analytical-method-validation

SAFE max severity SAFESkillSpector Caution 34 registry K-Dense-AI last scanned 1 scan

No security findings. Scanned 1 time, most recently 2026-10-21.

Second scanner: NVIDIA SkillSpector

Independent static run, no language model, over the same files as the Cisco scan above. How the two scanners compare across the whole corpus: Two scanners, one corpus.

What this skill does

Plans, executes, and documents 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",…

Package
17 files, 219 KB
SKILL.md
2570 words, 12+ sections
Code
Python (8)
Allowed tools
Read Write Edit Bash
License
MIT
Compatibility
Requires Python 3.11+. Scripts use only the standard library - no numpy, scipy, or network access. Statistical distributions are computed from first principles so results are reproducible in any conforming interpreter.

SKILL.md covers: Analytical Method Validation · When to use · The two rules · Scope · Copyright boundary · Frameworks · Scripts · Workflow · 1. Fix the framework and the required characteristics · 2. Generate the protocol and fill in the criteria · 3. Evaluate the response · 4. Evaluate accuracy and precision

Findings

No findings. SAFE

What is in the package

FileKindSize
SKILL.mddoc19 KB
assets/validation-protocol-template.mddoc4.1 KB
assets/validation-report-template.mddoc3.9 KB
references/compendial-and-clsi.mddoc7.6 KB
references/framework-selection.mddoc5.3 KB
references/ich-m10-bioanalytical.mddoc8.8 KB
references/ich-q2r2.mddoc13 KB
references/source-ledger.mddoc7.5 KB
references/statistics.mddoc13 KB
scripts/_catalog.pyscript23 KB
scripts/_common.pyscript34 KB
scripts/check_accuracy_precision.pyscript16 KB
scripts/check_bioanalytical_run.pyscript14 KB
scripts/check_detection_limits.pyscript14 KB
scripts/check_response.pyscript10 KB
scripts/compare_methods.pyscript9.1 KB
scripts/plan_validation.pyscript15 KB

External hosts referenced

clsi.org database.ich.org doi.usp.org www.cms.gov www.iso.org arxiv.org www.itl.nist.gov www.uspnf.com doi.org export.arxiv.org itl.nist.gov www.ema.europa.eu www.usp.org

Hostnames that appear in the skill's files. Referencing a host is not a finding; compare against the findings above and the skill's stated purpose.

Package contents recorded 2026-10-22 at commit 593377bb0487. The scan above ran against the version current at scan time; the two can differ if the skill has since been updated.

What we checked

What we did not check

Sources