Stratogene Pharma
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OPERATIONAL QUALIFICATION
Document No: QST-OQ-001
Version: 1.0
Status: COMPLETED ✅
OQ Date: 16–22 March 2026
Prepared by: Rajesh Kumar | QA Manager
Approved by: Amit Patel | Production Supervisor
Facility: Stratogene Pharma Pvt. Ltd.
Section 1: Purpose
This OQ protocol verifies that QsutraIPQA v1.0 operates as designed for all critical functions under defined operating conditions.
Section 2: OQ Test Summary
Total tests
24
Passed
24
Failed
0
Pass rate
100%
Section 3: Critical Function Tests (12)
| Test ID | Function | Description / Expected | Result |
|---|---|---|---|
| OQ-001 | eBR Creation | Create and save an eBR for a tablet batch. Expected: eBR saved, audit trail updated. | ✅ PASS |
| OQ-002 | E-Signature — First Signing | Complete a two-component e-signature (username + password). Expected: signature recorded with timestamp. | ✅ PASS |
| OQ-003 | E-Signature — 21 CFR §11.200 | Verify e-signature includes legal meaning, NTP timestamp and user identity. Expected: all three present. | ✅ PASS |
| OQ-004 | Audit Trail Integrity | Modify a saved check and verify audit trail records the change with user + time. Expected: original preserved. | ✅ PASS |
| OQ-005 | SHA-256 Record Integrity | Verify closed batch eBR SHA-256 hash matches independently computed value. Expected: hashes match. | ✅ PASS |
| OQ-006 | Deviation Workflow | Raise a deviation, assign CAPA, close CAPA. Expected: full workflow completes, audit logged. | ✅ PASS |
| OQ-007 | Role-Based Access Control | Verify Operator cannot access Audit Mode. Expected: Audit Mode hidden from Operator. | ✅ PASS |
| OQ-008 | IPQA Check Entry | Record an in-process check with OOS value. Expected: FAIL status, deviation prompted. | ✅ PASS |
| OQ-009 | Batch Closure — Quality Gate | Close a batch with 100/100 quality score. Expected: release approved, eBR sealed. | ✅ PASS |
| OQ-010 | Batch Closure — Hold | Attempt closure with OOS check present. Expected: closure blocked, hold required. | ✅ PASS |
| OQ-011 | Multi-Format Support | Verify Tablet, Capsule, Liquid eBRs render correctly with format-specific content. Expected: all 3 formats render. | ✅ PASS |
| OQ-012 | Audit Readiness Score | Verify CDSCO audit score updates when inspection gap increases. Expected: score reflects 85-day gap. | ✅ PASS |
Section 4: Major Function Tests (12)
| Test ID | Function | Result |
|---|---|---|
| OQ-013 | SPC Cpk computation | ✅ PASS |
| OQ-014 | Recall simulation | ✅ PASS |
| OQ-015 | Traceability genealogy | ✅ PASS |
| OQ-016 | Production overview charts | ✅ PASS |
| OQ-017 | CPV trending | ✅ PASS |
| OQ-018 | Machine state tracking | ✅ PASS |
| OQ-019 | Per-check approval workflow | ✅ PASS |
| OQ-020 | SHA-256 audit chain | ✅ PASS |
| OQ-021 | Golden batch analyser | ✅ PASS |
| OQ-022 | Batch statistics by state | ✅ PASS |
| OQ-023 | Approval queue | ✅ PASS |
| OQ-024 | PDF export | ✅ PASS |
Section 5: OQ Conclusion
All 24 operational qualification tests passed with a 100% pass rate. QsutraIPQA v1.0 operates as designed. The system is approved to proceed to Performance Qualification (PQ).
OQ Status: ✅ COMPLETED — 22 March 2026
OQ Executed by
Name: Rajesh Kumar
Title: QA Manager
Date: 22 Mar 2026
OQ Approved by
Name: Amit Patel
Title: Production Supervisor
Date: 22 Mar 2026