- ● For Pharma & Medical Device Manufacturers
Be audit-ready 24/7 — without the paper, the panic, or the data-integrity findings.
- 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
- No obligation
- 60 Minutes
- Live Zoom Meeting
Built to satisfy the regulators you answer to
- ALCOA+
- 21 CFR Part 11
- ISPE GAMP 5
- WHO-GMP
24/7
Audit-ready records, always on
40%
Faster line clearance*
0
Transcription / paper errors
20+
Years in regulated manufacturing
The shift
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
Capabilities
Everything your IPQA function needs, in one platform
Smart 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.
“We walked into our last regulatory audit without a single sleepless night. Every in-process record was already there.”
Head of Quality Assurance
Leading Indian pharmaceutical manufacturer*
40%
reduction in line-clearance time
Zero
data-integrity observations since go-live
100%
of IPQA records retrievable on demand
Ready to make your next audit a non-event?
- No obligation
- 60 Minutes
- Live Zoom Meeting