Design Data

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.

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.

Example: You could create a test definition for Appearance. Material A and Material B can use the same definition to test appearance.

Sample Plans

Release Testing

In release testing, Sample Plans indicate how many samples should get created when a batch is created for a given material. Sample plans are re-usable across materials as long as the sample definitions required for the materials are the same.

Example: If two materials use the same two testing labs, they can use the same sample plan.

Sample definitions within the sample plan are generally used to track the testing labs, one sample definition per testing lab. There can be one or more sample definitions for a sample plan, however, if there is only one testing lab used for testing a material, typically only one sample definition will be created.

Stability Testing

In stability testing, Sample Plans indicate the storage conditions being tested at the timepoints indicated in the protocol. Depending on your protocol, you can create one sample plan per timepoint or you can use a sample plan across timepoints where the conditions are the same.

When used for stability, sample definitions within the sample plan are created for each condition and orientation for a stability timepoint, as indicated in the protocol.

Spec Data

Release Testing

In release testing, Spec Data brings together the sample plan and test definitions, allowing the admin to specify which tests will be applicable to which sample, and allows for defining specification limits for the test results.

Stability Testing

In stability testing, Spec Data brings together the sample plan and test definitions, allowing the admin to specify which tests will be applicable to which sample, and allows for defining specification limits for the test results. Typically one stability spec data will be created for each time point in your protocol.

Change Analysis

Change analysis is used to do all the review and approvals of design data records. Change analysis also helps to make sure that if you upversion a design data component, such as a test definition, that any design data records that are referencing that test definition, like any spec data records, also get upversioned.

This keeps all associated design data records at the most current version, and everything is correctly referencing the newest version.

Spec Data Mapping

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.

Design Data Loader

Design Data Loader gives admins the ability to export test definitions, sample plans, and spec data records from one Vault and import them into another Vault.