INSTALLATION QUALIFICATION

Document No: QST-IQ-001

Version: 1.0

Status: COMPLETED ✅

IQ Date: 15 March 2026

Prepared by: Rajesh Kumar | QA Manager

Approved by: Amit Patel | Production Supervisor

Facility: Stratogene Pharma Pvt. Ltd.

Section 1: Purpose

This IQ protocol verifies that QsutraIPQA v1.0 is correctly installed, configured and documented per vendor specifications and facility requirements.

Section 2: System Installation Evidence

Item	Expected	Actual	Status
Application URL	ipqademo.qsutra.com	Confirmed	✅ PASS
Version	1.0	1.0	✅ PASS
Browser Support	Chrome ≥ 110	Chrome 124	✅ PASS
TLS Certificate	Valid	Valid (exp 2027)	✅ PASS
Data Residency	India (ap-south-1)	Confirmed	✅ PASS
Uptime SLA	≥ 99.5%	99.9%	✅ PASS

Section 3: Configuration Verification

Config Item	Setting	Status
User authentication	Username + Password	✅ PASS
Session timeout	30 minutes	✅ PASS
Audit trail	Enabled	✅ PASS
E-signatures	21 CFR §11.200 compliant	✅ PASS
SHA-256 hashing	Enabled	✅ PASS
NTP synchronisation	pool.ntp.org	✅ PASS
Data encryption	AES-256 at rest	✅ PASS

Section 4: User Role Configuration

Role	eBR	IPQA	Dev	CAPA	Audit	Valid
QA Manager	✅	✅	✅	✅	✅	✅
Production Supervisor	✅	✅	✅	✅	✅	❌
Solid Dosage Operator	✅	✅	❌	❌	❌	❌
Coating/Inspection Op	✅	✅	❌	❌	❌	❌
Packing Operator	✅	✅	❌	❌	❌	❌

Section 5: IQ Conclusion

All installation qualification criteria have been met. QsutraIPQA v1.0 is correctly installed and configured at Stratogene Pharma Pvt. Ltd. The system is approved to proceed to Operational Qualification (OQ).

IQ Status: ✅ COMPLETED — 15 March 2026

IQ Executed by

Name: Rajesh Kumar

Title: QA Manager

Date: 15 Mar 2026

IQ Approved by

Name: Amit Patel

Title: Production Supervisor

Date: 15 Mar 2026