Creating a Validation Protocol in Empower - Tip188

OBJECTIVE or GOAL

Get Empowered: Method Validation Manager 

Tip #188: Creating a Validation Protocol in Empower 

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. Note: This is only an example.

ENVIRONMENT

Empower

PROCEDURE

1. In the Validation Template Project, go to the Methods tab, right-click, and select New Method, and then select Validation Protocol Method.
   
2. The Validation Protocol Method Classification dialog opens with the Validation Manager in the background. There are several fields you must populate 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 you can create additional choices.) The Protocol Comments are optional. Once you have made your choices, click OK.
   
3. 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.
   
4. On the Acquisition tab, define how many injections you want for this test. Specify the number of levels, preparation per level, and injections per preparation. In this example, the total number of injections is 15. 
   
5. 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 is flagged as faulted and the test fails. Once you have made the selections, click OK. 
   

ADDITIONAL INFORMATION