Skip to content
Get packs

Analytical Method Validation

Plans and checks analytical method validation studies under ICH, USP, CLSI or ISO frameworks

Source Download skill
Repository
K-Dense-AI/scientific-agent-skills
Stars
55,780
Licence
MIT
Files
15 files

What it does

This skill teaches an AI agent how to plan and document whether a lab test procedure (for example HPLC, LC-MS/MS or qPCR) is fit for its purpose, following regulatory frameworks such as ICH Q2(R2) and ICH M10. Once installed, the agent first identifies which framework governs the work, insists on stating acceptance criteria before data are collected, and can run Python scripts that compute statistics like linearity, accuracy, precision, detection limits and ICH M10 bioanalytical run checks. It explicitly does not decide that a method is validated; qualified people must make that call.

Great for

  • Analytical chemists or QC staff drafting a validation protocol or report
  • Method transfer or verification teams comparing results against a stated framework
  • Students learning how ICH Q2(R2) and M10 structure validation studies

Skip it if

  • Making a release, batch acceptance or regulatory fitness decision: the skill explicitly reports computations only and cannot replace the quality unit or reviewers
  • Use with paywalled USP, CLSI or ISO thresholds: the skill does not supply that text, so numbers must come from an authorised copy
  • Clinical or patient-facing decisions based on unvalidated test results

Try asking

  • “Write a validation protocol for an HPLC assay of a drug product under ICH Q2(R2), with acceptance criteria set before testing”
  • “Check whether my calibration data across the range is linear using the response checker script”
  • “Evaluate a bioanalytical LC-MS/MS run against ICH M10 criteria for chromatographic assays”
  • “Compute detection and quantitation limits from my data by each allowed approach”
Step-by-step guide: how to use Analytical Method ValidationInstall, first run, examples, tips and FAQs

Install in 3 steps

  1. 1

    Download the skill

    The ZIP contains the 15 original files, the MIT licence and an attribution note.

    analytical-method-validation.zip
  2. 2

    Add it to your agent

    Claude Code (all projects)

    mkdir -p ~/.claude/skills && unzip analytical-method-validation.zip -d ~/.claude/skills/

    Claude Code / Agent SDK (this project only)

    mkdir -p .claude/skills && unzip analytical-method-validation.zip -d .claude/skills/

    Claude apps (web/desktop): Settings → Capabilities → Skills → Upload skill, and choose the ZIP.

  3. 3

    Ask for the task

    No special command needed — the agent reads the skill's description and loads it when your request matches. Try one of the prompts above.

Get better results

  • Tell the agent which framework governs your work before asking for a design, since the frameworks differ in required characteristics and criteria.
  • Set your acceptance criteria in writing before running the scripts, and keep the saved outputs with your records.
  • Use the --format json option and check exit codes (0, 1, 2) if you want to gate a workflow, and re-run older analyses because version 2.0 changed input rules.

What's inside

  • assets/validation-protocol-template.md
  • assets/validation-report-template.md
  • references/compendial-and-clsi.md
  • references/framework-selection.md
  • references/ich-m10-bioanalytical.md
  • references/ich-q2r2.md
  • references/source-ledger.md
  • references/statistics.md
  • scripts/_catalog.py
  • scripts/_common.py
  • scripts/check_accuracy_precision.py
  • scripts/check_bioanalytical_run.py
  • scripts/check_detection_limits.py
  • scripts/check_response.py
  • SKILL.md

Redistributed unmodified from K-Dense-AI/scientific-agent-skills under the MIT licence. The assessment was drafted with AI from the skill's files on 2026-10-29. Skills can instruct your agent to run code — read SKILL.md and any scripts before installing.