Many pharmaceuticals and biological products require specific temperature conditions during manufacturing, storage, and transport to ensure their quality and safety. Failure to maintain these conditions can lead to product degradation, making them less effective or even dangerous. To protect public health, regulatory authorities like the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have established strict guidelines to manage these products. To comply with these regulations, life science companies must adopt advanced temperature monitoring systems that can track and record conditions continuously and reliably. This whitepaper explains the main requirements from both the FDA and EMA, the role of technology in maintaining compliance, and the best practices for setting up effective temperature monitoring systems.

At this year's LogiPharma Europe 2025 in Lyon, Anita Leposa, Key Account Manager at TSS, and Neil Malkin, Business Process Owner for Temperature Management at AstraZeneca, took the stage to discuss one of the most pressing challenges in the pharmaceutical supply chain: temperature excursions and their impact on medicine availability.

Reactive Excursion Intervention with Real-Time Temperature Data: From reactive crisis management to proactive supply chain optimization

TSS, a global company specializing in temperature monitoring for the pharmaceutical supply chain, is proud to announce that it has received an 'SME B' rating from the 2024 CDP SME Climate Score. This recognition highlights TSS’s commitment to being open about its environmental impact and taking steps to reduce it.

At this year’s Clinical Trial Supply Europe event in Barcelona, TSS took center stage to discuss one of the most pressing challenges in clinical trial supply chains—temperature monitoring. Our Key Account Manager, Anita Leposa, highlighted how automation is revolutionizing temperature integrity management, reducing manual work, and ensuring compliance for global pharmaceutical sponsors.

February 11 marks the International Day of Women and Girls in Science, a day dedicated to recognizing the invaluable contributions of women in STEM fields and inspiring future generations to follow in their footsteps.

Curious about how to up-scale you Clinical Trials? Join us at the 26th Annual Clinical Trial Supply Europe in Barcelona to explore your possibilities for optimizing the supply chain.

As the global healthcare industry focuses more on sustainability, temperature management in clinical trials is becoming more important. Research organizations and clinical trial sponsors are starting to see that making clinical trial processes more sustainable is not only good for the environment but also improves efficiency and cuts costs.

Customer onboarding is one of the most important steps in making sure your customers are happy and confident in using your product. At TSS, we help companies in life sciences monitor complex temperature budgets with our advanced automated cloud software and temperature loggers. Making the onboarding process smooth is key to long-term customer satisfaction.

TSS, a leading provider of temperature-monitoring solutions for the life-science industry, proudly announces that it has retained the EcoVadis Silver Medal for the second consecutive year. This recognition is a testament to TSS’s ongoing commitment to sustainability, even as EcoVadis raised the bar for its assessment criteria in 2024.

We are thrilled to announce a new chapter at TSS as we bid farewell to our esteemed CEO, Niclas Ohlsson.

Pharmaceutical companies are under pressure to bring new drugs to market quickly. This urgency is driven by the needs of patients, requirements from authorities, and investors. Clinical trials are a crucial part of this process, but they can be delayed by manual processes.

In the complex world of pharmaceuticals, sustainability is becoming a key part of business strategy. The push for a greener future is driven not only by government rules but also by the expectations of communities and customers. However, making the supply chain sustainable while balancing costs and maintaining high quality can be challenging. This requires careful planning and a commitment to long-term goals.

In the life-science industry, finding the right balance between cost and quality in the supply chain is crucial. This balance ensures that pharma companies remain financially healthy while delivering safe and effective products to patients. However, achieving this balance can be challenging due to the complexities of quality management, procurement, and temperature control.

World Telecommunication & Information Society Day (WTISD), celebrated annually on May 17th, highlights the pivotal role of digital technologies in fostering societal progress. This day serves as a reminder of the transformative power of innovation and digitalisation in building a sustainable future. At TSS, we are dedicated to leveraging advanced technologies to enhance the pharmaceutical supply chain while promoting sustainability.

In the pharmaceutical industry, maintaining precise temperature control is paramount to ensuring product quality and compliance with regulatory standards. The integrity of pharmaceutical products is heavily reliant on storage conditions, with deviations in temperature potentially compromising their efficacy and safety.

The Future of Temperature Monitoring: How to lower the CO2 footprint with a Circular Supply Solution

TSS AB proudly announces its Calibration Laboratory's ground-breaking achievement of ISO/IEC 17025 accreditation by Swedac. This milestone sets a new standard for precision and reliability in temperature monitoring services.

Are you in pursuit of optimizing the temperature management of your clinical trials supply chain? Get inspired by experts from the field, and learn from their experiences.

The TSS User Forum is a platform for thought leadership and innovation in supply chain and temperature control technologies. This forum gathered industry experts from some of the most respected life science companies worldwide, covering topical realities such as automation benefits, data management, supply chain sustainability, and Direct-To-Patient.

TSS, a prominent provider of temperature monitoring solutions, is delighted to announce the appointment of Gustaf Rasin as its new Chief Operations Officer (COO). Gustaf Rasin will play a vital role in refining the company's operational workflows and fostering its growth and environmental sustainability vision.

Where do the majority of your temperature excursions occur? Why not eliminate them?

TSS, a leading temperature monitoring solutions provider, is pleased to announce the appointment of Thomas Lindén as its new Chief Technology Officer (CTO). In this role, Thomas Lindén will play a crucial part in shaping the company's technological landscape and driving its growth strategies.

In light of the recent EMA and FDA guidelines, this session will discuss what role temperature monitoring may play in decentralized (DCT) and direct-to-patient (DTP) studies.

Is it possible to cut costs, increase efficiency, and improve quality—all at the same time? The GSK (GlaxoSmithKline) UAE division and their main logistics company GAC (Gulf Agency Company) exceeded their expectations when they implemented temperature monitoring solutions from TSS in outbound shipments from Dubai. Additionally, they reassured the safety of what's most valuable—the patient.

Loggers with reusable components can decrease the carbon footprint by almost 90% compared to disposable. These important discoveries were made during a close collaboration between business, research, and authorities to prepare for more environmentally and socially sustainable business practices.

TSS, a leading Swedish Software-as-a-Service (SaaS) company specializing in automated temperature monitoring solutions, is thrilled to announce that it has been awarded the prestigious EcoVadis Silver Medal for its advanced sustainability performance. With an overall score of 65, TSS has secured its position among the top 13% of sustainable world-leading companies, firmly establishing itself as a trailblazer in the industry.

In an era where people can make instant cash transfers electronically from their phone and order physical goods to be delivered in hours to their location, there is a portion of the Clinical Supply Chain that seems mired in a staff intensive, manual, reactive business process. That process is evaluating temperature excursions for Clinical Trial material.

Where do the majority of your temperature excursions occur? Why not eliminate them?

Seamless monitoring of direct-to-patient shipments within an end-to-end calculation engine enables a digital release in patient's homes. Site centric technology also allows for a decentralized and proactive approach, reducing waste. Furthermore, digitalizing temperature management end-to-end enables a faster release of products for all types of trials and creates a foundation for successful decentralized drives.

We are glad to announce that we’re exhibiting at the next Clinical Trial Supply Europe conference organized by Arena International.

We are excited to join the 20th Anniversary edition of Clinical Trial Supply East Coast on the 19th and 20th October 2022 in the Sheraton King of Prussia. The conference covers all things CTS from reducing timelines and streamlining processes to handling clinical supplies in a decentralized trial world. Along speakers from Pfizer, Merck, Janssen and many more we will present how digitalization of temperature processes can improve business outcomes in clinical trials.

This year several events are returning to in-person meetings, and the GCSG (Global Clinical Supply Group) European Knowledge Forum is one of them. GCSG is committed to making the world of clinical supplies a little less complex and more accessible to future clinical supplies leaders. They strive to connect all of us to share best practices while providing access to valuable education and resources. As a member of the GCSG, TSS is looking forward to interesting discussions, presentations and showcases at this year´s forum taking place in Dubrovnik Oct 4th-6th.

Since 2002, LogiPharma has been bringing together the top minds in life sciences and healthcare supply chain, logistics, distribution, planning, IT, quality and sourcing to share emerging best practices. This 2 -day meeting will dedicate he first day to “The Connected, Resilient and Agile Supply Chain” followed by “Supply Chain Innovation and Optimization to Support Customer Experience” on the second day. TSS is proud to present on the topic of “Using leading technology to enable harmonization of temperature management operations”.

Two-way integrations between IRT and the temperature system unlock cold chain consistency in clinical development – protecting patients, maximizing value and minimizing operational costs.

Digital transformation is having a huge impact on pharma supply chains, supporting patient safety and giving companies a competitive advantage. But key to this process are the integrations between different systems.

We’re glad to announce that we will participate in the Temperature Control and Logistics conference and exhibition for pharma supply chain professionals in Düsseldorf, Germany, on June 7th-8th.

Akanksha Sharma joined TSS in 2021 as a Quality Engineer in our Validation team, where she helped make sure our systems and processes are working exactly as they should. Always keen to continue expanding her skills and experience, in 2022 Akanksha took on a new challenge within our company.

Without a doubt, uncertainty and unpredictability will continue to increase. Whether you‘re a pharmaceutical company dealing with temperature excursions, or a manufacturer relying on critical assembly-line components, you’re bound to be affected. The amount of disruption in today’s business climate demands the ability to respond quickly, which can only be done if the entire supply chain is visible.

Even though Claes Kalderén only joined TSS at the beginning of 2022, his vast experience has allowed him to hit the ground running. As European Sales Manager, he is responsible for forging new customer relationships across the continent.

We are very excited to continue building an industry-leading team at TSS and so are delighted to officially welcome our new Chief Product Officer (CPO), Johanna Eriksson. Johanna has worked in the pharmaceutical industry for a number of years; she has lots of experience in collaborating with companies, agencies, and other stakeholders to create great products and solutions to make sure drugs are distributed safely for patients.

Watch this webinar in collaboration with endpoint Clinical to learn about using 2-way technology integrations to maximize value in clinical trial management.

New technologies for tracking and temperature logging hold great potential, but which to choose? Get a copy of our latest white paper.

We are glad to announce that we're participating in this year's Global Clinical Supply Conference organized by the Global Clinical Supply Group on May 1-4 in San Antonio, Texas.

We are working with pharma and life sciences companies worldwide to drive improvements in their temperature monitoring and drug delivery processes. The foundation of our approach is to ensure the integrity of data and the safety of patients through implementing digital solutions into supply chains.

Temperature excursion management is a prime example of a clinical process that automation can make more efficient. It is currently a highly burdensome activity, where every temperature excursion is evaluated regardless of how minor they are and if they fit well within the excursion budget.

Pharmaceutical supply chains are often defined by a lack of connectivity between tiers, stakeholders and operational islands. It doesn’t have to be that way.

Temperature management is critical when it comes to ensuring patient safety in clinical development, but we continue to use legacy point solutions that require heavy manual processes and duplication of data.

An important lesson of the first two decades of the millennium is that driving business value is often not about simply collecting as much data as you can. Instead, it is about creating systems that turn the data you have into useful insights and distribute them effectively to the people who need them.

We are glad to announce that we’re exhibiting at the next Clinical Trial Supply Europe conference organized by Arena International.

USB data loggers have been an important part of the life science temperature monitoring process for years. They have dramatically improved the safety of the drug distribution process by allowing the accurate measurement of temperature data at set points along the supply journey.

As 2021 draws to a close, we’ve rounded up the most-read stories we’ve published on our blog in the past 12 months – featuring automation, new technologies, data, clinical supply, and pharma logistics.

In Q4 of 2021, WBR Insights surveyed 100 Directors of Supply Chain Management and similar from pharma organizations across Europe and North America to find out about the challenges they face in 2021 and the innovative solutions they are putting in place.

If temperature data can’t be processed, visualized and compared on a global basis, the true performance will never be revealed.

We are delighted to officially welcome Nina Nilsson, our new Chief Revenue Officer. Nina is delivering great value to our customers by addressing key pain points, offering insight and understanding which can help to improve our customers business process.

In recent years, real-time temperature monitoring has become something of a buzzword in the industry for pharmaceutical logistics. Despite the fact that it is on everybody’s lips right now, it is definitely more than a one-day wonder.

Learn how one of the world’s largest pharma organisations saves millions of dollars and thousands of tonnes of CO2 with a clean, simple, and efficient supply chain.

Learn how one of the world’s largest pharma organisations saves millions of dollars and thousands of tonnes of CO2 with a clean, simple, and efficient supply chain.

Learn how clinical trial sponsors saves millions of dollars by replacing manual processes with a digital, automated solution.

The effective monitoring of temperature throughout the supply chain is of paramount importance in ensuring the safe and protocol-compliant conduct of a clinical trial. Each deviation causes the progress of the product along the supply chain to grind to a halt as checks are conducted to make sure it is still suitable to be dispensed.

Get introduced about how to implement digital efficiencies and inform the future of medical supply chains.

The effects of the Covid-19 outbreak are escalating daily and is first and foremost a human tragedy, affecting hundreds of thousands of people.

Moving to Stockholm’s new innovation and life science cluster in Hagastaden was a conscious choice for us at TSS.

When it comes to global transportation and shipping of drugs, simply knowing where they are is no longer enough. Pharmaceutical organisations are becoming increasingly aware of the safety regulations which go into storage and transportation, i.e. ensuring that every drug which reaches the patient end, is effective and safe for consumption.

For companies in the pharmaceutical and life sciences industry, GxP data is a critical element of supply chain best practices. Indeed, there is hardly any requirement, from visibility to synchronized logistics, which does not rely on accessing the right data.

When TSS received the request to support Sandoz, the Novartis generics and biosimilar division, from its client Novartis, a multinational pharmaceutical company based in Switzerland, citing their need for urgent support with surveillance of critical shipments related to a COVID-19, the obvious solution was TSS Real-Time Monitoring solution.

Digital temperature monitoring along every step of the pharmaceutical supply chain is quickly becoming the new norm. Government guidelines like the EU’s Good Distribution Practices (GDP) and the guidelines of UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) have seen to increased uptake of digital temperature monitoring across the Europe’s pharmaceutical industry.

The question of how to speed up clinical trials is complicated, especially considering that many trial stages simply cannot be rushed in the interest of trial subjects and the general public. However, process improvements can go a long way.

Supply chain digitalization, or rather digital transformation, provides a path to sustainable solutions for many of the challenges in managing the pharmaceutical industry’s supply chain such as compliance, traceability, end-to-end visibility, error-reduction, quality assurance and process efficiencies.

We are expanding our US operations, with Evan Hahn to be the new VP North America. Evan brings a wealth of knowledge of the pharmaceutical clinical trial space, supporting the TSS launch of its new offering in this category.

Automation of temperature excursion handling and data flow to streamline site activities

We’re pleased to announce the first TSS Clinical Trials Digitalization User Forum on February 10-11, 2021

The life science industry is always looking for ways to improve reliability and efficiency across the supply chain. New technologies for tracking and temperature logging hold great potential, but which to choose?

While cloud-based solutions have seen high implementation levels into specific portions of the supply chain in the pharma and life science industry, others have been neglected. Of course, one of the clear benefits of cloud-based temperature monitoring solutions for your data is cost-savings, but there are other tangible benefits for pharma companies that utilize cloud solutions to storage their temperature data.

International Women’s Day (IWD) is a global day celebrating the social, economic, cultural, and political achievements of women. The day also marks a call to action for accelerating gender parity. Significant activity is witnessed worldwide as groups come together to celebrate women’s achievements or rally for women’s equality.

Are healthcare professionals working at clinical sites across the world satisfied? It might seem like a strange question to ask, but the way we feel can impact our professional performance in important ways. Perhaps the question is not how satisfied Clinical Operations professionals are, but whether they feel their performance is impacted by lots of time-consuming manual processes that could benefit from automation? Are these processes hampering clinical trial performance?

Although clinical trials can cover a huge range of formats, from small academic assessments to global, multi-billion dollar ventures, they all have one thing in common. Their success (or failure) is determined by a consistent approach to data.

Get introduced to the solution tailored to GxP critical shipments – BLE technology for temperature monitoring

The Covid-19 pandemic has placed a global spotlight on pharmaceuticals and the importance of temperature control. The large-scale vaccination programs being rolled out across the world depend on operators and distributors being able to monitor and manage temperatures effectively. It has also shown just how challenging this can be.

We believe automation is essential to making supply chains more visible and removing inefficiencies that come with manual tasks. Watch our webinar to find out more about how to achieve automation in your clinical supply chain.

Our North America VP Evan Hahn, recently presented a webinar where he outlined three different approaches for automating clinical supply chains.

Data is an essential requirement for improving supply chain processes. But that doesn’t mean that simply collecting more of it will instantly lead to reductions in waste, increases in efficiency and lower excursion rates. Taking a more targeted approach will help you turn supply chain data into insights that can help you understand exactly what is happening at every stage of your pharmaceutical supply chain.

We’re pleased to announce that we’re attending LogiPharma 2022, the world’s leading Pharma Supply event, from April 05th to April 07th, in Nice, France.

There are a few key reasons why many sponsors are starting to ask whether current clinical supply processes are efficient enough.

TSS introduces a new era of efficiency, with next-generation Bluetooth Low Energy temperature monitoring solutions that help life science supply chain professionals automate their processes for time and cost savings while securing patient safety.

According to Lie Berglind, Chief Quality Officer at TSS, quality management is the soul of every organization. It is about doing what we say we should do, but also about measuring and determining how it was done, as well as documenting it to discover opportunities for improvement.

For the life science industry, optimizing temperature control processes has the potential to drive big improvements in the reliability and efficiency of supply chains.