Helix ALM - a great tool for traceability!
Use Cases and Deployment Scope
My organization uses HelixALM to manage and track our hardware/software bugs, along with our requirements (user needs and design inputs), risk management documentation (FMEAs) and verification/validation testing. The software is mainly used by the R&D and Quality departments. HelixALM addresses the business problems of maintaining traceability for design controls and effectively managing the bug tracking process.
Pros
- Traceability for design controls.
- Managing workflow of bugs/issues.
- Maintaining risk management information.
Cons
- Better integration with electronic document control systems like Arena PLM.
- Easier setup in the back end (customization is available but the interface is not intuitive).
Likelihood to Recommend
Helix ALM is very well suited for maintaining traceability between user needs, requirements and tests for medical device design controls. It allows users to customize the reports to create a traceability matrix or any other reports that are needed. It is also a good program for tracking issues and bugs and for storing/linking verification and validation test protocols and reports.
