Fully managed service · GxP · FDA 21 CFR Part 11

Know every degree, in every corner of your space.

Mapping proves how temperature and humidity behave across a fridge, chamber or warehouse, finding the hot and cold spots before they put your product at risk. ViGIE’s specialists run the entire study for you, from protocol and sensor placement to the final audit-ready report.

Present in 27 countries · ISO 9001 · FDA 21 CFR Part 11 · GxP
Warehouse · top view · 20 sensors
Study result
3.1°
3.8°
4.6°
4.9°
6.2°
3.9°
4.4°
4.8°
5.1°
6.8°
4.0°
4.5°
4.7°
5.9°
7.4°
3.3°
3.9°
4.6°
5.0°
6.5°
Within specification
Warmest zone
Coldest zone
What mapping is

A single sensor tells you one point. Mapping tells you the whole space.

Temperature and humidity are never perfectly even. Air near a door, a fan, a wall or the ceiling behaves differently from the middle of the room. A mapping study places sensors across the space, records how every zone behaves over time and pinpoints the hot and cold spots, so you know exactly where it is safe to store product, and can prove it.

◎

Find the hot & cold spots

See where the extremes really sit, so storage zones are qualified on evidence, not on assumption.

✓

Demonstrate compliance

A documented study is what auditors expect under GxP, ISO and FDA: proof the space holds conditions everywhere.

◆

Protect your product

Catch a marginal zone before a batch sits in it, turning a study into everyday protection for what you store.

A fully managed service

You tell us the space. We handle the entire study.

No staff to allocate, no loggers to collect, no spreadsheets to stitch together. Our team plans, installs, measures and reports, so you receive a finished, audit-ready study without disrupting your operations.

01

We plan the study

Our specialists define the sensor grid and study protocol based on the volume, equipment and regulatory requirements of your space.

02

We place the sensors

Our technicians install wireless data loggers at every grid point. No wiring, no drilling, minimal disruption.

03

We measure & collect

Sensors record over the full study window while our team manages the entire data acquisition, end to end.

04

We deliver the report

You receive a GMP-compliant mapping report with hot and cold spots, limits reached and conclusions, ready for your auditor.

Why ViGIE mapping

Expert-led studies, wireless by design

Wireless loggers let our team deploy the full mapping grid quickly and cleanly, while our specialists make sure every step meets the standards your auditors expect.

★

Specialists in GxP

A team that knows pharma, healthcare, IVF and laboratory requirements, and designs every study around them.

◉

Minimal disruption

No cables to run and quick installation, so your fridges, chambers and warehouses keep operating during the study.

⛨

Zero data loss

Integrated local backup in every sensor protects the data chain. Every reading is held safely, even if a connection drops.

Test scenarios

We simulate real-world conditions to fully understand how your system performs

A mapping study is more than a snapshot. Our specialists can challenge your storage under the conditions it faces every day, and the ones it may face only once, so your qualification reflects reality.

1
True system behavior

Minimum Load

Tests storage empty or lightly loaded.

Reveals
  • Hot & cold spots
  • Airflow imbalances
  • Temperature stratification
Shows how the system really behaves without product influence
2
Real operating conditions

Maximum Load

Tests storage under normal load.

Reveals
  • Real temperature distribution
  • Impact of stored products
  • Safest storage zones
Validates performance in day-to-day use
3
Operational stress limits

Door Opening Challenge

Simulates repeated door openings.

Reveals
  • Safe door open time
  • Recovery speed
  • Vulnerable zones
Identifies risks from daily access
4
Busiest moments

Peak Usage Simulation

Replicates real workflows during peak activity.

Reveals
  • Stability under pressure
  • Cumulative impact of usage
  • Operational weak points
Ensures compliance when it matters most
5
Loss of control

Power Failure Test

Simulates a power outage.

Reveals
  • Safe time without cooling
  • Fastest warming areas
  • Recovery performance
Defines your real safety margin
6
From off to stable

Startup / Restart Test

Monitors the system from startup.

Reveals
  • Time to reach setpoint
  • Stability across storage
  • Safe moment to use
Prevents premature product storage
7
Hidden fluctuations

Defrost Cycle Observation

Tracks temperature during defrost.

Reveals
  • Temperature peaks
  • Duration of impact
  • Affected zones
Ensures cycles remain within limits
8
Extreme conditions

Seasonal Worst-Case Study

Tests under environmental stress.

Reveals
  • Impact of ambient temperature
  • Year-round performance
  • Structural vulnerabilities
Proves compliance in any season

Every study is tailored: we combine the scenarios your protocol, risk assessment and auditors require.

Build your test plan with us
What we map

Temperature and relative humidity, mapped wirelessly

GMP-compliant mapping studies for the two conditions that define a qualified space, carried out by our team wherever your product is stored or transported.

Temperature

Temperature mapping

We qualify fridges, freezers, incubators, chambers and warehouses across their full range, proving every shelf and bay holds the temperature your product needs.

Humidity

Relative humidity mapping

We map moisture as well as heat where it matters: controlled rooms, stability chambers and storage areas where humidity is part of the specification.

Cold chain

Vehicle & container mapping

Mapping doesn’t stop at the warehouse door. We qualify refrigerated transport with the same wireless method.

  • Trailers and refrigerated trucks
  • Shipping containers, end to end
  • Same method, same compliant report
Accurate, reliable, with minimal long-term drift. Our wireless data loggers hold laboratory-grade precision over years, so every study we deliver can be trusted, not just the first one.
The deliverable

A finished study, delivered by our team

When the study window closes, our specialists analyse every measurement across the storage area over the full period, identify the hot and cold spots and the limits they reached, and deliver a report that demonstrates compliance.

  • Full summary of measurements over the whole study window
  • Hot and cold spots identified and documented
  • Audit-ready proof of compliance with GxP, ISO & FDA standards
  • Clear conclusions on where product can be safely stored
Mapping Report · Cold Store BPASSED
Study window72 h
Sensors in grid20
Hot spot (sensor 15)7.4 °C
Cold spot (sensor 01)3.1 °C
Specification2 – 8 °C
ComplianceGxP · 21 CFR Part 11
Efficient & economical

Mapping with ViGIE saves your team time and worry

No days of manual work, no equipment to buy or manage. We take care of the whole study so your team can stay focused on operations.

✕

Nothing to do on your side

From protocol to report, our team runs every step. No staff time spent placing, collecting or transcribing loggers.

◉

Operations keep running

Wireless installation means no cabling work and minimal interruption to your storage areas.

✓

Audit-ready deliverable

A complete, documented study that answers exactly what GxP, ISO and FDA auditors look for.

↻

Easy requalification

Repeat the study whenever your protocol or auditor requires it, with the same method and reliable, low-drift equipment.

27
countries with ViGIE
+978M€
savings generated
9.743M
hours saved through automation

Ready to qualify every corner of your space?

Talk to a ViGIE mapping specialist. Our team takes care of the whole study, from protocol and sensor placement to your audit-ready report.