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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.

76

Quality

96%

Does it follow best practices?

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Adds up to 20 points to the overall score

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SecuritybySnyk

Passed

No findings from the security scan

The canonical home for this skill is analytical-method-validation in K-Dense-AI/scientific-agent-skills

SKILL.md
Quality
Evals
Security

Quality

Content

92%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.

A strong, highly actionable skill body: a clearly sequenced workflow with real outputs and error-recovery guidance, and an appropriately split bundle with verified one-level-deep references. The only room for improvement is trimming the minor recap redundancy for token efficiency.

DimensionReasoningScore

Conciseness

The body is dense and most tokens earn their place — real script outputs, criteria tables, and copy-paste commands rather than explanations of generic concepts — but there is minor over-explanation that could be trimmed: the "What this skill exists to prevent" list recaps traps already covered in the Workflow steps, and the "Citing Scientific Agent Skills" section is administrative. This fits the 4 anchor ('minor instances of over-explanation'); it is clearly tighter than the 3 anchor's 'some unnecessary explanation'.

4 / 5

Actionability

Every workflow step supplies an executable command with flags (e.g., `check_response.py -i calibration.csv --max-back-calc-error 2`), the input file formats are specified ("Input is `level,response`, one row per injection"), real output blocks show what the scripts produce, and exit-code semantics ("0 for no findings, 1 when findings were raised, 2 for bad input") are documented for gating. Fully copy-paste ready with the common cases covered, matching the 5 anchor.

5 / 5

Workflow Clarity

A numbered 7-step sequence (fix framework → protocol → response → accuracy/precision → DL/QL → M10 runs → comparison) where each step includes a command, expected output, and interpretation, with explicit error-recovery guidance (heteroscedasticity flag → "Add `--weight 1/x2`"; the per-level QC finding example) and exit codes that gate workflows. The "What this skill exists to prevent" list acts as a final checklist, matching the 5 anchor's sequence, validation, feedback loops, and checklist.

5 / 5

Progressive Disclosure

The overview keeps only decision-critical material inline and defers detail to six one-line-described reference files (framework-selection, ich-q2r2, ich-m10-bioanalytical, compendial-and-clsi, statistics, source-ledger) and two asset templates — all verified to exist and contain real content. References are clearly signaled, one level deep, and easy to navigate, matching the 5 anchor; the 4 anchor would require organization gaps that are not present.

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.

An excellent description: concrete third-person actions, an explicit 'Use for...' clause with technique coverage, and a comprehensive trigger list with synonyms and abbreviations. The regulatory-framework scoping makes it highly distinct from other skills. No material weaknesses.

DimensionReasoningScore

Specificity

"Plan, execute, and document validation, verification, and transfer of analytical procedures" names multiple concrete actions across three service types, and the governing frameworks (ICH Q2(R2)/Q14, USP <1220>/<1225>/<1226>, ICH M10, CLSI EP, ISO/IEC 17025) are enumerated rather than gestured at. This is comprehensive and concrete, matching the 5 anchor; the 4 anchor would require minor gaps in coverage, which are not present.

5 / 5

Completeness

It explicitly answers both questions: what ("Plan, execute, and document validation, verification, and transfer of analytical procedures under the governing framework") and when ("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"), followed by a concrete trigger list. This matches the 5 anchor exactly; the 4 anchor requires the 'when' to be less explicit, which it is not.

5 / 5

Trigger Term Quality

The trigger list covers natural domain phrasing with synonyms and abbreviations — "LOD"/"detection limit", "LOQ"/"quantitation limit", "ISR"/"incurred sample reanalysis", "AMV", "intermediate precision", "Passing-Bablok", "Bland-Altman", "OOS investigation" — plus the technique names (HPLC, LC-MS/MS, qPCR, NIR) a user would naturally mention. Coverage is comprehensive including synonym pairs, matching the 5 anchor rather than the 4 anchor's 'a few natural terms missing'.

5 / 5

Distinctiveness Conflict Risk

A clear niche — analytical procedure validation under named regulatory frameworks — with highly distinctive trigger tokens ("Passing-Bablok", "Q2(R2)", "incurred sample reanalysis", "reportable range") that would not fire for unrelated skills. A few bare generic words ("linearity", "recovery") exist but sit inside an unambiguously scoped description, so conflict risk is minimal, matching the 5 anchor over the 4 anchor's 'minor overlap risk'.

5 / 5

Total

20

/

20

Passed

Validation

93%

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

Validation — 15 / 16 Passed

Validation for skill structure

CriteriaDescriptionResult

frontmatter_unknown_keys

Unknown frontmatter key(s) found; consider removing or moving to metadata

Warning

Total

15

/

16

Passed

Repository

synthetic-sciences/openscience

Path

backend/cli/skills/chemistry/analytical-method-validation/SKILL.md

Reviewed

Table of Contents

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