In the In Vitro Diagnostic and Medical Device industries compliance with IVDR, MDR and FDA regulations places heavy requirements on product development, documentation and the quality management system. In addition to validating that your product fits its intended use you must also validate that the software you use for developing these products is fit for its intended use.
At Thermo Fisher Scientific’s Vantaa site a ready-made Polarion process from Taipuva was used to validate Polarion itself. Similar process can be followed to validate any product development software using Polarion.
In addition to regulatory compliance validation of Polarion provides many benefits that support the creation of product documentation, such as ensuring that the intended use of the shared toolset is understood by all relevant stakeholders, and ensuring that the processes and outputs of the system function as expected. Lessons learned during the process of the implementation were that implementation gaps should be found in the before starting the formal testing phase – discover the limitations and failures early so you can adjust accordingly.
What made you choose Polarion?
– Our company chose Polarion mostly because of the expanded functionality over our previous tools. The editing of LiveDocs as a “what you see is what you want” type of document with both text and unique work items allows for a much more continuous process of that document’s life cycle: Instead of trying to separately create individual work items and put them together in another environment, and then try to form a complete picture, we can now put them into the LiveDoc and create that context through the text in that single document and get a better overall product.
What is the key benefit of the Polarion solution?
– The main benefit of Polarion in our organization is bringing more of the different research and development functions and their representatives into the same environment. Instead of certain representatives working only with a complete document and others working with only individual work items, we are all working in the same environment with the same work items and the same context of those documents.
How has Taipuva helped you in the process?
– Taipuva has been our main partner in setting up the environment, hosting our environment and making specific configurations and holding training sessions for us to understand how to utilize Polarion even better. Additionally, they were partnering with us to perform our validation so that we can show that Polarion is validated according to our standard operating procedures.
The main lessons learned from validating Polarion?
– The tool itself already carries a lot of functions, which we didn’t have to delve deeper into. It’s more sort of our specific configuration and our specific needs and implementations to support those needs, which benefited the most from the validation. So the tool itself is well-prepared and well-proven.
Is this your first time at Taipuva Polarion Days?
– This is my first time. I think the most benefit I’ve gained here is I’m seeing how many people are struggling with the same issues. I think a majority of the attendees here are also trying to figure out how to communicate between stakeholders, how to maintain a consistent environment for their requirements and know how to manage their requirement engineering process. In a way, this is like therapy.
Can you summarize your talk?
– My topic today was the validation of Polarion in a medical QMS environment, (quality management system) environment. We’ve taken Polarion quite recently into use. With the previous tool, the main users were the test engineers, but now we are bringing more awareness to project management, software engineers, mechanical engineers, electrical engineers, as well as test engineers, on how to bring information more visible to the other team members.
What made you choose Polarion in the first place?
– We originally ended up with Polarion because the most distinct feature was the LiveDoc environment. Many tools offer the same benefits for the traceability of work items, history and management of work items, reviewing, approvals and such, but not many offer the same kind of singular environment where one can get more context to individual work items to form a more complete picture.
What would you like to share with new users in Polarion?
– I think the biggest thing for new users to understand is that Polarion is very configurable. Even if you’re presented with a certain configuration from the start, it is very configurable for any process. So even an existing process can be emulated in Polarion so that there’s less need to make changes to your process just because of a tool change. But then there are many benefits in Polarion where the process can be made more efficient once you’ve first adapted the tool for your use.
How do you see Polarion being a part of your company’s vision?
– I wish to see that in our organisation we have fewer instances of miscommunication, and fewer misunderstandings in the contents of our documentation, our requirements or test cases or work items in general. I believe Polarion provides a good platform for it.
Siemens Polarion® ALM – take control
Get a holistic view, traceability and transparency for all product development and project management information. Everyone is aligned around what is being built while protecting integrity and compliance.
Key takeaways so far from the event?
– I think the key takeaways have been that requirement engineering is difficult. It’s not much of a surprise though, I don’t think anyone has said that making requirements was easy.
What do you think is the meaning of Taipuva Polarion Days?
– I think the role of Taipuva Polarion Days is a place where different users are in the same room and can get that feeling of support and togetherness. Many people are dealing with the same issues and are trying to produce the same sort of results as we are.
Do you have any key learnings from your process you would like to share with more recent user organisations?
– It’s good to evaluate your processes and try to see where Polarion fits in very well out-of-the-box, and where it requires more specific configuration or adaptation. It is a very flexible tool, but you shouldn’t expect it to fulfil all your needs out-of-the-box.
What has Taipuva meant for you?
– Taipuva has provided our company with the Polarion instance, and they also manage our instance. They’ve provided us with training to get us started with Polarion. As we’ve learned more on our own, they’ve been able to provide additional information as well as troubleshoot some issues that we’ve found during our use.
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