HelixOps Validation
PQ PQ-HELIX-001

Performance Qualification Protocol

HelixOps Quality Management System - GxP Validation Documentation

Version: Draft v0.1
Effective: January 2025
Status: Draft
Author
HelixOps Team
Reviewer
QA Lead
Approver
Quality Assurance

1. Introduction #

This Performance Qualification (PQ) protocol verifies that the HelixOps system performs as expected under real-world operating conditions. It validates that all functional requirements from FS-HELIX-001 are met.

PQ Purpose

PQ testing confirms that the system consistently performs according to its specifications under normal operating conditions with typical user scenarios.

16
Total Tests
4
Categories
60+
Requirements
0%
Complete

2. Test Scope #

1 Functional Testing

  • • GRC module operations
  • • Privacy module operations
  • • Audit trail verification
  • • Data export functions

2 Workflow Testing

  • • Approval workflows
  • • Multi-stage processes
  • • Task management
  • • Escalation handling

3 Integration Testing

  • • Cross-module data flow
  • • API integrations
  • • Authentication flow
  • • External system interfaces

4 Performance Testing

  • • Response time validation
  • • Concurrent user testing
  • • Large data set handling
  • • Stress testing

3. Functional Tests #

These tests verify core system functionality against the functional specifications.

Test ID Test Name Description Traces To Status
PQ-FUNC-001 Risk Creation Create risk with all required fields FUNC-RISK-001 Pending
PQ-FUNC-002 Risk Score Calculation Verify auto-calculated risk score FUNC-RISK-002 Pending
PQ-FUNC-003 Risk Heat Map Display Verify risks shown on heat map FUNC-RISK-003 Pending
PQ-FUNC-004 Control Creation Create control linked to risk FUNC-CTRL-001 Pending
PQ-FUNC-005 DPIA Workflow Execute complete DPIA workflow BUS-REQ-201 Pending
PQ-FUNC-006 DSAR Processing Process DSAR request end-to-end BUS-REQ-220 Pending
PQ-FUNC-007 Audit Log Generation Verify audit entries created BUS-REQ-007 Pending
PQ-FUNC-008 Report Export Export report to PDF/CSV BUS-REQ-014 Pending

4. Workflow Tests #

These tests verify end-to-end workflow execution across multiple system components.

1
PQ-WF-001 Risk Approval Workflow

Submit risk for approval, approve, verify status change

Pending
2
PQ-WF-002 DPIA Multi-Stage Approval

Execute DPIA through all approval stages

Pending
3
PQ-WF-003 Task Assignment & Completion

Assign task, complete, verify Action Center update

Pending
4
PQ-WF-004 Escalation Workflow

Verify overdue task escalation

Pending

5. Integration Tests #

These tests verify data flow and integration between system modules.

Test Scenario: Risk-to-Control Linkage

Create Risk → Create Control → Link Control to Risk → Verify Linkage → Audit Trail

Test Scenario: Cross-Module Compliance

DPIA Created → Risk Identified → Control Required → Task Created → Compliance Mapped

6. Performance Tests #

These tests verify system performance meets the specifications under various load conditions.

Test ID Test Name Target Actual Status
PQ-PERF-001 Page Load Time <2 seconds (P95) — Pending
PQ-PERF-002 API Response Time <500ms (P95) — Pending
PQ-PERF-003 Concurrent User Load 100 users without degradation — Pending
PQ-PERF-004 Large Data Set Query 50,000 records <3 seconds — Pending
<2s
Page Load Target
<500ms
API Response Target
100
Concurrent Users
99.5%
Uptime Target

7. Test Summary #

Execution Summary

16
Total Tests
0
Passed
0
Failed
16
Pending
0
Deviations
Test Environment: Production-like
Test Data: Synthetic (non-PHI)
Execution Start: —
Execution End: —

Release Criteria

  • [ ] All critical tests passed
  • [ ] No unresolved critical deviations
  • [ ] Performance targets met
  • [ ] Test summary approved by QA
  • [ ] Release authorization signed

Test Protocol Approval

Executed By
Signature
QA Tester
Quality Assurance
Reviewed By
Signature
QA Lead
Quality Management
Approved By
Signature
QA Manager
Quality Assurance

Electronic signatures are considered equivalent to handwritten signatures in accordance with 21 CFR Part 11 requirements.