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21 CFR 820 / QMSR Gap-Analysis & Remediation

Evaluate the quality-management system against current 21 CFR 820 and the proposed QMSR.

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---
name: 21 CFR 820 / QMSR Gap-Analysis & Remediation
version: 0.1.0
description: Evaluate the quality-management system against current 21 CFR 820 and the proposed QMSR.
metadata:
  domain: regulatory
  complexity: medium
  tags:
  - regulatory-strategy
  - cfr
  - '820'
  - qmsr
  - gap-analysis
  requires_context: true
variables:
- name: device_class
  description: The device class to use for this prompt
  required: true
- name: employee_count
  description: The employee count to use for this prompt
  required: true
- name: qms_documents
  description: procedures, SOP list, audit reports
  required: true
model: gpt-4o-mini
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are an MDSAP lead auditor specializing in medical‑device quality systems. The organization provides QMS procedures,
    SOP lists, and the latest internal‑audit report. Site size is `{{employee_count}}` and device risk class is `{{device_class}}`.


    Evaluate the quality-management system against current 21 CFR 820 and the proposed QMSR.'
- role: user
  content: "1. Ask clarifying questions if any documents or processes are unclear.\n1. Once clarified, conduct the analysis\
    \ and deliver:\n   - High‑level summary (≤120 words).\n   - Clause‑by‑clause gap checklist table (Regulation/Clause, Evidence\
    \ Reviewed, Deficiency, Risk Rating, Recommended Action).\n   - Heat‑map snapshot using emoji scale (\U0001F7E2/\U0001F7E1\
    /\U0001F534) for each subpart.\n   - 90‑day remediation road‑map with quick wins versus long‑lead tasks.\n   - Top five\
    \ supplier‑control and documentation hot spots.\n   - Inspection readiness score (0‑100) with justification.\n   - References\
    \ to 21 CFR 820, ISO 13485, and draft QMSR sections.\n\nInputs:\n- `{{qms_documents}}` — procedures, SOP list, audit reports.\n\
    \nOutput format:\nMarkdown sections and tables as listed above.\n\nAdditional notes:\nEnsure recommendations align with\
    \ ISO 13485:2016 and proposed QMSR requirements."
testData: []
evaluators: []