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Commercial Off the Shelf (COTS) Software Validation : COTS Version 4 Level 1.1 Validation: May 2003 : Validation Overview : Validation Qualification Protocol published Tue, Jun 3, 2003 - 12:42 EDT

Validation Qualification Protocol

Approach to IQ, OQ, and PQ


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QUALIFICATION PROTOCOL

 

Installation Qualification (IQ)

System Information

1.    System Requirements (mfg. recommended)

 

1.       O/S Requirements…

2.       Other software requirements…

3.       CPU requirements…

4.       Memory requirements…

5.       Other hardware requirements…

2.    Configuration Requirements

[specify default settings.  attach list if necessary]

3.    System Specifications

Test Machine

Production Machine

Type A: [machine name]

Type B: [machine name]

Software:

·    O/S version x.x

·    Other sw version y.y

·    Etc…

 

Hardware

·    CPU speed/type

·    yyyMb Ram

·    Other hw…

Software:

·    O/S version x.x

·    Other sw version y.y

·    Etc…

 

Hardware

·    CPU speed/type

·    yyyMb Ram

·    Other hw…

4.    System Configuration

[specify any changes to default settings.  Attach list if necessary]

[specify any changes to default settings.  Attach list if necessary]

5.    Migration Plan (test box to production)

[Describe the milestones that must be successfully completed and documented prior to moving the system into production]


Installation Plan

1.    Installer

John Doe

2.    Date Installed

3/19/2003

3.    Hardware/Software Compatibility

 

IQ Successful.

 

COTS v4.1.1 system requirements have been found to be compatible with the hardware and software utilized for installation in the test and production environment.

Operation Qualification (OQ)

Functionality/Test Requirements

1.    Machine Identification

Type X: [machine name]

Software:

·    O/S version x.x

·    Other sw version y.y

·    Etc…

 

Hardware

·    CPU speed/type

·    yyyMb Ram

·    Other hw…

2.    Time line/responsibility for completion

Project Manager: Jane Smith

§      See Project Timeline (attached)

3.    Matrix – functionality versus test used to verify

[tests must ensure requirements of system operate as expected.  describe or attach functionality vs. test matrix. summarize the testing process, which can also be documented in the map]

4.    Compatibility statement

OQ successful, results communicated.

 

[include compatibly statement, such as The comparisons of the actual results vs. the comparator results were found to have no significant differences.]

Training Plan

1.    User notification

[describe how users will be trained in use of system. attach email of training notice, dates of training, email of how to use, enhanced functionality of this version, etc.]

Communication Plan

1.    User notification

[describe how users will be told system is available. attach or link to notification notice]

2.    Notification of identified bugs and resolutions

[list any identified and/or known bugs, and how they were resolved, or should be managed]

Performance Qualification (PQ)

Implementation Plan

1.    User Verification Testing Plan and timeline

[describe or refer to user verification test plan, include specifics of performance testing]

2.    Accessibility

 

[list directions on how to access]

3.    Limitation to universal effectivity?

[note any limitations on user access, e.g. number licenses, specific machines, permissions, appropriate training req’d, etc.]

4.    Effectivity Date

[date software was put into production]

 

 

 

 


Commercial Off the Shelf (COTS) Software Validation : COTS Version 4 Level 1.1 Validation: May 2003 : Validation Overview : Validation Qualification Protocol published Tue, Jun 3, 2003 - 12:42 EDT
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