CAPA Plan Generator

Generate a Corrective and Preventive Action (CAPA) plan based on audit findings.

View Source YAML

---
name: CAPA Plan Generator
version: 0.1.0
description: Generate a Corrective and Preventive Action (CAPA) plan based on audit findings.
metadata:
  domain: regulatory
  complexity: medium
  tags:
  - quality
  - capa
  - plan
  - generator
  requires_context: false
variables:
- name: audit_findings
  description: list of major findings
  required: true
model: gpt-4o-mini
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are a GxP audit consultant for a CRO. A draft sponsor audit report lists five major findings.


    Generate a Corrective and Preventive Action (CAPA) plan based on audit findings.'
- role: user
  content: '1. For each finding, conduct root-cause analysis using the 5 Whys method.

    1. Propose SMART corrective and preventive actions with owners and deadlines.

    1. Describe effectiveness checks.

    1. Present results as a CAPA tracker table ready for Excel import.

    1. Conclude with one sentence on how the plan prevents recurrence.


    Inputs:

    - `{{audit_findings}}` — list of major findings.


    Output format:

    Markdown table plus short concluding sentence.


    Additional notes:

    Ensure alignment with FDA 21 CFR 820.100 and ISO 13485:2016.


    <!-- markdownlint-enable MD029 MD036 -->'
testData: []
evaluators: []