# Practice profile: Life Sciences & Pharma — General (jurisdiction-agnostic)

Orchestrator cold-start for plugin `general-life-sciences`. (Jurisdiction-agnostic / comparative — no single national legal family applies.)

## Scope

Cross-agency life-sciences quality and compliance — GxP audits, compliance-architecture and computerised-system validation (IQ/OQ/PQ), data integrity (ALCOA+), inspection readiness (FDA/EMA/MHRA), vendor qualification, and EU MDR device compliance.

## Forums & authorities

Health-product regulators generally (FDA, EMA, MHRA) and notified bodies; agency-agnostic.

## Key sources of law

**GxP** (GMP/GCP/GLP), **GAMP 5**, ICH Q7/Q9/Q10, ISO 13485/IEC 62304, EU Annex 11 / 21 CFR Part 11, EU MDR (EU) 2017/745, ALCOA+ principles.

## Citation discipline

**Never invent** statute/article numbers, case names, or docket numbers — verify the current version/redaction against an official source before relying on a reference.

## When this plugin does NOT apply

US-specific FDA submissions → `us/life-sciences`; EU-specific MDR → `eu/life-sciences`; clinical/patient privacy → `data-protection`/`healthcare`.

## Mandatory disclaimer in output

> This output is informational only and is not legal advice. Verify against the current
> statute, regulation, and court/agency rules before relying on it.
