NeuraTrace — from data to trust.
The read-only analytical batch release review layer for pharmaceutical QA. One AR number, every source system, every SOP check — resolved before a reviewer opens the batch.
Your systems capture the data faithfully. Nothing evaluates it.
Caliber records the sample. Empower records the chromatography. The QMS records the deviation. Each one is complete, and each one is separate. The reviewer is the integration layer — opening five systems, cross-referencing a printed checklist, and leaving behind a signature but no evidence of what was actually checked.
Capture is solved
Your LIMS and CDS record everything faithfully and have done for years. That was never the bottleneck.
Review is manual
Nobody built the layer that evaluates what those systems recorded against your own review criteria.
Evidence is thin
LIMS captures data. It does not create evidence that a review happened the way the SOP says it did.
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.
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
A check is a rule with a named SOP behind it. Not a model's opinion.
Every check NeuraTrace runs is deterministic and configured against your site's own SOP or STP. It resolves to expected, actual, and the system the value came from — so a reviewer can defend every one of them in front of an inspector.
Configured at site onboarding
Audit Trail module
Sequence 04 run 18 Aug 2026
Deterministic, not inferred
No model makes a judgment call on GMP data. Whether a standard was expired is a lookup, not an opinion. AI is used only where it cannot make a compliance decision — OCR to digitise paper logbooks, as a supplementary input the reviewer still verifies.
On-premise, inside your network
NeuraTrace is deployed inside the plant network. GMP data never leaves the site and there is no cloud dependency in the review path. An architectural decision, not a deployment option we offer reluctantly.
Read-only, always
Every connector is independently read-only. No shared write path exists anywhere in the architecture. We never write to Caliber, Empower, the QMS or SAP, and we do not recommend release. QA keeps the release decision entirely.
What we deliberately do not track
NeuraTrace does not record individual reviewer activity time. Our design partner told us directly that regulators weaponise that data in inspections. We also removed analyst qualification from the instruments view, because surfacing it draws auditor attention to qualification records that were never in scope.
Your vocabulary, not ours
Never "approved" — always review authorised. Never "passed" — always compliant. The workspace speaks the language of your SOPs, because a term that does not appear in your quality system is a term a reviewer has to defend.
In 2033, the FDA asks about a batch released in 2026. That is a lookup.
21 CFR 211.180 requires batch records to stay producible for up to seven years after distribution. Today the review itself leaves behind a paper checklist — and the reviewer who signed it has left the company while the underlying records sit across five systems and a filing cabinet. Every NeuraTrace review produces a persistent structured record instead.
product Paracetamol Tablets 500 mg · Batch FP-2411-A
parameter Related Substances
check_id CHK-STD-004
check_basis SOP/QC/012 §7.3
source_system eLIMS Reference Standard Audit Trail
expected standard_valid_on = 2026-08-18
actual WS-PCM-0231 expiry 2026-08-12
outcome FLAGGED
observation "Sequence 04 re-run on 21 Aug 2026 with WS-PCM-0244.
Original sequence excluded from reportable result.
Deviation DEV-2609-118 raised."
reviewed_by QC-REV-0117
reviewed_at 2026-08-21T14:32:09+05:30
authorised_by QA-APR-0042
authorised_at 2026-08-22T09:14:51+05:30
retention_until 2033-08-22
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
The reviewer must open every flagged item and record what they found 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.
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.
| System | Interface | Retrieved | Licence | Connector |
|---|---|---|---|---|
| Caliber LIMS | REST web services | Sample, results, column injection count, chemicals | Included in standard site licence | Available |
| Waters Empower FR5 | Empower Toolkit (COM/DLL) | Chromatography, system suitability, sequences | Free from FR5 onwards | Available |
| eLIMS RS Audit Trail | Caliber web services layer | Reference standard potency and validity | Same licence as Caliber | Available |
| Metrohm tiamo | XML export | Karl Fischer titration results | Native export | Available |
| Shimadzu LabSolutions | LIMS interface | GC and HPLC instrument data | Native interface | Available |
| Paper logbooks | OCR capture | Standalone instrument logs, verified by reviewer | — | Available |
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.
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.
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.
Regulated-industry operators, with an active QA reviewer in the room.
NeuraTrace was built alongside active QA batch release reviewers at Caliber + Empower sites, and every screen was validated parameter by parameter against the checklists they use on the floor.
Contact us
See it run against a batch you already released.
Give us one AR number you have already reviewed and compare what we flag against what your reviewer found. Read-only, inside your network, on your terms.