VALIDATION MASTER PLAN

1.1 Purpose
This Validation Master Plan (VMP) defines the strategy, scope, responsibilities and schedule for the validation of QsutraIPQA v1.0 at Stratogene Pharma Pvt. Ltd., Bengaluru.

QsutraIPQA is a computerised system used for In-Process Quality Assurance (IPQA) across solid dosage (tablet and capsule) and liquid manufacturing operations.

1.2 Scope
This VMP covers:

• Computer System Validation (CSV) per GAMP 5
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• 21 CFR Part 11 compliance assessment
• CDSCO Schedule M compliance assessment

This VMP does not cover:

• Infrastructure validation (servers, network) — covered in separate infrastructure qualification documents.
• User access control procedures — covered in SOP-IT-022.

2.1 System Overview

2.2 System Functions
QsutraIPQA supports the following GxP functions:

• Electronic Batch Records (eBR)
• In-Process Quality Checks (IPQA)
• Deviation Management
• CAPA Workflow
• Audit Trail (21 CFR Part 11 compliant)
• Electronic Signatures (21 CFR §11.200)
• Audit Readiness Management (CDSCO / FDA / EMA)
• Statistical Process Control (SPC)
• Traceability and Recall Management

2.3 User Roles

3.1 Risk-Based Approach
Validation activities are risk-based per GAMP 5. QsutraIPQA is classified as Category 4 (Configured Software) — vendor-supplied with facility-specific configuration.

Risk Classification:

• Critical Functions: eBR, e-signatures, audit trail, IPQA checks
• Major Functions: Deviation, CAPA, SPC
• Minor Functions: Reporting, dashboards

3.2 Validation Lifecycle

• Phase 1: Planning — VMP (this document)
• Phase 2: IQ — Installation verification
• Phase 3: OQ — Functional testing
• Phase 4: PQ — Performance under load
• Phase 5: Report — CSV Summary Report

3.3 Acceptance Criteria

• All critical function tests: 100% pass rate
• Major function tests: ≥95% pass rate
• No critical or major defects at release

Version History