Analytical Method Validation Workbook | ICH Q2(R2) Linearity, Accuracy, Precision, LOD/LOQ (Excel)

Validating an analytical procedure means a lot of statistics, and many free templates cover only linearity. The Method Validation Workbook brings the whole ICH Q2(R2) set into one Excel file: specificity, linearity, accuracy, precision, detection and quantitation limits, range and robustness.

Type the acceptance criteria from your approved protocol once. Enter raw results and the workbook calculates least-squares regression (slope, intercept, R², residual SD, standard errors, 95% confidence intervals, residual plot, y-intercept as % of the 100% response), recovery per level with mean, RSD and t-based confidence interval, repeatability, and intermediate precision by one-way ANOVA.

DL and QL are calculated three ways (residual SD, SD of intercept or blank, and signal-to-noise), with QL confirmation replicates. Robustness compares each varied condition with nominal and your limit. Every characteristic shows Pass, Fail or Incomplete, and the Dashboard gives a summary table ready for your validation report.

A complete fictional EXAMPLE validation shows how every tab works. The statistics were recomputed independently in Python on the example data.

What's included

• Method-Validation-Workbook.xlsx (10 tabs)

• Start Here: quick start, colour key, the formula behind each result, disclaimer

• Dashboard: status tiles, validation summary table, key numbers, linearity and residual charts

• Method & Criteria: method details, 16 acceptance criteria, in-scope switch per characteristic

• Specificity (20 checks), Linearity (25 points), Accuracy (30 determinations, up to 5 levels)

• Precision: repeatability (10 replicates) and intermediate precision (6 series x 6) with ANOVA

• LOD-LOQ: three approaches plus QL confirmation; Robustness: 25 conditions; Lists and settings

• User-Guide.pdf (8 pages): set-up, every formula and pass / fail rule, public references and disclaimer

• Fictional EXAMPLE data: a complete HPLC assay validation (EX-AMV-001) to learn from, then clear

Who it's for

• Analytical development and QC chemists who write validation protocols and reports

• Method transfer and verification teams who need the same statistics in a consistent layout

• Small labs, CROs and start-ups without a statistics package or LIMS module

• QA reviewers who want to check reported numbers against raw data

File formats and compatibility

• Microsoft Excel .xlsx workbook plus a PDF user guide, delivered as one zip

• Built for Microsoft Excel 2019/365 (.xlsx, no macros). Tested in LibreOffice Calc. Google Sheets import is possible but not officially supported.

• No add-ins, internet connection or macros required

• Instant digital download; no physical item is shipped

FAQ

Q: Does it follow ICH Q2(R2)?

A: It is organised around the validation characteristics and calculation approaches described in the public ICH Q2(R2) guideline, with USP 1225 concepts. You set the acceptance criteria from your own approved protocol; the workbook does not decide them for you.

Q: How is intermediate precision calculated?

A: By one-way ANOVA across up to 6 series: repeatability variance is the within-series mean square, and the between-series variance is added (never below zero) to give the intermediate precision SD and RSD.

Q: Is it validated or compliant out of the box?

A: No. It is a template. No spreadsheet is compliant on its own, and this file is not a validated computerised system or a Part 11 / Annex 11 electronic records system. Verify the formulas with your own data and approve it under your own procedures before GMP use.

Q: Can I use it for several methods?

A: Use one file per validation: save a copy for each method or study so every report has its own record.

Q: Is the example data real?

A: No. EX-AMV-001 and all its results are fictional. Clear the input cells before first use.

Disclaimer: Template only. This workbook is a tracking and calculation aid. It is not regulatory, legal or quality advice, it does not make your processes compliant, and it is not a validated computerised system: validate it for your intended use under your own procedures before relying on it for GMP decisions. Public guidelines (ICH, EU GMP, US 21 CFR, USP and others) are cited for concepts only. Rangefolio is not affiliated with or endorsed by ICH, USP, EDQM, FDA, EMA or PIC/S. All example data is fictional.