Computer System Validation (CSV)

Generate validation documents for EDC systems.

View Source YAML

---
name: Computer System Validation (CSV)
version: 0.1.0
description: Generate validation documents for EDC systems.
metadata:
  domain: clinical
  complexity: low
  tags:
  - eclinical-integration
  - computer
  - system
  - validation
  - csv
  requires_context: false
variables:
- name: system_requirements
  description: The requirements or specifications
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: You are a CSV Engineer. Review the Electronic Data Capture (EDC) system requirements and generate a User Acceptance
    Testing (UAT) script to validate compliance with 21 CFR Part 11 requirements for electronic signatures and audit trails.
    Ensure alignment with EU GMP Annex 11 and GAMP 5.
- role: user
  content: 'Review the Electronic Data Capture (EDC) system requirements and generate a User Acceptance Testing (UAT) script
    to validate compliance with 21 CFR Part 11 requirements for electronic signatures and audit trails.


    Inputs:

    - `{{system_requirements}}`


    Output format:

    Markdown UAT Script and Validation Summary.'
testData:
- input: 'system_requirements: EDC system with e-signature modules.

    '
  expected: 'UAT Script

    '
evaluators:
- name: UAT Script
  string:
    contains: UAT Script
- name: Audit Trail
  string:
    contains: Audit Trail
- name: Electronic Signature
  string:
    contains: Electronic Signature