OQ Documentation

Main Process

 

An OQ protocol describes the approach used to qualify the system. It should include:

• Execution instructions
• Qualification scripts
• Qualification data and data set-up requirements
• Justification for the choice of data
• Expected results
• Resolution procedure for unexpected results
• Acceptance criteria for qualification -- this will be based on the appropriate and corresponding design specifications

Qualification scripts, or test plans, describe the step-by-step procedure for qualifying the system. The procedure may be broken down into multiple discrete scripts for ease of use.

The scripts should verify that the system performs as intended against the system specification created during the development process. They should include information about test conditions such as:

1. Security
2. Screen flow
3. Data validation
4. Data updates

There should be a direct reference between the test script and the specification against which the testing is being performed.

If the OQ Report generates extensive documentation, then a summary report should be written. This report may be reviewed by the system validation steering team instead of reviewing all the raw data. A knowledgeable and responsible person who reviews all the raw data should write the report.

The summary report should include this information:

• Whether or not the qualification scripts were followed
• Whether or not the expected results were attained
• Description of any deviation from expected results
• Any follow-up activities to correct any deviations
• Statement of whether the operational qualification results meet the acceptance criteria
• Justification for the acceptance of the validation of the system