Define the intended use first
Before planning experiments, define the specimen types, target regions, variant classes and reporting boundaries. A validation for small sequence variants does not automatically establish performance for copy-number changes or RNA fusions.
Make the claims explicit
Separate accuracy, repeatability, reproducibility and analytical sensitivity. Decide which reference materials and clinical specimens can address each question, and document acceptance criteria before reviewing the results.
Include the complete workflow
Extraction, library preparation, sequencing, bioinformatics and reporting all contribute to the result. Changes to the workflow should trigger a review of which performance claims need renewed verification.
Keep evidence and limitations together
A useful report states what was assessed, under which conditions, what passed and where uncertainty remains. This makes the validation useful for staff introducing the assay and for later quality reviews.
Scientific reference: AMP/CAP consensus recommendations for validation of NGS-based oncology panels.