Veeva LIMS Basics on Veeva Basics Help

Offboard a User

Mon, 13 Apr 2026 00:00:00 +0000

When a user leaves your organization, follow this checklist to ensure a smooth transition.

If the user leaving is a domain admin, they should make a different user a domain admin before they leave.
If the user is a stability study owner, assign a new owner to the study. To do this, navigate to LIMS > Stability > Stability Studies, edit the columns to add the Owner column. Then double-click into the field, select a new owner, and click out of the field.

Stability Process Flow

Mon, 13 Apr 2026 00:00:00 +0000

This diagram shows the stability process in Veeva LIMS Basics.

Legend

= Stability Design & Study Admin

= Stability Design & Study Reviewer

= Stability Approver

= Results Entry

Stability Studies

Sun, 12 Apr 2026 00:00:00 +0000

Stability studies allow you to monitor quality of a material over time under different storage conditions and orientations. When you create a stability study, you will specify the timepoints at which specified tests will be performed and under what conditions.

Stability Study Process

The high level stability study process is as follows:

Create Stability Study

Sat, 11 Apr 2026 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Stability Design & Study Admin

Create Study

To create a stability study:

Navigate to Design & Admin > Stability > Stability Studies and click Create.
Enter the Study Name.
Optionally, enter the following:
- Study Type: Commercial, Clinical, or Experimental.
- Batch: The release batch for this stability study, if it was added in LIMS Basics. If specified, the results of this batch can optionally be used for the T0/Initial timepoint when the study is initiated.
- Organization: The organization that is running the stability study.
Enter the Start Date for the study.

Perform Final Review & Approval of a Stability Study

Fri, 10 Apr 2026 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Stability Approver

The purpose of giving final approval to a study is to lock down the fields and ensure none of the related spec exes can be reactivated.

You will likely be reviewing the Stability Report and the study at the same time, but the report needs to be finalized first, then the study.

Perform Initial Review & Approval of a Stability Study

Fri, 10 Apr 2026 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Stability Design & Study Reviewer

When the Stability Design & Study Admin creates a stability study, they will specify the timepoints at which specified tests will be performed and under what conditions. They will then send it for initial study approval.

To perform the initial review and approval of a stability study:

Refresh a Stability Report

Fri, 10 Apr 2026 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Stability Design & Study Admin

If a Stability Report has been generated for a study and then changes are made to that study, for example, results are entered for a timepoint that initiated after the Stability Report was last generated, or if you populated the Report Text Fields, you will need to refresh the Stability Report in order for it to reflect those changes.

Review & Approve a Stability Spec Execution Record

Fri, 10 Apr 2026 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Stability Approver

To review and approve a stability spec execution record:

When a stability spec ex is sent for approval, a task is sent to the specified approver(s). Click the task link.
If the spec execution record was sent to a group for approval, click Accept to accept the task. Only one person needs to accept it.

Send Stability Study for Final Approval

Fri, 10 Apr 2026 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Stability Design & Study Admin

Once all timepoints for a study are complete and the final Stability Report has been generated, you can send the study for final approval.

Note Stability report approval can be going on in parallel to final study approval but ultimately the study needs to be approved last.

To send a stability study for final approval:

Send Stability Study for Initial Approval

Fri, 10 Apr 2026 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Stability Design & Study Admin

When a stability study is created, all necessary timepoints have been added, and spec data versions are in the correct state, you can start the initial approval workflow.

Spec Data Version Check

Before sending a study for initial approval, you can run the Spec Data Version Check to see if there are any spec data records for the study where there is only a draft version.

Stability Report

Fri, 10 Apr 2026 00:00:00 +0000

A Stability Report is automatically generated once all timepoints are complete. However the Stability Design & Study Admin has the option to generate an interim Stability Report, for example, after a condition has been completed.

The Stability Report shows:

Information about the study and batch,
Test results for each timepoint by storage condition/orientation combination
Other optional information as provided, such as packaging information, timepoint comments, intro and conclusion text

Note The Stability Report generated after a study reaches Timepoints Complete must be approved before the study can receive final approval.

Create a Storage Condition

Thu, 09 Apr 2026 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Stability Design & Study Admin, Vault Admin

Storage conditions allow you to define what condition, like temperature and humidity, a sample for a batch is being stored at during a stability study. You will create storage conditions, as dictated by the protocol, and specify the appropriate storage condition to a sample plan definition.

Reactivate a Stability Study

Tue, 07 Apr 2026 00:00:00 +0000

There may be times when you need to reactivate a completed stability study, for example, if an edit to the stability study report is required.

Note Reactivating a study will not affect any of the timepoint spec execution records and their related records (samples, tests, results, etc); if changes are needed for any of these records, you can reactivate the record.

Request Study Reactivation

Who can complete this task? Any LIMS Basics user

To request reactivation of a stability study:

Record Pulled Date

Tue, 07 Apr 2026 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Stability Design & Study Admin, LIMS Results Entry user

If your organization wants to track pulled date and pull compliance for stability samples (i.e., if samples were pulled early, late, or within compliance), there is an optional workflow for that. The workflow can be executed on one or more samples, as long as the Pulled Date is the same for those samples. The workflow is available for stored stability samples (i.e., not timepoint zero) that are in a non final state (i.e., not cancelled, approved, or rejected).

Cancel a Stability Study

Mon, 06 Apr 2026 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Stability Design & Study Admin

A stability study record can be cancelled prior to it being initiated (i.e., from the Draft or Pending Start states). If an initiated/in progress study will not be completed, pending timepoints will need to be cancelled.

To cancel a stability study:

Open the study record you want to cancel and select Cancel Study from the All Actions menu.

Cancel a Timepoint

Mon, 06 Apr 2026 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Stability Design & Study Admin

There may be times when you want to cancel a timepoint, for example, if a study is cancelled midway through or a given timepoint is no longer requried.

If needed, you can cancel a non-initiated timepoint while a study is In Progress or In Revision

LIMS Basics: Design Data Loader

Thu, 02 Apr 2026 00:00:00 +0000

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LIMS Basics: Stability Approver

Thu, 02 Apr 2026 00:00:00 +0000

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LIMS Basics: Stability Design & Study Admin: Design Data

Thu, 02 Apr 2026 00:00:00 +0000

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LIMS Basics: Stability Design & Study Admin: Study Process

Thu, 02 Apr 2026 00:00:00 +0000

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LIMS Basics: Stability Design & Study Reviewer

Thu, 02 Apr 2026 00:00:00 +0000

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Enter Retest Results

Tue, 16 Dec 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Results Entry user

You can record two sets of test results if needed, in the case of a retest.

To enter retest results:

From the Spec Ex, navigate to the Tests section. Hover your mouse over the test you need to enter retest results for and select Retest from the Actions menu.

Reject an In Progress Spec Ex, Sample, or Test

Tue, 16 Dec 2025 00:00:00 +0000

Once you launch sample review entry, the associated Spec Ex, Sample(s), and Test(s) change to In Progress. Once In Progress, these records can no longer be cancelled. If you don’t want to enter results for a Spec Ex, Sample, or Test, you will need to Reject In Progress. Rejected tests become invalid and are not included on the CoA or the Stability Report.

Reject a Spec Execution

Who can complete this task? Veeva LIMS Basics: Batch Creator, QA User (release spec exes)

Veeva LIMS Basics: Stability Approver (stability spec exes)

Rejecting a Spec Ex will also reject any associated in progress Samples and Tests. If applicable, any not started Samples and Tests will be cancelled. If there were any cancelled samples or tests prior to the spec execution rejection, they will remain cancelled.

Send Test for Rejection

Tue, 16 Dec 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Results Entry user

After entering lab test results, you have the option to send the test record(s) for rejection. This is an optional workflow that would be used to reject/invalidate a test (for example, in the case of a retest). If used, a task will be sent to a user with the Results Reviewer role.

Start a Multi-Record Workflow

Tue, 16 Dec 2025 00:00:00 +0000

Workflows in LIMS Basics can be started for multiple records at once, if applicable. For example:

Cancel
Reactivate
Reject & Invalidate
Reject in Progress
Review / Approval for Release Spec Ex, Stability Spec Ex, Spec Data Mapping, or Sample
Test Rejection
Record Pull Dates
Cancel Timepoints

From Spec Ex Record

To start a multi-record workflow from a spec execution record:

Open the applicable section of the spec execution record (for example, Samples or Tests) and click Show in Tab.

Reactivate a Spec Ex, Sample, or Test

Mon, 15 Dec 2025 00:00:00 +0000

You can reactivate a Spec Ex, Sample, or Test record if it is in its final state: Approved, Cancelled, Rejected.

Note Reactivation is not available for stability records if the study is in the Completed state. You must first reactivate the study, then reactivate any spec ex, sample, or test records.

Note Reactivation will not be available for a stability record when the Spec Execution has been Cancelled.

Reactivation rolls up:

Reopen & Edit a Completed Test

Mon, 15 Dec 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Results Entry user

If you need to update a test result for a test that is in the Testing Complete state, you will need to reopen it.

To reopen a test:

Open the Test record you want to reopen and select Reopen Test from the All Actions menu.

Cancel a Spec Ex, Sample, or Test

Fri, 12 Dec 2025 00:00:00 +0000

You may need to cancel a release spec ex or a stability spec ex:

Release Spec Ex

If you need to cancel a Batch after it has been created, you can cancel it by cancelling the associated Spec Execution record.

Note The Batch ID field is unique. If you plan to log another batch with the same Batch ID (for example, because this batch was created with the wrong material or the wrong spec data was assigned), first update the Batch ID before cancelling the spec execution.

If needed, you can cancel a Sample or Test without cancelling the entire Spec Ex.

Initiate Release Spec Ex & Assign Spec Data

Fri, 12 Dec 2025 00:00:00 +0000

A spec data mapping ties together a specific material, country, and manufacturing site. When you log a batch with that specific combination of values, the corresponding spec data mapping will automatically be assigned and it will create the necessary samples, tests, results, and criteria records.

If you log a batch that doesn’t have an associated spec data mapping, you can still initiate the spec ex, but you will have to send it to QA to assign spec data to it and bring in those samples, test, results, and criteria records.

LIMS Basics: LIMS User

Tue, 09 Dec 2025 00:00:00 +0000

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Change Analysis Workflow

Thu, 04 Dec 2025 00:00:00 +0000

New Records

This diagram shows the Change Analysis workflow if the Change Analysis envelope contains only new Design Data records (i.e. no previous versions).

Versioned Records

This diagram shows the Change Analysis workflow if the Change Analysis envelope contains any versioned Design Data records.

LIMS Basics Jobs

Tue, 25 Nov 2025 00:00:00 +0000

Note Times listed in this table are shown in Standard Time. If your Vault is in a location that observes Daylight Saving Time, add one hour to the times shown during the Daylight Saving Time period.

Job Name	Description	Schedule
LIMS Test Definition: Make Effective	Makes a Test Definition effective if the Test Definition is Approved and has an Effective Start Date equal to or before the job run date/time.	Runs every 1 hour
LIMS Sample Plan: Make Effective	Makes a Sample Plan effective if the Sample Plan is Approved and has an Effective Start Date equal to or before the job run date/time.	Runs every 1 hour
LIMS Spec Data: Make Effective	Makes a Spec Data effective if the Spec Data is Approved and has an Effective Start Date equal to or before the job run date/time.	Runs every 1 hour
LIMS Change CoA State to Final	Moves a CoA document to the Final state if the associated Spec Execution is in Approved.	Runs every 1 hour
User Account Activation	Automatically activates user accounts when the Activation Date is reached.	Runs daily at 12:15 AM in the Vault’s time zone
LIMS Study Timepoint Initiation	Initiates any timepoints that are locked, if the study state is In Progress and the earliest pull date has been reached.	Runs every 1 hour

If you’re unsure of your Vault’s timezone, you’ll find it listed on every timestamp within the Vault. Contact support for help changing your Vault’s timezone.

Reports

Tue, 25 Nov 2025 00:00:00 +0000

Note Reports in Veeva Basics are curated by the Veeva Basics team, and cannot be created from scratch. If you would like to submit a request for a specific report, use this form.

Reports

Reports can be accessed by navigating to LIMS > Reports & Dashboards > Reports.

Name	Description
Active User Report	Lists Active users by last login time stamp with the people who logged in least recently listed first so a decision can be made to potentially inactivate users.
Approved Batches by Material and Status	Lists approved Batches grouped by Material. (For Release Testing)
Batches with no Specification	Lists spec execution records with no specification (spec data). These records will need to be cancelled or sent for spec data assignment. (For Release Testing)
In Progress Batches	Lists batches which are in progress and provides batch details such as material, manufacture date, and due date. (For Release Testing)
In Progress Spec Executions	Lists spec executions which are in progress and provides details such as material, manufacture date, and CoA comment. (For Release Testing)
In Progress Stability Studies by Material	Lists in progress stability studies by material.
Non Conforming Tests	This report first prompts the user to enter a spec execution creation date range, as well as a material (both filters are optional). It then returns corresponding non-conforming tests and results.
Open Batches by Material	Lists open batches (spec executions) grouped by material. (For Release Testing)
Open Stability Reports	Lists stability reports that have not been approved/fizalized.
Open Stability Samples with no Pull Details	Lists non finalized (i.e., not approved, rejected, or cancelled) stability samples with no pull dates.
Open Stability Studies with Inactive Owners	Lists non completed/non cancelled stability studies with inactive owners.
Overdue Lab Samples	Lists Samples which are overdue and do not have all test results entered. (For Release Testing)
Results Report with Sample and Spec Ex Details	This report first prompts the user to select material(s), studies, test definition(s), and spec execution(s) (all filters are optional). It then returns valid test results and details such as formatted result, unformatted/raw result, unit of measure, testing lab, date entered, and sample and spec execution details.
Samples due within a Week	Lists samples which are coming due in the next week and do not have all test results entered. (For Release Testing)
Spec Executions Ready for Review	Lists spec execution records which need to be sent for review/approval. (For Release Testing)
Stability Samples Pending Results	Lists stability samples pending results.
Stability Study and Associated Spec Data	This report allows the user to specify a stability study and see all of the associated Spec Data Criteria (limits). This allows the user to review criteria/limits across timepoint records.
Stability Timepoints Ready for Review	Lists stability timepoints (stability spec executions) ready for review.
Studies to be Initiated	Lists stability studies that are ready to be initiated.
Test Conformity	Lists all valid tests with details such as test definition, spec execution, and sample. (For Release Testing)
Test with Retests	Lists any non cancelled tests which have been retested or are a retest.
Upcoming Stability Timepoints (by month)	Lists the stability timepoints scheduled in the next 3 months.
Upcoming Stability Timepoints (flash report)	Flash report that runs once a week and will send an email to all LIMS users if there are any pending timepoints with an Earliest pull date within the next 2 weeks.

Dashboards

Dashboards can be accessed by navigating to LIMS > Reports & Dashboards > Dashboards.

Change Analysis

Sun, 02 Nov 2025 00:00:00 +0000

Every time an admin creates a design data record (Test Definition, Sample Plan, Release Spec Data, or Stability Spec Data), a Change Analysis is automatically created. This is true for new and versioned design data records.

Change Analysis is used to do all the review and approvals of design data records and helps keep associated design data records at the most current version so that everything is correctly referencing the newest version.

Certificate of Analysis (CoA)

Tue, 28 Oct 2025 00:00:00 +0000

The Certificate of Analysis (CoA) is automatically generated by the system after results are entered for a spec execution.

The Material record associated to the Batch dictates what is displayed on the CoA.

The CoA includes:

Summary of batch information
Optional comments provided by Results Entry User and Spec Ex Reviewer
Testing results
Testing location(s)
CoA release statement
Signature (after the spec ex is reviewed and approved)

Send Release Spec Execution for Review

Tue, 28 Oct 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: any user but generally a Results Entry user

If you are not using the optional sample review workflow or if you are and the sample review workflow is completed, the next step is to send the release spec execution record for review and approval.

To send a release spec ex for review:

Send Samples for Review

Tue, 28 Oct 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: any user but generally a Results Entry user

After entering lab test results, you have the option to send the sample record(s) for review. This is an optional workflow and can be used for both release and stability testing. If used, a task will be sent to a user with the Results Reviewer role.

Send Stability Spec Execution for Review

Tue, 28 Oct 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: any user but generally a Results Entry user

If you are not using the optional sample review workflow or if you are and the sample review workflow is completed, the next step is to send the stability spec execution record for review and approval.

To send a stability spec ex for review:

Enter Test Results

Mon, 27 Oct 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Results Entry

In LIMS, there are two types of testing that you may enter results for:

In Release Testing, once the Batch Creator has created the batch and the results have come back from the external testing laboratory, the next step is for the Results Entry user to enter those results into the system.

Export Stability Study Test Results

Mon, 27 Oct 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Stability Design & Study Admin, LIMS Approver

You can export the results of a stability study to CSV or Excel. This is useful when the data is required for reporting outside of LIMS or for ingestion into another system.

You can export the results only for Initiated studies in the following lifecycle states:

Review Sample

Mon, 27 Oct 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Results Reviewer

When results entry is complete and sample has a status of Testing Complete, the Results Entry user can optionally send any sample records for review prior to sending the release or stability spec execution for approval.

To review a sample:

When the Results Entry user sends sample record(s) on the optional approval workflow, a task is sent to the specified approver(s). Click the task link.

Create a Batch

Thu, 18 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Batch Creator

To create a batch:

Navigate to LIMS > Release Testing > Batches and click Create.
In Batch ID, enter a unique identifier for the batch.
Select the Material that you’re logging the batch against.
Select the Country and Manufacturing Site. These fields are optional, but it is best practice to enter them.

Design Data

Thu, 18 Sep 2025 00:00:00 +0000

In Veeva LIMS Basics, admins (Design Data Admin, Stability Design & Study Admin) are primarily responsible for creating and maintaining the design data used for release and stability testing, including the associated tests and result specification limits.

Best Practice It is best practice to create design data first in your Sandbox Vault and then move it to your Production Vault using Design Data Loader.

Design Data Types

Test Definitions

A test definition is a set of instructions that describes the test method and how the results are captured and displayed. Test definitions are reusable across different products or materials as long as the underlying test and the results that they’re capturing are the same.

Setup Data

Thu, 18 Sep 2025 00:00:00 +0000

In Veeva LIMS Basics, admins (Design Data Admin, Stability Design & Study Admin) are responsible for creating and maintaining the setup data used for release and stability testing.

Setup Data Types

Materials

Materials represent manufactured product such as drug substances and drug products, and are often dosage specific. When a batch is logged, based on the material and other fields populated, if a matching spec data record is found, the system will assign the spec data record which then dictates the samples, test, and limits that are created. Used for release testing.

Approve a Spec Data Mapping

Wed, 17 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Design Data Reviewer

Spec data mapping links spec data to a material, country, and organization. When a batch is logged, based on the material and other fields populated, if a matching spec data record is found, the system will assign the spec data record which then dictates the samples, test, and limits that are created.

Create a Spec Data Mapping

Wed, 17 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Vault Admin, Design Data Admin

Generate a Stability Report

Wed, 17 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Stability Design & Study Admin

A Stability Report is automatically generated once all timepoints are complete. However, you also have the option to generate an interim Stability Report. For example, you may choose to generate an interim Stability Report after a condition has been completed.

Note If the stability study’s owner is inactive, they will need to be replaced with an active user in order for the Stability Report to generate. The Open Stability Studies with Inactive Owners report lists non-completed, non-cancelled stability studies with inactive owners.

Generate Stability Report

To generate a Stability Report:

LIMS Basics: Batch Creator

Wed, 17 Sep 2025 00:00:00 +0000

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LIMS Basics: Design Data Admin

Wed, 17 Sep 2025 00:00:00 +0000

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LIMS Basics: Design Data Reviewer

Wed, 17 Sep 2025 00:00:00 +0000

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LIMS Basics: QA User

Wed, 17 Sep 2025 00:00:00 +0000

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LIMS Basics: Results Entry

Wed, 17 Sep 2025 00:00:00 +0000

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LIMS Basics: Results Reviewer

Wed, 17 Sep 2025 00:00:00 +0000

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LIMS Basics: Vault Admin

Wed, 17 Sep 2025 00:00:00 +0000

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Merge Change Analysis for Review & Approval

Wed, 17 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Design Data Admin, Stability Design & Study Admin, Vault Admin

Best Practice Before merging change analysis, it is best practice to run change analysis verification to make sure there is nothing structurally missing from or improperly set up on your design data record.

Every time an admin creates a design data record (Test Definition, Sample Plan, Release Spec Data, or Stability Spec Data), a Change Analysis is automatically created.

Review & Approve a Change Analysis Envelope

Wed, 17 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Design Data Reviewer, Stability Design & Study Reviewer

Review & Approve a Release Spec Execution Record

Wed, 17 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: QA User

To review and approve a release spec execution record:

When the Results Entry user enters results for a batch into the spec execution record and sends it for QA approval, a task is sent to the specified approver(s). Click the task link.

Run Change Analysis Verification

Wed, 17 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Design Data Admin, Design Data Reviewer, Stability Design & Study Admin, Stability Design & Study Reviewer, Vault Admin

Every time an admin creates a design data record (Test Definition, Sample Plan, Release Spec Data, or Stability Spec Data), a Change Analysis is automatically created.

Use Design Data Loader

Wed, 17 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Design Data Admin, Stability Design & Study Admin, Vault Admin

Design Data Loader gives you the ability to export test definitions, sample plans, and spec data records from one Vault and import them into another Vault. This process will be used to move design data records that were created in the Sandbox Vault to the Production Vault. To ensure a successful export and import, you should make sure that any referenced data, like organizations, lab result picklists, or storage conditions already exist in the target vault and that they have the same name in both vaults.

Create a Design Data Version

Tue, 16 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Design Data Admin, Stability Design & Study Admin, Vault Admin

Design Data records (Test Definition, Sample Plan, Release Spec Data, or Stability Spec Data) can be upversioned if changes are needed after they have been made effective.

Change Analysis is used for review and approval for upversioned records, just like with new records when they were initially created.

Create a Sample Plan

Tue, 16 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Design Data Admin, Stability Design & Study Admin, Vault Admin

Release Testing

In release testing, sample plans indicate how many samples will be created when a batch is created for a given material. Sample plans are reusable across materials as long as the sample definitions required for the materials are the same.

Create a Test Definition

Tue, 16 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Design Data Admin, Stability Design & Study Admin, Vault Admin

A test definition is a record that defines how test results are captured and displayed. Test definitions are reusable across materials as long as the underlying test is the same.

Example You could create a test definition for Appearance. Material A and Material B can use the same definition to test appearance. In the spec data record, you would add a criteria/limit to define what the appearance should be.

Create Test Definition

To create a test definition:

Create a User

Tue, 16 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Vault Admin

Domain User

To create a Domain User:

Navigate to Design & Admin > Users, and click Create
On the Create User page, select Create Domain User from the Domain User drop-down. If a user record for one of your users already exists in one of your other domains, such as Quality Basics or RIM Basics, you can select that existing user to automatically populate some of the user’s information.

Create Release Spec Data

Tue, 16 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Design Data Admin, Vault Admin

Release Spec Data brings together the sample plan and test definitions, allowing the Design Data Admin to specify which tests will be applicable to which sample, and allows for defining specification limits for the test results.

Note You will use your Product Specification document to create the Spec Data record.

Create Spec Data

To create a release spec data record:

Create Stability Spec Data

Tue, 16 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Stability Design & Study Admin, Vault Admin

Spec Data brings together the sample plan and test definitions, allowing the Stability Design & Study Admin to specify which tests will be applicable to which sample, and allows for defining specification limits for the test results. Typically you will create one stability spec data for each time point in your protocol.

Initiate a Stability Study

Tue, 16 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Stability Design & Study Admin

There are two options to start a study:

Using batch release results for the T0/Initial timepoint that are already in the system
Without using batch results if you don’t have the appropriate batch release results in the system

Start Study

Using Batch Results

First, ensure the Start Date is populated

Initiate a Timepoint

Tue, 16 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Stability Design & Study Admin

A stability timepoint record will automatically be initiated by the system when the Earliest Pull Date is reached. If a timepoint needs to be initiated prior to the Earliest Pull Date, you can manually initiate the timepoint.

Note This workflow can only be used for timepoints in the Locked state.

To initiate a timepoint:

Review & Approve a Stability Report

Tue, 16 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Stability Approver

Note The Stability Report generated after a study reaches Timepoints Complete must be approved before the study can receive final approval.

To review and approve a Stability Report:

Revise a Stability Study

Tue, 16 Sep 2025 00:00:00 +0000

Initiated Study

You can revise a study after it has been initiated while it’s in the In Progress or Timepoints Complete state, for example, to add additional timepoints.

Best Practice While a study is being revised, no timepoints will be initiated. Spec Data updates can be made at any point (e.g., even when a study is not in revision), however, if a Spec Data update is required for a timepoint that is scheduled to be initiated before the Spec Data update will be completed, we recommend that you start revisions on the study so that the affected timepoint(s) are not initiated.

Revise an Initiated Study

Who can complete this task? Veeva LIMS Basics: Stability Design & Study Admin

To revise an initiated study:

LIMS Basics Users

Mon, 15 Sep 2025 00:00:00 +0000

Vault users are managed by Vault Admins, and can be customized to perform various tasks throughout LIMS Basics.

User Types

Vault users are categorized into two (2) different user types:

Domain Users: Users from your company’s domain, such as your peer employees. This is the most common type for new users.
Cross-Domain Users: Users from external organizations, such as vendors or consultants, who can use their existing Veeva Vault credentials to access your company’s vault. Cross-Domain Users can log into any Vault they have access to using their existing home domain login credentials, or using SSO if it is enabled for your organization.

User Access

You can provide users access to LIMS Basics based on their role at your organization using security profiles and, optionally, LIMS roles.

Activate a Country

Fri, 05 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Design Data Admin, Vault Admin

All Country records will be preloaded into your Vault by default in an Inactive state, but you can choose which records you want to activate. Countries can be tied to spec data mappings and can be used when creating a batch.

To activate a country record:

Create a Lab Result Picklist

Fri, 05 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Design Data Admin, Stability Design & Study Admin, Vault Admin

Lab result picklists are predefined dropdown list of possible results that a Results Entry user can select from when entering results for a test.

Some common lab result picklists are preloaded into your Vault but you can add additional ones as needed.

Create a Material

Fri, 05 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Design Data Admin, Vault Admin

Materials represent manufactured product such as drug substances and drug products, and are often dosage specific.

Create a Material

To create a material:

Navigate to Design & Admin > Setup Data > Materials and click Create.
Enter a unique Material ID.

Create an Organization

Fri, 05 Sep 2025 00:00:00 +0000

Who can complete this task? Veeva LIMS Basics: Design Data Admin, Stability Design & Study Admin, Vault Admin

Organizations are the external companies such as a Contract Development & Manufacturing Organization (CDMO) or a Contract Testing Lab (CTL) that perform manufacturing and/or testing of Materials. In LIMS Basics, they can be an external organization or external site. Organizations can be tied to spec data mappings and can be used when creating a batch and can be tied to a sample to indicate where testing is performed.

Units of Measure

Fri, 05 Sep 2025 00:00:00 +0000

All Units of Measure records will be preloaded into your Vault by default. Units of Measure can be used in numeric Test Definition Results and on a Batch in conjunction with the Amount field.

If you need a Unit of Measure that does not exist in your Vault, contact the Global Service Center (GSC) with your request.

LIMS Object Relationships

Thu, 09 Jan 2025 00:00:00 +0000

This diagram shows the Design, Setup, and Runtime Data objects for Release and Stability testing in Veeva LIMS Basics.

Release Testing

Legend

= Design Data Object

= Setup Data Object

= Runtime Object

Stability Testing

Legend

= Design Data Object

= Setup Data Object

Mon, 01 Jan 0001 00:00:00 +0000