Get Empowered: Method Validation | Tip #193, Validation Protocols: Setting up Approvals and Sign Offs in Empower

By September 30, 2020


Tip #193: Validation Protocols: Setting up Approvals and Sign Offs 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 configure the System Precision Test (Tip #192).

In this week’s tip, we will continue our discussion on Validation Protocols and learn how to set up Approvals and Sign offs.

You can configure each Validation Protocol method to enforce Approval requirements, Sign off requirements, or both, during various stages of your Method Validation workflow. Approval and Sign off capabilities enable you to establish quality control check points that your SOPs might require. For example, you might want a qualified staff member to review and approve all protocol methods before using them to create a validation study. You might also want all chromatographic results reviewed and signed off before using them to create validation results within a study.

When Approval and/or Sign off is required, users cannot perform the next step in the workflow until the Approval and/or Sign off is completed. (Refer to Tip #187 for more information about the workflow) (NOTE: As mentioned previously, you should follow your own SOP, this is only an example.)

Let’s get started.

Step 1

Click the ‘Approvals/Sign Offs’ tab in the Validation Protocol. Notice the ‘Validation Protocol Approval’ field is empty (figure 1).

Figure 1

Figure 1

Step 2

From the ‘Validation Protocol’ drop down list, select ‘Required’ (figure 2).

Figure 2

Figure 2

Step 3

To approve the protocol, go to the ‘Edit’ pull down menu and select ‘Approve Protocol Method’ (figure 3).

Figure 3

Figure 3

Step 4

Enter your username and password, then click ‘OK’ (figure 4).

Figure 4

Figure 4

Step 5

The ‘Validation Protocol Approval’ field is now populated; you can now create a new Validation Study using this Protocol (figure 5).

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 #194 – We will revisit our VLOG series showcasing Empower as an important tool to implement Method Lifecycle Management (MLCM) and discuss reducing method related investigations caused by incorrect Sample Set methods with Empower’s Sample Set method templates.

 

JOIN US for an Empower: Ask Me Anything Webinar on September 30, 2020
Neil will answer your questions about working with the Method Validation Manager option in Empower Software.  Learn More and Register

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Categories: Empower Tips