Line
Decides fast. Irreversible.
At the line, control decisions happen in milliseconds and physically commit. If the surrounding context is not captured at that instant, it is gone — there is nothing to reconstruct afterwards.
ms · irreversible5
Perspectives
7
Decision steps
8
Decision objects
3
Audit layers
Proximity
GMP scales with proximity
The closer to the physical process a decision is made, the faster and more irreversible it becomes — and the harder the evidence is to reconstruct later. Switch perspective above; filter by decision layer to focus on one system level.
Site
Decides formally. Approval required.
Release, deviation and disposition decisions are deliberate, reviewed and signed. They are slower by design — accountability matters more than speed.
reviewed · signedCloud
Can trigger, never decide.
Cloud and analytics layers see aggregated history. They can surface a signal or trigger a review, but a GxP-relevant decision is never made far from the process.
triggers, not decisionsLine
Real-time window
Context exists for milliseconds to seconds. If it is not recorded at decision time, it cannot be reconstructed — the value loses its meaning the moment it passes.
ms – sSite
Batch & shift window
Decisions span a batch or a shift. Intervals are not abstractions — they are commitments that define meaning, responsibility and comparability.
min – hCloud
Historical window
Baselines and trends are built over days to months — from structured snapshots, not raw logs. This is the reference live values are compared against.
days – monthsAttributable
Who & what
Every record carries the identity behind it — which client, user or service triggered the event, and under which permissions.
Contemporaneous
At the moment
Evidence is captured when the decision happens — not assembled after the fact from scattered logs.
Original
First record
The structured record is the source of truth, not a copy or a transformation that can drift from the original.
Accurate
Verified value
Values are checked against context and baselines, so a deviation is recorded as a deviation — not silently passed through.
Complete + Consistent
Nothing dropped
Missing context is made explicit — deferred and queued — rather than dropped, so the record stays complete and consistent.
Enduring + Available
Still there later
Hash-chained, append-only records remain readable and retrievable when an auditor asks months after the event.
Line
Accept / Block
Inline enforcement at the edge. The policy that allowed or blocked the message is recorded with its version.
inline · versionedLine
Rate-limit
Protect downstream systems from floods while keeping every throttling decision visible in the trail.
protectiveSite
Defer / Queue
When required context is missing, the action is held in a reviewable queue instead of being silently skipped.
deferred · retryableSite
Escalate / Approve
Route GxP-relevant decisions to a human gate — review, approval and sign-off become part of the evidence.
human gateCloud
Flag / Recommend
Surface anomalies and recommend a review. The cloud never auto-decides a regulated action on its own.
advisory only1
Machine publishes a live value
An OEE / temperature value arrives over MQTT from the filler on line 1.
2
Domain context extracted
Line, machine, batch and metric are resolved from the topic and payload.
3
Historical baseline resolved
The expected reference value is fetched from the historical context feed.
4
Deviation calculated
Live vs. baseline is compared; the deviation and its severity are computed.
5
Decision gate evaluated
The active policy decides accept, block, rate-limit or escalate — recorded with its version.
6
Missing context is deferred
If a baseline is unavailable, the calculation is queued for review rather than skipped.
7
Evidence linked to the audit chain
Value, context, baseline, deviation and decision are hash-chained into one reviewable record.
This is a conceptual model of how regulated decisions and evidence relate across system layers. It informs the TrailMQ design; it is not a certification claim. Read the underlying concepts →