Veeva LIMS users can track stability study conditions and results as testing occurs or transcribe these results after receiving them from an external lab. Veeva LIMS uses Lab Study Design records to serve as templates for creating Lab Study records. These templates include timepoints, storage conditions, storage orientations, testing methods, and specifications for ease of creating multiple studies for the same product. As a part of the Lab Study Design, one or more Lab Study Timepoint Designs are also created. These objects represent a Spec Execution that will occur within a specified date range.
Creating a Lab Study Design
Prior to creating a Lab Study Design, you should already have the relevant Spec Data, Test Definition(s), and Sample Plan(s) created.
To create a Lab Study Design:
- Navigate to Stability > Study Design and click Create.
- Enter a Name.
- Click Save.
- On the Lab Study Design record’s details page, expand the Lab Study Design Timepoints section and click Create.
- Select the Spec Data that should apply to the Lab Study Design. You cannot choose Spec Data that is not Stability Study Spec Data for non-initial Timepoints.
- Enter the Time Stored. This dictates the length of time the samples are stored and thus, the Timepoint’s length.
- Select the Time Stored Units.
- Enter the Pull Window. This represents the +/- range allowed for a pull to be completed relative to the scheduled pull date per the Timepoint’s Time Stored. For example, in a study initiated on April 1, the 1M timepoint has a Time Stored of 1 month, which makes the scheduled pull date May 1. A Pull Window of 1 day allows the pull to be completed between the dates of April 30 - May 2.
- Select the Pull Window Units.
- Select whether the timepoint is the Initial Timepoint.
- Select whether to Prevent Sample Creation. If you choose Yes, LIMS will only create samples via Aliquot Actions (Stability Pull(s)) for collection of stored material in the Stability Chamber(s). If you choose No, samples will log as defined in the Sample Plan.
- Enter any other necessary details.
- Click Save.
- Repeat steps 4-7 for any additional timepoints required.
On the resulting Lab Study Design record page, you can add and modify Lab Study Design Timepoints as needed. Select Actions > Review Study Overview to view the full overview.
Once a Lab Study Design has been created, it must be reviewed and approved before it can be used to generate new Lab Study records. During review, the Spec Data Version Check can be initiated. This is an action (either an entry action in the record’s lifecycle or manually started by a user via Actions > Spec Data Version Check) that verifies that each Spec Data record associated to the Timepoints has an Effective version.
Generating a Lab Study
To create a Lab Study:
- From your approved Lab Study Design record, select Actions > Generate Lab Study.
- Enter a Name for the Lab Study. If you do not enter a name, the Lab Study will have the same name as the Lab Study Design.
- Click Generate.
On the resulting Lab Study record page, you can add and modify Lab Study Timepoints as needed. Select Actions > Review Study Schedule to view the full schedule.
In the Schedule table, the first column shows the Initial Timepoint, and the following columns show any subsequent Timepoints. For each Timepoint, the label shows the timepoint itself followed by its Pull Window in parentheses and the associated Spec Data below. Each row represents a scheduled test.
Click the Exit icon in the upper right to close the schedule.
To begin the Lab Study:
- Select Start Workflow > Initiate Lab Study.
- Optional: Enter a Start Date. If you leave this field blank, it defaults to the current date.
- Click Start.
Initiating the Lab Study performs the following actions:
- Sets the Study Start Date
- Set Scheduled Start Dates on all Timepoints
- Initiates any Initial Timepoints
- Sets the Date Initiated
- Sets the Spec Data field with the Spec Data version at timepoint initiation
- Generates the Spec Execution for the Initial Timepoint
- Sets the Study information on the Spec Execution
Once the Lab Study has been initiated, you can expand the Lab Study Timepoints section of the study’s record details page to view a summary that includes the initiation date, scheduled dates for each Timepoint, and related Spec Executions.
You can also initiate additional Timepoints by selecting Actions > Initiate Lab Study Timepoint in the Timepoint’s cell within the Lab Study Timepoints section of the* Lab Study* record’s details page. Initiating a Timepoint creates a Spec Execution for it based on its Spec Data and relates it to the Batch associated with the Lab Study.
Note: For Initial Timepoints, the Spec Execution is not initiated automatically, so you must do that manually.
Veeva LIMS automatically initiates Timepoints once their scheduled start dates are reached via the Lab Study Timepoint Initiation job. This job does not initiate a Lab Study Timepoint if it is not Locked, or if the Lab Study is in Revision.
As a Stability Study progresses, the Summary shows the results for all Timepoints that have results, including any exceptions.
Exporting Stability Data
If configured, users with the correct permissions can export the data from a Lab Study to an Excel or CSV file by selecting Actions > Export to Excel or Export to CSV.