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 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

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 requirements Dedicated environments Server requirements Platform requirements Client requirements

Deployment Process

Application requirements– Hardware and network– Software licenses– Security policies– IT staff

Deployment Process

Dedicated environments– Development– Validation (Test/QA)– Production

Deployment Process

Server requirements– 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-bitDatabase Server

64 – BitClient64 - 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 Requirements Design / Configuration Qualification

– 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

Backups Updates and patches Performance monitoring Change management Periodic review

Maintenance

Backups – 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