Qsutra IPQA — Audit-Ready In-Process Quality Assurance




Qsutra IPQA
US FDA · EMA · 21 CFR Part 11 ready
+91 80 40109783

● For Pharma & Medical Device Manufacturers

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

24/7Audit-ready records, always on
40%Faster line clearance*
0Transcription / 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

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.

“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
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

Qsutra® IPQA
A unit of Swajyot Technologies · 2002–2026 · +91 80 40109783


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