Create Stability Spec Data

Spec Data brings together the sample plan and test definitions, allowing the Stability Design & Study Admin to specify which tests will be applicable to which sample, and allows for defining specification limits for the test results. Typically you will create one stability spec data for each time point in your protocol.

To save you time and to keep spec data records consistent, we recommend first creating a spec data for the timepoint that has the most conditions/orientations, tests, and criteria. Then make copies of the spec data and alter as needed.

Create Spec Data

To create a stability spec data record:

1. Navigate to Design & Admin > Design Data > Spec Data and click Create.

   

   Note If you also have permission to create release spec data records, you will need to select the type of spec data you want to create.

2. Enter the Spec Data Name.

3. Select the Sample Plan that will be used for this spec data.

   Note You must select a sample plan that contains only the conditions/orientations applicable to the timepoint.

4. Click Save.

   

Create Samples to Test

After creating the stability 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:

1. Navigate to the spec data record and select Create Samples to Test from the All Actions menu.

   

2. Select one or more sample definitions and click OK.

   

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:

1. Navigate to the Tests to Execute section of the spec data record and click Create.

   

2. Select a Sample To Test and a Test Definition.

3. 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 on the results document by the third-party testing lab.

4. Enter the Number of Tests to indicate how many tests will be created at runtime. This is generally 1.

5. Click Save.

   

6. Check the Test Method in the list view. It will default from the test definition (if populated) after the test to execute is created. If needed, you can add/edit the test method by clicking the test name and editing the record.

   

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:

1. Navigate to the Tests to Execute section of the spec data record and click one of the test records to open it.

   

2. Navigate to the Specification Criteria section for the test record and click Create.

   

3. 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.

   

4. Click Check Syntax to make sure the syntax is valid.

   

5. Enter the human-readable specification limit in the Criteria Description field. The Criteria Description will display on appliable reports, such as the Stability Report.

6. Select the Indication. Indication determines how this criteria is represented and, if failing, this criteria prevents spec conformance.

7. Select one or more Purpose options.

   • Internal: When the indication is Alert, purpose will typically be Internal.
   • Stability Study Report: Select this option for any limits that should be included on the system-generated Stability Report.
   • COA: This option is only used for release spec data only. You will not be able to save the stability spec data if you select this option.

8. Specify the Order in which the limits and results should be shown in the table of results on the Stability Report.

9. Click Save.

   

Deep Copy Record

To deep copy a sample to test:

1. Select Deep Copy Record from the All Actions menu of the sample you want to copy. A copy of the sample is created, along with its associated tests and specification criteria.

2. Return to the spec data record.

3. Make any changes, if needed. For example:

   • To change the sample definition, select the correct one right from the Samples to Tests grid. Click out of the field to save.

   • To remove a test for a particular condition, select Power Delete from the All Actions menu of the test. Power delete also deletes the spec criteria associated with the test.

Create Stability Spec Data from Release Spec Data

If the specifications between release and stability are very similar and a release spec data is available, it can be used to create Initial/T0 or timepoint specifications.

To create a stability spec data from a release spec data:

1. From the release spec data you want to copy, select Create Design Data Copy from the All Actions menu.

   

2. From the new spec data record, select Change Type from the All Actions menu.

   

3. Select Stability Study Spec Data and click Continue.

   

4. Update the Spec Data Name, select a new Sample Plan (sample definitions must have a sample type of Stability).

5. Click Save.