Get Empowered: Method Validation | Tip #196, Validation Protocols: Carrying Out a Validation Study in Empower
Tip #196: Validation Protocols: Carrying Out a Validation Study
In this week’s tip, we will learn how to carry out a Validation Study.
The workflow within the Validation Manager window includes a status update for each test as it is carried out and results are generated.
Let’s get started.
The Test Status is ‘Sample Sets Incomplete’; therefore, we need to acquire the data needed for the tests. Click the ‘Run Samples’ tool to access the Run Samples window and acquire the data (figure 1).
Once the data has been acquired, Click the ‘Attach Sample Set’ tool to attach the Sample Set to the study (figure 2).
In the Project Window, highlight the newly acquired Sample Set and Click ‘Attach Sample Set’ (figure 3).
If needed, Click the ‘Alter Sample’ tool to add or modify information to the Sample Set prior to processing. The ‘SS Status’ field now has a green check mark (figure 4).
The Test Status for the first test has changed to ‘Result Sets Incomplete’; therefore, we need to process the Sample Set. Click the ‘Process Chromatographic Data’ tool to process the data in the usual manner (figure 5).
When the Background Processing dialogue opens, select the ‘Processing Method’ or ‘Method Set’ to process with and Click ‘OK’ (figure 6).
Once the Sample Set has been processed, attach the ‘Result Set’ to the Study. Click the ‘Attach Result Set’ tool to attach the Result Set to the study (figure 7).
In the project window, highlight the newly generated Result Set and Click ‘Attach Result Set’ (figure 8).
If needed, Click the ‘Review Chromatographic Data’ tool to bring the Result Set into Review. The ‘RS Status’ field now has a green check mark (figure 9).
The Test Status for the first test has changed to ‘Validation Results Incomplete’; therefore, we need to generate the Validation Results. Click the ‘Validation Process’ tool to generate the Validation Results and have them compared to the Acceptance Criteria specified in the test parameters (figure 10).
The Test Status for the first test has changed to ‘Test Complete’ and there is a green check mark in the ‘VR Status’ field (figure 11).
Repeat the above steps for each test in the Study.
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 #197 – We will discuss reviewing Validation Results.
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