A laboratory information management system (LIMS) facilitates sample management and test execution against the specification criteria in a compliant, scientific platform to produce the data required to generate a Certificate of Analysis (CoA). Vault LIMS is an application in Vault Quality Suite that manages the quality control testing of manufactured batches for market release. Batches must be sampled and tested according to health authority-approved registrations for market release.

Vault LIMS enables seamless information sharing between lab users, delivering real-time data for more informed decision-making. Automated digital workflows improve test efficiency, reliability, and accuracy. As part of the Vault Quality Suite, LIMS leverages all functionality from licensed applications, including quality document management, training, quality events, and more.

Vault LIMS Data Model

There are two broad categories of components in the Vault LIMS data model: Static data management and execution data entry. Static Data includes the lab methods, protocols, and specifications, including the mapping of the components to particular Materials, Country, and Organization combinations, which allows LIMS to automatically select them upon batch creation. Execution Data is created from Static Data, and facilitates high volume, controlled data capture throughout the QC process, from sample receipt to batch release.

LIMS Data Model

Static Data

These objects and their supporting objects form the design from which Vault generates the execution data records.

Static Data

Execution Data

When a user creates a Batch, LIMS automatically selects the relevant Protocol, Release Specification, and Control Specification records for the selected Material, Country, and Organization combination, and uses this to generate the execution data records.

Execution Data

LIMS Terminology

When used in LIMS help articles, the following terms refer to specific Vault objects in the LIMS data model:

Term Vault Object
Lab Method Lab Method (lims_method__v)
Lab Method Input Lab Method Input (lims_lab_method_input__v)
Lab Result Definition Lab Result (lims_result_definition__v)
Protocol Lab Protocol (lims_protocol__v)
Sample Definition Lab Sample Definition (lims_sample_definition__v)
Specification Lab Specification (lims_specification__v)
Specification Criteria Lab Specification Criteria (lims_specification_criteria__v)
Batch Batch (quality_batch__v)
Lab Sample Lab Sample (lims_sample__v)
Lab Test Lab Test (lims_sample_test__v)
Lab Test Input Lab Test Input (lims_lab_result__v)
Lab Result Lab Result (lims_result__v)

LIMS Roles

For the purposes of this Vault LIMS documentation, users are classified into several basic roles:

Static Data Admin

A Static Data Admin user is responsible for creating and versioning Lab Methods, Lab Protocols, and Lab Specifications.

Lab Analyst

A Lab Analyst user is responsible for executing tests on lab samples and capturing the results.

Lab Manager

A Lab Manager is responsible for managing all the tests that need to be executed for samples received by the lab, and monitoring tests for out of control or out of specification.

Vault Admin

The Vault Admin user is responsible for configuring the objects, document types, lifecycles, workflows, and other components of the Vault, to ensure a compliant LIMS implementation.