Traceability

Finnish Red Cross Leverages End-to-End Traceability for Complex Blood Information Project

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Traceability

No organization can thrive for nearly 70 years without evolving its processes, and Finnish Red Cross Blood Service (FRCBS) is no exception. The FRCBS’s Vein-to-Vein project is a prime example of how the organization has evolved to meet the digital age in order to provide the best care possible for those in need.

In 2016, FRCBS began to build the Vein-to-Vein system, a new information system for blood supply chain that covers blood donation and blood product manufacture, storage, and delivery to hospitals nationwide. Blood test results are also integrated into the information system. For the Vein-to-Vein information system project to be successful, data on blood products must work together seamlessly and the chain of data must remain unbroken, making the need for end-to-end traceability an incredibly important component.

This was one of many reasons the FRCBS began their search for a requirements and test management solution that could help them manage the complexity of the project. Their current test management solution, a pieced together system of Microsoft Excel and Microsoft Word documents, could not link risks and requirements to testing. Traceability was lacking, and the team knew the project’s success hinged on a solution that could clearly trace stakeholder requirements through testing, verification, and validation.

Like most organizations in 2020, FRCBS are working remotely throughout the country. Communication and collaboration were top priorities for the team. They knew that version control and review cycles would be compromised if they continued to use Excel and Word for their requirements and test management.

With the Vein-to-Vein information system, we are building the foundation for the digital future of the blood supply chain. It was abundantly clear to us that Word and Excel could not handle the amount of test cases and plans this project required.”

– Susanna Pöhö Development Manager, Digital Services at FRCBS

Finnish Red Cross Blood Services Sees Improved Traceability, Communication, and Collaboration

In June of 2018 FRCBS began onboarding Jama Connect and with the help of CGI Finland — and Jama Software’s easy-to-use platform — they were up and running in 6 months. The FRCBS now uses Jama Connect for testing and risk management.

FRCBS estimates that the testing team has improved their communication and collaboration by 50%, and with the improved communication, the team estimates that their review cycles have been shortened by 80%.

“With Jama Connect, we can link high-level system requirements and risks and test cases. Jama Connect makes it possible to ensure the test cases cover the entire information system, and nothing is being overlooked.”

– Susanna Majuri, System Specialist at FRCBS

Jama Connect has enabled improved end-to-end traceability and test management and allowed the teams to put more efficient processes in place. Because of Jama Connect, FRCBS estimates that the testing team has improved their communication and collaboration by 50%, and with the improved communication, the team estimates that their review cycles have been shortened by 80%.

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Audit Preparation Simplified and Shortened

While the system is not technically a CE-marked medical device, the Vein-to-Vein system must meet high quality standards, including GxP quality guidelines and other key regulations. Jama Connect has allowed them to easily demonstrate compliance in a digital format. The FRCBS team estimates that Jama Connect has helped reduce audit preparation time by more than 50%.

“Jama Connect plays a central role in our audit process. We’re able to easily show executed tests, and the whole hierarchy of high-level system requirements, risks, test cases, and scenarios,” said Pöhö.

Finnish Red Cross’ Digital Future with Jama Connect

As the Finnish Red Cross organization continues its efforts to digitize development projects, FRCBS sets a great example with their implementation of Jama Connect.

“We implemented Jama Connect in the middle of large-scale information system project. Our only regret is that we didn’t implement it sooner in the project so we could leverage Jama Connect’s full capabilities,” said Pöhö. “In the future, it will be easier once we widen the range of usage across the organization.” “We’d like to broaden our use of Jama Connect across the company, especially for testing and validation. It’s a new, modern way of working that’s improved our processes immensely,” said Pöhö.

To see more information about the importance of traceability in complex product development, we’ve compiled a handy list of valuable resources for you!

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McKenzie Jonsson
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