Ketryx supports producing different documents for different regulatory regions from the same design controls within a single project. This is specifically designed for cases where you need different variations of quality documents for different regulatory environments.
Here's how you can implement this:

1. Define your regions - First, configure the available regions in your project using the organization-level advanced setting "Select text field options". Caution: If Field names is used in the organization to map a custom field in Jira to "Regions", and you are using enforcer mode in a project, this will overwrite the options for that field. For example:

{
  "regions": [
    {
      "value": "EU"
    },
    {
      "value": "US"
    }
  ]
}

2. Label your configuration items - Individual configuration items can be "labelled" with one or more regions using the built-in Regions field, making them specific to those regions. Items without region labels are considered region-independent and will appear in all region-specific documents.

3. Configure region-specific documents - Use the "Region-specific documents" advanced setting to specify which release documents should be region-specific. These documents will only include items explicitly marked for their respective region, plus any region-independent items.

This approach allows you to maintain a single project while still producing documentation tailored to different regulatory requirements. For more complex scenarios where the differences between regions are substantial, you might consider using separate projects for different regions, with cross-project references between them.

Additionally, Ketryx's advanced templating mechanism can be used to further customize document generation for different regions, allowing you to create standardized documents that comply with specific regulatory requirements.