Sample Installation Qualification Plan
SampleInstallationQualification PlanRevision Number: 1.0Page 1 of 16Revision Date: 8/7/2012
Installation Qualification PlanSampleSignatory PagePREPARED BY:Functional RoleName/Title/DepartmentProject ManagerHelen Hill /SignatureDateSr. Manager – IS Operations /Information SystemsREVIEWED BY:By affixing their signatures, the individuals below acknowledge that they have reviewed the scope of the effortdescribed in this Installation Qualification Plan for Sample.Functional RoleName/Title/DepartmentTechnical ReviewerAlan Runck/SignatureDateSr. Manager – IS Operations /Information SystemsValidation QualityReviewerJoyce Brendle /Lead Compliance Analyst /Information SystemsAPPROVED BY:By signing this section, the individuals below agree that they have reviewed and approved the scope of theeffort described in the Installation Qualification Plan for Sample. The signatures below represent the approvalof the Installation Qualification Plan for Sample and acceptance by Technology Workshop Managementrepresenting the Qualification Team.Functional RoleName/Title/DepartmentIS ManagementDeborah Urbanek /SignatureDateVice President /Information SystemsRevision Number: 1.0Page 2 of 16Revision Date: 8/7/2012
Installation Qualification PlanSampleRevision HistoryVersion1.0Date8/7/2012Revision Number: 1.0Author(s)Helen HillNotesInitial creationPage 3 of 16Revision Date: 8/7/2012
Installation Qualification PlanSampleTable of ContentsPage1.02.03.04.05.0Purpose .5Scope.5Reference Documents .6Roles and Responsibilities .7Qualification Approach .85.16.0Qualification Activities. 85.1.1 Prerequisite Software and Hardware . 85.1.2 Installation. 85.1.3 Configuration . 85.2Qualification Deliverables . 9Project Acceptance Criteria .107.0Installation Qualification Summary Report .108.0Appendix A – Prerequisite Software and Hardware .119.0Appendix B –Installation.1210.0Appendix C –Configuration .15Revision Number: 1.0Page 4 of 16Revision Date: 8/7/2012
Installation Qualification PlanSample1.0PurposeThe purpose of this Installation Qualification Plan for Sample is to define the testing activities,expected results, and acceptance criteria for qualifying the installation and configuration ofSample. This Installation Qualification Plan for Sample is based on Technology Workshop’sapproved procedure – IS-175.000 “Master Validation Plan” procedure.2.0ScopeA key component of Technology Workshop’s Disaster Recovery Procedure is offsitereplication of essential Concert Drive Data Center files. Concert Drive Data Center files arestored on two types of computers:Computers running VMware ESX 3.0 ServerComputers running WindowsAll offsite computers are configured with VMware ESX 3.0 Server.esxReplicator will be used to replicate the virtual machines (VMs) that are running on ESXServer computers. Sample, available from Sample Software, will be used to replicate key datafrom the Windows computers.Concert DriveBackup DestinationHost ComputerVMHost ComputerVMESX ServervariousESX Serversame as sourceWindowsN/AESX ServerWindowsReplication MethodesxReplicatorSampleentire VMselected filesThe scope of this Installation Qualification Plan is limited to the qualification of the installationand configuration of Sample software.Note: Refer to the esxReplicator Installation Qualification Plan for testing activities planned for theesxReplicator software.Revision Number: 1.0Page 5 of 16Revision Date: 8/7/2012
Installation Qualification PlanSample3.0Reference DocumentsDocument NumberDocument TitleIS-072.000Computer System Validation ProcedureIS-075.000Master Validation PlanIS-073.000IS Good Documentation PracticesIS-074.001IS Good Testing PracticesRevision Number: 1.0Page 6 of 16Revision Date: 8/7/2012
Installation Qualification PlanSample4.0Roles and ResponsibilitiesThe roles and responsibilities associated with the Sample qualification are listed below.Additional members may be added to the team and existing members may be utilized to assistin and/or perform additional roles.Functional RoleProject ManagerValidation QualityReviewerTesterTechnicalReviewerIS ManagementRevision Number: 1.0ResponsibilitiesCoordinates, reports on and is accountable for activitiesregarding the installation qualification of SampleControls the technical aspects of the project.Helps resolve issues and scope changes.Is responsible for the technical quality of the solution.Prepares the Installation Qualification Plan and testscript(s) for SamplePrepares qualification summary reportEnsures the quality of the qualification process and thedeliverables meet Technology Workshop’s policies andprocedures.Reviews the Installation Qualification Plan and testscript(s) for SampleReviews the executed test script(s).Reviews the qualification summary report and/orvalidation deliverable(s)Responsible for executing the test scriptsResponsible for documenting the test resultsProvides assistance in preparing the test summaryreportEnsures that software documentation and testprocedures comply with approved procedures.Coordinates the availability of resources.Is responsible for the resolution of issues and scopechanges.Reviews the Installation Qualification Plan andapproves test scripts for Sample.Reviews qualification summary reportProvides guidance to the project team and assists teammembers in use of methodology.Approves the Installation Qualification Plan forSample.Approves the qualification summary report.Page 7 of 16Name/Title/DepartmentHelen Hill /Sr. Manager – ISOperations /Information SystemsJoyce Brendle /Lead Compliance Analyst/Information SystemsHelen Hill /Sr. Manager – ISOperations /Information SystemsAlan Runck /Sr. Manager – ISOperations /Information SystemsDeborah Urbanek /Vice President /Information SystemsRevision Date: 8/7/2012
Installation Qualification PlanSample5.0Qualification Approach5.1Qualification ActivitiesAs part of the Sample qualification process, the following activities will be performed.5.1.1Prerequisite Software and HardwareSource and target servers will be examined to verify that the minimum softwareand hardware requirements necessary for proper operation of Sample are met.The qualification deliverables and list of test script(s) associated with this activityare attached in Appendix A.5.1.2InstallationProcedures for successful installation of Sample software will be documentedand tested. The qualification deliverables and list of test script(s) associated withthis activity are attached in Appendix B.5.1.3ConfigurationConfiguration of Sample will be verified. The qualification deliverables and listof test script(s) associated with this activity are attached in Appendix C.Revision Number: 1.0Page 8 of 16Revision Date: 8/7/2012
Installation Qualification PlanSample5.2Qualification DeliverablesThe following list of validation deliverables will be generated as a part of the Samplequalification process.DeliverableInstallation Qualification Plan for Sample (this document)Installation Qualification Summary Report for SampleThe execution of test scripts associated with the Sample qualification process will beperformed manually in accordance with IS-074.001, “IS Good Testing Practices” andentries made in accordance with IS-073.000, “IS Good Documentation Practices”.Output generated during testing will be referenced from the actual results column ofthe corresponding test step and will be clearly labeled, dated, and initialed by the testerprior to being attached to the test script. Incidents that occur during testing will berecorded using LNIS1263, “Incident Form” and entered onto LNIS1265, “Incident LogForm”. The Tester will be trained in IS-073.000, “IS Good Documentation Practices” andIS-074.001, “IS Good Testing Practices” prior to the execution of test scripts.The Project Manager is responsible for maintaining the documentation in a securelocation during the qualification process. The approved documents will be stored inaccordance with IS-073.000, “IS Good Documentation Practices”.Revision Number: 1.0Page 9 of 16Revision Date: 8/7/2012
Installation Qualification PlanSample6.0Project Acceptance CriteriaThe Sample Installation Qualification Project will be accepted when the following conditionsare met:All qualification activities identified in this document have been completed anddocumented and workarounds have been identified and implemented for any requiredfunctionality not met.All documentation and deliverables defined in this document are complete andapproved as designated.7.0Installation Qualification Summary ReportAn Installation Qualification Summary Report for Sample will be generated, which describesthe activities associated with the qualification process. This report will summarize thequalification environment, testing performed, test results and any unresolved errors. If thereare any gaps in the qualification process, the test will be labeled as Fail. Otherwise, the test willbe labeled as Pass.The project team shall accept the outstanding issues through their approval of the InstallationQualification Summary Report. Furthermore, the qualification summary report shall constitutequalification of the Sample installation as per applicable Technology Workshop proceduresand predicate rules.Revision Number: 1.0Page 10 of 16Revision Date: 8/7/2012
Installation Qualification PlanSample8.0Appendix A – Prerequisite Software and Hardware8.1BackgroundAs part of the Installation Qualification Plan for Sample, the hardware and softwarerequirements for the Sample source and target servers will be verified.8.2Sample RequirementsUnlike esxReplicator, which replicates the entire image of a virtual machine, Samplereplicates selected drives, directories, and/or files on Windows servers.Sample requires a physical or virtual machine running Windows 2003 with a minimumof 128 MB memory. Sample also requires that the source and target servers are mirrorimages of each other except for the server name and IP address, which must be unique.8.3Sample Application Manager RequirementsIn addition to the above requirements, the server running Sample Application Managermust have Microsoft .NET Framework version 2.0 or later installed.8.4Qualification ApproachThe following test script will be executed to ensure that the Sample source and targetservers meet the minimum hardware and software requirements.Test Script IDTest Script TitleSample-PRE-01Sample System Requirements Verification8.5Acceptance CriteriaThe qualification activities associated with the Prerequisite Software and Hardwaresection will be accepted when all qualification activities identified in Sample-PRE-01have been completed and documented and workarounds have been identified andimplemented for any required functionality not met.Revision Number: 1.0Page 11 of 16Revision Date: 8/7/2012
Installation Qualification PlanSample8.6Installation Qualification Summary ReportThe Installation Qualification Summary Report for Sample will be updated to describethe testing associated with the Prerequisite Software and Hardware section, includingrelated incidents and resolutions if any, and the final testing status (Pass or Fail).9.0Appendix B –Installation9.1BackgroundThis section provides installation procedures for Sample and Sample ApplicationManager.9.2Sample Installation Instructions1Note: Use these instructions if you are installing Sample for the first time or if you havecompletely uninstalled any previous version of Sample.1.Close any open applications.2.Start the installation program by loading the Sample CD into the local CDROM drive. If auto-run is enabled, the program will start automatically.To manually start the program, select "Start Run" and specify: cd drive :\autorun.exe.3.The Sample installation program starts with an initial screen allowing youto install the software or read associated files. Select "Install Sample forWindows".4.When the Sample installation program begins, you will be given theopportunity to check for more recent versions of the software.Note: If you do not want to check for later versions, select "No" and click"Next."Note If you want to check for later versions, select "Yes" and click "Next." Theinstallation program will establish an Internet connection from your machine tothe Sample Software web site.15.Review and accept the Sample license agreement to continue with theinstallation program. Click "Next" to continue.6.Select "Client and Server Components" and click "Next."Refer to Sample Getting Started for additional information.Revision Number: 1.0Page 12 of 16Revision Date: 8/7/2012
Installation Qualification PlanSample9.37.Select "Complete" for the type of Sample installation and click "Next."8.Enter your User Name, Organization, and Activation Code (a16-character, alphanumeric activation code that applies the appropriateSample license to your installation). Click "Next" to continue.9.Confirm the Activation Code and click "Next."10.Sample uses system memory to store data in queues. Specify themaximum amount of system memory to be used.11.When the Sample system memory queue is exhausted, Sample will queueto disk. Specify the size and location of the disk queue.12.Click "Next" to continue.13.The Sample security information screen appears next. Review thisinformation and click "Next" to continue with the installation.14.If you are satisfied with the selections you have made and are ready tobegin copying the Sample files, click "Install."15.After the files have completed copying, click "Finish" to exit theinstallation program.16.Restart the computer to complete the Sample installation.Sample Application Manager Installation2The Sample Application Manager automates the setup and configuration of replicationand failover monitoring for Exchange and SQL servers. Sample Application Manager isinstalled on the target server by running the Application Manager installation filedownloaded from the Sample Software support website or from the installation media.2See Sample Application Manager User’s Guide for additional information.Revision Number: 1.0Page 13 of 16Revision Date: 8/7/2012
Installation Qualification PlanSample9.4Qualification ApproachThe following test script will be executed to ensure that the Sample applications areproperly installed.Test Script IDTest Script TitleSample-INS-01Sample Source Server Installation VerificationSample-INS-02Sample Target Server Installation Verification9.5Acceptance CriteriaThe qualification activities associated with the Installation section will be acceptedwhen all qualification activities identified in Sample-INS-01 and Sample-INS-02 havebeen completed and documented and workarounds have been identified andimplemented for any required functionality not met.9.6Installation Qualification Summary ReportThe Installation Qualification Summary Report for Sample will be updated to describethe testing associated with the Installation section, including related incidents andresolutions if any, and the final testing status (Pass or Fail).Revision Number: 1.0Page 14 of 16Revision Date: 8/7/2012
Installation Qualification PlanSample10.0Appendix C –Configuration10.1BackgroundAfter successful installation of Sample, the server settings need to be configured orverified.10.2Server PropertiesThe following settings, located in the Sample Server Properties dialog box will beverified:CategorySettingsGeneralBasic settings including the machine's identitySetupSettings that are initialized when Sample is startedNetworkSettings that control network communicationsQueueSettings for Sample queue usageSourceSetting specific to the source computerTargetSettings specific to the target computerDatabaseSettings that specify the name and location for the database files used by SampleLoggingSettings for Sample log filesE-mail NotificationSettings that enable messages logged to the Windows Event Viewer to be sent as email messages to a specified address10.3Qualification ApproachThe following test script will be executed to ensure that Sample is properly configured.Test Script IDTest Script TitleSample-CFG-01Sample Source Server Configuration VerificationSample-CFG-02Sample Target Server Configuration VerificationRevision Number: 1.0Page 15 of 16Revision Date: 8/7/2012
Installation Qualification PlanSample10.4Acceptance CriteriaThe qualification activities associated with the Configuration section will be acceptedwhen all qualification activities identified in Sample-CFG-01 and Sample-CFG-02 havebeen completed and documented and workarounds have been identified andimplemented for any required functionality not met.10.5Installation Qualification Summary ReportThe Installation Qualification Summary Report for Sample will be updated to describethe testing associated with the Configuration section, including related incidents andresolutions if any, and the final testing status (Pass or Fail).Revision Number: 1.0Page 16 of 16Revision Date: 8/7/2012
Installation Qualification Plan Sample Revision Number: 1.0 Page 12 of 16 Revision Date: 8/7/2012 8.6 Installation Qualification Summary Report The Installation Qualification Summary Report for Sample will be updated to describe the testing associated with the Prerequisite Software and Hardware section, including
An equipment qualification is handled in different phases of the equipment lifecycle, start-ing with design qualification, installation qualification, and then operational qualification and performance qualification. Every step in the equipment qualification formally comprises a plan, the execution and a report.
5.D Qualification of water supplies 5.D.1 Introduction 5.D.2 Risk analysis 5.D.3 Design qualification 5.D.4 Installation qualification 5.D.5 Operational qualification (OQ) 5.D.6 Transfer to the user 5.D.7 Process validation/performance qualification (PQ) 5.D.8 Qualification report 5.E Operation of water supplies
exempting qualification. B Structure of the qualification The structure of the qualification and syllabus subjects is shown on the following diagram. C Progression through the qualification Subjects within each learning pillar of the qualification are designed to be sequential, from operational to strategic level, encouraging
Operational qualification Operational qualification (OQ) 13. Operational qualification (OQ) should follow Installation qualification. 3.10 OQ normally follows IQ but depending on the complexity of the equipment it maybe performed as a combined Installation/Operation Qualification (IOQ). OQ could include but is not be limited to the following:
INSTALLATION QUALI INSTALLATION QUALIFICATION FICATION (1) INSTALLATION INSTALLATION QUALIFICATION QUALIFICATION (1) 1 rue du Petit Clamart - B.P. 50 78142 VELIZY CEDEX - FRANCE Tél. 01.46.29.99.60 - Fax. 01.46.30.87.30 ETUDES & DEVELOPPEMENT VALIDATION C 1/4 NSCA 161/16 LC reference : 37K53E Page Rev. Page Customer reference : 45382135/392 IQ .
covers the three stages of qualification needed to release a temperature-controlled storage area for routine use: installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). Related topics are covered in the following Technical Supplements: Temperature mapping of storage areas.
The installation qualification must be completed prior to execution of the operational qualification phase. Operational Qualification Operational qualification demonstrates that the installed equipment is functioning within established limits as specified by Helmer. The operational qualification must be completed prior to the execution of the .
Introduction to Groups, Rings and Fields HT and TT 2011 H. A. Priestley 0. Familiar algebraic systems: review and a look ahead. GRF is an ALGEBRA course, and specifically a course about algebraic structures. This introduc-tory section revisits ideas met in the early part of Analysis I and in Linear Algebra I, to set the scene and provide motivation. 0.1 Familiar number systems Consider the .
