In some cases, United States Pharmacopeia (USP) methods may require multiple sequential stages or levels of testing for Dissolution (testing how the drug behaves in an environment mimicking the human body) and Content Uniformity (making sure that every single sample in a batch has exactly the same amount of the active ingredient). If configured by an Admin, Veeva LIMS allows Design Data Admins to set up multi stage tests at the Test Definition level, in turn simplifying running the tests for Lab Analysts.
Creating a Test Definition for Multi Stage Testing
The Test Definition Builder guides you through the creation of each stage in a multi stage test, defined using a Test Definition Variation. All stage Variations for the same multi stage test are grouped together in a Test Definition Variation Group. The builder automatically creates a default group when creating a multi stage test, but you can also create additional groups in cases where the same test method will be reused for multiple products. For example, you can model the same dissolution method used for two finished products as two Test Definition Variation Groups instead of separate Test Definitions.
Creating a Test Definition for multi stage testing follows the standard Test Definition Builder process for creating a Test Definition except as noted below:
- In the Create Test Definition dialog, after selecting a Mode of Entry, set Test Type to Multi-Stage.
- In the Define Steps section, enter a Number of Replicates as needed to be automatically created for each Result. Replicates are copies of existing Results used to capture information that may be performed multiple times during test execution.
- When adding Test Definition Result Criteria to Results, select Stage Evaluation in the Purpose field.
- The Define Groups & Stages section includes a subsection for each Test Definition Variation Group you defined and each subsection contains a column for each stage you defined. Here, you can change the order of the stages and set stage-level acceptance criteria.
Working with Multi Stage Tests
As a Lab Analyst, Test Execution for a multi stage test is the same as for a standard test except as noted here. Once you perform the required tests, enter your results, and click Evaluate, the system evaluates all criteria as normal, but uses only the Stage Evaluation Criteria to determine whether the stage passes or fails. If it fails, testing must progress to the next stage. Select Actions > Generate Next Test to proceed.
As you progress through stages, the system calculates aggregate values such as averages, minimum, and maximum across all stages, as applicable
Required Permissions
Design Data Admins must have the following permissions to set up Test Definitions for multi stage tests:
- Lab Test Definition object: Read/Edit access on the Test Type field
- Lab Test Definition Variation Group: Create/Read/Edit/Delete (for the Staged Testing Group object type)
- Lab Test Definition Variation Group: Read/Edit on the Order field
- Method Criteria object type for the Lab Test Definition Criteria object: Read/Create/Edit/Delete
- Spec Data Sample Action: Read/Edit access on the Test Definition Variation Group field