Rally Software Review

You can view the hierarchy of issues. It is not compliant with FDA regulations on electronic signatures.


What is most valuable?

Visibility of the backlog hierarchy and issue status are valuable features.

I like the way you can view the hierarchy of issues, i.e., within the tool in a tree view, showing the traceability between epics, features, stories and tasks. This is something that is not available in the other tools that we currently use.

What needs improvement?

It is not compliant with the FDA regulations on electronic signatures (21 CFR part 11), which is required for regulated industries.

We produce medical devices, which means we have to comply with the FDA regulations if we wish to sell in the U.S. One of these relates to being able to have electronic signatures within the tool, when we close or reject future defects.

CA Agile Central does not have this functionality and when we asked them, they said they had no plans to implement this. As a result, we cannot use this tool for defect management. In fact, the tool has such few security features that you cannot stop anyone with an account from editing, deleting, or otherwise interfering with the records storied within it. As a result, we cannot use the information stored within it as part of our quality system.

For how long have I used the solution?

I have used this solution for six months.

What do I think about the stability of the solution?

I have not encountered any stability issues.

What do I think about the scalability of the solution?

I have not encountered any scalability issues.

How are customer service and technical support?

I have not used it personally.

Which solution did I use previously and why did I switch?

We are using Atlassian JIRA. We have not switched tools but currently we use both solutions in parallel, due to the FDA regulation issues.

What's my experience with pricing, setup cost, and licensing?

It is very expensive; currently it is the single biggest tool cost that we have.

What other advice do I have?

Make sure it meets your needs before rolling it out. Don’t buy it just because it is recommended as the “safe” tool.

Disclosure: I am a real user, and this review is based on my own experience and opinions.
1 Comment
author avatarDon Young
TOP 20Consultant

While Agile Central isn't 21 CFR 11 compliant, you can leverage access controls at the project level to manage who can edit work items (e.g., stories, defects, etc.). An approach one can use is once a work item (Defect in the original poster's comments) needs to be placed under "control" it gets administratively moved to a side or subproject where only the anointed few (CM managers) have edit privileges.

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