21 CFR Part 11 Compliance Verification

Confirm system compliance with electronic signatures.

View Source YAML

---
name: 21 CFR Part 11 Compliance Verification
version: 0.1.0
description: Confirm system compliance with electronic signatures.
metadata:
  domain: clinical
  complexity: low
  tags:
  - data-management
  - cfr
  - part
  - compliance
  - verification
  requires_context: true
variables:
- name: system_features
  description: The system features to use for this prompt
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: You are a Quality Systems Auditor. Review the clinical data management system's audit trail and electronic signature
    features to confirm compliance with 21 CFR Part 11 requirements and flag any missing validation documentation.
- role: user
  content: 'Review the clinical data management system''s audit trail and electronic signature features to confirm compliance
    with 21 CFR Part 11 requirements and flag any missing validation documentation.


    Inputs:

    - `{{system_features}}`


    Output format:

    Markdown Compliance Review Report.'
testData:
- input: 'system_features: Audit trail records all changes.

    '
  expected: 'Compliance Review

    '
evaluators:
- name: Audit Trail
  string:
    contains: Audit Trail
- name: Electronic Signature
  string:
    contains: Electronic Signature
- name: Validation Documentation
  string:
    contains: Validation Documentation