Overall Satisfaction with Jama Connect
Jama Connect is being used by our organization for product development. It addresses requirements management and traceability. We are working on implementing test management and defect tracking within JAMA. My company is very unique in the fact that the product we produce is regulated under a pharmaceutical NDA and is required to be designed according to FDA design controls 21 CFR part 820.30. And while it is similar to what most would think of as a medical device, it is not actually classified as a medical device, so the entirety of 21 CFR part 820 does not apply. JAMA currently only helps us solve the design inputs problem and a portion of the design verification problem for meeting 21 CFR 820.30.
- Jama organizes requirements extremely well into logical hierarchies.
- Jama uses a general requirements structure that is highly customizable.
- Jama's test management is weak for allowing medical device companies to manage verification efforts to meet the FDA's 21 CFR 820.30 design controls.
- Jama still doesn't understand and give enough tools to integrate part 11 compliance.
- We do better regression analysis as a result.
- We have more complete requirements, which results in fewer missed user-need targets.
We were sold Jama with the understanding that test management for a medical device company was doable but were disappointed by the lack of flexibility in the test management structure and the ability to meet regulatory needs through the verification/validation process. We also were sold Jama on the premise that it could be used for risk management. Imagine our surprise when Jama tried to upsell us for a risk management module. We were sold Jama on the idea that it would improve requirements management, and we have been more than satisfied in that regard. This has provided us significant value in the positive side effects of getting our requirements management under control.
The review center functionality for requirements is very good. It allows us to collaborate inside and outside of our organization. Traceability management is great, but it is a wee bit clunky to produce the actual traceability documentation we need to satisfy regulators. We are looking at methods of integrating with other software management tools, and believe the rest API will allow us to link those systems together effectively.
Jama does the requirements management piece better than anyone else, which is why we chose it. The cost was hard to swallow, given the limitations of the other areas of the product (test management, risk management). Products like Helix are better for testing, but are pretty clunky and fall down on requirements. Jama is object-oriented and database-driven, which is essential for effective management of requirements. Steer clear of "document-driven" solutions; despite the need for good documentation one is best off with an object-oriented tool that can also build quality documentation.
For requirements management, JAMA is very effective. They've nailed that. Once you start moving into other areas, it starts dropping off in functionality. JAMA seems to have taken a more rigid approach to these other areas (test management, design reviews, traceability, risk management). If only they could design these other areas to be as wonderfully flexible as the core requirements management functionality.