Your Manufacturing Team's AI Partner

AI Co-Pilot for Pharma Manufacturing Investigations

Lumis helps you interrogate your batch genealogy in plain English, returning source-attributed answers and compressing deviation investigations from weeks to hours.

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Why Deviation Investigations Stall in GxP Manufacturing

Deviation investigations stall because analysts manually pull and reconcile PDFs, LIMS exports, and batch records across disconnected systems — turning a single root cause question into a slow, fragmented investigation.

60–80%

of investigation is effort spent on manual data collection

Weeks

are wasted on average to resolve a single deviation

HOW IT WORKS

How Lumis Compresses Investigation Cycle Time From Weeks to Hours

Lumis is an AI co-pilot that interrogates your batch genealogy in plain language, returning source cited answers in one workflow — compressing deviation cycle time from weeks to hours and accelerating CAPA closure.

Natural Language Interface
LUMIS - AI Assistant
Which batches were impacted by DEV-1428?
You   10:43 AM
Lumis is Typing
Ask in plain English

An analyst types the investigation question directly — no query language, no specialized training.

Unified Data Foundation
Equipment EQ-17
Material RM-7782
Deviation DEV-1428
Batch DP-205
Location Line 3
Operator OP-3021
Test Result LR-8891
Lumis does the heavy lifting

Lumis converts the question into a structured query, traverses the validated genealogy across systems, and assembles the complete picture.

Audit Ready Traceability
Answer Ready
Found 12 affected batches across 3 production campaigns.
Today, 18 Jun 3 mins ago
Source traceability
Batch Record DP-205
Deviation DEV-1428
Lab Result LR-8891
Return a source cited answer

Every finding comes back attributed to the specific record it came from, ready to drop into the investigation file.

GraphRAG vs. Vector RAG: Why Knowledge-Graph Retrieval Minimizes Hallucination

GraphRAG retrieves answers through validated knowledge paths, not text similarity. Every Lumis response is grounded in source genealogy data and fully traceable — delivering defensible answers without hallucination risk.

DIMENSION VECTOR RAG LUMIS GRAPH RAG
Retrieval Approach Similar text chunks Knowledge graph paths
Answer Grounding Probable text Source records
Source Traceability Partial lineage Full lineage
Hallucination Risk Possible Minimizes
GxP Validability Not reproducible Audit-ready
Fit for Batch Genealogy Breaks relationships Preserves relationships
LIMS
MES
ERP
BATCH RECORD
Mareana Contextual Layer
Lumis
LUMIS - AI Assistant
Compare dissolution results for Batch A-2291 and A-2304, flag any parameter that drifted beyond spec, and cite the source for each.
You   10:43 AM
  • 1 parameter out of spec: Dissolution @30min (A-2304: 78%, spec ≥80%)
  • Sources: LIMS result LR-44817 • Batch Record BR-A2304 • MES log MES-99213
  • Lineage: genealogy node A-2304 › Stage 4 › QC sampling
Lumis   10:43 AM
Sourced & Traceable

Natural Language Querying Across LIMS, MES, and ERP Without a Data Lake

Mareana layers a unified contextual graph over your existing LIMS, MES, ERP, and batch record systems — no centralized data lake or ETL required, so analysts query across sources in plain English.

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Connects to Existing Systems
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No Data Lake or ETL
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Unified Context Layer
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Query in Plain English
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Sourced Responses
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Cross Source Comparison
FAQ

Your Questions, Answered

Have more questions?

Not sure if Lumis fits your use case? Let's discuss your investigation challenges and show how Lumis can help.

Lumis is an AI co-pilot for pharmaceutical manufacturing investigations. It uses GraphRAG technology to interrogate your batch genealogy — querying across LIMS, MES, ERP, and batch record systems in plain English and returning source-attributed answers in minutes instead of weeks.

No. Lumis layers a unified contextual graph over your existing systems — LIMS, MES, ERP, and batch records — without requiring a data lake or ETL. Analysts can query across sources immediately.

Lumis uses GraphRAG (Knowledge Graph Retrieval) instead of vector similarity. Every answer is retrieved through validated knowledge paths grounded in your actual batch genealogy data, so responses are always attributed to specific source records — eliminating hallucination risk.

Yes. Lumis is built for regulated pharmaceutical manufacturing. Every answer is source-attributed and traceable, and the output is designed to meet 21 CFR Part 11 audit requirements. Full investigation traceability is maintained from query to cited record.

Lumis compresses deviation investigation cycle time from weeks to hours. By automating the manual data collection and reconciliation process that typically accounts for 60-80% of investigation effort, teams can close CAPAs significantly faster.

Your next answer is already in your data.

Discover how Lumis helps teams uncover trends, investigate deviations, and generate audit-ready summaries instantly.

Accelerate RCA Investigations
Audit Ready RCA Summaries
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Lessons from the First FDA Warning Letter on AI Misuse
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Lessons from the First FDA Warning Letter on AI Misuse

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