Empower Tip: Method Validation Manager

Tip #192: Validation Protocols: Setting up the System Precision Test

In this tip, we will continue our discussion on Validation Protocols and learn how to set up the System Precision test.

So far in this series, we reviewed Validation Tests that determined whether the ‘chromatographic method’ is valid (Tip 188, Tip 189, Tip 190 & Tip 191). The System Precision Test determines whether the ‘chromatographic system’ is valid. (NOTE: As mentioned previously, you should follow your own SOP, this is only an example.)

STEP 1

Click the ‘System Precision’ tab in the Validation Protocol.

STEP 2

In the ‘Component Type’ table, located at the top, select the field(s) that you want evaluated for system precision. Select the ‘Component Type’, such as Main Component, from the ‘Component Type’ field. Select the field of interest, such as Area, from the ‘Assessed Field’.

STEP 3

In the ‘Per Component Type’ table, located in the middle, select how the selected field will be evaluated. Highlight the row in the Component Type table created in Step 2. In the ‘Per Component Type’ table, select the ‘Field Type’, such as Assessed Field Type %RSD. Enter an appropriate Target value and limits.