With our latest release we aim to make it much easier for teams to ensure compliance and streamline collaboration within Design Controls, please find more information on the key changes below!
This update will be enabled for all sandbox accounts on May 13th, followed by production on June 12 2025.
Key features of the update
New 'Traceability' Tab: Provides an interactive view within the platform showing the connections between different elements (e.g., requirements, risks, test cases).
The columns shown will depend on the names given in your product configuration.
This view can be exported at any time.
Clicking the connector icon on each element will highlight all related parent or child elements.
N.B. Within the review you will also find a traceability tab, this view of traceability shows all elements included in the current and earlier reviews.
Gap Analysis: These icons are present on the Requirements, Risks, Test Cases, and Traceability tabs, visually indicating:
Missing or failing tests
Missing parent or child links between elements
Unmitigated risks.
An icon will not appear if it is not needed, for instance, if the requirement is at the top level it will not require a parent.
Issues identified by the gap analysis also appear as options on the Filter next to Search on the Requirements, Tests and Risks tabs, to allow you to find all elements with the same problem.
If you have amber warnings on your requirements, tests or risks then clicking its title will open the element to make edits to correct either directly within Qualio or in your third party system.
These issues will also appear as warning banners when opening design elements to ensure corrective action is taken quickly.
New Attributes: These attributes have been added to the display and can be used as filters on the aforementioned tabs, allowing for better organization and analysis of product elements.
Categories: Implement sub-categories on Requirements, and Risks for design controls. Each type of design element has its own category:
Requirements: Safety, Labeling, Compliance, etc.
Design Inputs: Functional Spec, Architecture Spec, etc.
Design outputs: Design Spec, UI/UX design, Code item, etc.
Risk: Safety, Cyber Security, Operational, etc.
Components: Adding 'components' to the requirements shown in Design Controls provides valuable context.
Many products consist of multiple modules, subsystems or components. Adding the ability to group design elements under components means teams can model their architecture in their requirements.
The components are determined by the user and relate to the parts of the given product they develop.
Both categories and components are created and managed from within the Resource Library.
Improved reviewer experience: full screen reviews with access given to system-generated files once the review is sent for approval.
A 4th level of requirements to support your needs: you can manage this from the 'Configure product' page.
Direct Deletion of Integrated Elements: Users can now delete elements brought in through self-service integrations directly from these tabs.
Simplified Status Field: The initial status field at creation has been removed, leaving only one dynamic status field to reduce confusion.
Simplified Navigation: The 'Open Issues' and 'Dashboard' tabs have been removed, streamlining the navigation within Design Controls.
In the video below, we're excited to share the latest improvements in our Design Controls, which serve as the foundation for your design elements. We encourage you to explore these updates and provide any feedback you may have.
Importance of the Update
Improve Traceability: Provide instant and interactive visibility of connections between product elements, making it easier to follow the relationships and dependencies.
Accelerate Issue Identification: The new icons and filters make it quicker to identify gaps (missing tests, links) and unmitigated risks that require attention.
Enhance Product Understanding: Combining the traceability features with the new 'Categories' and 'Components' attributes offers a richer and more comprehensive view of the product.
Streamline Workflows: The ability to directly delete integrated elements and the simplified navigation reduce friction and improve efficiency.
Facilitate Submission and Audit Readiness: By making it easier to trace issues and ensure all necessary elements are linked and addressed, the update helps users prepare their product documentation for regulatory submissions and audits.
If you are interested in Design Controls and have questions, reach out to either our Support team via in-app chat, or your Customer Success Manager. Or, you can continue to browse other articles to learn more about Design Controls: