How We Use Notion as a Traceability Tool in our IEC 62304-Compliant Software Development Process

Traceability is a cornerstone of IEC 62304 compliance, ensuring that every software component is traceable throughout its lifecycle - from requirements to testing and maintenance. Traditionally, tools like Microsoft Excel or Word are used for this purpose. However, they often require labor-intensive tasks like manually generating unique identifiers and linking artifacts. On the other hand, specialized solutions from eQMS vendors such as Greenlight Guru or Matrix Requirements provide robust functionality but come with higher costs. Moreover, integrating multiple tools into the development process can increase complexity and create challenges in maintaining and synchronizing information across different platforms.

At ITR, we use Notion as a project management, documentation, and traceability tool in our IEC 62304-compliant process. It streamlines workflows, reduces context switching, and simplifies managing complex development processes.

Brief intro of Notion

Notion is a powerful productivity and collaboration tool renowned for its high level of customization, enabling users to create personalized workspaces tailored to their specific needs. Widely popular among startups, Notion serves as an all-in-one project management solution that seamlessly supports agile workflows. It enables teams to manage tasks, track project progress, and collaborate efficiently within a single, centralized platform.

Using Notion for Traceability

Here’s how we have leveraged Notion to meet the stringent requirements of IEC 62304:

Flexible Databases

Database is really like a table or sheet in Excel. You can create separate databases to document user needs, system requirements, software requirements, test cases, risk items, and more. The columns of the table can be tailored by adding relevant properties for a particular database. The best part? You can customize your database view to suit your specific needs without duplicating content. For instance, for the Product Requirements database below, we created three different views: one to list all requirements, one to show them in a Kanban board, and one to show their timelines. This feature is especially useful for startups that prefer Agile methodology.

Automatic Unique IDs

IEC 62304 needs each software requirement, test case, and risk item to have a unique ID. With Notion, we don’t have to manually manage and number each requirement or test case like we would with Word or Excel. That would be a lot of work and prone to mistakes.

By using the ID property of Notion database, IDs are automatically assigned whenever a new requirement or test case is added. Notion ensures that the IDs remain unique within a database.

Link Databases for Traceability

Notion makes it very easy to link and trace connected items. You connect items across multiple databases using two key features: Relations and Rollups.

• Relations enable you to connect pages from one database to another.
• Rollups allow you to pull specific properties from one database to display in another.

We leverage this feature to build traceability between user needs, system requirements, software requirements, V&V test cases, and risk items.

As an example, we set up a Relation property in the Verification database (shown in Figure 3) to link each test case directly to its corresponding requirement in the Software Requirements database.

This connection creates a handy “Verifies” column in the Verification database (Figure 4) and a “Verified by” column in the Software Requirements database (Figure 5). With this setup, selecting the requirement that each test case aims to verify becomes a seamless process. Any changes made through the Relations property will automatically update in both databases, keeping everything in sync.

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Take a look at the “TC-ID” (test case IDs) column in the Software Requirements database above. Instead of filling it in manually, we used the Rollup property to pull the “ID #” column from the Verification database through the “Verified by” Relation (Figure 6), which connects to the Software Requirements.

The same approach can be applied to establish traceability between other configuration items. This setup ensures compliance with IEC 62304 traceability requirements while eliminating the manual effort typically required to update traceability when configuration items change.

For example, if you use Excel, what would you need to do when you update or remove a software requirement? You would need to locate all documents referencing the requirement ID and make the necessary updates. During this manual process, you might encounter issues such as missed or incorrect updates, causing synchronization problems, and wasting time. With Notion databases, these edits are instantly reflected across all connected documents, ensuring everything stays accurate and up-to-date effortlessly.

In Summary

Notion is an efficient tool for managing traceability in our IEC 62304-compliant process. Its flexibility and features, like Relations and Rollups, simplify connections between requirements, test cases, and other items, streamlining updates and reducing manual effort.

I hope our approach provides some inspiration and proves practical for your own projects. If you have any questions or need guidance on setting up your Notion workspace for your medical device software development process, our team at ITR would be happy to help!