Managing Design Data Components (LIMS)

Design Data forms the basis of all runtime data generated by Vault LIMS. For some runtime data, such as Tests, the spec data provides a template, in the form of a Test Definition record, for the Steps, Results, and Inputs that the system should create when creating those tests. Some runtime data is used in conjunction with spec data to produce new records, such as Criteria Evaluations, which are created when comparing Spec Data Criteria to Results.

Spec Data includes the following key data in Vault LIMS:

• Materials
• Countries
• Organizations
• Spec Data Mapping
• Spec Data
  • Spec Data Criteria
  • Sample Actions
• Sample Plans
  • Sample Definitions
• Test Definitions
  • Test Definition Steps
  • Test Definition Inputs
  • Test Definition Results
  • Method Documents
  • Variables and Calculations
• Version Control and Change Analysis

About Spec Data Build Order

There is a prescribed order of operations when building your Spec Data:

1. Create your Test Definition, including the Test Definition Steps, Test Definition Inputs, Test Definition Results and any calculations.
2. Create your Sample Plan, and its child Sample Definitions.
3. Create your Spec Data. The Spec Data must reference a Sample Plan. Create one or more Samples to Pull (Spec Data Sample action, Pull Sample action) and one or more Tests to Execute (Spec Data Sample action, Test Sample action). Ensure that any cross-method calculation variables have been accounted for. Optionally, create:
   1. Spec Data Criteria
   2. Spec Data Criteria Sets
4. Complete Change Analysis.
5. Create Spec Data Mapping records which match a Material (and potentially Country and/or Organization) to the Spec Data record. Ensure that Spec Data Mapping record is Active.

Related Permissions

For Spec Data Admins to build a set of Vault LIMS Spec Data components and make changes where necessary, they must have a security profile or role which grants them Read, Create, and Edit permissions for the following objects and their related objects (and object types where applicable):

• Test Definition
  • Test Definition Input
  • Test Definition Result
  • Test Definition Result Variable
  • Test Definition Step
• Sample Plan
  • Sample Definition
• Spec Data
  • Spec Data Sample Action
  • Spec Data Criteria
  • Spec Data Criteria Set
  • Spec Data Criteria Set Country
• Spec Data Mapping (including View access to the Spec Data object control)
• Lab Result Picklist
  • Lab Result Picklist Option

Spec Data Admins should have View permissions for the following objects (and object types where applicable) in order to manage Spec Data records:

• Material
• Country
• Organization
• Product
• Unit of Measure

Spec Data Admins should also have Read and Edit permissions for the following objects (and object types where applicable) in order to manage Spec Data records:

• LIMS Change Analysis
  • LIMS Change Analysis Blocking Item
  • LIMS Change Analysis Item
  • LIMS Change Analysis Signature (Read only)

To view and manage calculation formulas, users need a permission set with View access to the Calculation Formula object control permission on the Test Definition Result object.