Hyderabad, India From data to trust hello@neuratrace.co
AI that connects data, evidence and context

The intelligence layer for pharma.
Less data wrangling. More science.

NeuraTrace connects pharmaceutical data and evidence, uses AI to surface the context that matters, and helps keep traceable audit evidence ready when you need it.

✓ FDA inspection evidence, ready when you need it. Source-linked. Traceable. Human-controlled.
CONNECT · UNDERSTAND · ACT Traceable evidence · Inspection readiness
LIMSChromatography data systemsMESQMSERP · SAPRIMSDocuments & SOPsPaper logbooks LIMSChromatography data systemsMESQMSERP · SAPRIMSDocuments & SOPsPaper logbooks
The problem

Your batch is connected. Your evidence isn't.

Quality evidence lives across ERP, LIMS, chromatography systems, MES, QMS and documents. Reviewers still have to find it, reconcile it and interpret it by hand — every batch, every time.

01

Chasing records

Hours spent locating the evidence behind one decision, across five or more systems and a filing cabinet.

02

Reconciling data

Manual cross-checks between records, results and specifications, with no shared view of what belongs together.

03

Managing backlogs

Limited visibility into what is blocked, why it is blocked, and which batches actually need a reviewer's attention.

04

Preparing for audits

Reconstructing the trail months or years later, when the reviewer who signed it has moved on.

What that costs you

The reviewer becomes the integration layer.

What changes

From scattered records to a review you can explain.

01

Find what needs attention

Missing evidence, inconsistent values and the quality events that bear on this batch, surfaced before the reviewer opens it.

02

See the evidence

Every finding traces to its source record, the system it came from, and the requirement it was checked against.

03

Keep QA in control

The reviewer investigates, records an observation and makes the decision. NeuraTrace does not recommend release.

04

Reconstruct the story

When someone asks why a decision was made, the supporting evidence is already assembled and still producible.

Interactive concept

Explore a batch.

Pick a related record. This is how a connected review behaves — follow a relationship and the context comes with it, instead of opening another system.

B-24081 BATCH MATERIAL LOT LAB RESULT DEVIATION SPECIFICATION

All identifiers and relationships shown here are illustrative. This is a concept of how a connected review behaves, not live NeuraTrace data or a claim about current functionality.

Who it's for

One review. Four reasons to want it.

QA reviewer

Spend less time chasing evidence. More time reviewing quality.

Find the relevant batch records, analytical results, deviations and supporting documents in one connected review.

Less manual investigation per batch
QA head · Site quality head

Clear the review backlog without lowering the quality bar.

See which batches need attention, why they need it, and what evidence is missing or inconsistent.

More review capacity and fewer surprises
VP Quality · CQO

Know where quality risk is building.

Identify evidence gaps, unresolved exceptions and recurring issues across batches and source systems.

Better oversight, more consistent decisions
Audit · Compliance lead

Be ready to show the evidence behind a decision.

Reconstruct the records, source references and review rationale without a last-minute scramble across departments.

Less audit preparation effort
Proof

Show the impact. Don't just claim it.

We measure evidence-gathering time, review completion, exception resolution and audit preparation against your own baseline — and publish validated results only once we have them. In the meantime, the arithmetic of your current workflow is worth looking at.

QA review-effort estimator Illustrative · enter your own figures
Hours released annually 1,600
Potential labour capacity value ₹24.0L

This estimates the value of released staff capacity, not guaranteed cash savings. It excludes implementation effort, product fees, and any further benefit from avoided delays, rework or audit preparation. It is not a NeuraTrace customer result.

Evidence

Every finding names its source.

A reviewer can follow any conclusion back to the record it came from, in the system it came from — and still do it in seven years, when an inspector asks and the person who signed it has left.

HPLC · Related substancesSequence 04 · 18 Aug 2026Illustrative
RRT 1.42 · above reporting threshold
CHK-STD-004·Working standard validity Blocking
Rule basis
SOP/QC/012 §7.3
Configured at site onboarding
Source of truth
Reference Standard
Audit Trail module
Expected
Standard valid on every injection date in the sequence
Actual
WS-PCM-0231 expiry 12 Aug 2026
Sequence 04 run 18 Aug 2026
Related event
DEV-2609-118
Linked automatically, not by hand
Model involvement
None. A date comparison against a retrieved field.

Two-level workflow

Reviewer and approver are separate roles with separate records. Neither can authorise a section while a flag is unaddressed.

Observation is mandatory

Every flagged item must be opened and answered in writing before the section closes. It is a gate, not a suggestion.

Provenance on every value

Each figure names the system it was retrieved from, so reconstruction never depends on anyone's memory.

Platform & trust

Works with your systems. Keeps people accountable.

NeuraTrace does not replace your LIMS, QMS, MES or ERP, and never becomes a system of record. It reads what they already hold.

READ-ONLY

No write path

Every connector is independently read-only. No component holds write credentials to any system of record.

DETERMINISTIC

Rules, not opinions

A specification limit is a comparison. An expiry date is a lookup. No model makes a compliance call.

IN YOUR ENVIRONMENT

Deployed inside your control boundary

On-premises inside the plant network, with role-based access, 21 CFR Part 11 e-signatures and a GAMP 5 validation pack.

How it works underneath. NeuraTrace builds a connected model of the entities a quality decision depends on — batches, materials, lots, tests, specifications, equipment, deviations, CAPAs and the documents behind them — and keeps every value's source, version and timestamp attached. That model is what makes one connected review possible, and what lets the same evidence serve deviation investigation, CAPA and inspection response later.

Where we start

Batch release first. The same evidence serves what comes next.

One application is live at our design partner's site. Everything else is labelled roadmap, and stays that way until it runs against real batches.

Batch Release

Live
DecisionCan this batch be released?
Evidence assembledManufacturing record, material lots, test results, specifications, deviations, documents.

Deviation Investigation

Roadmap
DecisionWhat happened and what was affected?
Evidence assembledBatch, equipment, material, test results, prior deviations, SOPs, changes, CAPAs.

Inspection Readiness

Roadmap
DecisionWhy was this decision made?
Evidence assembledHistorical records behind a past decision, and who authorised it.
Company

Built with an active QA reviewer in the room.

Fragmented enterprise systems, regulated decisions and applied AI are three different problems. Pharma quality needs all three solved at once — which is why the team is built the way it is, with a practising reviewer involved from the first screen rather than consulted at the end.

Suneel Lam
Founder · Architecture
18 years of QA and automation in regulated environments — JPMorgan, BNY Mellon, United Airlines, CWT. Owns the review engine, connectors and deployment architecture.
Srinivas Mullapudi
Co-founder · Product
20+ years in enterprise product, the last four building AI-native systems. ISB MBA. Author of The AI Product Manager Gita. Owns the review workspace and the evidence schema.
Rajesh Yerragunta
Co-founder · US Market
18 years in enterprise data and analytics — Microsoft, Molex, and 12 years at IBM. Kellogg MBA. Based in Houston, building the US commercial motion.
Shrikrishna
Domain expert · Design partner
Active QA batch release reviewer. Supplied the review checklist and validated the workspace parameter by parameter.
Start with one batch

See NeuraTrace on a batch you already released.

You don't need to connect your enterprise to find out whether this is useful. Give us one batch your team has already reviewed, and compare what NeuraTrace surfaces against what they found. Read-only, inside your network, on your terms.