Analytical Method Validation

The analytical-method-validation skill walks through validating, verifying, and transferring analytical procedures under the framework you actually need: ICH Q2(R2) and Q14, ICH M10 for bioanalytical work, USP <1225>/<1226>, CLSI EP, or ISO/IEC 17025. Its main discipline is picking the governing framework first and setting acceptance criteria before any data comes in, since mixing frameworks produces a protocol that satisfies none of them. The bundled scripts use only the standard library and handle response checks, accuracy and precision, detection limits, ICH M10 run checks, and method comparison, with exit codes that can gate a pipeline. It is careful about scope: it computes and structures, but leaves fitness-for-purpose decisions to the human reviewers, and it won't reproduce paywalled USP or CLSI text. Worth reaching for if you're building a validation protocol and want the statistics right.

skills.sh installs: 1.1K
GitHub stars: 56.6K
last updated: Jul 31, 2026

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Install

$ npx -y skills add K-Dense-AI/scientific-agent-skills --skill analytical-method-validation --agent claude-code

Installs into .claude/skills of the current project.

Files

Analytical Method Validation

When to use

Any time the question is whether an analytical procedure is fit for its intended purpose: designing a validation study, evaluating validation data, verifying a compendial procedure, transferring a procedure to another laboratory or instrument, or defending any of these in a report.

The two rules

1. Establish which framework governs before designing anything. The same assay validates differently under ICH Q2(R2), USP <1225>, ICH M10, CLSI EP, and ISO/IEC 17025. They differ in which characteristics are required, how the studies are laid out, and whether numeric acceptance criteria are supplied at all. Blending them produces a protocol that satisfies none of them.

SKILL.md on GitHub