Empower Tip: Method Validation Manager

In this tip, we will begin to create a Validation Protocol.

A Validation Protocol defines the tests to be run, the data to be acquired for each test, and the acceptance criteria for each test. The Validation Protocol and all the tests should be based on your own SOP. Please Note: This is only an example.

In the Validation Template Project, go to the ‘Methods’ tab, right-click and select ‘New Method’ and select ‘Validation Protocol Method’.

The Validation Protocol Method Classification dialogue opens with the Validation Manager in the background. There are several fields which need to be populated by selecting from the drop-down lists – ‘Compound Type’, ‘Analytical Method Type’ and ‘Development Phase’. (NOTE: The drop-down list choices are default strings and additional choices can be created.) The Protocol Comments are optional. Once you have made your choices, click ‘OK’.

The upper half of the Validation Manager window is where you select which tests will be part of the protocol. Select the first test you wish to configure from the ‘Test Name’ field. In this example, select ‘Linearity’. Highlight the row number for the test and click ‘Test Parameters’ tool.

On the Acquisition tab, define how many injections will be done for this test. The ‘number of levels’, ‘preparation per level’, and ‘injections per preparation’ are all entered. In this example, the total number of injections is ‘15’.

On the Processing and Acceptance Criteria tab, we define the acceptance criteria limits for the test. In this case, the Regression Coefficient has a lower limit of 0.999000. If the Regression Coefficient falls below this value, it will be flagged as ‘faulted’ and the test will fail. Once the selections have been made, click ‘OK’.

Attach the appropriate Sample Set Method to the test by selecting it from the ‘Sample Set Method’ field in the lower table. Empower checks that the number of injections in the Sample Set Method match the number of injections specified in the test. If they match, then a ‘green check mark’ appears in the ‘SSM Status’ field.

If the number of injections in the Sample Set Method do not match the number of injections specified in the test, a ‘red X’ appears in the ‘SSM Status’ field. Highlight the row number for the Sample Set method and click ‘Open/Edit Sample Set Method’ tool to view the Sample Set Method.

You’ll notice that for Level 5 (line 8), there are only two injections specified which would be a total of 14 injections for the Linearity test, one short of the requirement specified in the test.

It’s that easy!