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. 

How to Utilize Epics & Stories in Jira while Staying Compliant

To show this functionality in Jira, we will simulate an example customer who currently has an Epic to track an overall product requirement, such as an Insulin Pump Product Dosing Module (KD-12). The customer has a story to track a smaller component requirement - such as a Dose Suggestion Calculation (KD-13). We can see here, the 2 Jira Default items are linked through Jira Links. 

However, because they are Jira Defaults & not Ketryx issue types, they do not have the IEC 62034 compliant workflows that our Ketryx Default Issue types have. Lets help this customer set up 2 new items using the Ketryx Defaults.

We will first create 2 new Work Items, both will be Requirements. One of these will mirror our Epic, and one will mirror our Story. Because we are using Ketryx issue types, we can use the Ketryx Traceability Widget to link the two items, and use the Jira Links to link our Epic to our ‘Epic Mirror’ Requirement.

Now, you have 2 sets of these items - 1 for Project Management using the Jira Default item types and 1 set for Design Control using the Ketryx Default item types.