Simplify Compliance
Temperature monitoring and compliance for warehouse & logistics

Yes. Our monitoring systems meet FDA 21 CFR Part 11, GMP, GDP, MHRA, BRC, and HACCP requirements. You can generate audit-ready reports instantly to stay compliant and inspection-ready.

Good Distribution Practice (GDP) mandates absolute, verifiable control over your cold chain and logistics environments. Compliance is achieved not just through monitoring, but through a validated system of technical assurance.

TekTroniks are uniquely suited to assist with GDP compliance, supporting pharmaceutical, food safety, and cold chain logistics across every core quality signal:

• Thermal Validation: We provide UKAS-accredited Temperature Mapping, the essential service that thermally qualifies your sites, identifying all hot/cold spots for guaranteed storage suitability.

• Precision Monitoring: Our systems expertly track all critical quality signals: temperature, humidity, and door status, ensuring integrity in high-risk pharmaceutical and food storage areas.

• Validation: TekTroniks provides the documented validation (IQ, OQ, PQ) necessary to demonstrate that the monitoring system is correctly installed, operates reliably across its full range, and performs consistently under real-world conditions, satisfying MHRA and GxP standards.

• Certified Accuracy: We perform UKAS-accredited calibration services, guaranteeing all sensor data is traceable, reliable, and compliant.

With over 20 years of proven expertise supporting critical sectors like the NHS and pharmaceutical manufacturing, TekTroniks is uniquely suited to be your trusted partner for GDP compliance.

What It Is: Defining an Automated Environmental Monitoring System (AEMS)

An Automated Environmental Monitoring System (AEMS) for warehousing is a centralised, continuous data acquisition platform that provides real time surveillance of critical conditions, primarily temperature, relative humidity, and differential pressure. It is an industrial-grade solution built specifically for regulated environments.

• Continuous Data Acquisition: The system employs high-accuracy sensors to automatically capture and record data 24/7, providing uninterrupted temperature and humidity readings.

• Intelligent Alerting: It automatically triggers alarms when set limits (or set points) are breached. These alerts are managed according to a pre-defined Standard Operating Procedure (SOP) for effective response.

• System Redundancy: It relies on a highly robust network architecture (e.g. proprietary RF or mesh) with built-in battery and memory backups, ensuring data is not lost during power or network outages.

Why It's Required: The Mandate for Auditable Compliance

An AEMS is essential for maintaining product integrity and providing the technical evidence required to meet regulatory mandates.

• Compliance Validation: It is the core tool used to prove adherence to rigorous global standards, including GxP (GMP/GDP), HACCP, and FDA 21 CFR Part 11.

• Risk Mitigation: It protects high-value or sensitive inventory from being compromised by environmental excursions, ensuring batch traceability remains intact from receiving to dispatch.

• Immutable Audit Trail: The system automatically generates a tamper-proof digital record that logs every reading, alarm event, user acknowledgment, and corrective action, satisfying auditor scrutiny.

• Proactive Control: The intelligent escalation protocol ensures prompt human intervention, mitigating excursion duration and preventing minor deviations from becoming catastrophic product losses.

What Tek-Troniks Offers: Proven Expertise and Technical Assurance

TekTroniks provides a AEMS built upon decades of Expertise and trustworthiness, resulting in a reliable and compliant system.

• Data Integrity: Our architecture ensures data capture continues during facility failures, providing high system reliability that eliminates compliance gaps.

• Formal System Validation (IQ/OQ): We provide official documentation to confirm the system is correctly installed (IQ) and operates as specified (OQ). This is a critical step for regulatory approval.

• UKAS-Traceable Accuracy: We ensure the traceability of all measurements through routine, independent UKAS-traceable calibration, providing the highest level of accuracy evidence for audits.

• Simplify Auditing: Our platform transforms the complex data set into a secure digital audit trail, making complex regulatory reviews straightforward.

In short, an AEMS from TekTroniks provides the technical assurance necessary for operational excellence and total product integrity assurance in demanding warehouse and logistics environments.

TekTroniks provide the definitive qualification for temperature mapping temperature controlled storage, satisfying the most rigorous demands of Pharma (GxP), Logistics, and Food Safety audits.

The Assurance of UKAS Accreditation

Unlike providers who only use "UKAS-calibrated" loggers, our entire warehouse mapping process is independently audited and certified by UKAS (United Kingdom Accreditation Service) to ISO/IEC 17025:2017. This is the highest assurance for compliance.

This means every stage of your warehouse mapping, from initial sensor placement to final data analysis is guaranteed for accuracy, traceability, and reliability. Our reports simplify audits, as they are accepted by the MHRA, FDA, BRC, and GxP regulators.

We specialise in thermally qualifying ambient, chilled, or frozen warehouses. Our study identifies and documents all vulnerable areas: hot spots (near roofs, loading docks), cold spots (near cooling units, floors), and zones prone to air flow issues.

Warehouse temperatures are highly susceptible to exterior climate. We provide essential guidance and services for seasonal mapping (summer and winter) to prove your storage environment can consistently maintain specified limits against extreme external conditions.

Our engineers develop a custom protocol based on your warehouse's specific layout, racking, door usage, and HVAC systems, ensuring the study accurately reflects your operational risk.

The key outcome of your mapping report is a clear plan for your permanent monitoring system. We use the definitive hot and cold spot data to determine the required locations for your routine monitoring sensors.

We are your single partner for UKAS accredited temperature mapping, UKAS accredited calibration, and the installation of a continuous monitoring system, providing a streamlined, end-to-end solution that ensures ongoing compliance.

There are two primary reasons for monitoring humidity in a warehouse environment.

First, elevated humidity levels can lead to condensation forming on walls and ceilings, which promotes the growth of mould on stored goods and creates ideal conditions for pest infestations. This not only damages inventory but can also compromise the overall hygiene of the facility.

Second, humidity levels may need to be monitored and recorded based on the specific requirements of the stored goods, in accordance with relevant regulatory standards. For instance, warehouses storing pharmaceutical products must adhere to strict MHRA (Medicines and Healthcare Products Regulatory Agency) and GDP (Good Distribution Practice) guidelines to ensure product safety and quality.

Our advanced monitoring system continuously tracks both temperature and humidity levels and triggers alerts when predefined thresholds are exceeded, helping to safeguard your inventory and maintain compliance with industry regulations.

UKAS accredited calibration is critical for any storage that follows strict quality rules (like GxP warehouses and logistics) because it provides the highest level of independent proof that your temperature data is accurate, reliable, and legally traceable. This single factor protects your product quality and makes regulatory audits dramatically simpler.

Why auditors insist on UKAS Certificates

Auditors prefer UKAS accreditation because it eliminates doubt and speeds up the entire audit process.

• Highest Assurance: UKAS (The UK Accreditation Service) is the only national accreditation body recognized by the government. When an auditor sees a UKAS certificate, they immediately know the calibration service meets the rigorous international standard (ISO/IEC 17025).

• Proof of Competence: The accreditation proves the supplier's technical methods and staff are impartial and independently verified. This means the auditor can accept the data without needing to waste time validating the calibration procedure itself.

• Legal Defensibility: UKAS certificates explicitly state the Measurement Uncertainty (the maximum possible error). Auditors require this to confirm that, even accounting for error, your storage environment still kept sensitive products within their required limits.

Why do regulators require this kevel of proof?

In pharmaceutical, life science, and regulated food storage (known as GxP, GDP, and GMP), temperature logs are considered Official Quality Records. UKAS accreditation is necessary to:

• Provide Highest Proof: It gives you the strongest possible evidence that the devices monitoring your sensitive products (like medicines and vaccines) were measuring temperatures accurately and within required limits.

• Show Maximum Error: UKAS certificates explicitly state the Measurement Uncertainty (the maximum possible error). Auditors require this to confirm that, even accounting for error, your storage environment still kept sensitive products within their required limits.

• Demonstrate Responsibility: It proves you took every reasonable step (due diligence) to hire a competent, reliable, and independently checked calibration supplier.

Validation using Installation Qualification (IQ) and Operational Qualification (OQ) is a mandatory requirement under GxP and regulatory bodies like the FDA and MHRA. It provides documented, auditable evidence that your monitoring system is fit for its critical purpose.

What is the Goal of IQ OQ PQ Validation?

The goal is to prove, in an auditable way, that your temperature monitoring system and all its components will consistently perform as intended. It answers three key questions for auditors.

• Is the system installed correctly?: The IQ (Installation Qualification) verifies that all hardware (Base station, sensors, loggers) are installed according to specifications, all documentation is in place, and all sensors have current, traceable calibration certificates.
• Does the system work correctly?: The OQ (Operational Qualification) confirms the system's critical functions, such as alarm testing (simulating a high/low temperature event), power loss recovery, and critical software functionality such as audit trails work as intended.
• Does the system work correctly over time?: The PQ (Performance Qualification). Confirms the system operates correctly and continues to do so over time..

We recommend annual UKAS-accredited calibration for the sensors we manufacture, however, if your business/legislative requires mean you need more frequent calibration then this can be accommodated.

We provide both in-house and on-site calibration, accredited to ISO/IEC 17025:2017, with full certification for compliance records.

The placement of temperature sensors in a warehouse is a critical consideration, but there is no universal answer, as optimal sensor locations vary based on the facility’s unique layout and environmental conditions. The industry-standard approach is to conduct a comprehensive temperature mapping study.

A temperature mapping study involves monitoring temperature fluctuations across different areas of the warehouse over two cycles, covering both winter and summer months. This ensures that seasonal variations in temperature are accounted for, helping to identify any potential risk zones where temperature control may be compromised. Once the study is complete, the data can be used to determine the most appropriate sensor placement locations to ensure accurate and reliable monitoring throughout the facility.

We are fully UKAS-accredited for temperature mapping, allowing us to perform these studies to the highest standards of accuracy and compliance. This service ensures you meet regulatory requirements and maintain optimal storage conditions for your goods.

Contact one of our system specialists for advice or to arrange a site visit.

Yes. Our sensors are industrial-grade, long-range, and battery-powered. For racking, we use external probes dropped securely through racking legs, ensuring accurate readings at multiple heights across the warehouse area.

Our robust, industrial-strength wireless network is engineered specifically to conquer the challenges of large warehouses, distribution centres, and complex logistical spaces.

Engineered for Performance and Resilience

• Signal Penetrability: Our wireless sensors operate on the license-free 868MHz frequency band. This band is optimised for long-range communication and deep penetration through the very materials common in logistics: thick warehouse walls, racking systems, insulation, and dense stock.

• Coverage: This frequency offers significantly better coverage and signal reliability compared to standard technologies like WiFi, Bluetooth, or ZigBee. This is critical for industrial applications where maintaining stable connections over vast areas is non-negotiable.

• Dynamic Reliability: The network is designed for exceptional resilience, seamlessly routing data through complex structures and dynamically re-routing around new physical obstructions (like shifted stock or equipment) or evolving environmental conditions. You get uninterrupted data, providing exceptional performance where other systems fail.

Real-Time Data for Compliance

Our wireless infrastructure ensures consistent and dependable monitoring across your entire facility. This delivers critical benefits:

• Audit-Proof Uptime: Continuous, accurate data transmission, even during power loss, is critical for maintaining GxP compliance and preventing product loss in cold chain logistics.

• Enhanced Operational Efficiency: Reliable real-time data allows you to proactively manage conditions, maintain safety standards, and optimize your processes without connectivity downtime.

Contact our team if you wish to trial the system for up to 30 days.

Yes. Our D3 Base Stations support API and Modbus, making integration with ERP, SCADA, or building management systems fairly straightforward.

You can connect up to 150 sensors to one D3 base station and you can have multiple base stations on a single site!

With MyDataPortal, you can monitor multiple warehouses or sites from a single dashboard.

You can receive alerts via SMS, email, push notifications, or automated calls. You set thresholds, and our alarm escalation rules ensure the right people act quickly.

The D3 system stores data locally and continues to monitor and trigger alarms during an outage.

Once power or connectivity returns, it automatically triggers alarms to be sent and data is available to your system users.

Yes. You can export data to CSV files for analysis. Our graphing tool lets you compare multiple data points over time for deeper insights.

We use AES encryption for all wireless transmissions. Data is stored securely on-site and viewed by MyDataPortal. Your in control of your data at all times.

No. Our D3 systems are standalone with no licence fees and no dedicated server requirements.

MyDataPortal is an add on enhanced service and gives additional notification capabilities, there are fees for using MyDataPortal.

Yes. You can trial the system for up to 30 days in your own environment to see how it performs.

Continuous monitoring prevents spoilage, equipment failure and frees up your staff from manual monitoring. By protecting stock, reducing waste and better utilisation of your staff, the system delivers a fast return on investment.

You can choose self-installation for smaller sites or professional installation by Tek-Troniks engineers for regulated or multi-site operations. Our engineers provide IQ/OQ documentation, staff training, and compliance assurance.

We provide year-round service contract support, calibration services, and temperature mapping studies. With over 30 years of experience, we remain a long-term partner for your compliance and monitoring needs.