Qsutra IPQA
US FDA · EMA · 21 CFR Part 11 ready
+91 80 40109783
Be audit-ready 24/7 — without the paper, the panic, or the data-integrity findings.
Qsutra IPQA digitises in-process checks, line clearance and BMR/BPR on the shop floor — so every record is traceable, ALCOA+ compliant, and inspection-ready the moment an auditor walks in.
- Eliminate manual logbooks and transcription errors
- Cut line-clearance time with guided digital workflows
- Real-time alerts the moment a process drifts out of spec
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See how it works
Trusted across regulated manufacturing since 2002 · No obligation · 30-minute walkthrough
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Built to satisfy the regulators you answer to
ALCOA+
21 CFR Part 11
ISPE GAMP 5
WHO-GMP
ISO / IATF 16949
40%Faster line clearance*
0Transcription / paper errors
20+Years in regulated manufacturing
From paper-driven firefighting to a controlled, traceable line
Most quality teams still discover problems after the batch. Qsutra IPQA catches them as they happen.
📋 Without Qsutra IPQA
- Manual logbooks, illegible entries, missing signatures
- Deviations found at batch review — too late to fix
- Scramble to assemble records before every audit
- Data-integrity observations and 483 risk
- Line clearance delays holding up production
✅ With Qsutra IPQA
- Guided digital checks with enforced sequence & e-signatures
- Real-time alerts the instant a parameter drifts
- Every record retrievable in seconds, audit-ready
- Closed system, Zero-Trust e-records, full ALCOA+
- Faster, documented line clearance on the shop floor
Everything your IPQA function needs, in one platform
Automated Data Capture
Manual, semi-automated or fully automated entry from gauges, scales and instruments — with ERP/database integration.
Real-Time Monitoring
Live charts and dashboards flag out-of-spec conditions instantly, so the shop floor can act before defects occur.
Data Integrity & Traceability
Closed, Zero-Trust system for e-records and e-signatures. Meets ALCOA+, GMP and ISO/IEC 17025 expectations.
Smart Workflows
Standardised, enforced inspection rules and process workflows tailored to your line and your SOPs.
Smart Alerts
Instant, relevant notifications for every IPQA task — nothing slips, nothing is forgotten.
Governance & Reporting
KPI dashboards across shifts, people and processes — reduce variability, scrap and the cost of quality.
Head of Quality Assurance
Leading Indian pharmaceutical manufacturer*
40%reduction in line-clearance time
Zerodata-integrity observations since go-live
100%of IPQA records retrievable on demand
*Illustrative — replace with a verified, named or anonymised customer result.
Ready to make your next audit a non-event?
Book a free 30-minute walkthrough. We’ll map Qsutra IPQA to your line, your SOPs and your regulators.
Book a Free Demo
No obligation
Tailored to your facility
30 minutes