Create and Configure Validation Rules

This activity describes the implementation of client-specific validation rules within AssayNet LIMS, which are essential criteria designed to carry out rule-based verification on analytical results. These rules can be tailored to meet various requirements, including regulatory standards, quality benchmarks, and internal protocols, all of which support informed decision-making.

Validation rules can be applied to any required QC sample, providing flexibility to accommodate the specific needs of your laboratory. Several configuration options are available to ensure these rules align with your unique requirements. Custom actions can be configured to notify users when validation rules pass or fail, enabling prompt responses based on the outcome. Retest packages can be created automatically for failing rules.

Validation checks can be performed automatically after results are entered, ensuring real-time monitoring, or they can be triggered manually.

Activity Steps

1. On the QC/QA ribbon tab, in the General field group, click Validation.

   The Verification Rules screen displays.

2. To add a new validation rule, click New.

   The Add Verification Rule screen displays.

   1. Enter a unique Rule Name (maximum of 100 characters).

   2. Select the QC standard type that the validation rule Applies To.

   3. In the Action on Pass field group, select:

      • Alert—The alert that displays when the rule passes.

      • Disposition Flag—Indicates what happens to the samples after they have been analyzed.

   4. In the Action on Fail field group, select:

      • Alert—The alert that displays when the rule fails.

      • Disposition Flag

        Note: The Flag Color is set automatically when a new rule is created.

   5. In the Group Result field group, select how the results are grouped:

      • Single Results

      • Instrument Run

      • Rack

      • Laboratory Job

      • Tray

      • Client Job

   6. To apply an action when the verification rules fails, select:

      • Hold Results—Results are hold and are not exported.

      • Trigger Retest—Creates a new job with the selected retest package.

   7. Click OK.

3. To set up the verification rule:

   1. Select the Rule.

   2. Click Setup » Rule Setup.

      The Rule tab in Verification Rule screen displays.

   3. To define the formula to be tested:
      1. Click the Edit button in the calculator screen.
      2. Select the Scheme Code from the Analyte Schemes list. You can filter the scheme code by selecting the Analyte and/or Method.
      3. Click the Add Analyte icon to move the scheme to the calculator formula window.
      4. Use the operators in the calculator interface to define the formula. For example, Ag < 100. If the expression evaluates to true then verification succeeds and the Action on Pass is executed.
      5. Click the Edit button to save the changes.
   4. To set the criteria:

      Note: A criterion defines the conditions under which the rule operates.

      1. Select the Criteria tab.

         A blank calculator formula window displays.

      2. Press the Edit button in the calculator screen.
      3. Select the Scheme Code from the Analyte Schemes list if required. You can filter the scheme code by selecting the Analyte and/or Method.
      4. Click the Add Analyte icon to move the scheme to the calculator formula window.
      5. Use the operators in the calculator interface to define criterion formula. For example, enter [Ag] > 0.1 to only apply the rules for values above 0.1.

   5. To set the schemes, which allows you to specify which scheme must be present in the analysis to trigger the validation rule:

      1. Select the Schemes tab.

         The Selected Schemes list displays. All the schemes defined in the formula on the rule page would be include in the schemes list.

      2. To add additional schemes, select theScheme Code from the Analyte Schemes list.

      3. Click the Add Analyte icon to move the scheme to the Selected Schemes list.

      4. Repeat steps e 2-3 to select additional schemes.

   6. Click OK.

4. To add a package for retest when the validation rules fail:

   1. Click Setup » Retest Packages.

      The Verification Rule Packages screen displays.

   2. Select the package from the Available Packages list.

   3. Click the Add Code icon to add the package to the Selected Packages list.

   4. Repeat steps 4 b-c to select additional packages.

   5. Click Close.

5. Click Close.