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Document No: Prepared by: Date: Version: DD-MMM-YYYY

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Document Approval
Name <Author> Role Author IT Validation Client Date Signature

Document Control
Version 1.0 Author <Author> Date DD-MMM-YYYY Description First Version

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Table of Contents

1 Introduction................................................................................................................................4 1.1 Objective..............................................................................................................................4 1.2 Scope....................................................................................................................................4 2 System Description.....................................................................................................................5 3 Testing.........................................................................................................................................6 3.1 Test Plans.............................................................................................................................6 3.2 Test Cases............................................................................................................................6 3.3 Acceptance Criteria............................................................................................................6 4 Report for System Tests (Operational Qualification Report).....................................................7 5 Summary and Conclusions (Operation Qualification Report)..................................................8 6 Protocol Result Acceptance (Operational Qualification Report)..............................................9

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1
1.1

Introduction
Objective
This section should contain details of the objectives of conducting the Operational Qualification Process. For example, to ensure that the system meets the functional requirements as described in document 1234.

1.2

Scope
This section should describe the scope of the Operation Qualification.

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System Description
The system description of the Operational Qualification must describe: The major functions of the system; The interfaces to the system (application and human interfaces); The operating environment of the production system including: the servers, the physical location, and the network; The hardware and software environment to be used for OQ testing including: servers, PCs, network, any peripheral devices specific, and versions of operating system and application software installed.

If the above information is contained in existing documentation references to these documents may be used.

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Testing
This section of the OQ protocol identifies the test plans and cases that will be executed to test the system.

3.1

Test Plans
The test plan section of the OQ Protocol must identify all test plans that will be used in the testing process.

3.2

Test Cases
This section of the Operational Qualification must identify the Test Cases that will be executed during the testing of the system.

3.3

Acceptance Criteria
List the criteria the system must meet to satisfy the objectives of the OQ.

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Report for System Tests (Operational Qualification Report)

This section identifies: The iterations of system Test Plans and associated Test Cases carried out during the OQ testing process; Details of the incident reports generated during the OQ testing process including the severity of the incident. Details of the change requested generated during the OQ testing process.

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Summary and Conclusions (Operation Qualification Report)

Provide a summary of all testing results and any encountered deviations.

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Protocol Result Acceptance (Operational Qualification Report)

Completion of the following signature blocks signifies that the appropriate parties have reviewed the data and results generated during the validation testing and agree that the conclusions drawn from the data are accurate based on the acceptance criteria stated in the protocol. Approved of the completed protocol indicates that the equipment, process, system, or utility meets the established acceptance criteria.

Department

Name

Signature

Date (dd-mmm-yy)

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