report is a summary of the
evidence leading to the conclusion that the system
has
been successfully validated



Maintenance


Backups


Updates and patches


Performance monitoring


Change management


Periodic review

Maintenance


Backups




Define backup schedule


Define what type of backups


Storage of b
ackups


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 L
ife
S
ciences 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