GMP Pharmaceutical Compliance Self-Check

Problem

After pharma IT plans go live, they may still lack auditable GMP evidence: audit trails disabled, shared accounts, missing CSV documentation, CAPA not closed, and backups not rehearsed. Manual document reviews are slow and dependent on reviewer experience.

How It Works

The skill turns GMP compliance checking into a maintainable baseline plus rule-based scanning:
- The built-in baseline includes 10 compliance domains and 20 check items, covering ALCOA+, CSV, audit trails, e-signatures, batch traceability, change control, CAPA, and backup/recovery.
- review.py scans target text with keyword and rule matching, then outputs a coverage score, risk level, and remediation advice.
- generate_report.py can generate an HTML health-check report with a print button; webapp.py provides a self-service page where customers upload materials, generate reports, and leave lead information.
- Optionally, an OpenAI-compatible endpoint can perform semantic confirmation for missing or partially covered items, automatically falling back to pure rules if unavailable.

Boundaries

It is a keyword/substring rule scanner, not a general LLM reviewer: if a document uses alternate terminology not present in the baseline keyword list, items may be missed. Accepted input is limited to .txt and .md, with a 3MB per-upload limit. webapp.py is a lightweight service without login or database, so public deployment requires HTTPS, access control, rate limiting, and privacy notices. The baseline can be extended per customer, with an independent gmp_requirements.md for each account.