Inspection-ready, first time
Every acceptance criterion cites its source.
GxP qualification, temperature mapping and monitoring across EuropeInspection-ready.
One partner for your GxP cold chain. A fixed price before any work starts.
We work to
- EU GDP 2013/C 343/01
- EU GMP Annex 15
- Annex 11
- WHO TRS 961
- USP <1079>
- 21 CFR Part 11
- GAMP 5
One partner
The whole lifecycle, one audit trail.
- 01CalibrationBefore first use
- 02Qualification and mappingDQ · IQ · OQ · PQ
- 03Continuous monitoring24/7, with alarms
- 04AuditsRecords ready
- 05RecalibrationTypically yearly
- 06RequalificationAfter changes, or by risk
↺ and around again
Less chasing. More certainty.
One fixed price
Agreed in writing before work starts.
One partner
Mapping decides where monitoring sensors go.
Services
Everything that keeps product in range.
DQDesign vs URS
IQInstalled as specified
OQWorks across its range
PQPerforms under load
Qualification and validation
Cold rooms, warehouses, freezers, incubators, stability chambers.
QualificationExample
−20.0 °C✓ −20.1
5.0 °C✓ 5.0
25.0 °C✓ 25.1
Calibration
Fresh sensors swapped in. No downtime.
CalibrationExample data
2 °C8 °C
Temperature mapping
Find the hot and cold spots, empty and loaded.
MappingExample data
Cold room · 2–8 °C24 h
Continuous monitoring
Wireless sensors, SMS and email alarms, full audit trail.
MonitoringTemperature mapping
Do it yourself, with us, or leave it to us.
You run it
For teams with validation experience.
YouPlace loggers, write report
C3Calibrated loggers, software, support
You place, we plan
For sites with staff but little time.
YouPlace loggers
C3Protocol, analysis, report
We run it
For new sites, inspections, tight deadlines.
YouSign off the protocol
C3Everything else, on site
Continuous mapping. Sensors stay in place and keep proving the whole space is in range. No separate re-mapping study.
Triggers
When is it due?
- New site or unit
Before first use.
GDP 3.2.1 - After a change
Layout, HVAC, F-gas swaps.
GDP 3.3.2 - Summer and winter
Where outside air reaches in.
WHO TRS 961 - On schedule
Risk-based interval.
Annex 15 - Before an inspection
Records checked, gaps listed.
GDP · GMP
Coverage
From −196 °C to +400 °C.
- Fridges
- Freezers
- ULT freezers
- Incubators
- Stability chambers
- Cold rooms
- Warehouses
- Trailers
- Autoclaves
−196 °CLN2
−80 °CULT, dry ice
2–8 °CCold room
15–25 °CAmbient
37 °CIncubator
121 °CSteam
+400 °CDry heat
Deliverable
A report your inspector can follow.
- Scope and references
- Risk assessment
- Loggers and calibration
- Method
- Acceptance criteria
- Results per logger
- Heatmaps
- Conclusion and probe positions
Founder
Done this 250+ times.
250+
qualification and mapping projects across EMEA, before C3, at Sensitech (Carrier).
Yaroslav Derevianko, founder
ENDENLUKRU
“Technically excellent, and easy to work with. Yaro took time to understand our sites and our people before proposing anything. That built trust quickly.”
Stig Robert GustavsenFormer Supply Chain Director, Fresenius Kabi Norway
Previous employer's clients, not C3 clients
Without C3. With C3.
Without
- Scattered vendors
- Day rates
- Re-mapping surprises
- Paper certificates
With C3
- One partner
- A fixed price
- A planned lifecycle
- Digital records
Europe
Your country. Your language.
Calls and documents in English, German or Dutch.
- DEGermany
- ATAustria
- CHSwitzerland
- NLNetherlands
- BEBelgium
- DKDenmark
- SESweden
- NONorway
- FIFinland
- PTPortugal
- ESSpain
- IEIreland
- UKUnited Kingdom
Not ready to talk?
Take the checklist or the service catalogue. One email, PDF.
FAQ
Good to know.
Anything else? Ask on the call.
How long does temperature mapping take?
Cold room: 24 to 72 hours. Ambient storage: at least 7 days. The protocol sets the exact duration.
WHO TRS 961 Annex 9, Suppl. 8What's the difference between IQ, OQ and PQ?
IQ: installed as specified. OQ: works within limits across its range. PQ: performs under real conditions, like a loaded cold room.
EU GMP Annex 15Is mapping required under EU GDP?
Yes. Before first use, then by risk assessment or after significant changes.
EU GDP 2013/C 343/01, 3.2.1How often should a warehouse be mapped?
After significant changes and at a risk-based interval. Most sites map in summer and winter.
EU GDP 3.2.1 · WHO TRS 961What is continuous mapping?
Sensors stay in place and keep proving the whole space is in range, so a separate re-mapping study may not be needed.
Qualification or calibration?
Calibration checks an instrument against a traceable reference. Qualification proves a room or unit is fit for use.
EU GDP 3.3 · 3.3.2Is C3 a certification body?
No. We do the work and write the documents. Approval stays with your QA and the authority.
Which countries?
DACH, Benelux, the Nordics, Portugal, Spain, Ireland and the UK.
Ready for your next inspection?
30 minutes. No sales deck. A clear next step.
- 1Pick a time
- 2Talk for 30 minutes
- 3Get a fixed-price scope
Visit us
c/o UtrechtInc
Princetonlaan 6, Vening Meinesz Building C (VMC)
3584 CB Utrecht, Netherlands
Based in Utrecht.
C3 Cold Chain Compliancec/o UtrechtInc
Princetonlaan 6, Vening Meinesz Building C (VMC)
3584 CB Utrecht, Netherlands
At UtrechtInc on Utrecht Science Park.