Get Empowered: Method Validation | Tip #197, Validation Protocols: Reviewing Results of a Validation Study in Empower
Tip #197: Validation Protocols: Reviewing Results of a Validation Study
In this week’s tip, we will learn how to review the results of a Validation Study.
There are many calculations done, particularly statistical calculations, when you perform the Validation Process step. We will review some of the results generated last weeks’ tip (Tip #196).
Please Note: If you are new to the Method Validation Manager option, I highly recommend you contact the Professional Services group to organize training and/or consultation so that you can take full advantage of this very powerful option for Empower.
Let’s get started.
Let’s start by reviewing the results for the ‘Linearity’ test. Highlight the test and click the ‘Review Validation Result(s)’ tool (figure 1).
The Validation Review window opens and displays the results for the ‘System Precision’ test. The System Precision tab is selected, and it displays the ‘mean for area’ and ‘retention time’ (Refer to Tip #192 for more details on the System Precision Test) (figure 2).
The Data tab displays the individual values for the six injections (figure 3).
Select the ‘Linearity’ test in the tree. The Linearity Result tab is selected and displays the equation for the line. There are a variety of plots available, including ‘Linearity Plot’ (amount or concentration versus response) and a ‘Regression Plot’ (level versus residual) (figure 4).
The Data tab displays the ‘Response Factor’ and the ‘Relative Response Factor’. The Response Factor is simply the response (y value) divided by the amount or concentration of the analyte (x value) and can be seen in the table. The Relative Response Factor is the Response Factor divided by the slope of the calibration curve (figure 5).
The Regression Coefficient tab displays the slope (figure 6).
Looking at another Validation Study, you see that the Validation Result (VR) Status displays an ‘exclamation mark in a yellow triangle’ for the Repeatability test, indicating a problem with the validation results (figure 7).
Before looking at the Validation Results for this test, let’s first look at the ‘acceptance criteria’ entered when the test was configured. The range for the average percent recovery is 95 to 105%. The %RSD for this field has an upper limit of 10% (figure 8).
In the Validation Review window, you can easily see the problem. The ‘average percent recovery’ for Impurity A is 105.621088%, clearly above the upper limit of 105% (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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Next week in Empower Tip #198 – We will revisit our VLOG series showcasing Empower as an important tool to implement Method Lifecycle Management (MLCM) and discuss using Peak Tracker™ in S-matrix® Fusion QbD® to provide a more comprehensive approach to automated, AQbD robust method development.
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