As you’ll notice, this validation pack looks much different than what you’re used to seeing!

Qualio is utilizing our own design control feature to meet traceability of user needs, to function, to testing of these needs. With the FDA’s and other regulatory agencies’ “Least Burdensome Approach” in mind, these automated tests are being leveraged to support the validation of these new features.

What am I looking at here?

When opening the validation pack, you’ll see a collection of PDFs, an Excel file, and many mp4 videos.

  • The RTM visually represents the traceability between the user need, the “why” of the need (or user story), and the test for this need

  • The Test Plan summarizes how the automated test scripts have been written, the “passing results,” and the date the testing was performed

  • The Requirement Specification lists all requirements

  • The Software Design Specifications lists design requirements that were part of this release

  • All mp4 videos are your objective evidence of these tests being performed. You’ll see two views within these videos:

    • On the left, you’ll see the test script itself being run

    • On the right, you’ll see the in-app view of this test being performed

What does this mean for you?

By taking this “auto-validation” approach, all core functionality of the tool has passed and the associated video evidence can be found within the validation pack. For any additional testing that you deem necessary, you will be responsible for writing these test cases and executing them. We encourage you to “play” with the new feature in your sandbox and test out any scenarios you deem important in alignment with your internal validation policies.

If no additional testing is needed, then you’re all set! The only action needed on your end is to upload this validation pack into your Qualio production account and approve the documentation. Please note, there were no new risks associated with the new features, so your existing risk assessment covers these new areas of Qualio also.

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