Test system definition

Use Test system definition documents to define a collection of suitability tests and corresponding margins for dose response assays.

Tip: Before you start working with this document type, we recommend becoming familiar with the documents concepts in PLA 3.0. For details, see the Documents topic.

About this document type

Test system definition documents let you set up a centralized suitability test system for repeated use. Instead of defining tests within each Dose-response analysis document, you reference a shared Test system definition document to ensure consistency across your assays.

Tip: You can identify documents of this type by the

icon in the upper right corner of the Content editor.

You can include one or more suitability tests in each Test system definition document and define their parameters, scope, and severity level. For details on these settings, see the Suitability tests topic.

In the following example, a Test system definition document is referenced by three Dose-response analysis documents:

Flowchart with three blue boxes labeled ‘Dose-response analysis 1,’ ‘Dose-response analysis 2,’ and ‘Dose-response analysis 3,’ each pointing upward to a dark teal box labeled ‘Test system definition.’ — Figure 1. Test system definition document referenced by three Dose-Response Analysis Package documents

To set up these references, you use the Content editor of your Dose-response analysis document. For details on the required steps, see the Create references to documents topic.

Important: Tests defined in a such a test system do not block the execution of calculations. They are used to assess the validity of results based on preconfigured conditions, such as variance checks or recovery criteria.

Document structure

Each Test system definition document has one default section, that is Suitability tests, plus one or more optional Comment sections. Use the subsections to add the assay and sample suitability tests you require.

Figure 2. Sections of a Test system definition document displayed in the Content editor

Suitability tests

Test system definition documents for dose-response analysis offer a variety of tests from the following groups. For details on each test, see the respective subtopic.


Group	Includes
ANOVA terms	F-test (model, lack of fit), mean squares, sum of squares (both: model, residual error, lack of fit, pure error, total error)
Equivalence tests	Parameter estimates with their confidence intervals (nonlinear models: A, B, C, D, G, A-D, A/D; linear models: intercept, slope)
Regression parameters	Parameter estimates (nonlinear models: A, B, C, D, G, A-D, A/D, slope; linear models: intercept, slope)
Observation data	Number of outliers, sequence step CV, response value range
Calculation results	r², interpolation (mean, interval, width), effective concentration (concentration, response), transduction unit, recovery rate

Tip: Test system definition documents created by Equivalence margin development documents list all test strategies as sample suitability tests by default. Before you begin working with the Test system definition document, make sure to move any tests you intend to use as assay suitability tests to the appropriate section.