In pharmaceuticals, ensuring that the right conditions are maintained throughout the entire delivery chain can be the difference between life and death. The efficacy of many drugs is heavily dependent on the product being stored and shipped at the right cold temperature levels. Sometimes consistent humidity levels and other factors also come into play. To make sure that hospitals, pharmacies, and patients can trust the drugs they have receive from the manufacturer to deliver their healing properties, special logistics solutions are needed. Envirotainer is the global leader in secure cold chain solutions for air transport of pharmaceuticals. The company has developed a range of advanced transportation and logistics solutions where specialized are equipped with climate control systems and a set of tracking and logging devices to provide a verifiable unbroken cold chain for pharmaceuticals.
When Envirotainer began to develop its latest generation of its shipping containers, Taipuva and Polarion soon came into the picture.
– I quickly realized that we needed to upgrade our documentation structures and process tools, says Dan Mattsson, head of technical product management at Envirotainer and one of the persons responsible for the new generation of containers. We are in a business that combines two of the most heavily regulated industries in the world – aviation and pharmaceuticals – and the specifications are getting stricter all the time. This meant that our verification and testing methods, and how this is documented, must be second to none. I had been in contact with some of the people at Taipuva before, and their approach to application lifecycle management seemed like a great fit with our needs.
Envirotainer employs around 40 R&D engineers, plus between 25 and 30 consultants at any one time.
– With large projects involving many different teams and specialists, the need for communication and documentation rises exponentially, Dan Mattsson explains. Our key objective in engaging Taipuva and Polarion was to both be able to ensure the highest quality levels in our new generation of products and to mitigate risk as much as possible across all stages. Aspects such as traceability and verification were therefore high on our list of priorities. Initially, we looked at setting requirements on a system level, but gradually we went into more detail and focused on both a customer level and subsequently on the component level. Personally, I also believe that the focus on testing and verifying on a requirement level, rather than testing an entire document, simplifies the testing and verification process considerably.
A solution that pays for itself
The deployment of Taipuva and Polarion resulted in demonstrable improvements in operational efficiency. Envirotainer estimates that the new tool saved the equivalent of two man-years of project administration time, which more than covered the cost of the new system tool.
– For us, the focus was much more on the improvements in verification, quality assurance and risk mitigation rather than looking at potential cost savings, Dan Mattsson says. Our old system was basically a manual one, with documents in Word and Excel, which clearly was not optimal for the levels of verification and traceability that we were looking for. The fact that we can reach these targets with a solution that basically pays for itself is further icing on the cake. We are also adding further modules, where Risk Management is next for us.
Three key learnings
Dan Mattsson believes there are a few key success factors when working with Taipuva to implement a system like Polarion. These are his top three learnings:
- Don’t try to do everything in one big bite. Introduce the tools and their scope gradually in a stepwise approach, so that the project team becomes familiar with the tools and can see new opportunities and ways of working smarter.
- Set clear and realistic targets. You should expect the new tools to deliver clear benefits across many areas, and hence it helps to be specific about where your priorities lie and how these will be evaluated. At the same time, you should also be realistic about the implementation learning curve and how this impacts the type of targets you set and at which levels.
- Allow time for internal preparation and acceptance. When we started working with Taipuva, there was some support for this within Envirotainer. But as the project evolved and more and more people saw the benefits and how it helped make our work better and more productive, enthusiasm for the new tools and processes grew correspondingly. It takes time to implement new ways of working, but once they start to root the impact grows each day.
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