Empower Tips: Method Validation Manager

In this 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.)

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

From the ‘Validation Protocol’ drop down list, select ‘Required’.

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

Enter your username and password, then click ‘OK’.

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

It’s that easy!