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----
-title: User and developer aspects - regulatory
-subtitle: Developer and user specific documentation for regulatory aspects in nf-core
-weight: 1
----
-
-## Scope
-
-This document intends to provide further context for maintainers and developers.
-
-## Validation & integrative testing
-
-- Scope :
-  This part of the document provides information on which features should be included with each pipeline, which would facilitate regulatory approvals:
-- Features to include:
-  Pipeline level:
-  - Integration testing: an analysis of the test in the production environment with real data
-    - Compare the performance of the test system in your dataset with those
-      specifications defined by the user. This includes the following performance
-      characteristics:
-      • Accuracy
-      • Precision
-      if applicable • Reportable range
-      if applicable • Reference intervals/range (normal values) for the laboratory’s patient population
-- [if applicable] Controls to be included to unit tests:
-  • Positive control
-  • Negative control
-  • Additional controls (for example PCR reagent controls, amplification control gene, calibration curve,... )
-- Set of expected results for all controls.
-- Set assay acceptance criteria
-- Set rejection criteria.
-
-  - Add automated quality checks that will be stopping points for the pipeline, if fail.
-
-- Store results to an automated report / stats file
-- Automate risk management based on results stored in the stats file