Spec Data brings together the sample plan and test definitions, allowing the Design Data Admin to specify which tests will be applicable to which sample, and allows for defining specification limits for the test results.
Create Spec Data
To create a spec data record:
Navigate to Design & Admin > Design Data > Spec Data and click Create.
Enter the Spec Data Name.
Select the Sample Plan that will be used for this spec data.
Click Save.
Create Samples to Test
After creating the spec data record, the next step is to add a Sample to Test record for each sample definition in the sample plan.
To create samples to test:
Navigate to the spec data record and select Create Samples to Test from the All Actions menu.
Select one or more sample definitions and click OK.
Note All sample definitions from the sample plan should be included.
Create Tests to Execute
The next step is to add tests to execute for each of the samples to test. This determines which test definition(s) should go with which sample.
To create a test to execute:
Navigate to the Tests to Execute section of the spec data record and click Create.
Select a Sample To Test and a Test Definition.
Enter the Test Order. This is the order in which the test should appear on the sample result entry screen.
Best Practice Match the Order to the results summary that will be provided by the third-party testing lab, such as the Certificate of Analysis or Certificate of Testing.Enter the Number of Tests to indicate how many tests will be created at runtime. This is generally 1.
Click Save.
Create Specification Criteria
The next step is to add spec limits, or criteria records, for each test to execute.
To create specification criteria for a test:
Navigate to the Tests to Execute section of the spec data record and click one of the test records to open it.
Navigate to the Specification Criteria section for the test record and click Create.
Refer to the Helpful Information section, find the applicable type of result and example limit, copy and paste the syntax into the Criteria field. Then modify is as necessary.
Click Check Syntax to make sure the syntax is valid.
Enter the human-readable specification limit in the Criteria Description field. The Criteria Description will display on appliable reports, such as the Certificate of Analysis.
Select the Indication. Indication determines how this criteria is represented and, if failing, this criteria prevents spec conformance.
Select one or more Purpose options.
- Internal: When the indication is Alert, purpose will typically be Internal.
- Stability Study Report: To prepare for future LIMS Basics functionality, select this option for any limits that, in the future, should be included for stability initial / t=0 exports.
- COA: When the indication is Out of Specification, purpose will typically be COA, meaning the limit and associated result will be displayed on the system-generated COA.
Specify the Order in which the limits and results should be shown in the table of results on the Certificate of Analysis.
Click Save.
