How to create adapted protocols in 21 CFR part 11 mode (NC-200)

Background

In the NucleoCounter NC-200 all protocols are user adaptable. The feature to create adapted versions of protocol by utilizing the Protocol Adaptation Wizard window. 

When the NucleoView software is running in 21 CFR p11 mode it is not feasible to create adapted protocol. To circumvent this there are several ways an adapted protocol can be created in Normal mode and then transferred for use in 21 CFR p11 mode. This is described in detail below.

Create adapted protocol via Protocol Adaption Wizard

  • Choose a file with an already performed assay that the adapted protocol should be based on. 
  • In the menu entry of NucleoView software, click on Tools and choose Protocol Adaptation Wizard. A window opens, which is used to create user adapted protocols. 
  • It is not necessary to have any instrument connected when creating an adapted protocol. 

Protocol Adaptation Wizard

The Protocol Adaptation Wizard will guide you through adapting different parameters and saving the adapted protocol as a user adapted protocol.

  • Step 1: Check that it is the correct selected protocol and proceed to next step.

Step 2: Adapt gating and/or table by following the explanation below.

Step 3: Change different parameters (Sample Volume, dilution volume etc.).

Step 4: Save selection by add in Title, purpose – remember to choose Save and Lock option, which necessary for using with 21 CFR p11 mode

When creating an adapted protocol on a workstation with 21CFRp11 mode enabled 

  • Step 1. Disable 21CFRp11 mode (only those with administrator rights).

Click on Tools and choose Options, go to Authorization and disable 21 CFR part 11 and press OK.

  • Step 2. Follow the steps above to create the adapted protocol, Save and Lock.
  • Step 3. Enable 21CFRp11 mode (only those with administrator rights).

Click on Tools and choose Options, go to Authorization and enable 21 CFR part 11 and press OK.

  • Step 4: Use of adapted protocol.

Click on the folder button to launch the Select Protocol window, choose the adapted protocol and Select.  

When creating an adapted protocol on a workstation with Normal mode

  • Step 1. Follow the steps above to create the adapted protocol, Save and Lock.
  • Step 2. Transfer of locked protocol to instrument with 21CFRp11 mode enabled.

Click on the folder button to launch the Select Protocol window, right click on the adapted protocol and choose Export Protocol Adaptation for copying to another workstation.  

  • Step 3: Import of protocol to another workstation that have the NucleoView™ NC200™ software installed. Click on File and choose Import package, locate the exported file and click Open.
  • Step 4: Use of adapted protocol, see description on above page.
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