Frequently Asked

Yes, ISO 9001:2015 and ISO 17025. Read more:

• About us

• Calibration

We offer SaaS solutions for shipment, facility and automated end-to-end monitoring of GxP critical operations. Read more about our solutions here

We have over 30 years of experience in temperature monitoring and actionable supply chain insights. Our offer of SaaS, data loggers and services have been developed in close collaboration with the life science industry to ensure safe and sustainable end-to-end drug delivery. Today, over 20,000 users in 150 countries use TSS solutions. Read more about TSS here

Our solutions are designed based on the requirements of our life science customers, and our solutions are used for GxP compliant release of goods. Our software complies with 21 CFR Part 11 and GAMP standards.

Our software is under 24/7 monitoring, with full redundancy and backup. We are proud to have a track record of 100% uptime. We offer different levels of SLA (service level agreements) with regards to response times, RTO and RPO, dependent on your needs.

Yes, one of our specialist areas is integrations with 3rd partner software for operational efficiencies and cost savings. We have experience of integrating several ERP, IRT, Freight Forwarders, WHM-systems and more. Read more about our integrations here

We offer a broad range of strategic and operational services, such as 24/7 monitoring and intervention of shipments, calibration services, business analytics and insights for cost savings.

Yes, our 24/7 Control Tower services compose of a range of services configurable for each client’s need, and span over vendor managed inventory, reverse logistics of used devices to intervention. It can be used with any of our hardware technologies but is most requested for shipments under the surveillance of active loggers (Bluetooth, GPS, Cellular network). Read more about our services here

Yes, TSS operates a calibration lab certified to ISO 17025 but also works with other ISO certified partners. Read more about our calibration services here

You can reach TSS customer service on +46 8 630 06 06 or at customer.service@tss.se. Support is available all day, every day, with global access. See all contact details here

We offer a broad range of data loggers for both shipment and facility monitoring that capture data on location, temperature, humidity and other conditions. They transmit data in different ways, from common USB upload to active transmission via Bluetooth or Cellular network, as well as location over GPS. Read more about our data loggers here

Yes, we offer a broad range of our own hardware but also integrate 3rd party data loggers from qualified suppliers into our technology-agnostic platform. Read more about our SaaS platform here

Yes. TSS data loggers are IATA compliant, which makes them suitable for air shipments and all other modes of transport. Read more about our data loggers here

We support all modes of transportation, from road and rail over sea and air - independent of the length of shipment and the regulatory requirements, such as IATA approval.

A temperature data logger is a small device that records temperature at set intervals while medicines are stored or shipped, so you can prove they stayed within their approved range. TSS offers seamless (Bluetooth), real-time, USB, facility monitoring and humidity loggers.

It depends on the temperature range you need to prove, whether you need the reading in real time or only on arrival, and how the data must reach your system. USB loggers suit simple shipments, Bluetooth loggers speed up handling at the site, and real-time loggers report location and temperature continuously for high-value routes. All should be calibrated against a traceable standard so the records hold up in an audit.

Yes. Every TSS logger is delivered calibrated to the ISO/IEC 17025 standard, with full details of the procedure, date and equipment. TSS has its own validated calibration lab in Solna, Sweden, certified by Swedac, and also works with other ISO-certified partners.

Yes. TSS loggers are qualified and validated: reliable devices of high standards that meet the usability and performance requirements of GxP operations.

We offer SaaS solutions for shipment, storage and end-to-end monitoring of GxP critical operations. Read more about our packaged solutions here

Yes, we offer both real-time monitoring for shipment and storage, including software, data loggers and 24/7 Control Tower services, including device management and intervention. Read more about our real-time monitoring solutions here

We offer a broad range of strategic and operational services, such as 24/7 monitoring and intervention of shipments, calibration services, business analytics and insights for cost savings. Read more about our services here

Clinical trial supply temperature monitoring is the tracking and recording of temperature for investigational medicines from manufacturing to the patient, so a sponsor can prove every kit stayed within its approved range. The TSS Clinical Module automates this for each individual kit, with a complete audit trail.

Yes. GxP is the umbrella term for the "good practice" quality rules in pharma. The Clinical Module is a cloud-based, GxP-validated solution, and TSS software complies with the 21 CFR Part 11 and GAMP standards. Every temperature data point and disposition decision is tracked at the individual kit level, creating a complete audit trail for inspection readiness.

A temperature excursion is any period when a product goes outside its approved range. Every time data is uploaded, the Clinical Module compares the logged temperatures against the product-specific, kit-level stability budget. Most evaluations are completed in less than a second, with an instant decision: OK to Use or Quarantine. The outcome is instantly communicated to the relevant systems and personnel.

Yes. The module is logger-agnostic, so you can use your preferred hardware, including mixed fleets across global trials, whether TSS or 3rd party. It integrates with RTSM/IRT systems, CTMS platforms, and inventory and depot systems. TSS also has a standardized integration process that can be applied to most IRTs.

Shipment temperature monitoring is the tracking of temperature while medicines are in transit, so they stay safe and effective for patients. TSS offers options ranging from real-time tracking to fully automated workflows and cost-effective manual uploads, with automatic temperature excursion evaluations and a full audit trail.

A temperature excursion is any period when a product goes outside its approved range, for example a vaccine that should stay between 2 and 8°C briefly reaching 10°C. It must be recorded, assessed against the product's stability data, and released or rejected through a documented decision. TSS evaluates temperature excursions automatically and manages deviations with a full audit trail for compliance.

It depends on your requirements. Real-time loggers are cellular-connected, track temperature and location continuously and send instant alerts; they suit high-value, high-risk and time-sensitive shipments. Bluetooth (BLE) loggers upload data automatically via e.g. gateways and mobile apps; they suit large-scale pharmaceutical distribution. USB loggers are uploaded manually on arrival; they suit regional shipments with predictable routes.

GxP temperature monitoring is the continuous tracking and recording of temperature for medicines so a company can prove, to regulators, that products stayed within their approved range at every step. GxP is the umbrella term for the "good practice" rules in pharma. TSS solutions support FDA and EMA regulations, TSS is ISO 9001 certified, and TSS software complies with the 21 CFR Part 11 and GAMP standards.

The TempMonitor BLE is a wireless logger for facility monitoring. It monitors fridges, freezers and small spaces at clinical sites, pharmacies and other locations. It uses an internal temperature sensor, supports up to two probes, and transmits data in real time to TSS Cloud via the TSS Gateway or the TSS Mobile App.

The operating range is -90°C to +80°C (probe), with a temperature accuracy of ±0.5°C and a resolution of 0.0125°C. Two probes are available: Ambient/Cold and Dry Ice.

The TSS Gateway collects data in real time from all TSS Bluetooth loggers and connects to TSS Cloud via Ethernet, Wi-Fi or a cellular network. You can also connect to the logger and upload data with the TSS Mobile App by scanning a barcode. The TempMonitor BLE records up to 50,000 data points, with a sample rate of 1 minute to 18 hours.

Yes. It gives a live feed of protected temperature data for remote site monitoring, with automatic notifications. It is integrated with the TSS Facility and Clinical Module applications, with site-specific settings and configurable user access rights.

Monitoring is the ongoing measurement of conditions during storage or transport, so you know a product stayed in range. Mapping is a study that shows the air temperature profile throughout a storage area or vehicle, defines zones that should not be used for storage, and shows how long it takes for temperatures to exceed the limits if power or cooling fails. TSS offers both, including facility and vehicle temperature mapping.

Getting started with digitalization of temperature monitoring with TSS solutions is often faster than expected, and we will guide you through the process of setup, configuration and process development. Read about how to get started here