Method Validation Calculator

MT.Co

Contains adsIn-app purchases

About this app

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.

What’s new

fix crash bug