Test Execution (LIMS)

The Vault LIMS test execution page allows Analysts to perform complex tests on samples and input the results. The page combines a view of the method document, controlled via the QualityDocs application, with a streamlined result input interface. While the Analyst inputs results, Vault LIMS also ensures that every value entry is captured immediately per FDA data integrity requirements.

About the Test Execution Page

The Vault LIMS test execution page provides an intuitive interface to assist you in performing tests on a sample or set of samples.

Results Grid

The left side of the test execution page is a grid, which lists the lab results to input in rows and the samples as columns. In each cell, you can input a result corresponding to the row’s result and the column’s sample. You can add samples to the grid by performing the Add Samples action. A calculator icon indicates that Vault LIMS will automatically calculate the result based on static data when you click the Review button.

Results Grid Keyboard Shortcuts

These keyboard shortcuts help you navigate in the Results Grid:

Shortcut	Function
`<Enter>`	If not editing a result, `<Enter>` puts the result in editing mode. If currently editing a result, `<Enter>` navigates down a result row while remaining in editing mode. If currently editing a result which requires an eSignature, `<Enter>` keeps focus on the current result cell.
`<Tab>`	Navigates to the right across samples for the result row.
`<Shift + Tab>`	Navigates to the left across samples for the result row.
Arrow Keys	Navigates between results while not in editing mode.

Test Step Selector

The Test Step Selector bar above the Results Grid allows you to navigate between steps in the test. Click the name of the step to display a drop-down menu and select between all available steps. To proceed in the test, click the Next, Evaluate, or Review button in the top right of the Results Grid. The button displayed depends on the types of results in the test:

Evaluate: Either the set of results contains a calculated result, or is referenced by a Specification Criteria, which must be evaluated before proceeding. Once evaluated, the button will change to either Next or Review.
Next: This set of results is complete, but there are remaining results to complete in other test steps.
Review: You have completed all results in all test steps.

Procedure Document

If the test has a procedure document, Vault LIMS displays it on the right side of the test execution page in a document viewer. This viewer allows many of the same navigation features as the standard Vault document viewer.

Exiting a Test

Click the Exit Test button to leave a test in progress. Vault retains any progress and will start from the same state when you resume the test.

Executing a Test

To execute a Lab Test:

From a Lab Test record’s Actions menu, perform the Begin Test action. Vault adds a Test Start date and time value to the Lab Test upon performing this action.
The results required for the test appear as rows in the Results Grid on the left side of the page, while the sample tests for which you will collect results appear as columns.
If the test is divided into multiple steps, you can navigate between them using the Test Step Selector above the Results Grid.
If the test has an associated procedure document, you can navigate through the document for instructions or reference on the right side of the page.
Perform the required tests, while inputting values for each result in the appropriate cell. When you enter a value, Vault automatically adjusts it for rounding requirements, including either decimal places or significant figures. Cells for calculated results are locked, and you cannot manually input values.
Address any Lab Results that display alerts. While you can modify values for Lab Results as needed prior to entering the review phase of testing, Vault logs all inputted values in the Lab Result’s record audit trail, even during the initial result input.
If the test is divided into multiple steps, click the Next, Evaluate, or Review button in the top right of the Results Grid to proceed.
Once all required Lab Results have been added, click Review to enter the review phase of testing. Clicking the Review button causes all calculated results to execute.

Reviewing a Test

When you click the Review button on a Lab Test, Vault evaluates the inputted and calculated results against the relevant specification criteria. If the values fall outside of the specified ranges, Vault displays additional symbols in the Results Grid, alerting the Analyst to various exceptions.

Once the Lab Test enters test set evaluation, changes to result values require a change reason and eSignature.

Editing a Lab Result After Evaluation

To edit a Lab Result after it has been evaluated:

Click into the cell in which you want to make changes.
Enter the adjusted value. Upon leaving the cell, Vault displays a Commit button and a Discard button.
If the new value is incorrect, click the Discard button to return to the original value.
If the new value is correct, click the Commit button. Vault displays a task dialog where you can enter a change reason and your eSignature.
Click Confirm.

Any calculated results will be recalculated upon committing the new result value, which is included in the calculation.

Completing a Lab Test

To complete a Lab Test, click Complete. Vault adds a Test End date and time value to the Lab Test upon performing this action.

Canceling or Rejecting a Test

To cancel tests, perform the Cancel [object] action on a Lab Test, Lab Sample, or Batch record. For example, Cancel Lab Test.

To reject tests, perform the Reject [object] action on a Lab Test, Lab Sample, or Batch record. For example, Reject Lab Test.

You can cancel any Lab Test, Lab Sample, or Batch which has not been started. You can reject any Lab Test, Lab Sample, or Batch which is in progress. When performed, the action changes the relevant record’s state to a Canceled or Rejected state type based on that status, and cascades the cancellation or rejection down to lower-order Lab Sample, Lab Test, and Lab Results. For example:

Canceling or rejecting a Batch causes all of its related Lab Samples to be canceled or rejected.
Canceling or rejecting a Lab Sample causes all of its related Lab Tests to be canceled or rejected.
Canceling or rejecting a Lab Test causes all of its related Lab Results to be canceled or rejected.

Reopening a Test

Reopening a test allows you to revise the results of a test without re-running it. To reopen a test:

Perform the Reopen Lab Test action on a Lab Test record or on the test execution page.
Enter a Reason in the dialog.
Click Confirm.

When you confirm this action, Vault LIMS automatically makes the following changes to the Lab Test and related records:

The Lab Test changes to the In Review state type
The Reopened field on the Lab Test is set to True
The entered reason is added to the Lab Test’s Reopen Reason field
Related Lab Results change to the In Review state
The related Test Set changes to the Evaluate state
The related Lab Sample changes to the In Testing state
The related Batch changes to the In Testing state

After making any necessary changes to the reopened test’s Lab Results, click the Complete button to move the Lab Test back to the Testing Complete state type. Once a reopened test is completed, Vault LIMS recalculates any affected calculations.

Retesting

Retesting allows you to perform an entire test again. To retest:

Perform the Retest and Replace Lab Test action on a Lab Test record.
Select whether to generate the replacement test with the version of the Lab Method used during initial Lab Test creation, or to generate it with the latest version of that Lab Method.
Enter a Reason in the dialog.
Click Confirm.

When you confirm this action, Vault LIMS automatically changes the affected Lab Test to the Rejected state type. Calculations that reference Lab Results in the replaced test will be updated to reference corresponding Lab Results in the new Lab Test. Lab Tests that had calculations changed in this way are reopened, and their calculated values are removed until the replacement test is completed. This action cascades further until there are no more affected results.

Lab Result Alerts

The Results Grid displays alerts for cells under certain circumstances. While some alerts are only displayed in the review phase of testing, the following can also be displayed during initial input:

Alert Symbol	Indicates	Description
	Invalid Entry	The value in this cell is not of the type expected for this Lab Result.
	Locked	The value in this cell cannot be manually inputted.

Review Alerts

The following alerts can only display once the test has entered the review phase:

Alert Symbol	Indicates	Description
	Out of Specification	Appears when the result does not meet Release Specification Criteria
	Previously Out of Specification	Appears when a result was out of specification prior to being edited, and is no longer out of specification
	Out of Control	Appears when the result does not meet Control Specification Criteria
	Revised	Appears when a result was changed in the review phase
	Overridden Data Entry Method	Appears when a value was expected to be a calculation or from an instrument and it was manually entered instead
	Reopened	Appears when the Lab Test has been reopened
	Retested	Appears when the Lab Test has been retested

For Analysts to execute tests, they must have a security profile or role which grants them the following permissions:

Type	Permission	Controls
Security Profile	Object: Lab Test: View, Edit	Ability to view and begin Lab Tests.
Security Profile	Object: Lab Location: View	Ability to view the Lab Location of a Lab Sample
Security Profile	Objects: Lab Method, Lab Method group, Lab Method Step, Lab Protocol, Lab Protocol Group, Lab Protocol Signature, Lab Result Definition, Lab Result Picklist, Lab Result Picklist Option, Lab Sample Definition, Lab Sample Definition Method, Lab Specification, Lab Specification Criteria, Lab Specification Group, Lab Specification Signature: View	Ability to view the static data from which the testing is performed and evaluated
Security Profile	Object: Lab Result: View, Edit	Ability to view and edit Lab Results
Security Profile	Objects: Lab Result Evaluation, Lab Result Signature, Lab Sample, Lab Test, Lab Test Signature: View	Ability to view data related to the Lab Test or Lab Result