CMCfyMethod Validation Studio
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Method

Example data is loaded in every section. Replace it with your own results; criteria are editable.

1 · Protocol

Example protocol loaded. It contains a few deliberate gaps so you can see the alerts.

2 · Data: linearity

2 · Data: accuracy

2 · Data: precision

2 · Data: specificity and robustness

3 · Alerts to resolve

Validation summary

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Linearity and range

Accuracy

Precision

4 · Report draft

AI writes the narrative from your protocol and the calculated results. Numbers and pass/fail outcomes always come from the calculations. Any number in the draft that does not appear in your data is flagged.

5 · Word report

The report follows ICH Q2(R2): scope, each validation characteristic with data, results and discussion, a summary table, resolved alerts and blank sign-off lines. It uses your edited AI draft when there is one.

Calculations: least-squares linearity with correlation coefficient and residual SD; LOD = 3.3σ/S and LOQ = 10σ/S using the residual SD of the calibration line (ICH Q2(R2) calibration-curve approach); recovery = found / theoretical × 100; %RSD = sample SD / mean × 100. Acceptance criteria come from your protocol. This is a draft for review by a qualified person.