Operational Qualification Protocol
HelixOps Quality Management System - GxP Validation Documentation
1. Introduction #
This Operational Qualification (OQ) protocol verifies that the HelixOps system is correctly installed and configured according to the specifications defined in DS-HELIX-001.
OQ Purpose
OQ testing ensures the system operates within specified parameters in the installed environment, verifying installation, configuration, and security controls.
2. Test Scope #
Verify correct deployment of all system components
Verify system settings match specifications
Verify security controls are operational
3. Prerequisites #
Before Testing
- [ ] Test environment provisioned and isolated
- [ ] Test data loaded (non-production data only)
- [ ] Tester credentials created for all roles
- [ ] DS-HELIX-001 approved and available
- [ ] Test tools installed (browser, API client)
4. Installation Tests #
These tests verify that all system components are correctly installed and operational.
| Test ID | Test Name | Expected Result | Status | Tester | Date |
|---|---|---|---|---|---|
| OQ-INST-001 | Database Connection | PostgreSQL connection established | Pending | — | — |
| OQ-INST-002 | Application Server Start | Server starts on port 5000 | Pending | — | — |
| OQ-INST-003 | Frontend Build | React app builds without errors | Pending | — | — |
| OQ-INST-004 | Environment Variables | All required env vars present | Pending | — | — |
| OQ-INST-005 | Database Migration | All migrations applied successfully | Pending | — | — |
5. Configuration Tests #
These tests verify that system configuration matches the design specifications.
| Test ID | Test Name | Expected Result | Status | Tester | Date |
|---|---|---|---|---|---|
| OQ-CONF-001 | OIDC Provider Config | Authentication flow completes | Pending | — | — |
| OQ-CONF-002 | Session Timeout | 15-minute timeout enforced | Pending | — | — |
| OQ-CONF-003 | RBAC Configuration | Admin/Manager/Viewer roles functional | Pending | — | — |
| OQ-CONF-004 | Audit Logging | All actions logged with timestamp | Pending | — | — |
| OQ-CONF-005 | TLS Configuration | TLS 1.3 enforced | Pending | — | — |
6. Security Tests #
These tests verify that security controls are properly implemented and functional.
| Test ID | Test Name | Expected Result | Status | Tester | Date |
|---|---|---|---|---|---|
| OQ-SEC-001 | Authentication Required | Unauthenticated requests blocked | Pending | — | — |
| OQ-SEC-002 | Authorization Enforcement | Role-based access enforced | Pending | — | — |
| OQ-SEC-003 | SQL Injection Prevention | Parameterized queries used | Pending | — | — |
| OQ-SEC-004 | XSS Prevention | Output encoding applied | Pending | — | — |
| OQ-SEC-005 | CSRF Protection | CSRF tokens validated | Pending | — | — |
7. Test Summary #
Execution Summary
Test Protocol Approval
Electronic signatures are considered equivalent to handwritten signatures in accordance with 21 CFR Part 11 requirements.