Seven purpose-built modules. One compliant AI core.
Every YuktraOS module shares the same cited reasoning, audit trail, e-signature, and validation pack. Turn them on individually, or run the full stack on-prem — the compliance story is identical.
Your SOPs — cited, searchable,in the operator’s language.
Yuktra IQ parses every SOP, specification, and batch record into source-grounded, Part 11-compliant answers. No hallucinations. No out-of-date copies. No language barriers.
- Ingests SOPs, specs, and batch records — no re-authoring
- Answers operator questions in 18+ languages with citations
- Writes a tamper-evident log for every interaction
Source-grounded answers
Every answer cites the exact SOP, section, and paragraph. If the content isn't indexed, Yuktra says so.
Multilingual input, validated output
Ask in Hindi, Marathi, Spanish, Mandarin — the answer cites the English SOP that remains the source of truth.
E-signed execution
When a step is executed from a Yuktra answer, an e-signature and comment are written to the audit trail.
Version-controlled content
New SOP approved? Yuktra flags superseded content, publishes the update, and pushes microlearning to affected roles.
Connector ecosystem
SharePoint, Documentum, Veeva Vault, TrackWise, MasterControl, SAP — index without copying files.
Part 11 by default
Audit trail, user attribution, e-signature and tamper-evidence enabled on day one. Validation pack included.
OEM manuals — deployable on a single industrial PC at the line.
Yuktra EQ turns OEM manuals, schematics, and troubleshooting guides into an on-prem co-pilot for your equipment. Deflect Tier-1 support. Keep every byte inside the plant perimeter.
- Ingests PDFs, schematics, CAD metadata — no cloud dependency
- Troubleshooting with decision-tree guardrails
- Back-feeds gaps to your OEM engineering team
Troubleshooting with guardrails
Decision trees built from the manual ensure the operator never skips a safety step — and never gets an invented answer.
Single-PC, air-gapped deployment
Runs on one industrial PC at the line. No outbound network. Your data never leaves your perimeter.
Schematic & CAD awareness
Answers reference diagrams, part numbers, and assembly steps — with click-through to the underlying schematic.
Field-ticket deflection
80%+ of Tier-1 support questions resolved at the line. Engineers focus on the work only they can do.
SOP-gap back-feed
Repeated questions surface where manuals fall short — aggregate feedback to your OEM's engineering team.
Fast installation
Ship a preloaded industrial PC, connect to one ethernet port, live in 48 hours. Nothing else required.
Capture the deviation. Draft the CAPA. Close the loop.
Yuktra QMS reads the deviation description, matches it to prior events, suggests root cause, and pre-populates a draft CAPA. Your QA team edits — never starts from a blank spreadsheet.
- Pattern-matches deviations against 10,000+ prior events
- Drafts CAPA from historical open and closed actions
- Writes change control with full impact assessment
Deviation intake in seconds
Voice-capture at the line. Yuktra classifies severity, pulls the batch record, and links to prior similar events.
Root-cause prompts
Ishikawa and 5-Why scaffolding, contextualized to the specific equipment, process step, and product.
CAPA draft, not CAPA blank
Draft pulls from prior closed actions on similar failures — your QA team edits the 20% that's new.
Change-control acceleration
Impact assessment writes itself from the linked SOPs, batches, and equipment. Reviewers see the full chain.
E-sign at every gate
Part 11 e-signature at submission, review, and closure. Nothing leaves a state without attribution.
Trend intelligence
See repeat patterns across lines, shifts, and products before they trigger an observation.
A 90-second module — the moment something changes.
TrainingOS generates role-scoped microlearning the instant an SOP updates or a deviation closes. Operators see it at their next login, e-sign on comprehension, and the audit trail writes itself.
- Auto-generates microlearning from SOP updates and closed deviations
- Role-scoped — only what's relevant to each operator
- Part 11 e-signature on every completion
Auto-authored microlearning
An SOP update or closed deviation yields a 90-second module — authored by Yuktra, reviewed by QA, assigned automatically.
Role and line scoping
Operators see only what's relevant to their line, role, and shift. No spam-training; no click-fatigue.
Comprehension checks
Every module ends with a short comprehension check. Fail the check and you re-train before the next shift.
E-signature on completion
Part 11 e-sign, timestamped, user-attributed. Your LMS is never the bottleneck again.
Compliance dashboards
Site, line, role, and shift views — see training debt before the audit does.
Multilingual delivery
Each operator sees the module in their preferred language, while the source of record stays validated in English.
Three more modules extend the same compliant core deeper into the plant.
LabOS, ManufacturingOS, and SafetyOS inherit YuktraOS’s citation, audit, e-sign and validation by construction. Shipping plan targets H2 2026 → H1 2027.
From test method to result review — with every data point audit-ready.
LabOS brings YuktraOS to QC benches and stability labs. Analysts interrogate test methods, pull spec limits, investigate OOS events, and draft analyst-reviewed reports — all cited back to the controlled method document.
- Method-aware Q&A across compendial, in-house, and stability methods
- OOS / OOT investigation scaffolding with decision-tree support
- LIMS-integrated: Empower · LabWare · Sample Manager
Method intelligence
Parse compendial, stability, and in-house methods into cited Q&A with step-level context.
OOS / OOT scaffolding
Phase-1a / 1b / 2 investigation flow, pre-populated from SOP-QC and prior similar events.
LIMS integration
Empower, LabWare, Sample Manager — read result/sample context, write investigation records.
Data-integrity by default
ALCOA+ alignment: attributable, legible, contemporaneous, original, accurate — and complete.
Stability cockpit
Trend chamber, time-point, and lot data; surface early drift before spec breach.
Analyst-language input
Ask in the lab's working language; the answer cites the validated English method.
From batch record to real-time release — one intelligent layer over MES.
ManufacturingOS sits above your MES and historian to answer real-time production questions: batch progress, yield, cycle time, cleaning-verification status, and changeover readiness — cited to the controlling recipe and master batch record.
- Real-time batch-record awareness on PAS-X, POMSnet, Werum
- Process-historian queries: OSIsoft PI, AspenTech, Canary
- Golden-batch comparison and deviation-to-yield correlation
Live batch awareness
Ask where a batch is, why it paused, or what's next — cited to the master recipe and current record.
Golden-batch comparison
Overlay current-batch trajectory on the golden batch; flag divergences before they breach spec.
Historian-native
OSIsoft PI, AspenTech IP.21, Canary — query time-series with natural language.
Changeover readiness
Cleaning, line-clearance, calibration, operator-training state — all in one answer.
Real-time release support
Pull critical quality attributes and process parameters into review-by-exception batch release.
GxP-grade by construction
Same audit trail, e-sign, validation pack as every other YuktraOS module.
Bring the same compliant memory to EHS and pharmacovigilance.
SafetyOS extends YuktraOS into site EHS and post-market safety: incident capture, near-miss trending, PSUR/PBRER scaffolding, signal-detection support, and hazard / SDS lookups at the point of use.
- Near-miss and incident capture with SDS-aware triage
- Pharmacovigilance signal scaffolding with cited literature
- Periodic-report drafting: PSUR, PBRER, DSUR
Incident intake
Voice capture at the line — classified by severity, hazard class, OEL band, and body system involved.
SDS-aware answers
Every answer cites the active SDS revision; outdated sheets are flagged and removed.
Near-miss trending
Pattern detection across lines and shifts; surface precursors before a recordable incident.
PV signal scaffolding
Aggregate post-market cases, cite literature, support signal-detection reviews with traceable logic.
Periodic reports
PSUR / PBRER / DSUR structure and cross-reference; humans review, don't assemble.
Audit-ready logs
Every triage, every classification, every narrative — attributed, timestamped, exportable.
Want to see the full stack on your SOPs & manuals?
We’ll index a small corpus (10–50 documents), wire up a demo plant, and run cited queries against your own content.