Method Validation Copilot Pro App 1-Year License

Method Validation Copilot Pro App 1-Year License

Twelve months of full access. Thirteen validation characteristics, eleven document generators, ICH Q2(R2) and Q14.

Method Validation Copilot Pro turns validation data into a defensible assessment and a drafted document set, in an afternoon rather than a fortnight.

You enter the results you already have. It runs the statistics from first principles, judges each characteristic against the criteria for your procedure’s purpose, tells you exactly what is blocking your report, and then writes the documentation.

This license gives you twelve months of full access.

Thirteen validation characteristics

Specificity and forced degradation across all six ICH conditions, with mass balance and peak purity. Accuracy with recovery, confidence intervals and a proportional-bias check. Precision with one-way ANOVA variance components separating within-day from between-day. Linearity with weighted regression, residual plots, back-calculated standards and lack-of-fit F-test. Range. LOD and LOQ by both σ/S and signal-to-noise, with the origin of σ tracked explicitly. Robustness with ranked factor effects and a draft MODR statement. Solution stability with supported hold time and the resulting limit on sequence length. Filter compatibility. System suitability against USP <621>, Ph. Eur. 2.2.46 or JP 2.01. Carryover.

The readiness review

One screen that answers the only question that matters before you start writing: is this package ready?

It gives you a headline verdict, the critical actions that are actually blocking you, and the recommended actions that simply need a sentence of justification in the report. It distinguishes a failed criterion from a missing experiment from a thin margin, because each one leads somewhere completely different, and confusing them is how a week disappears.

Eleven document generators, straight to Word

Validation protocol · validation report · method development report (Q14) · method transfer protocol and report · robustness study report · forced degradation report · analytical procedure description · deviation assessment · investigation summary · CAPA support · change control assessment.

Each one arrives as a real .docx with proper heading styles, bordered tables, a shaded draft-status callout, a running header and page numbers. Edit it in Word, or lift the sections into your own company template. Every outstanding field is highlighted in yellow so nothing goes out half-finished.

Statistics you can defend in an audit

t and F distributions computed via the regularized incomplete beta function, no lookup tables that silently stop at 30 degrees of freedom. Ordinary and weighted least squares with standard errors and confidence intervals on slope and intercept. Lack-of-fit ANOVA. Variance components. Grubbs. HorRat. The engine is verified against published textbook values.

And the acceptance limits are yours. ICH Q2(R2) specifies which characteristics must be evaluated; with very few exceptions it does not specify numbers. Every default in the application is a clearly labelled, editable industry starting point and the criterion actually applied is printed in the document.

It does not approve anything, and it says so

Every output is an AI-generated scientific draft requiring analyst and QA review. It does not release batches, approve documents or make regulatory decisions. Human oversight is designed in rather than added as a disclaimer, which is the direction FDA and EMA guidance on AI has been pointing since the start of 2026.

Your laboratory data stays on your machine

No database, no upload, no cloud storage of validation results. Everything is computed and stored in your own browser.

What is included

• Twelve months of full access from the day you activate

•  All thirteen modules and all eleven document generators

• The AI validation scientist

• Quick start guide and full user handbook

• All updates released during your license period

Getting started

Buy, receive your license key, open the application in your browser, paste the key once. Nothing to install and nothing to configure.

Windows, Mac and Linux. Chrome, Edge, Firefox or Safari.