Assay Validation Data Management Must Preserve the Claim
Holding
Assay validation systems should connect every performance claim to its protocol, dataset, calculation, and approval record.
Issue
Sensitivity, specificity, precision, linearity, and stability claims are only as credible as the evidence trail behind them. A polished report cannot repair missing source data or undocumented exclusions.
Analysis
The failure mode is report-first validation: summary tables are retained while raw observations, protocol deviations, calculation versions, and reviewer decisions become difficult to recover.
Resolution
The system should version protocols and analysis methods, preserve raw and derived results, record deviations, and link each reported metric to the exact evidence used to calculate it.
Evidence Package
The evidence package should include validation plans, raw observations, analysis scripts or formulas, locked datasets, deviation assessments, reviewer sign-off, and approved report versions.
Conclusion
An assay claim should be traceable backward to observations without relying on personal memory or hidden spreadsheets.