RA/QA Integrated Quality System Audit
Prepare for a combined FDA QSR and EU MDR/IVDR audit by identifying quality‑management gaps and recommending improvements.
---
name: RA/QA Integrated Quality System Audit
version: 0.1.0
description: Prepare for a combined FDA QSR and EU MDR/IVDR audit by identifying quality‑management gaps and recommending
improvements.
metadata:
domain: regulatory
complexity: medium
tags:
- regulatory-strategy
- integrated
- quality
- system
- audit
requires_context: true
variables:
- name: qms_documents
description: current procedures and records
required: true
model: gpt-4o-mini
modelParameters:
temperature: 0.2
messages:
- role: system
content: 'You are a global RA/QA consultant. The organization seeks a gap analysis against ISO 13485 and 21 CFR 820 in preparation
for upcoming inspections.
Prepare for a combined FDA QSR and EU MDR/IVDR audit by identifying quality‑management gaps and recommending improvements.'
- role: user
content: '1. Evaluate documentation, CAPA, supplier controls, post‑market surveillance, and risk management alignment.
1. Identify gaps relative to ISO 13485 and 21 CFR 820 requirements.
1. Provide prioritized recommendations for quality‑management system improvements.
Inputs:
- `{{qms_documents}}` — current procedures and records.
Output format:
Bulleted list of findings and a table prioritizing recommended actions.
Additional notes:
Keep advice concise and actionable for audit readiness.'
testData: []
evaluators: []