Most users are familiar with Jira’s issue types of Epics, Stories, Tasks.
- Epics and Stories focus on what the software needs to achieve.
- Tasks and Sub-tasks are the work that needs to be done to achieve those needs.
The gap, compliance-wise, in using these item types for design control, is that there’s no formal definition of how software should support defined needs. This ambiguity leads to compliance risk. Ketryx proposes the use of a 'Requirement' issue type, which allows users to link requirements directly to specific design elements, development tasks, and testing activities using Ketryx. This linkage is crucial for effective submission of design documentation and compliance auditing.
If you’d like to continue to use Epics and Stories for project management, we pose the following solution. Continue to utilize the issue types “Epics" and "Stories” to track the development cycle of certain features of your product, but utilize the Ketryx requirement type for design control documentation. This would require the user to extract information specifically related to user needs and functional requirements from the existing Epic or Story and create Requirement issue types. The Epic and Story can then still be used to track the development of the related requirement, but the Epic and Story will not show up in the design history file.
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