Configuring SpiraTeam for Testing in Validated Environments (Part 4)

December 7th, 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. This is the fourth article in the blog series, and covers the configuration of the release workflows.

Configuring the Release Workflow

In the previous article we described how to setup the workflows for managing your test cases. Now that this is in place, the last step is to configure the release workflow. To access the release workflow, log in as a project administrator and go to the Administration > Planning > Release Workflows screen:

You can have different workflows for each of your different types of release, or simply use the same workflow for all of them. We shall illustrate the recommended workflow configuration for a life sciences customer, you can then apply it to the appropriate release types.

By default, SpiraTeam is configured with a pretty unrestricted release workflow designed for agile software development projects (vs. validated life science projects), so that means:

  • A large selection of roles that can execute most of the transitions
  • The owner/detector can execute most of the transitions
  • Most fields are listed as:
    • Not required
    • Visible
    • Enabled
  • The releases are not formally locked once they are marked as 'Completed' or 'Closed' 

So, we recommend that you make the following changes to your release workflows:

1) Restrict the Roles/Permissions in the Transitions

Next you should click on each of the release workflow transitions and view the list of users that can execute such transitions:

Typically most of the test case workflow transitions will be set to allow:

  • The Creator to be able to execute
  • The Owner to be able to execute
  • The Project Owner and Manager roles to be able to execute.

You should now review your release validation process to see how the different roles in SpiraTeam and the steps in the process will be aligned to ensure that the correct personnel can mark a release as comleted. For a life sciences customer we would recommend:

Planned > In Progress Creator, Manager, Project Owner
In Progress > Completed Owner
Completed > Closed Manager, Project Owner

 

We have only listed our suggestions for the forward transitions, make sure you have also determined the correct permissions for the reverse ones. We have also omitted the Cancelled and Deferred paths, you would need to define the roles for the rejection process as well. We have also only utilized the built-in default roles. Depending on how you have configured the roles, you may want to change the roles used in each transition.

2) Add Electronic Signatures to Specific Transitions

Now that you have updated the permissions, you can now set the Electronic Signature options to the appropriate transitions:

 

 

We would recommend applying the electronic signature to the following forward transitions (typically the reverse ones do not need to be signed):

  • In Progress > Completed
  • Completed > Closed

3) Restrict Field Editing by Status

Finally you will want to update the fields in the system so that certain fields are required at specific stages and other fields become read-only once the release has been completed (and is therefore locked):

 

 

We would recommend the following field configurations for use in validated life sciences projects:

 

Planned Most fields should be visible and enabled. You should make the Name, and Owner required at least.
In Progress Most fields should be visible and enabled. You should make the Name, and Owner required at least. You might want to disable the changing of dates.
Completed All fields should be read-only (disabled = Yes) at this point
Closed All fields should be read-only (disabled = Yes) at this point

 

Congratulations, you have now completed the configuration of SpiraTeam.

validation healthcare medical devices cfr part 11 fda 21 CFR Part 11

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