Validation Reports & Audit Trail
Review completed test runs, apply QA approval signatures, and export 21 CFR Part 11 compliant reports
Test Runs
Empower CDS v3.6.2 Installation Qualification
Validation Report — Protocol IQ-EMPOWER-CDS-3.6-001 Rev. 2.0
100%
Pass Rate
run-2026-0525-003
Marcus Okafor
2026-05-25 09:00
2026-05-25 14:32
Waters ACQUITY UPLC H-Class
H16UPL001M
Greenfield Research Campus, Building 4
Analytical Development
15
Total Steps
14
Pass
0
Fail
1
N/A
Step Result Distribution
Step-by-Step Results
10 steps| # | Section | Test Step Title | Expected Result | Actual Result | Result | Evidence | Deviation | Executed By | Executed At |
|---|---|---|---|---|---|---|---|---|---|
| 01 | 1 | Verify Empower 3 software installation completes without errors | Installation wizard completes successfully. No error messages. Service "Empower 3 Service" running in Windows Services. | Installation completed successfully. Empower 3 Service confirmed running. No errors or warnings in installation log. | Pass | 3 | — | Marcus Okafor | 2026-05-25 09:18 |
| 02 | 1 | Verify correct software version is installed | Help > About displays version "Empower 3 Feature Release 4 SR1 (Build 3471.35)". | About dialog confirmed: Empower 3 Feature Release 4 SR1 (Build 3471.35). Version matches specification. | Pass | 1 | — | Marcus Okafor | 2026-05-25 09:24 |
| 03 | 2 | Verify Oracle database connection | Database connection test returns "Connection Successful". Database version Oracle 19c confirmed. | Connection successful. Oracle 19.3.0.0 confirmed. | Pass | 2 | — | Marcus Okafor | 2026-05-25 09:55 |
| 04 | 2 | Verify user accounts and roles created | All 3 user roles (Analyst, Manager, Admin) created with correct permissions per URS-0042. | All user roles confirmed in Administration panel with permissions matching URS-0042 specification. | Pass | 2 | — | Marcus Okafor | 2026-05-25 10:20 |
| 05 | 3 | Verify ACQUITY UPLC H-Class driver installation | Instrument driver v3.10.1 installed. Device appears in Empower instrument configuration. | Driver v3.10.1 installed and instrument detected in configuration. | Pass | 2 | — | Marcus Okafor | 2026-05-25 11:05 |
| 06 | 4 | Verify firewall and network port configuration | Required ports (1521, 5001, 8080) are open and accessible from client workstations. | All required ports confirmed open via network port scan. Client connectivity verified. | Pass | 1 | — | Marcus Okafor | 2026-05-25 11:40 |
| 07 | 4 | Verify SSL certificate installation | Valid SSL certificate installed. Certificate expiry > 12 months from installation date. | SSL certificate valid. Expiry: 2027-05-24. 364 days remaining. | Pass | 1 | — | Marcus Okafor | 2026-05-25 11:58 |
| 08 | 5 | Verify automated backup configuration | Backup schedule configured for daily at 02:00. Backup destination \\backup-server\empower confirmed accessible. | Backup schedule confirmed. Destination path accessible. Test backup completed successfully. | Pass | 2 | — | Marcus Okafor | 2026-05-25 12:30 |
| 09 | 5 | Verify backup restore procedure (N/A — restore lab not available) | Full restore completes within 4-hour RTO. | N/A — dedicated restore environment not available at this site. Covered under DR-TEST-2026-Q2. | N/A | — | — | Marcus Okafor | 2026-05-25 12:35 |
| 10 | 6 | Verify system configuration documentation is complete | System Configuration Specification document SCS-EMPOWER-001 v2.0 is filed and approved. | SCS-EMPOWER-001 v2.0 confirmed approved in document management system (DocTrack ID: DOC-4492). | Pass | 1 | — | Marcus Okafor | 2026-05-25 13:00 |
Electronic Signature Chain
Marcus Okafor
Validation Analyst II
2026-05-25 14:35
Signature Meaning
"I have performed the described test activities"
Reason
All IQ test steps executed per protocol. No deviations observed. System installation verified as per specification.
Sarah Chen
QA Manager
2026-05-26 10:12
Signature Meaning
"I have reviewed and approve this test run"
Reason
IQ protocol execution reviewed. All steps pass. No open deviations. Approved for OQ commencement.
Audit Trail
10 entriesAll timestamps in UTC · Secure hash verified