Method Validation Calculator Live

Method Validation replaces the spreadsheets a pharmaceutical QC laboratory uses to validate an analytical method. Enter the raw data — weights, volumes, peak areas, absorbances — and the app computes every validation parameter, applies the acceptance criteria and gives a three-state verdict for each one: PASS, FAIL or INSUFFICIENT DATA. WORKFLOWS • HPLC / GC assay according to ICH Q2(R2): system suitability (RSD, tailing, plate count), linearity and working range (slope, intercept, r, R², residuals, response factor), repeatability on three matrices, accuracy with 9 spiked samples and 95 % confidence interval, intermediate precision (day 2, F-test), Grubbs outlier check, measurement uncertainty (top-down). • Heavy metals by GF-AAS / ICP according to Ph. Eur. 2.4.27: calibration curve at the start and end of the run (slope drift), reagent blanks with LOD / LOQ, standard addition recovery on several matrices, repeatability (independent flasks), intermediate precision by ISO 5725 ANOVA, drift trend and a full top-down uncertainty budget. • Generic profile for ICH / USP <1225> / ASEAN / ISO 17025 methods: assay, SST, accuracy, precision, linearity with LOD / LOQ from the calibration line. CORRECT BY CONSTRUCTION Every formula was verified cell by cell against the laboratory's original validated workbooks (≈ 600 cells, relative tolerance 1e-9). Excel semantics are kept where they matter (sample SD, TINV / FINV, regression statistics). Blank or zero cells count as "not entered", never as data. BUILT FOR THE BENCH • Column quick-entry (Enter → next row), paste a whole column from Excel, or import a column straight from the instrument's CSV / TSV export (Empower, Chromeleon, LabSolutions…). • Vietnamese and English number formats (1.234,56 and 1,234.56) are both understood. • Live verdict bar while you type; KPI dashboard; formula trace for every result. • Undo / redo and a full audit trail of every changed cell (21 CFR Part 11 style). • Record lifecycle Draft → Reviewed → Approved with optional PIN e-signature. REPORTS • PDF report with your laboratory name, logo, form code, page numbers, sign-off table and an optional raw-data appendix — Vietnamese fonts embedded. • Excel workbook (.xlsx) with one sheet per parameter and yellow input cells, plus CSV. • Project bundle (.mvproj) for backup and transfer between devices. • Share, open, or save any export to Downloads / Google Drive. ORGANISE Search, filter and sort projects; tags; duplicate a project; save the settings and criteria of a project as a template and start the next validation from it; archive finished work. PRIVACY All data stays on your device — there is no server and no account. The app is free with ads; an optional Pro upgrade (lifetime or yearly) removes ads and unlocks lab branding, Excel export, templates, PIN sign-off and the advanced tools. Full English and Vietnamese interface — including every data-entry tab, the conclusion and the PDF/CSV/Excel reports — following the device language or the setting in the app. Disclaimer: this app is a calculation aid. The laboratory remains responsible for reviewing the inputs, the acceptance criteria and the final conclusion. **What's new (500):** 1.3.1 — Full English interface and reports (data-entry tabs, conclusion, PDF/CSV/Excel), follows the device language. Free + Pro model: lifetime or yearly Pro removes ads and unlocks lab branding, Excel export, templates, PIN sign-off and advanced tools. Extended HPLC parameters (specificity, stability, LOD/LOQ, robustness), bottom-up uncertainty budget, titration / Karl Fischer module, multi-element panel, two-lab comparison, SST control chart, dissolution f2, ICH Q3D limits.