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 release to market, but also on raw materials, excipients, or active product ingredients (APIs) for the purpose of releasing for use in manufacturing.
About Lab Specification Criteria
Each Lab Specification contains a set of Lab Specification Criteria, each targeting a specific Lab Result Definition from a Lab Method in the selected lab protocol. The criteria defines the acceptable limits for the selected result, both descriptively and also as a formula.
Lab Specifications can be configured as Control specifications, providing early warning limits, or Release specifications (failing these would prevent batch release).
Lab Specification Version Control
Lab Specification records are under Vault LIMS version control. 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.
When a specification is created, Vault automatically creates an associated Lab Specification Group record in the background. This is how LIMS knows these records are versions of the same specification, and is used to display the Version History section on your specification record.
Creating Lab Specifications
Before creating a lab specification, 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 specifications:
- Navigate to Admin > Business Admin > Lab Specifications, or to a custom object tab.
- Click Create.
- From the drop-down, select either Release or Control. Release specifications may be for a particular product and market or material and supplier, while Control specifications may be used in the lab during test execution. Specifications for Process Intermediates only use the Control type.
- Enter a Name.
- Click Save.
Vault populates the Effective Date field on the specification when the record enters the Effective lifecycle state. Vault does not allow a specification to enter the Effective state until you add at least one (1) Specification Criteria related record.
Creating Lab Specification Criteria
Each specification has one or more criteria which define the detailed data limits for the specification. Vault creates Lab Sample records for each criteria during sample initiation. To create these criteria:
- In the Lab Specification Criteria section of a Lab Specification record, click Create.
- Enter a Name.
- Select a Lab Method and the Lab Result to Evaluate within that method.
- Define a formula in the Criteria field that controls data limits based around the
$resulttoken, for example:
$result < 0.5
- Enter a value in the Criteria Order field. This order can be used later when rendering your test summary page.
- Select a Rounding Type.
- If you chose a Numeric Result component, select a Rounding Rule and the corresponding number of Decimal Places or Significant Figures for the criteria. This is used to convert the raw Lab Result value for specification criteria evaluation.
- If you chose a Text Result component, enter a Description Criteria.
- Click Save.
Vault moves Criteria records to the Effective state upon their parent Material Analysis Specification being made Effective.
Specification Mapping to Country and Organization
Before making your Lab Specification effective, you can map it to a specific Country or Organization. You can only create one mapping per combination of Material:Country, or Material:Organization. The Material is inherited from the Lab Specification.
Vault LIMS uses this mapping to automatically select the Lab Protocol, Release Specification, and Control Specification on a Batch record when it is created. The Batch must have a Lab Protocol and Release Specification in place before it can be initiated. Once initiated, Vault LIMS generates Lab Samples and Lab Tests.
To view and manage specifications, a user needs a permission set with View access to the Criteria field object control permission on the Lab Specification Criteria object.