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analytical-method-validation

Plan, execute, and document validation, verification, and transfer of analytical procedures under the governing framework - ICH Q2(R2) and Q14, USP <1220>/<1225>/<1226>, ICH M10 bioanalytical, CLSI EP, or ISO/IEC 17025. Use for HPLC, LC-MS/MS, GC, CE, ICP-MS, dissolution, qNMR, qPCR, NIR, and ligand binding or cell-based assays whenever the question is whether a procedure is fit for its intended purpose. Triggers include "method validation", "analytical method validation", "AMV", "validation protocol", "acceptance criteria", "linearity", "reportable range", "accuracy and precision", "repeatability", "intermediate precision", "recovery", "LOD", "LOQ", "detection limit", "quantitation limit", "specificity", "robustness", "method transfer", "method comparison", "Deming", "Passing-Bablok", "Bland-Altman", "equivalence testing", "OOS investigation", "ICH Q2", "Q2(R2)", "Q14", "USP 1225", "ICH M10", "incurred sample reanalysis", "ISR", "CLSI EP", and any request to show that an assay works.

77

Quality

96%

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SecuritybySnyk

Passed

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SKILL.md
Quality
Evals
Security

Quality

Content

93%Weight 40%Scale 1-5

Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.

An expertly structured body: executable commands with real outputs, a sequenced multi-step workflow with exit-code checkpoints, and clean progressive disclosure to verified reference/asset/script files. Only minor gap is explicit per-step fix-retry loops.

Suggestions

Add a short 'If a script raises findings (exit 1): review the finding, correct the data or criteria, and re-run until exit 0' feedback-loop note to lift workflow_clarity to anchor 5.

Consider a one-line 'Prerequisites' note pointing to the Python 3.11 / standard-library-only constraint from the frontmatter so users hit it before the first command.

DimensionReasoningScore

Conciseness

Lean and domain-dense: it encodes exactly what Claude lacks (Q2(R2) restructuring, M10 modality splits, statistical traps) with no padding and no basic-concept explanations; every section earns its place.

5 / 5

Actionability

Copy-paste-ready commands for every script (e.g. 'python3 check_response.py -i calibration.csv --max-back-calc-error 2') alongside real example outputs and exact input formats, covering the common cases.

5 / 5

Workflow Clarity

A clearly sequenced 7-step workflow with validation via exit-code gating (0/1/2), pre-data criteria enforcement, and a closing 'What this skill exists to prevent' checklist; falls just short of anchor 5 because per-step fix-and-retry feedback loops are implied rather than spelled out.

4 / 5

Progressive Disclosure

Well-signaled one-level-deep references: a References section maps six reference files (all verified present), an Assets section lists two templates, and a Scripts table indexes six scripts, with the SKILL.md body acting as a navigable overview.

5 / 5

Total

19

/

20

Passed

Description

100%Weight 40%Scale 1-5

Based on the skill's description, can an agent find and select it at the right time? Clear, specific descriptions lead to better discovery.

A high-quality description: concrete actions, an explicit 'Use for'/'Triggers include' structure, broad synonym coverage, and a sharply defined regulatory niche. It uses third-person voice throughout with no over-claims.

DimensionReasoningScore

Specificity

Lists multiple concrete actions — 'Plan, execute, and document validation, verification, and transfer of analytical procedures' — across an explicit set of governing frameworks, giving comprehensive coverage rather than generic verbs.

5 / 5

Completeness

Explicitly answers both what (plan/execute/document validation, verification, transfer) and when ('Use for ... whenever the question is whether a procedure is fit for its intended purpose' plus a dedicated 'Triggers include' clause).

5 / 5

Trigger Term Quality

Comprehensive natural-term coverage including synonyms and abbreviations users actually say: 'method validation', 'AMV', 'LOD'/'LOQ'/'detection limit'/'quantitation limit', 'ISR'/'incurred sample reanalysis', 'Passing-Bablok', 'Bland-Altman', 'OOS investigation'.

5 / 5

Distinctiveness Conflict Risk

Occupies a clear niche (analytical procedure validation under named regulatory frameworks) with distinct, specialized triggers unlikely to fire for unrelated skills.

5 / 5

Total

20

/

20

Passed

Validation

100%

Checks the skill against the spec for correct structure and formatting. All validation checks must pass before discovery and implementation can be scored.

Validation16 / 16 Passed

Validation for skill structure

No warnings or errors.

Repository
K-Dense-AI/scientific-agent-skills
Reviewed

Table of Contents

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