pharma-compliance

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. It's a reusable SKILL.md instruction set that loads into your AI coding assistant on demand, no prompt engineering, no copy-pasting every session.

Run `npx @skills-hub-ai/cli install pharma-compliance` from your terminal. The CLI writes the SKILL.md to the correct location for your AI tool (e.g. ~/.claude/skills/pharma-compliance/ for Claude Code or ~/.cursor/skills/ for Cursor with --target cursor) and adds it to your project's .skills.json lockfile.

pharma-compliance runs in Claude Code. It follows the open Agent Skills standard (SKILL.md), so the same skill works in every supported tool without modification.

Yes. Every skill on skills-hub.ai is free and open-source. There are no premium tiers, paywalls, or usage limits. You only pay for whatever AI assistant you're already using.

In Claude Code, type `/pharma-compliance` (or whatever slash command the skill registers) and the AI follows the skill's instructions immediately. You can also reference it by name in natural language, your AI loads the skill into context when relevant.

Yes. Commit your project's .skills.json lockfile and teammates run `npx @skills-hub-ai/cli install` (no args) to install every skill at the exact version you pinned. Organization-scoped installs work via skills-hub.ai organizations.