Built to operate inside your control boundary.
NeuraTrace is deployed inside your network, holds no write credentials to any system of record, and produces a structured evidence record for every review that stays producible for the full retention period.
Read-only is a constraint, not a setting.
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 your LIMS, CDS, QMS or SAP, and we do not recommend release. QA keeps the release decision entirely.
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.
parameter Related Substances
check_id CHK-STD-004
check_basis SOP/QC/012 §7.3
source_system Reference Standard Audit Trail
expected standard_valid_on = 2026-08-18
actual WS-PCM-0231 expiry 2026-08-12
outcome FLAGGED
related_event DEV-2609-118
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