EU-GACP · EU-GMP · DATA INTEGRITY

Every setpoint is a record.
Every record is inspectable.

Records are written at the device as the event happens, not transcribed from a logbook afterwards. Attributable, contemporaneous, enduring. Growlink is the control layer that arrives with its records already structured for the handover from EU-GACP to EU-GMP.

Talk to our EU team See the regulation map
EU-GACP Rev. 1
Annex 11
Annex 15
Annex 22 (draft)
CE marked
WHERE THE LINE SITS

The licence covers the site. EU-GACP governs the grow. EU-GMP certifies the processing.

Between them sit qualification and data integrity, the two areas that most often send a certification back for rework. Growlink runs across the handover point so the grow-room record and the batch record are the same record.

01 · Licence

National competent authority

Your licence is granted by the national authority, for example INFARMED, I.P. under Decreto-Lei 8/2019 in Portugal. It sets the scope of activities and the traceability the site must reproduce on demand.

02 · EU-GACP

Cultivation, harvest and drying

EMA GACP Rev. 1 covers the growing rooms. Indoor cultivation now calls for continuous monitoring of climate, humidity, light, ventilation and irrigation, defined per room and attached to the batch.

  • Critical process parameters held per room
  • Calibration due dates and history per device
  • Excursions recorded with duration and response
03 · EU-GMP

Processing onward

EudraLex Volume 4 applies from processing forward. Its annexes on computerised systems, qualification and AI are what an inspector uses to judge whether the records arriving from cultivation can be trusted.

REGULATION MAP

What the regulation asks for. What Growlink provides.

Computerised systems

EudraLex Vol. 4, Annex 11 — revision expected 2026

Audit trail on every change: user, timestamp, old and new value, reason. Permanently enabled. Role-based permissions by site and room. Retention and export on demand. Security controls aligned to the EU Cyber Resilience Act.

Qualification

Annex 15 — IQ / OQ / PQ against your URS

Setpoints, alarm limits and control logic export as qualification evidence from the system that actually runs the room, so the protocol and the plant cannot drift apart. One control skid for nutrient delivery means one qualification, not one per room.

AI in GMP

Annex 22 — draft; critical use must be static and deterministic

Nova advises. Core executes. Recommendations are logged and approved by a named person before anything changes. No generative model sits in the critical control path.

Indoor cultivation

EMA GACP Rev. 1 — effective August 2025

Climate, humidity, light, ventilation and irrigation monitored continuously and attached to the batch. Critical process parameters defined and held per room, with aspirated canopy VPD, substrate VWC and EC, and per-event irrigation logs.

Traceability and inspection

National licence — e.g. Decreto-Lei 8/2019, INFARMED, I.P.

Room-to-lot environmental history reproducible on demand across cultivation, manufacturing and export files. One control system across cultivation and processing means one Site Master File entry.

Deviation handling

Alarm, excursion and out-of-limit events

Excursions raise an alarm, record the duration and the response, and stay attached to the batch record rather than living in an operator’s notebook.

DATA INTEGRITY

Written at the device. Attached to the batch.

Core logs, alarms and schedules on-device, so the record survives a network loss. Every change carries who, when, what and why.

GrowlinkOS  ·  Audit trail  ·  Flower A  ·  Batch PT-2611-A
Locked
TimeUserParameterChangeReason
14:02:11m.rochaFeed EC setpoint3.4 → 3.8 mSP2 steering step, QA-approved
11:47:03a.silvaNight VPD limit1.05 → 1.15 kPaBlueprint v4 rollout
09:15:52systemRH excursion64% · 8 minDehumidifier 2 restart
08:30:00m.rochaPhotoperiod12h00 confirmedDaily verification
CPPs in range
99.4%
Logged events
14,206
Open deviations
1
Retention
Per site policy
Interface shown for illustration. Values are representative, not from a live facility.
THE CONTROL LAYER

Qualified measurement. Deterministic control. Controlled inputs.

01 · Instrumentation

LINKS

Qualified measurement in every room. Add one device at a time, calibrate on schedule.

  • Terralink: substrate VWC, EC and root-zone temperature
  • Climalink: aspirated canopy VPD
  • lightLINK: four-channel 0–10V dimming and photoperiod records
  • valveLINK: eight irrigation channels, logged per event
  • Calibration due dates and history held against each device
Explore LINKS →
02 · Deterministic control

Core

Executes the approved recipe and nothing else. Static logic, on-device logging, no cloud dependency.

  • UL-listed and CE marked, aligned to the EU Cyber Resilience Act
  • BACnet, Modbus and SDI-12 to existing HVAC and plant
  • Blueprints: one approved room standard, versioned and pushed
  • Logging, alarming and scheduling survive a network loss
  • Role-based permissions by site and room
Explore Core Controller →
03 · Controlled inputs

Precision NDS

Every formulation in the facility fed from one skid, verified before it reaches the plant.

  • H.E. Anderson injection pumps, direct-inject or batch-tank
  • Dual inline pH and EC verification on every feed event
  • Paddlewheel flow sensing per zone, volume recorded
  • Formulation changes are controlled changes
  • One skid, one qualification
Explore Precision NDS →
WHAT IS AVAILABLE TODAY

Clear about what ships, what advises, and what is on the roadmap.

Advisory only

Nova

AI assistant
  • Anomaly detection across rooms
  • Plain-language answers on live data
  • Every recommendation logged and approved before it acts
Roadmap

Assure

Compliance layer
  • GACP and GMP record-keeping inside the platform
  • Batch documentation and deviation handling
  • Available for design partners, no shipping commitment
Available

Builder

Developer platform
  • Open API and webhooks into your QMS or ERP
  • Seed-to-sale and LIMS connections
  • Fleet-wide deployment across sites
Scope. Growlink supplies the control system, its records and the evidence they generate. EU-GACP and EU-GMP certification are granted to your facility by the competent authority. Annex 22 is currently in draft; finalisation is expected during 2026.
A control layer is cheaper to qualify than to re-qualify. Talk to our EU team →

Talk to us before the URS is written.

We will map Growlink against your Site Master File, your Annex 15 protocol set and the GACP-to-GMP handover point, before the concrete is poured.

Talk to our EU team