Tip #191: Validation Protocols: Setting up the Accuracy Test in Empower

Welcome back to Get Empowered! In the last Empower tip-of-the-week post for Empower Chromatography Data System, we continued the discussion on how to create a Validation Protocol using the Method Validation Manager (MVM) option in Empower and learned how to set up the Repeatability Test (Tip #190).

In this week’s tip, we will continue our discussion on Validation Protocols and learn how to set up the Accuracy Test. (NOTE: As mentioned previously, you should follow your own SOP, this is only an example.)

Let’s get started.

Step 1

Select the ‘Accuracy’ test from the ‘Test Name’ field in the upper table. In the ‘Test Status’ field, it indicates the test is ‘incomplete’ because it has not yet been configured. Highlight the row number for the test and click the ‘Test Parameters’ tool (figure 1).

Figure 1

Step 2

On the Acquisition tab the number of ‘levels’ ‘preparations per level’, and ‘injections per preparation’ are entered. In this example, the total number of injections is 9. From the ‘Levels’ field, Levels 1, 4 and 5 have been selected (figure 2).

Figure 2

Step 3

On the Processing and Acquisition tab, the ‘average for percent recovery’ has a target value of 100 and a range of 98 to 102. If the calculated value is ‘outside’ of the set range, it will be flagged and the test will fail. Additionally, we set an upper limit for the %RSD for the percent recovery at 2.000000. If the calculated value ‘exceeds’ the upper limit, it will be flagged and the test will fail (figure 3).

Figure 3

Step 4

Attach the appropriate Sample Set Method 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 to match the number of injections specified in the test. There is agreement, hence the green check mark in the SSM Status field. Now that we have configured the test, in the upper table the ‘Test Status’ field indicates that the ‘Sample Sets are Incomplete’ because we have not yet acquired the data (figure 4).

Figure 4

One Sample Set Method can be used for multiple tests. In the lower table, highlight the row number for the Sample Set Method and click the ‘Open/Edit Sample Set Method’ tool to view the Sample Set Method (figure 4).

Step 5

Note that the method contains the necessary injections for the three configured tests: Linearity, Repeatability, and Accuracy (figure 5).

Figure 5

It’s that easy!

Final Note: Please use the Pro interface when working with the Method Validation Manager option.

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Next week in Empower Tip #192 – We will continue our series on MVM and our discussion on Validation Protocols and will learn how to add system precision to the Validation Protocol and add approval requirements.

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