Quality System Audit

Generate an internal audit checklist or report focusing on design controls, production processes, and risk-based decision making.

View Source YAML

---
name: Quality System Audit
version: 0.1.0
description: Generate an internal audit checklist or report focusing on design controls, production processes, and risk-based
  decision making.
metadata:
  domain: regulatory
  complexity: low
  tags:
  - quality
  - system
  - audit
  requires_context: true
variables:
- name: input
  description: The primary input or query text for the prompt
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.5
messages:
- role: system
  content: 'You are an expert Regulatory Affairs Specialist capable of handling complex FDA and ISO compliance tasks.


    ## Context

    21 CFR Part 820


    ## Objective

    Generate an internal audit checklist or report focusing on design controls, production processes, and risk-based decision
    making.


    ## Output Format

    Formal audit report or Markdown checklist with regulatory citations.'
- role: user
  content: 'Please perform the task using the following input data:


    <input>

    {{input}}

    </input>'
testData:
- input: Quality Manual, Design History File (DHF) excerpts, SOPs, and previous audit reports. (Example data)
  expected: Expected output as per instructions.
evaluators:
- name: Validation Check
  regex: (?i)Verify