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COMPUTER SYSTEM VALIDATION SUMMARY REPORT
Document No: QST-CSV-001
Version: 1.0
Status: APPROVED ✅
Report Date: 15 April 2026
Prepared by: Rajesh Kumar | QA Manager
Approved by: Amit Patel | Production Supervisor
Facility: Stratogene Pharma Pvt. Ltd.
Section 1: Executive Summary
QsutraIPQA v1.0 has been successfully validated at Stratogene Pharma Pvt. Ltd. per GAMP 5 risk-based approach and 21 CFR Part 11 requirements.
Validation Period: 01 March – 01 April 2026
System Status: ✅ VALIDATED
Valid Until: 28 February 2027
Next Review: 28 February 2027
Section 2: Validation Summary
| Phase | Document | Date | Result |
|---|---|---|---|
| VMP | QST-VMP-001 | 01 Mar 2026 | ✅ Approved |
| IQ | QST-IQ-001 | 15 Mar 2026 | ✅ Completed |
| OQ | QST-OQ-001 | 22 Mar 2026 | ✅ Completed (24/24) |
| PQ | QST-PQ-001 | 01 Apr 2026 | ✅ Completed |
| CSV | QST-CSV-001 | 15 Apr 2026 | ✅ Approved |
Section 3: 21 CFR Part 11 Compliance Matrix
| Requirement | Section | Implementation | Status |
|---|---|---|---|
| Validation | §11.10(a) | IQ / OQ / PQ documents | ✅ |
| Audit Trail | §11.10(e) | 120+ entries logged | ✅ |
| Access Control | §11.10(d) | 5 roles, RBAC enforced | ✅ |
| E-Signatures | §11.200 | 2-component (user + password) | ✅ |
| Signature Meaning | §11.50 | Legal statement on every signing | ✅ |
| Record Integrity | §11.10(e) | SHA-256 hash chain | ✅ |
| Time Stamps | §11.10(e) | NTP-verified UTC | ✅ |
Section 4: Deviations During Validation
No critical deviations were observed during the validation period. All minor observations were resolved and documented in the OQ deviation log.
Section 5: Conclusion and Certification
QsutraIPQA v1.0 is declared fully validated and compliant with:
- 21 CFR Part 11 (Electronic Records)
- 21 CFR Part 211 (cGMP)
- CDSCO Schedule M (Revised 2023)
- EU GMP Annex 11
- GAMP 5 Category 4
This system is approved for use in GxP-regulated manufacturing operations at Stratogene Pharma Pvt. Ltd.
Section 6: Signature Block
SYSTEM VALIDATED ✅
QA Manager
Name: Rajesh Kumar
Title: QA Manager
Date: 15 Apr 2026
Production Supervisor
Name: Amit Patel
Title: Production Supervisor
Date: 15 Apr 2026
QA Director (if applicable)
Name: —
Title: —
Date: —