Get Empowered: Method Validation | Tip #199, Validation Protocols: Reporting Results of a Validation Study in Empower

By November 11, 2020


Tip #199: Validation Protocols: Reporting Results of a Validation Study

Welcome back to Get Empowered! In the last Empower tip-of-the-week post for Empower Chromatography Data System, we revisited our video blog (VLOG) series featuring Empower as an important tool to implement method lifecycle management (MLCM) and learned how to use PeakTrackerTM in Fusion QbD® to provide a more comprehensive approach to automated, AQbD robust method development (Episode #8 /Tip #198).

In this week’s tip, we turn our attention back to the use of the Method Validation Manager option for Empower and learn how to report the results of the Validation Study. We can report the results of a Validation Test or the entire Validation Study.

Let’s get started.

Step 1

The MVM Defaults project, which comes with Empower, has a number of preconfigured report methods which you can copy to your working project. These report methods can be used as is or tailored to your needs (figure 1).

Figure 1

Figure 1

Step 2

To report the results of a test, highlight the test and click ‘Preview/Publisher Validation Result(s)’ tool (figure 2).

Figure 2

Figure 2

Step 3

Select the desired Report Method and click ‘OK’ (figure 3).

Figure 3

Figure 3

Step 4

The ‘Linearity Data Detailed’ report method displays the Linearity plot on page 1 (figure 4).

Figure 4

Figure 4

 

Step 5

The subsequent pages of the report contain some of the details reviewed for the results of the Linearity test in Tip #197 (figure 5).

Figure 5

Figure 5

Step 6

To report the results of the entire study, click ‘Preview/Publisher Validation Study’ tool (figure 6).

Figure 6

Figure 6

Step 7

In this example, use the ‘Method Validation Study’ report method. The first page displays a list of the tests within the study (figure 7).

Figure 7

Figure 7

Step 8

Page 6 displays the ‘acquisition and processing & acceptance criteria’ parameters for the Linearity test (figure 8).

Figure 8

Figure 8

Step 9

In the Report Publisher window, view the Method Validation Groups available for either modifying an existing report method or creating a new one (figure 9).

Figure 9

Figure 9

It’s that easy!

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

 

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Categories: Empower Tips