Jama Connect Risk Management Center
May 22, 2019
Software has expanded Jama Connect Risk Management Center across
regulated industries and platforms – both cloud and self-hosted. Until
today, the capabilities were available exclusively for medical device
companies using Jama's cloud offering.
"From working with hundreds of customers in regulated industries, we
realized that risks are requirements," said Jama CEO, Scott Roth. "There
are nuances in how risk is handled from industry to industry, but risk
management is a core principle of product development, just like
requirements. And when you bring risks directly into requirements
management, they are much easier to control."
Aerospace, automotive, semiconductor, and other industries are facing a
growing risk management dilemma. Mistakes can endanger lives and
permanently mar a company's reputation. In addition, product safety
regulations are getting stricter, and recalls are rising. At the same
time, risk management can be cumbersome, frustrating, and inefficient.
Many companies use multiple spreadsheets, paper records, or software
that is ill-suited for risk management and requirements tracking, as
well as for following industry standards such as FMEA and ISO 14971.
In a recent white paper, Frost & Sullivan noted: "Legacy systems
struggle to keep up with changing regulations, which can lead to
compliance costs down the road. They can also introduce challenges with
version control and be prone to errors. Due to their complicated
functionality, legacy systems also inadvertently promote silos, forcing
teams to prioritize the accuracy and timeliness of specific tasks in a
way that can inhibit collaboration with other teams."
Jama Connect Risk Management Center addresses these challenges by
providing industry-standard customizable templates, enhancing
collaboration, and offering a single system of record for risks and
requirements. The platform also enhances risk analysis, giving teams
stronger tools to identify and mitigate issues and move rapidly through
the development process.
Specifically, the center helps
in risk assessment, including preliminary hazard analysis (PHA) and risk
•Incorporate FMEA and ISO
14971-aligned risk management templates
•Connect verifications to
•Export plans for approval
"Risk management should not be siloed away from product requirements,"
Roth added. "There must be a streamlined mechanism for all teams to work
together towards common goals. We believe the Risk Management Center
equips companies with the tools they need to identify mistakes before
they become serious regulatory and reputational problems, and to develop
successful, sustainable products rapidly."