Brilliant and Flexible Requirements Management Tool, Rigid and Limited for Other Uses
February 12, 2020

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

Erik Bluemner | TrustRadius Reviewer
Score 7 out of 10
Vetted Review
Verified User

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.

Pros

  • Jama organizes requirements extremely well into logical hierarchies.
  • Jama uses a general requirements structure that is highly customizable.

Cons

  • 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.
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.

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