Software Validation

Section One Source of Validation Complaint Change of Material/Process General Improvement New Machinery Audit Purpose of Validation Software Manufacturer Version Serial Number

Ref:

Start of Validation Process: ________________ Completion Date of Validation Process ________________ Signed (Dept Manager) ____________________________ Date _______________ Signed (Quality Manger.) ____________________________ Date _______________ INSTALLATION QUALIFICATION (IQ) System Information 1. System Requirements O/S Requirements.. (mfg. recommended) Other Software requirements. CPU requirements.. Memory Requirements. Other hardware requirements 2. Configuration Requirements 3. System Specification [specific default settings] Test Machine O/S Requirements.. Other Software requirements. CPU requirements.. Memory Requirements. Other hardware requirements

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4. System Configuration 5. Migration plan (test box to production) Installation Plan 1. Installer 2. Date Installed 3. Hardware/Software Compatibility

[Specify any changes to default settings. Attach a list if necessary] [Describe milestones that must be achieved and documented prior to moving the system to production]

OPERATION QUALIFICATION (OQ) Functionality/Test Requirements 1. Machine Identification Machine ID: O/S Requirements.. Other Software requirements. CPU requirements.. Memory Requirements. Other hardware requirements 2. Time line/responsibility for Project Manager: completion [create project timeline] 3. Matrix-functionality versus test used to verify 4. Compatibility statement Training Plan 1. Users 2. User notification Communication Plan 1. User notification 2. Notification and identified bugs and resolution [Attach test Matrix] [Include a compatibility statement such as The comparison of the actual results vs. the comparator results was found to have no significant differences. (see attached)] [Notate who will be the end users] [Describe how users will be trained in the use of the system. Attach an email of training notice, dates of training] [Describe how users will be told system is available] [List any identification and/or known bugs and how they will be resolved]

PERFORMANCE QUALIFICATION (PQ) Implementation Plan 1. User Verification Testing Plan [Describe user verification test plan include specifics of and Timeline performance testing]

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2. Accessibility 3. limitation to universal effectivity 4. Effectivity Date

[List directions on how to access software] [Note any limitation on user access, e.g. number of licenses, specific machines, permissions] [Date software was put into production]

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Protocol Development and Approval signatures that follow indicate that the Software Validation for the designated equipment has been reviewed, approved and implemented.

_____________________________________ Joe Doe Production Manager

____________________ Date

_____________________________________ Jack Doe Quality Manager _____________________________________ Mike Doe Process Improvement

____________________ Date

____________________ Date

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