Spec Data (LIMS) | Vault Help

Vault LIMS Spec Data records contain information about what samples to collect, what tests to run, and what evaluation criteria is used to determine if what’s tested is in or out of specification. Such criteria may be internal limits, specific to a market, or relate to a particular time point in a stability study. Spec Data records contain Spec Data Mapping records, which match Materials and Countries to Test Definition records.

About Spec Data Mapping & References in Vault LIMS

Spec Data Mapping records match the Materials and Countries/ Organization on a Batch to Spec Data records.
Spec Data records reference Sample Plans (and their Sample Definitions, for use in Sample Pull actions) and contain Spec Data Criteria and Sample Actions.
Sample Actions reference Sample Definitions in the Sample Plan associated with the Spec Data record. Sample Actions can be of different types: Pull Sample, Test Sample, Aliquoting Sample, Pool Sample.
Spec Data Criteria reference Test Definitions and Results to Evaluate.

When products are registered with a governing health authority, a specification is established to use for quality control. The specification defines what tests will be done and the expected outcome. Each batch of a product is then tested and compared to the criteria set forth in the specification. This is done on finished products for the purpose of releasing to market, but also on raw materials, excipients, or active product ingredients (APIs) for the purpose of releasing for use in manufacturing.

About Spec Data Criteria

Each Spec Data contains a set of Spec Data Criteria, each targeting a specific Test Definition Result from a Test Definition in the selected lab protocol. The criteria defines the acceptable limits for the selected result, both descriptively and also as a formula.

Spec Data can be configured as Control specifications, providing early warning limits, or Release specifications, which would prevent batch release if failed.

Spec Data Change Analysis

Spec Data records are under version control via Vault LIMS Change Analysis. Once these records enter the Effective lifecycle state, they cannot be edited. Instead, you must create a new version using the Create New Version action on the record.

Creating Spec Data

Before creating a Spec Data record, you need to first have a lab protocol in the Effective state type. And before creating a lab protocol, you need to first have lab methods in the Effective state type.

To create Spec Data:

From the Spec Data tab, select Create.
Choose Batch Release Spec Data or Stability Study Spec Data in the Select Spec Data Type drop-down.
Click Continue.
Enter a Name.
Select the Sample Plan that will be used for this Spec Data.
Select Yes or No for Initial Auto Sample Action. This determines whether the Spec Execution Auto Sample Action job will be run at spec execution initiation.
Click Save.

Vault populates the Effective Date field on the Spec Data when the record enters the Effective lifecycle state.

Creating Spec Data Criteria

Each Spec Data record has one or more criteria which define the detailed data limits for the Spec Data. Vault creates Lab Sample records for each criteria during sample initiation.

To create these criteria:

In the Criteria to Evaluate section of a Spec Data record, click Create.
Select a Test to Evaluate. This automatically populates the Test Definition field.
Optional: Select a Test Definition Variation if applicable.
Select a Result to Evaluate. This automatically populates the Result Object Type and Unit of Measure fields. It also populates the Variation Result Object Type field if you selected a Test Definition Variation.
Enter a Name.
Select an Indication. This determines how the criteria is represented during test execution and whether failing the criteria prevents spec conformance.
Select a Purpose.
Define a formula in the Criteria field that controls data limits based around the $result token, for example: $result < 0.5
Enter a Criteria Description. This field serves as a human-readable explanation of the Criteria formula.
Select a Spec Data Criteria Set.
Click Save.

Note: Once a Spec Data record has been Approved, none of its standard fields can be edited, and standard relationships cannot be added or removed.

Specification Mapping to Country and Organization

Before making your Spec Data effective, you can map it to a specific Market or Organization. You can only create one mapping per combination of Material:Market, or Material:Organization. The Material is inherited from the Spec Data.