Hyderabad, India From data to trust hello@neuratrace.co
Applications · Live

Reconstruct the complete context behind every batch release.

NeuraTrace connects manufacturing, materials, laboratory results, quality events, specifications and source evidence before the reviewer begins — the first application built on the Life Sciences Knowledge Graph.

Today

The human reviewer has become the integration layer.

The current process

One reviewer, five systems, a printed checklist.

Today
ReviewerSAPLIMSQMS ChromatographyDocumentsExcel / checklistDecision
With NeuraTrace
SAP · LIMS · MES · QMS · Docs · CDS NeuraTrace — evidence reconstructed Review workspace Human decision
40 min
QC review then QA review, per batch — measured at our design partner's site.
~4,000
Samples sitting in the QC review backlog at that single site.
5
Separate systems a reviewer cross-references by hand for one batch.
7years
Batch records must stay producible after distribution — 21 CFR 211.180.
What NeuraTrace does

"Show me everything I need to know about Batch FP-2411-A."

Evidence reconstructed

Every record across every connected system that bears on this batch, assembled through the graph rather than by hand.

Required records checked

Deterministic checks against your own SOPs and STPs, each resolving to expected, actual and the system the value came from.

Exceptions surfaced

What deserves attention and why, rather than a flat dump of everything the systems hold.

Provenance attached

Every value names its source system and record, persisted for the full retention period.

Observations captured

The reviewer must open every flagged item and record what they found before the section closes.

Approver stays independent

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

Products · The workspace

Everything behind one AR number, organised the way a reviewer works.

NeuraTrace pulls every record associated with an AR number across all connected systems and lays it out by test parameter — not by source system. Five review domains, every test parameter, one workspace.

AR-2609-0418/Paracetamol Tablets 500 mg/Batch FP-2411-AREAD-ONLY
Test parameters
Description & IdentificationCompliant
Assay by HPLCCompliant
Related Substances2 flags
DissolutionCompliant
Water Content by KF1 flag
Residual Solvents (GC)Not reviewed
A section cannot be marked reviewed until every flag carries a recorded observation.
Flag 1 of 2 · Related Substances
CHK-STD-004 · Working standard validity

Working standard WS-PCM-0231 expired before the injection sequence in which it was used.

Expected
Valid on 18 Aug 2026
Actual
Expiry 12 Aug 2026 — 6 days lapsed
Used in
Injection sequence 04 · 11 injections
Source
eLIMS Reference Standard Audit Trail
Rule basis
SOP/QC/012 §7.3
Business · Integrations

Built on the interfaces your site already licenses.

Each source system has its own independent read-only connector. Both primary integration paths are confirmed and included in licences you already hold — no additional vendor purchase is required.

SystemInterfaceRetrievedLicenceConnector
Caliber LIMSREST web servicesSample, results, column injection count, chemicalsIncluded in standard site licenceAvailable
Waters Empower FR5Empower Toolkit (COM/DLL)Chromatography, system suitability, sequencesFree from FR5 onwardsAvailable
eLIMS RS Audit TrailCaliber web services layerReference standard potency and validitySame licence as CaliberAvailable
Metrohm tiamoXML exportKarl Fischer titration resultsNative exportAvailable
Shimadzu LabSolutionsLIMS interfaceGC and HPLC instrument dataNative interfaceAvailable
Paper logbooksOCR captureStandalone instrument logs, verified by reviewer—Available
Deployment & validation

Validated for a regulated site. Installed inside yours.

NeuraTrace ships as a complete, validated on-premise platform. Everything a GxP site needs to qualify, deploy and inspect it is included.

Five review domainsFinished Product, Raw Material, Packing Material, In-Process, Stability — every test parameter section, out of the box.Included
Reviewer / approver workflowTwo-level sign-off with mandatory observation gate and a management dashboard for review throughput.Included
Read-only connectorsCaliber LIMS, Waters Empower FR5, eLIMS RS Audit Trail, Metrohm tiamo, Shimadzu LabSolutions, QMS, SAP and OCR logbook capture.Included
21 CFR Part 11 electronic signaturesCompliant e-signature on every review and authorisation, with full audit trail.Included
Role-based accessSite directory integration for reviewer, approver and administrator roles.Included
GAMP 5 Category 4 validation packURS, FS, DS and IQ/OQ/PQ documentation delivered with every installation.Included
Reviewer-validated designBuilt line by line with active QA batch release reviewers at Caliber + Empower FR5 sites.Included
GETTING STARTED

Live in weeks, not quarters

Connectors are configured against systems you already run, your SOP checks are loaded at onboarding, and the validation pack is executed with your QA. Your release process stays exactly as it is — NeuraTrace writes nothing back. Reviewers open their first batch with every check already run.

WHY NOW

The inspection pressure is rising

The FDA issued 59% more drug and biologics warning letters in FY2025 than FY2024, and 60% of letters to Indian sites cite data integrity. What gets cited is rarely the analysis — it is the inability to evidence that the review happened the way the SOP says it did.

Start with one decision

See it run against a batch you already released.