validation
Audit

Computer System Validation

QsutraIPQA v1.0 — Validation Package

VALIDATION STATUS
System: QsutraIPQA v1.0
Facility: Stratogene Pharma Pvt. Ltd.
Status: ✅ VALIDATED
Valid from: 01 Mar 2026
Valid until: 28 Feb 2027
Next review: 28 Feb 2027
Validated by: Rajesh Kumar (QA Manager)
Approved by: Amit Patel (Production Supervisor)
📋
Validation Master Plan
QST-VMP-001 · v1.0 · 01 Mar 2026
✅ APPROVED

Defines the scope, strategy, responsibilities and schedule for validation of QsutraIPQA v1.0.

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⚙️
Installation Qualification
QST-IQ-001 · v1.0 · 15 Mar 2026
✅ COMPLETED

Documents that QsutraIPQA v1.0 is correctly installed and configured per manufacturer specifications.

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🔬
Operational Qualification
QST-OQ-001 · v1.0 · 22 Mar 2026
✅ COMPLETED

Verifies that QsutraIPQA v1.0 operates as designed across all critical functions and workflows.

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✅
Performance Qualification
QST-PQ-001 · v1.0 · 01 Apr 2026
✅ COMPLETED

Confirms QsutraIPQA v1.0 performs consistently under actual production conditions.

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📄
CSV Summary Report
QST-CSV-001 · v1.0 · 15 Apr 2026
✅ APPROVED

Consolidated validation summary for regulatory submission. Covers IQ, OQ and PQ conclusions.

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Regulatory Basis
21 CFR Part 11Electronic Records & Electronic Signatures
21 CFR Part 211Current GMP for Finished Pharmaceuticals
CDSCO Schedule MGMP Requirements (2023)
EU GMP Annex 11Computerised Systems
GAMP 5Risk-Based Approach to Computerised Systems
Change Control Register
IDChangeDateStatus
CC-001Initial Release01 Mar 2026✅ Validated
CC-002Capsule Module01 May 2026✅ Validated
CC-003Liquids Module01 Jun 2026✅ Validated