ClaudSkills / General / legal-compliance

Pharma Compliance

Quality score: 70/100  ·  Category: General  ·  Sub-category: legal-compliance
type:audit
Audit pharmaceutical regulatory compliance -- inspection readiness, CAPA system effectiveness, change control pipeline, data integrity (ALCOA+), and validation lifecycle tracking. Covers FDA 21 CFR 210/211, EU GMP Annexes, ICH Q7-Q12, WHO Prequalification, and PIC/S guidelines. Evaluates 483 observation history, SOP currency, equipment qualification, training matrices, and compliance gap remediation. Use when preparing for FDA or EMA inspection, assessing CAPA closure rates, evaluating change control backlogs, or auditing data integrity per 21 CFR Part 11.

What this skill does

Pharma Compliance is a production-ready Claude Code skill (quality score 70/100) in the legal-compliance sub-category. It ships as a SKILL.md file that Claude Code auto-discovers under ~/.claude/skills/pharma-compliance/ and loads when your prompt matches the skill's trigger.

When to invoke it: Use when preparing for FDA or EMA inspection, assessing CAPA closure rates, evaluating change control backlogs, or auditing data integrity per 21 CFR Part 11.

Who uses this skill

The Pharma Compliance skill is built for Claude Code users and developers across all disciplines looking for general-purpose AI assistance. It is part of the open ClaudSkills registry, a community-curated catalog of 15,000+ capabilities you can install for Claude Code — the Claude CLI agent.

How to install

Free

Manual install (2 steps)

mkdir -p ~/.claude/skills/pharma-compliance
curl -L https://claudskills.com/skills/pharma-compliance/SKILL.md \
  -o ~/.claude/skills/pharma-compliance/SKILL.md

Or just download SKILL.md directly and drop it into ~/.claude/skills/pharma-compliance/. Claude Code auto-discovers it on next session.

Skills live at ~/.claude/skills/pharma-compliance/SKILL.md on macOS/Linux, or %USERPROFILE%\.claude\skills\pharma-compliance\SKILL.md on Windows. See the full install guide for step-by-step instructions.

Pro

One-click install via the desktop app

The ClaudSkills desktop app installs any skill directly into ~/.claude/skills/ with one click — no terminal required. Pro starts at $9/mo or $149 lifetime.

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