IQ/OQ/PQ Validation

Design and execute a series of IQ, OQ, and PQ validation tests for clinical systems.

View Source YAML

---
name: IQ/OQ/PQ Validation
version: 0.1.0
description: Design and execute a series of IQ, OQ, and PQ validation tests for clinical systems.
metadata:
  domain: clinical
  complexity: high
  tags:
  - eclinical-integration
  - validation
  requires_context: false
variables:
- name: cdms_specs
  description: 'Validation tests: `{{validation_tests}}`'
  required: true
- name: crf_draft
  description: The crf draft to use for this prompt
  required: true
- name: dmp
  description: 'Clinical Protocol: `{{protocol}}`'
  required: true
- name: protocol
  description: 'CRF Design Draft: `{{crf_draft}}`'
  required: true
- name: validation_tests
  description: 'Clinical Data Management Plan (DMP): `{{dmp}}`'
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: You are a Clinical Systems Validation Specialist. Perform Installation Qualification (IQ), Operational Qualification
    (OQ), and Performance Qualification (PQ) for clinical systems and verify that the CRF captures data as specified in the
    protocol. Ensure compliance with 21 CFR Part 11, ICH GCP E6(R2), and FDA IQ/OQ/PQ Standards.
- role: user
  content: 'Design and execute a series of IQ, OQ, and PQ validation tests for the new CDMS and compare CRF fields against
    the protocol to ensure all required endpoints and variables are captured.


    Inputs:

    - Clinical Data Management System (CDMS) specifications: `{{cdms_specs}}`

    - Validation tests: `{{validation_tests}}`

    - Clinical Data Management Plan (DMP): `{{dmp}}`

    - Clinical Protocol: `{{protocol}}`

    - CRF Design Draft: `{{crf_draft}}`


    Output format:

    Markdown Validation Report with sections for IQ, OQ, PQ, and CRF Verification.'
testData:
- input: 'cdms_specs: "Version 2.0"

    validation_tests: "Test Case 1: Login"

    dmp: "DMP v1"

    protocol: "Protocol A"

    crf_draft: "CRF v0.9"

    '
  expected: 'Validation Report

    '
evaluators:
- name: IQ Section
  string:
    contains: Installation Qualification
- name: OQ Section
  string:
    contains: Operational Qualification
- name: PQ Section
  string:
    contains: Performance Qualification