Setup Data

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.

Organizations

Organizations are the quality system owning facilities, like manufacturers, suppliers, or contract testing labs and their associated sites. Organizations can be tied to spec data mappings as well as sample plans. Used for both release and stability testing.

Units of Measure

Units of measure help ensure that results are accurate, comparable, and meaningful. They can be used in test definitions. Units of measure are preloaded into your Vault, but if you don’t see the unit of measure you need, contact Veeva Basics support. Used for both release and stability testing.

Lab Result Picklist

Lab result picklists are predefined dropdown list of possible results that a Results Entry user can select from when entering data results for a test. Used for both release and stability testing.

Countries

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. Used for release testing.

Storage Conditions

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. Used for stability testing.