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For Pharma Manufacturers

Continuous audit-readiness across every shift, every line, every site.

Built for QA, Plant Managers, Heads of Operations, and Compliance. Yuktra turns SOPs, deviation history, and tribal knowledge into cited, real-time answers for your operators — so every shift executes like your best shift.

  • Deploy air-gapped in 4 weeks
  • 21 CFR Part 11 · EU GMP Annex 11
  • Validation pack included
The Knowledge Gap

The knowledge gap is costing pharma millions — every shift.

The best operators know where to look. The rest guess — and the cost shows up in deviations, overdue CAPAs, and observations no one meant to earn.

01 · CAPA
6–8wk
Average CAPA closure time

Most overdue actions are knowledge-retrieval failures, not analysis failures.

02 · Deviations
40%
of deviations are repeat offenses

Tribal knowledge never made it to the SOP. The same failure happens on the next shift.

03 · Audit cost
$1M+
Average cost of one 483 observation

Audit-readiness is a daily discipline, not a quarterly project.

04 · Productivity
70%
Operator time lost to document search

Manuals are 500 pages. Shifts are 8 hours. The math never worked.

Why Yuktra works

Eight reasons pharma & life-sciences teams choose Yuktra.

Every capability is designed against the same bar: safe for GxP, fast on the floor, and verifiable in an audit.

01

GxP-compliant by design

Aligned to 21 CFR Part 11, EU GMP Annex 11, and GAMP 5 — built for validated environments, not retrofitted.

02

Real-time execution intelligence

Step-by-step guided workflows on the line — no more paper SOPs, tribal shortcuts, or blind deviations.

03

Multilingual & multi-device

Voice & text in 15+ languages. Works on phone, tablet, industrial PC, and AR headset. Same answer, everywhere.

04

Cited, traceable answers

Every response traces to a specific SOP, manual page, or batch record. No hallucination. Inspector-ready.

05

On-prem & air-gapped

Deploy on a single industrial PC, in private cloud, or fully air-gapped. Your IP never leaves your perimeter.

06

Tribal knowledge, captured

Converts senior-operator know-how into structured, searchable workflows before it walks out the door.

07

Faster CAPA & deviations

Root-cause hints, precedent cases, and draft CAPAs surfaced in minutes — not weeks of back-and-forth.

08

Always audit-ready

Tamper-evident audit trail, e-signatures, version control — Part 11 compliant out of the box.

What customers measure

Outcomes pharma buyers actually care about.

Each number below comes from a live deployment. Numbers are current through 2026 Q1.

81%
Faster CAPA closure

Across pilot deployments, 2024–2025.

78%
First-pass batch release rate

Measured across 3 WHO-GMP sites.

48hr
Change-control approval

Down from a multi-week average.

85%
Reduction in L1 OEM calls

Yuktra EQ deployment, European OEM, Q1 2025.

Voices from the floor

What pharma and OEM teams say after 90 days with Yuktra.

We turned 12,000 pages of OEM manuals into a one-question answer for our line operators. CAPA closure went from weeks to days.
Head of QA
Top-10 Indian formulations CDMO
Our field engineers used to spend half their visit re-explaining things the manual already covered. Yuktra deflected 80%+ of L1 questions in the first quarter.
VP Customer Service
European packaging-line OEM
For the first time, a Hindi-speaking operator on night shift can ask a question and get the same answer the day-shift senior would give. That is what audit-readiness actually looks like.
Plant Director
WHO-GMP sterile facility, India
Questions pharma teams ask first

The answers your QA, IT, and validation leads want up-front.

How do you handle hallucination risk in a regulated environment?

Yuktra answers are source-grounded: the model can only compose responses from indexed content inside your perimeter, and every answer carries a citation to the exact document and section. When a question falls outside the indexed corpus, Yuktra says so explicitly rather than guessing.

Is Yuktra a validated system or a supporting tool?

Yuktra classifies as a GAMP 5 Category 4 configurable product. We provide a validation pack (URS/FS/IQ/OQ/PQ templates, traceability matrix, risk assessment) and support customer-side validation. Configuration changes follow controlled change management.

How is Yuktra deployed — cloud, on-prem, or air-gapped?

All three. Air-gapped deployments run on a single industrial PC at the line, with no outbound connectivity. On-prem runs inside your data center or private cloud. Managed cloud is hosted in your region of choice, with your data isolated per tenant. Your data never trains our models.

Which languages does Yuktra support on the floor?

English, Hindi, Marathi, Telugu, Tamil, Gujarati, Bengali, Punjabi, Spanish, Portuguese, Mandarin, Arabic, French, German, Italian, Polish, Japanese, and Korean. Operators can ask in their language while the underlying SOP text remains validated in English.

What integrations are supported?

Out-of-the-box connectors for SharePoint, Documentum, Veeva Vault QualityDocs, TrackWise, MasterControl, SAP, and common MES platforms (Rockwell PharmaSuite, Körber PAS-X, Emerson Syncade, Siemens Opcenter). New connectors can be added in 2–3 weeks.

Ready when you are

Make audit-readiness a daily default.

See a cited Yuktra answer on a real SOP — yours or ours — in 30 minutes.

Request a demo