Module · Sensors & IoT

Sensorsthe readings that prove the batch was in control.

Cold-chain fridges, cleanroom humidity, filling-line PSI, motor vibration — the readings that prove the batch was in spec the whole time it was running. V5 ingests sensor streams from Bluetooth, LoRaWAN, Modbus, MQTT and OPC UA, applies per-sensor min/max bands, opens a deviation automatically on excursion, and seals the reading window into the batch record so the eBMR / eDHR can be reconstructed minute-by-minute.

Start free — no card
Signals from the floor

What changes once Sensors & IoT readings is live.

Indicative ranges from V5 pilot deployments. Your numbers will land near these once the workflow is operator-led and e-signed at the step.

Time to first batch
90 days
validated, e-signed, live
Audit-ready records
0%
Part 11, immutable, queryable
Operator adoption
0%
kiosk-first, no training-week
Manual paperwork
100
eliminated at the step
Before / after

What changes the day you switch this on.

Before V5
  • Manual, paper-driven, and only audited after the fact.
  • Records reconciled and re-typed at end-of-batch.
  • Tribal knowledge in spreadsheets and shared drives.
  • Errors caught at month-end — too late to fix the batch.
With V5
  • Many transports, one register
  • Excursion → deviation, automatically
  • Sealed to the batch record
  • Long-term trend + export

What you actually get

Operator-led, e-signed, immutable. Engineered for regulated manufacturers — not retrofitted.

Many transports, one register

Bluetooth (Sensirion, Govee), LoRaWAN (Dragino, Milesight), Modbus TCP, MQTT broker, OPC UA — all land in one sensor register with min/max bands and a sample rate.

Excursion → deviation, automatically

A fridge that breaches its band raises a deviation with the reading attached, the affected stock auto-quarantined, and the on-call engineer paged via SMS.

Sealed to the batch record

A WO that ran on Line 2 between 06:00 and 14:00 carries the Line 2 cleanroom humidity, the filler PSI and the autoclave temperature for that window — no separate spreadsheet to reconcile.

Long-term trend + export

12-month trend per sensor with annotations for excursions, calibrations and door-open events. CSV export for any window.

What this leaves behind

One operator action — a complete, signed record.

Built-in evidence

What it leaves behind

  • Bluetooth / LoRaWAN / Modbus / MQTT / OPC UA transports
  • Excursion auto-opens deviation + quarantines stock
  • Readings sealed to eBMR window
  • 12-month trend with annotations
Regulatory anchor

The clauses this satisfies

21 CFR 211.142 (warehousing — temperature)21 CFR 211.46 (ventilation, air filtration, air heating & cooling)21 CFR Part 11 audit trail on sensor dataEU GMP Annex 15 (qualification of cold-chain)
Engineered on
21 CFR Part 11 e-signatures
Immutable audit trail
Multi-tenant RLS isolation
GS1-128 license plates
Two-way ERP adapters
Common questions

What buyers ask before they switch on Sensors.

Got questions, or want to see it on your shop floor?

Ask V5 — our code-aware assistant — or spin up a workspace. Both are free.