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Pharma Compliance

Category: General  ·  Sub-category: legal-compliance  ·  Last updated:
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.
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From the source SKILL.md

You are an autonomous pharmaceutical compliance analyst. Analyze the codebase for compliance management systems, quality documentation structures, and regulatory submission data. Do NOT ask the user questions. Produce a comprehensive compliance assessment.

What this skill does

Pharma Compliance is a community-contributed Claude Code skill 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 Claude Code skill is built for Claude Code users and developers across all disciplines looking for general-purpose AI assistance. It's part of ClaudSkills (also referred to as Claude Skills or Claude Code Skills) — the open community-curated registry of 146,000+ SKILL.md files for Anthropic's Claude Code agent and the wider Claude ecosystem (Claude API, Claude Agent SDK).

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.

Telegram

📱 Install from your phone or desktop Telegram

Open @claudskills_bot on Telegram, tap Open Desktop App, and the desktop app installs this skill for you. Or share the bot link with a colleague — they get the same one-tap install. Learn more →

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.

Pro

For the full experience including quality scoring and one-click install features for each skill — upgrade to Pro.

See pricing → Download desktop app

Frequently asked questions

How do I install the Pharma Compliance Claude Code skill?
Install via the ClaudSkills desktop app (one click) or copy SKILL.md from the source repository to ~/.claude/skills/pharma-compliance/SKILL.md and restart Claude Code. Both flows are detailed at claudskills.com/install/.
What does the Pharma Compliance skill do?
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.
Is this skill free to install?
Yes. ClaudSkills is an open registry — every skill keeps its source repository's license, and manual install via copy is free. ClaudSkills Pro ($9/mo, $79/yr, or $149 one-time) adds one-click install via the desktop app and a multi-signal Quality Score.
When should I use the Pharma Compliance skill?
Use Pharma Compliance when your Claude Code task falls under the General category — specifically in the legal compliance area. Claude Code auto-discovers installed skills and invokes the right one based on the task description, so you can also ask Claude directly (e.g. "use Pharma Compliance" or describe the task and let Claude pick). Browse related skills at /category/general/.
What is a Claude Code skill and how does the Pharma Compliance skill fit in?
A Claude Code skill is a SKILL.md file that lives under ~/.claude/skills/<name>/ and tells the Claude Code CLI agent how to perform a specific task (instructions, prompts, allowed tools). Skills are auto-discovered at session start. Pharma Compliance is one of 67,000+ skills indexed in the open ClaudSkills catalog, classified under the General category. Learn more at /learn/what-is-a-claude-skill/.

Cite this skill

If you reference this skill in a blog post, paper, or documentation, you can cite it as:

APA
ClaudSkills. (2026). Pharma Compliance [Claude Code skill]. ClaudSkills. https://claudskills.com/skills/pharma-compliance/
BibTeX
@misc{pharma-compliance-2026,
  author    = {ClaudSkills},
  title     = {Pharma Compliance [Claude Code skill]},
  year      = {2026},
  publisher = {ClaudSkills},
  url       = {https://claudskills.com/skills/pharma-compliance/}
}

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Grade A · scanned 2026-07-06 — free static scan against the OWASP Agentic Skills Top 10.

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