Basic concepts

Equivalence margin development documents use a set of concepts you should be familiar with when working with this document type.

The following figure gives an overview of the concepts and their dependencies:

As your source assays, you use historic assay documents you deem acceptable. To prepare for margin development, you use the References editor of your Equivalence margin development document. In this editor, you add references to the historic assay documents you want to use as source assays. For details on how to work with this editor, see the References editor topic.

After adding the references, you mark your source assays as development or verification assays. You can also mark individual assays for exclusion as technical outliers.

• Development assays are the assays that you use to develop equivalence margins. The expected test result of these assays is always 'passed.'

• Verification assays are the assays that you use to verify the behavior of the test strategy you develop. The expected test result of these assays can be 'passed' or 'failed.'

  • If the test strategy rejects a verification assay that you expect to pass, this indicates that your development assays did not cover the full range of acceptable assays.

  • If the test strategy accepts a verification assay that you expect to fail, this indicates that the test strategy is not yet fit for the intended purpose.

To retrieve data from your source assays, Equivalence margin documents employ data aggregation. Data aggregation in PLA 3.0 lets you automatically transfer data and results from source to target PLA 3.0 documents, thus supporting complex and compliant operations. Manually entering data in spreadsheets or other programs is not necessary.