November 29th, 2017 by inflectra
At Inflectra we like to make the lives of customers easier and share knowledge. We have lots of customers 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 second article in the blog series, and covers the configuration of the requirements workflows.
In the previous article we described how to setup the roles and permissions in SpiraTeam for a validated project. Now that this is in place, the next step is to configure the requirements workflow. To access the requirements workflow, log in as a project administrator and go to the Administration > Requirements > Edit Workflows screen:
You can have different workflows for each of your different types of requirement, 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 requirement types.
By default, SpiraTeam is configured with a pretty unrestricted requirements workflow designed for agile software development projects (vs. validated life science projects), so that means in most of the transitions and states we have:
This also allows the items to be easily and quickly moved between priorities, statuses, people and releases/iterations on the Agile Planning Board that is included with SpiraTeam.
So, we recommend that you make the following changes to your workflow:
Firstly you should click on each of the requirement workflow transitions and view the list of users that can execute such transitions:
Typically most of the requirements transitions will be set to allow:
You should now review your test 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 approve the requirements. For a life sciences customer we would recommend:
|Requested > Under Review||Author & Manager Only|
|Requested > Accepted||Remove this Transition|
|Under Review > Accepted||Owner Only|
|Accepted > Planned||Manager Only|
|Planned > In Progress||Owner Only|
|In Progress > Developed||Owner Only|
|Developed > Tested||Owner Only|
|Tested > Completed||Manager Only|
|Completed > Obsolete||Manager Only|
We have only listed our suggestions for the forward transitions, make sure you have also determined the correct permissions for the reverse ones.
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):
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 they have been approved:
We would recommend the following field configurations for use in validated life science projects:
|Requested||Most fields should be visible and enabled. You should make the Name, Owner and Importance required at least|
|Under Review||Most fields should be visible and enabled. You should make the Name, Owner, Comments and Importance required at least|
|Accepted||All fields should be read-only (disabled = Yes) at this point.|
|Planned||All fields should be read-only (disabled = Yes) at this point.|
|In Progress||All fields should be read-only (disabled = Yes) at this point.|
|Developed||All fields should be read-only (disabled = Yes) at this point.|
|Tested||All fields should be read-only (disabled = Yes) at this point.|
|Completed||All fields should be read-only (disabled = Yes) at this point.|
|Obsolete||All fields should be read-only (disabled = Yes) at this point.|
You have now configured your requirements workflow for a validated life sciences project. In our next article in the series, we shall be configuring the test case workflows.
validation healthcare medical devices cfr part 11 fda 21 CFR Part 11
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