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.
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:
||If not editing a result,
||Navigates to the right across samples for the result row.|
||Navigates to the left across samples for the result row.|
|Arrow Keys||Navigates between results while not in editing mode.|
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 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.
- 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.
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:
|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.|
The following alerts can only display once the test has entered the review phase:
|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|
For Analysts to execute tests, they must have a security profile or role which grants them the following permissions:
|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|