November 20th, 2017 by inflectra
At Inflectra we like to make the lives of customers easier and share knowledge. We have lots of customer in the life sciences industries using SpiraTeam to manage and test medical device systems and products. Since such products have to follow the FDA 21 CFR Part 11 requirements, we thought it would be useful to highlight some of the best practices we have for configuring SpiraTeam in such environments.
In the first article in this series, we'd like to discuss one of the foundational aspects of using SpiraTeam in a validated environment - you need to make sure that the roles and permissions in the system are configured to match your documented process.
Inside SpiraTeam, go to Administration > View / Edit Roles:
By default, most of the roles in SpiraTeam include the 'Bulk Edit' and 'Modify All' permission. This allows those users to edit the requirements and test cases on the main list pages and do bulk/mass edits regardless of the status of the artifact:
Now in a regulated environment you will most likely be restricting the editing of artifacts to specific workflow states (e.g. once a test case is approved, it should no longer be editable). We will be covering that in a future article, but for now, it is necessary to create or edit the roles to restrict the permissions:
Now in the current version of SpiraTeam as of writing this article (v5.3) the Bulk Edit permission is not active, instead the Modify All does two things:
But in v5.4 we will be changing this functionality so that:
So in a regulated system, you will need to limit Bulk Edit in future versions, but in the current version you will need to also limit 'Modify All' permissions.
In the next installment of this blog series, we'll be discussing how to configure the requirements workflow for a regulated project.
validation healthcare medical devices cfr part 11 fda 21 CFR Part 11
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