Brilliant and Flexible Requirements Management Tool, Rigid and Limited for Other Uses

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.

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.