Qualification & Validation

Temperature Mapping & Validation

Ensuring regulatory compliance and product integrity for the pharmaceutical and food industries with precision engineering and advanced data logging solutions.

−80 °C ULF 2–8 °C Cold chain Ambient
Temperature mapping of a pharmaceutical storage facility

Every controlled environment in your supply chain

Strategic placement of data loggers to capture temperature and humidity fluctuations across large volumes, analysed and issued as OQ/PQ documentation against WHO and GDP guidelines.

Warehouses

Large-scale temperature mapping for ambient and controlled temperature storage areas.

Ambient · controlled

Cold Rooms

Precise validation of walk-in refrigerators and cold storage facilities.

2 °C – 8 °C

Transport Vehicles

Mapping and validation of refrigerated trucks and vans for safe GDP transport.

GDP transport

Freezer & ULF

Validation for cryogenic and ultra-low freezer units used in high-value labs.

−20 °C · −80 °C

Five steps from site audit to audit-ready report

  1. Site Audit

    Physical assessment of storage dimensions and sensor placement.

  2. Protocol (VMP)

    Custom validation protocol designed against a specific risk assessment.

  3. Execution

    Deployment of high-precision, NIST-traceable data loggers.

  4. Data Analysis

    Statistical review of MKT, hot spot and cold spot trends.

  5. Final Report

    Generation of audit-ready compliance documentation.

Your mapping data, analysed and signed in one place

Every study we run is delivered through GXPWAY Mapping Cloud, so your team can review the analysis behind the report rather than just the PDF.

What the platform does

  • Event-windowed analysis — the whole study, plus each door-opening, power-failure or recovery window on its own.
  • Mean Kinetic Temperature at a fixed 83.144 kJ/mol activation energy, per ICH Q1.
  • Hot spot, cold spot and MKT drift identified against the entire-study reference.
  • Floor-plan pin placement, so every logger position is recorded, not described.
  • Two-signatory electronic signatures and a tamper-evident audit trail, under 21 CFR Part 11 and EU Annex 11.

Why industry leaders choose GXPWAY

ISO 17025 Accredited Methods globally recognised and fully accredited.
Calibrated Equipment NIST-traceable, high-resolution data loggers.
Serving Qatar since 2014 Hundreds of successfully delivered projects.
Audit-Ready Reports Built to withstand MOPH and international inspections.

Trusted across pharma, logistics and healthcare

  • Milaha
  • Doha Drug Store
  • Pharma World
  • Sharjah Drug Store
  • Trans Arabia Drug Store
  • Aida Holding
  • Saha Jamal
  • Helsenmed
  • IMQ
  • Kulud
  • Delta
  • Abcon

What clients ask before a mapping study

How often should temperature mapping be repeated?

Studies are normally run during both summer and winter seasons, so the data accounts for external environmental extremes at either end of the year.

What are hot spots and cold spots?

They are the areas within a storage facility that consistently show the highest or lowest temperature readings. Identifying them determines where monitoring sensors should permanently live once the study is complete.

What documentation do we receive?

Full Operational Qualification (OQ) and Performance Qualification (PQ) protocols and reports, including both empty-state and loaded-state mapping.

Can we review the underlying data ourselves?

Yes. Every study is delivered through GXPWAY Mapping Cloud, where your team can inspect per-logger statistics, excursions and the floor-plan layout behind each figure in the report.

Ready to secure your compliance?

Contact our engineering team for a free consultation and a customised quote for your facility or transport fleet.